RGDGRADE_TXT,VISIT,VACN,RGEVAL,RGEVALC,RGBASEFLAG,RGPARAM,RGPARAMC,RGTYPE,RGLOC,RGDGRADE,PUB_ID
None,2.0,1,0,Baseline,1,ery,Erythema,local,left arm,0,130-01
None,2.0,1,1,Early,0,ery,Erythema,local,left arm,0,130-01
None,2.0,1,2,Day 0,0,ery,Erythema,local,left arm,0,130-01
None,2.0,1,3,Day 1,0,ery,Erythema,local,left arm,0,130-01
None,2.0,1,4,Day 2,0,ery,Erythema,local,left arm,0,130-01
None,2.0,1,5,Day 3,0,ery,Erythema,local,left arm,0,130-01
None,2.0,1,0,Baseline,1,ind,Induration,local,left arm,0,130-01
None,2.0,1,1,Early,0,ind,Induration,local,left arm,0,130-01
None,2.0,1,2,Day 0,0,ind,Induration,local,left arm,0,130-01
None,2.0,1,3,Day 1,0,ind,Induration,local,left arm,0,130-01
None,2.0,1,4,Day 2,0,ind,Induration,local,left arm,0,130-01
None,2.0,1,5,Day 3,0,ind,Induration,local,left arm,0,130-01
None,2.0,1,0,Baseline,1,pain,Pain or Tenderness,local,left arm,0,130-01
None,2.0,1,1,Early,0,pain,Pain or Tenderness,local,left arm,0,130-01
None,2.0,1,2,Day 0,0,pain,Pain or Tenderness,local,left arm,0,130-01
None,2.0,1,3,Day 1,0,pain,Pain or Tenderness,local,left arm,0,130-01
None,2.0,1,4,Day 2,0,pain,Pain or Tenderness,local,left arm,0,130-01
None,2.0,1,5,Day 3,0,pain,Pain or Tenderness,local,left arm,0,130-01
None,2.0,1,0,Baseline,1,arth,Arthralgia,systemic,,0,130-01
None,2.0,1,1,Early,0,arth,Arthralgia,systemic,,0,130-01
None,2.0,1,2,Day 0,0,arth,Arthralgia,systemic,,0,130-01
None,2.0,1,3,Day 1,0,arth,Arthralgia,systemic,,0,130-01
None,2.0,1,4,Day 2,0,arth,Arthralgia,systemic,,0,130-01
None,2.0,1,5,Day 3,0,arth,Arthralgia,systemic,,0,130-01
None,2.0,1,0,Baseline,1,chill,Chills,systemic,,0,130-01
None,2.0,1,1,Early,0,chill,Chills,systemic,,0,130-01
None,2.0,1,2,Day 0,0,chill,Chills,systemic,,0,130-01
None,2.0,1,3,Day 1,0,chill,Chills,systemic,,0,130-01
None,2.0,1,4,Day 2,0,chill,Chills,systemic,,0,130-01
None,2.0,1,5,Day 3,0,chill,Chills,systemic,,0,130-01
None,2.0,1,0,Baseline,1,flush,Facial Flushing,systemic,,0,130-01
None,2.0,1,1,Early,0,flush,Facial Flushing,systemic,,0,130-01
None,2.0,1,2,Day 0,0,flush,Facial Flushing,systemic,,0,130-01
None,2.0,1,3,Day 1,0,flush,Facial Flushing,systemic,,0,130-01
None,2.0,1,4,Day 2,0,flush,Facial Flushing,systemic,,0,130-01
None,2.0,1,5,Day 3,0,flush,Facial Flushing,systemic,,0,130-01
None,2.0,1,0,Baseline,1,gprur,Generalized Pruritis,systemic,,0,130-01
None,2.0,1,1,Early,0,gprur,Generalized Pruritis,systemic,,0,130-01
None,2.0,1,2,Day 0,0,gprur,Generalized Pruritis,systemic,,0,130-01
None,2.0,1,3,Day 1,0,gprur,Generalized Pruritis,systemic,,0,130-01
None,2.0,1,4,Day 2,0,gprur,Generalized Pruritis,systemic,,0,130-01
None,2.0,1,5,Day 3,0,gprur,Generalized Pruritis,systemic,,0,130-01
None,2.0,1,0,Baseline,1,head,Headache,systemic,,0,130-01
None,2.0,1,1,Early,0,head,Headache,systemic,,0,130-01
None,2.0,1,2,Day 0,0,head,Headache,systemic,,0,130-01
None,2.0,1,3,Day 1,0,head,Headache,systemic,,0,130-01
None,2.0,1,4,Day 2,0,head,Headache,systemic,,0,130-01
None,2.0,1,5,Day 3,0,head,Headache,systemic,,0,130-01
None,2.0,1,0,Baseline,1,mf,Malaise/fatigue,systemic,,0,130-01
Mild,2.0,1,1,Early,0,mf,Malaise/fatigue,systemic,,1,130-01
Mild,2.0,1,2,Day 0,0,mf,Malaise/fatigue,systemic,,1,130-01
Mild,2.0,1,3,Day 1,0,mf,Malaise/fatigue,systemic,,1,130-01
None,2.0,1,4,Day 2,0,mf,Malaise/fatigue,systemic,,0,130-01
None,2.0,1,5,Day 3,0,mf,Malaise/fatigue,systemic,,0,130-01
None,2.0,1,0,Baseline,1,myal,Myalgia,systemic,,0,130-01
None,2.0,1,1,Early,0,myal,Myalgia,systemic,,0,130-01
None,2.0,1,2,Day 0,0,myal,Myalgia,systemic,,0,130-01
None,2.0,1,3,Day 1,0,myal,Myalgia,systemic,,0,130-01
None,2.0,1,4,Day 2,0,myal,Myalgia,systemic,,0,130-01
None,2.0,1,5,Day 3,0,myal,Myalgia,systemic,,0,130-01
None,2.0,1,0,Baseline,1,naus,Nausea,systemic,,0,130-01
None,2.0,1,1,Early,0,naus,Nausea,systemic,,0,130-01
None,2.0,1,2,Day 0,0,naus,Nausea,systemic,,0,130-01
None,2.0,1,3,Day 1,0,naus,Nausea,systemic,,0,130-01
None,2.0,1,4,Day 2,0,naus,Nausea,systemic,,0,130-01
None,2.0,1,5,Day 3,0,naus,Nausea,systemic,,0,130-01
None,2.0,1,0,Baseline,1,ndysp,Non-exertional Dyspnea,systemic,,0,130-01
None,2.0,1,1,Early,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-01
None,2.0,1,2,Day 0,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-01
None,2.0,1,3,Day 1,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-01
None,2.0,1,4,Day 2,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-01
None,2.0,1,5,Day 3,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-01
None,2.0,1,0,Baseline,1,ntach,Non-exertional Tachycardia,systemic,,0,130-01
None,2.0,1,1,Early,0,ntach,Non-exertional Tachycardia,systemic,,0,130-01
None,2.0,1,2,Day 0,0,ntach,Non-exertional Tachycardia,systemic,,0,130-01
None,2.0,1,3,Day 1,0,ntach,Non-exertional Tachycardia,systemic,,0,130-01
None,2.0,1,4,Day 2,0,ntach,Non-exertional Tachycardia,systemic,,0,130-01
None,2.0,1,5,Day 3,0,ntach,Non-exertional Tachycardia,systemic,,0,130-01
< 37.9C (None),2.0,1,0,Baseline,1,tempc,Temperature (C),systemic,,0,130-01
< 37.9C (None),2.0,1,1,Early,0,tempc,Temperature (C),systemic,,0,130-01
< 37.9C (None),2.0,1,2,Day 0,0,tempc,Temperature (C),systemic,,0,130-01
< 37.9C (None),2.0,1,3,Day 1,0,tempc,Temperature (C),systemic,,0,130-01
< 37.9C (None),2.0,1,4,Day 2,0,tempc,Temperature (C),systemic,,0,130-01
< 37.9C (None),2.0,1,5,Day 3,0,tempc,Temperature (C),systemic,,0,130-01
None,2.0,1,0,Baseline,1,udiap,Unexplained Diaphoresis,systemic,,0,130-01
None,2.0,1,1,Early,0,udiap,Unexplained Diaphoresis,systemic,,0,130-01
None,2.0,1,2,Day 0,0,udiap,Unexplained Diaphoresis,systemic,,0,130-01
None,2.0,1,3,Day 1,0,udiap,Unexplained Diaphoresis,systemic,,0,130-01
None,2.0,1,4,Day 2,0,udiap,Unexplained Diaphoresis,systemic,,0,130-01
None,2.0,1,5,Day 3,0,udiap,Unexplained Diaphoresis,systemic,,0,130-01
None,2.0,1,0,Baseline,1,urtic,Urticaria,systemic,,0,130-01
None,2.0,1,1,Early,0,urtic,Urticaria,systemic,,0,130-01
None,2.0,1,2,Day 0,0,urtic,Urticaria,systemic,,0,130-01
None,2.0,1,3,Day 1,0,urtic,Urticaria,systemic,,0,130-01
None,2.0,1,4,Day 2,0,urtic,Urticaria,systemic,,0,130-01
None,2.0,1,5,Day 3,0,urtic,Urticaria,systemic,,0,130-01
None,2.0,1,0,Baseline,1,ery,Erythema,local,left arm,0,130-02
None,2.0,1,1,Early,0,ery,Erythema,local,left arm,0,130-02
None,2.0,1,2,Day 0,0,ery,Erythema,local,left arm,0,130-02
None,2.0,1,3,Day 1,0,ery,Erythema,local,left arm,0,130-02
None,2.0,1,4,Day 2,0,ery,Erythema,local,left arm,0,130-02
None,2.0,1,5,Day 3,0,ery,Erythema,local,left arm,0,130-02
None,2.0,1,0,Baseline,1,ind,Induration,local,left arm,0,130-02
None,2.0,1,1,Early,0,ind,Induration,local,left arm,0,130-02
None,2.0,1,2,Day 0,0,ind,Induration,local,left arm,0,130-02
None,2.0,1,3,Day 1,0,ind,Induration,local,left arm,0,130-02
None,2.0,1,4,Day 2,0,ind,Induration,local,left arm,0,130-02
None,2.0,1,5,Day 3,0,ind,Induration,local,left arm,0,130-02
None,2.0,1,0,Baseline,1,pain,Pain or Tenderness,local,left arm,0,130-02
None,2.0,1,1,Early,0,pain,Pain or Tenderness,local,left arm,0,130-02
None,2.0,1,2,Day 0,0,pain,Pain or Tenderness,local,left arm,0,130-02
None,2.0,1,3,Day 1,0,pain,Pain or Tenderness,local,left arm,0,130-02
None,2.0,1,4,Day 2,0,pain,Pain or Tenderness,local,left arm,0,130-02
None,2.0,1,5,Day 3,0,pain,Pain or Tenderness,local,left arm,0,130-02
None,2.0,1,0,Baseline,1,arth,Arthralgia,systemic,,0,130-02
None,2.0,1,1,Early,0,arth,Arthralgia,systemic,,0,130-02
None,2.0,1,2,Day 0,0,arth,Arthralgia,systemic,,0,130-02
None,2.0,1,3,Day 1,0,arth,Arthralgia,systemic,,0,130-02
None,2.0,1,4,Day 2,0,arth,Arthralgia,systemic,,0,130-02
None,2.0,1,5,Day 3,0,arth,Arthralgia,systemic,,0,130-02
None,2.0,1,0,Baseline,1,chill,Chills,systemic,,0,130-02
None,2.0,1,1,Early,0,chill,Chills,systemic,,0,130-02
None,2.0,1,2,Day 0,0,chill,Chills,systemic,,0,130-02
None,2.0,1,3,Day 1,0,chill,Chills,systemic,,0,130-02
None,2.0,1,4,Day 2,0,chill,Chills,systemic,,0,130-02
None,2.0,1,5,Day 3,0,chill,Chills,systemic,,0,130-02
None,2.0,1,0,Baseline,1,flush,Facial Flushing,systemic,,0,130-02
None,2.0,1,1,Early,0,flush,Facial Flushing,systemic,,0,130-02
None,2.0,1,2,Day 0,0,flush,Facial Flushing,systemic,,0,130-02
None,2.0,1,3,Day 1,0,flush,Facial Flushing,systemic,,0,130-02
None,2.0,1,4,Day 2,0,flush,Facial Flushing,systemic,,0,130-02
None,2.0,1,5,Day 3,0,flush,Facial Flushing,systemic,,0,130-02
None,2.0,1,0,Baseline,1,gprur,Generalized Pruritis,systemic,,0,130-02
None,2.0,1,1,Early,0,gprur,Generalized Pruritis,systemic,,0,130-02
None,2.0,1,2,Day 0,0,gprur,Generalized Pruritis,systemic,,0,130-02
None,2.0,1,3,Day 1,0,gprur,Generalized Pruritis,systemic,,0,130-02
None,2.0,1,4,Day 2,0,gprur,Generalized Pruritis,systemic,,0,130-02
None,2.0,1,5,Day 3,0,gprur,Generalized Pruritis,systemic,,0,130-02
None,2.0,1,0,Baseline,1,head,Headache,systemic,,0,130-02
None,2.0,1,1,Early,0,head,Headache,systemic,,0,130-02
None,2.0,1,2,Day 0,0,head,Headache,systemic,,0,130-02
None,2.0,1,3,Day 1,0,head,Headache,systemic,,0,130-02
None,2.0,1,4,Day 2,0,head,Headache,systemic,,0,130-02
None,2.0,1,5,Day 3,0,head,Headache,systemic,,0,130-02
None,2.0,1,0,Baseline,1,mf,Malaise/fatigue,systemic,,0,130-02
None,2.0,1,1,Early,0,mf,Malaise/fatigue,systemic,,0,130-02
None,2.0,1,2,Day 0,0,mf,Malaise/fatigue,systemic,,0,130-02
None,2.0,1,3,Day 1,0,mf,Malaise/fatigue,systemic,,0,130-02
None,2.0,1,4,Day 2,0,mf,Malaise/fatigue,systemic,,0,130-02
None,2.0,1,5,Day 3,0,mf,Malaise/fatigue,systemic,,0,130-02
None,2.0,1,0,Baseline,1,myal,Myalgia,systemic,,0,130-02
None,2.0,1,1,Early,0,myal,Myalgia,systemic,,0,130-02
None,2.0,1,2,Day 0,0,myal,Myalgia,systemic,,0,130-02
None,2.0,1,3,Day 1,0,myal,Myalgia,systemic,,0,130-02
None,2.0,1,4,Day 2,0,myal,Myalgia,systemic,,0,130-02
None,2.0,1,5,Day 3,0,myal,Myalgia,systemic,,0,130-02
None,2.0,1,0,Baseline,1,naus,Nausea,systemic,,0,130-02
None,2.0,1,1,Early,0,naus,Nausea,systemic,,0,130-02
None,2.0,1,2,Day 0,0,naus,Nausea,systemic,,0,130-02
None,2.0,1,3,Day 1,0,naus,Nausea,systemic,,0,130-02
None,2.0,1,4,Day 2,0,naus,Nausea,systemic,,0,130-02
None,2.0,1,5,Day 3,0,naus,Nausea,systemic,,0,130-02
None,2.0,1,0,Baseline,1,ndysp,Non-exertional Dyspnea,systemic,,0,130-02
None,2.0,1,1,Early,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-02
None,2.0,1,2,Day 0,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-02
None,2.0,1,3,Day 1,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-02
None,2.0,1,4,Day 2,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-02
None,2.0,1,5,Day 3,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-02
None,2.0,1,0,Baseline,1,ntach,Non-exertional Tachycardia,systemic,,0,130-02
None,2.0,1,1,Early,0,ntach,Non-exertional Tachycardia,systemic,,0,130-02
None,2.0,1,2,Day 0,0,ntach,Non-exertional Tachycardia,systemic,,0,130-02
None,2.0,1,3,Day 1,0,ntach,Non-exertional Tachycardia,systemic,,0,130-02
None,2.0,1,4,Day 2,0,ntach,Non-exertional Tachycardia,systemic,,0,130-02
None,2.0,1,5,Day 3,0,ntach,Non-exertional Tachycardia,systemic,,0,130-02
< 37.9C (None),2.0,1,0,Baseline,1,tempc,Temperature (C),systemic,,0,130-02
< 37.9C (None),2.0,1,1,Early,0,tempc,Temperature (C),systemic,,0,130-02
< 37.9C (None),2.0,1,2,Day 0,0,tempc,Temperature (C),systemic,,0,130-02
< 37.9C (None),2.0,1,3,Day 1,0,tempc,Temperature (C),systemic,,0,130-02
< 37.9C (None),2.0,1,4,Day 2,0,tempc,Temperature (C),systemic,,0,130-02
< 37.9C (None),2.0,1,5,Day 3,0,tempc,Temperature (C),systemic,,0,130-02
None,2.0,1,0,Baseline,1,udiap,Unexplained Diaphoresis,systemic,,0,130-02
None,2.0,1,1,Early,0,udiap,Unexplained Diaphoresis,systemic,,0,130-02
None,2.0,1,2,Day 0,0,udiap,Unexplained Diaphoresis,systemic,,0,130-02
None,2.0,1,3,Day 1,0,udiap,Unexplained Diaphoresis,systemic,,0,130-02
None,2.0,1,4,Day 2,0,udiap,Unexplained Diaphoresis,systemic,,0,130-02
None,2.0,1,5,Day 3,0,udiap,Unexplained Diaphoresis,systemic,,0,130-02
None,2.0,1,0,Baseline,1,urtic,Urticaria,systemic,,0,130-02
None,2.0,1,1,Early,0,urtic,Urticaria,systemic,,0,130-02
None,2.0,1,2,Day 0,0,urtic,Urticaria,systemic,,0,130-02
None,2.0,1,3,Day 1,0,urtic,Urticaria,systemic,,0,130-02
None,2.0,1,4,Day 2,0,urtic,Urticaria,systemic,,0,130-02
None,2.0,1,5,Day 3,0,urtic,Urticaria,systemic,,0,130-02
None,2.0,1,0,Baseline,1,ery,Erythema,local,left arm,0,130-03
None,2.0,1,1,Early,0,ery,Erythema,local,left arm,0,130-03
None,2.0,1,2,Day 0,0,ery,Erythema,local,left arm,0,130-03
None,2.0,1,3,Day 1,0,ery,Erythema,local,left arm,0,130-03
None,2.0,1,4,Day 2,0,ery,Erythema,local,left arm,0,130-03
None,2.0,1,5,Day 3,0,ery,Erythema,local,left arm,0,130-03
None,2.0,1,0,Baseline,1,ind,Induration,local,left arm,0,130-03
None,2.0,1,1,Early,0,ind,Induration,local,left arm,0,130-03
None,2.0,1,2,Day 0,0,ind,Induration,local,left arm,0,130-03
None,2.0,1,3,Day 1,0,ind,Induration,local,left arm,0,130-03
None,2.0,1,4,Day 2,0,ind,Induration,local,left arm,0,130-03
None,2.0,1,5,Day 3,0,ind,Induration,local,left arm,0,130-03
None,2.0,1,0,Baseline,1,pain,Pain or Tenderness,local,left arm,0,130-03
None,2.0,1,1,Early,0,pain,Pain or Tenderness,local,left arm,0,130-03
None,2.0,1,2,Day 0,0,pain,Pain or Tenderness,local,left arm,0,130-03
None,2.0,1,3,Day 1,0,pain,Pain or Tenderness,local,left arm,0,130-03
None,2.0,1,4,Day 2,0,pain,Pain or Tenderness,local,left arm,0,130-03
None,2.0,1,5,Day 3,0,pain,Pain or Tenderness,local,left arm,0,130-03
None,2.0,1,0,Baseline,1,arth,Arthralgia,systemic,,0,130-03
None,2.0,1,1,Early,0,arth,Arthralgia,systemic,,0,130-03
None,2.0,1,2,Day 0,0,arth,Arthralgia,systemic,,0,130-03
None,2.0,1,3,Day 1,0,arth,Arthralgia,systemic,,0,130-03
None,2.0,1,4,Day 2,0,arth,Arthralgia,systemic,,0,130-03
None,2.0,1,5,Day 3,0,arth,Arthralgia,systemic,,0,130-03
None,2.0,1,0,Baseline,1,chill,Chills,systemic,,0,130-03
None,2.0,1,1,Early,0,chill,Chills,systemic,,0,130-03
None,2.0,1,2,Day 0,0,chill,Chills,systemic,,0,130-03
None,2.0,1,3,Day 1,0,chill,Chills,systemic,,0,130-03
None,2.0,1,4,Day 2,0,chill,Chills,systemic,,0,130-03
None,2.0,1,5,Day 3,0,chill,Chills,systemic,,0,130-03
None,2.0,1,0,Baseline,1,flush,Facial Flushing,systemic,,0,130-03
None,2.0,1,1,Early,0,flush,Facial Flushing,systemic,,0,130-03
None,2.0,1,2,Day 0,0,flush,Facial Flushing,systemic,,0,130-03
None,2.0,1,3,Day 1,0,flush,Facial Flushing,systemic,,0,130-03
None,2.0,1,4,Day 2,0,flush,Facial Flushing,systemic,,0,130-03
None,2.0,1,5,Day 3,0,flush,Facial Flushing,systemic,,0,130-03
None,2.0,1,0,Baseline,1,gprur,Generalized Pruritis,systemic,,0,130-03
None,2.0,1,1,Early,0,gprur,Generalized Pruritis,systemic,,0,130-03
None,2.0,1,2,Day 0,0,gprur,Generalized Pruritis,systemic,,0,130-03
None,2.0,1,3,Day 1,0,gprur,Generalized Pruritis,systemic,,0,130-03
None,2.0,1,4,Day 2,0,gprur,Generalized Pruritis,systemic,,0,130-03
None,2.0,1,5,Day 3,0,gprur,Generalized Pruritis,systemic,,0,130-03
None,2.0,1,0,Baseline,1,head,Headache,systemic,,0,130-03
None,2.0,1,1,Early,0,head,Headache,systemic,,0,130-03
None,2.0,1,2,Day 0,0,head,Headache,systemic,,0,130-03
None,2.0,1,3,Day 1,0,head,Headache,systemic,,0,130-03
None,2.0,1,4,Day 2,0,head,Headache,systemic,,0,130-03
None,2.0,1,5,Day 3,0,head,Headache,systemic,,0,130-03
None,2.0,1,0,Baseline,1,mf,Malaise/fatigue,systemic,,0,130-03
None,2.0,1,1,Early,0,mf,Malaise/fatigue,systemic,,0,130-03
Mild,2.0,1,2,Day 0,0,mf,Malaise/fatigue,systemic,,1,130-03
None,2.0,1,3,Day 1,0,mf,Malaise/fatigue,systemic,,0,130-03
None,2.0,1,4,Day 2,0,mf,Malaise/fatigue,systemic,,0,130-03
None,2.0,1,5,Day 3,0,mf,Malaise/fatigue,systemic,,0,130-03
None,2.0,1,0,Baseline,1,myal,Myalgia,systemic,,0,130-03
None,2.0,1,1,Early,0,myal,Myalgia,systemic,,0,130-03
None,2.0,1,2,Day 0,0,myal,Myalgia,systemic,,0,130-03
None,2.0,1,3,Day 1,0,myal,Myalgia,systemic,,0,130-03
None,2.0,1,4,Day 2,0,myal,Myalgia,systemic,,0,130-03
None,2.0,1,5,Day 3,0,myal,Myalgia,systemic,,0,130-03
None,2.0,1,0,Baseline,1,naus,Nausea,systemic,,0,130-03
None,2.0,1,1,Early,0,naus,Nausea,systemic,,0,130-03
None,2.0,1,2,Day 0,0,naus,Nausea,systemic,,0,130-03
None,2.0,1,3,Day 1,0,naus,Nausea,systemic,,0,130-03
None,2.0,1,4,Day 2,0,naus,Nausea,systemic,,0,130-03
None,2.0,1,5,Day 3,0,naus,Nausea,systemic,,0,130-03
None,2.0,1,0,Baseline,1,ndysp,Non-exertional Dyspnea,systemic,,0,130-03
None,2.0,1,1,Early,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-03
None,2.0,1,2,Day 0,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-03
None,2.0,1,3,Day 1,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-03
None,2.0,1,4,Day 2,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-03
None,2.0,1,5,Day 3,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-03
None,2.0,1,0,Baseline,1,ntach,Non-exertional Tachycardia,systemic,,0,130-03
None,2.0,1,1,Early,0,ntach,Non-exertional Tachycardia,systemic,,0,130-03
None,2.0,1,2,Day 0,0,ntach,Non-exertional Tachycardia,systemic,,0,130-03
None,2.0,1,3,Day 1,0,ntach,Non-exertional Tachycardia,systemic,,0,130-03
None,2.0,1,4,Day 2,0,ntach,Non-exertional Tachycardia,systemic,,0,130-03
None,2.0,1,5,Day 3,0,ntach,Non-exertional Tachycardia,systemic,,0,130-03
< 37.9C (None),2.0,1,0,Baseline,1,tempc,Temperature (C),systemic,,0,130-03
< 37.9C (None),2.0,1,1,Early,0,tempc,Temperature (C),systemic,,0,130-03
< 37.9C (None),2.0,1,2,Day 0,0,tempc,Temperature (C),systemic,,0,130-03
< 37.9C (None),2.0,1,3,Day 1,0,tempc,Temperature (C),systemic,,0,130-03
< 37.9C (None),2.0,1,4,Day 2,0,tempc,Temperature (C),systemic,,0,130-03
< 37.9C (None),2.0,1,5,Day 3,0,tempc,Temperature (C),systemic,,0,130-03
None,2.0,1,0,Baseline,1,udiap,Unexplained Diaphoresis,systemic,,0,130-03
None,2.0,1,1,Early,0,udiap,Unexplained Diaphoresis,systemic,,0,130-03
None,2.0,1,2,Day 0,0,udiap,Unexplained Diaphoresis,systemic,,0,130-03
None,2.0,1,3,Day 1,0,udiap,Unexplained Diaphoresis,systemic,,0,130-03
None,2.0,1,4,Day 2,0,udiap,Unexplained Diaphoresis,systemic,,0,130-03
None,2.0,1,5,Day 3,0,udiap,Unexplained Diaphoresis,systemic,,0,130-03
None,2.0,1,0,Baseline,1,urtic,Urticaria,systemic,,0,130-03
None,2.0,1,1,Early,0,urtic,Urticaria,systemic,,0,130-03
None,2.0,1,2,Day 0,0,urtic,Urticaria,systemic,,0,130-03
None,2.0,1,3,Day 1,0,urtic,Urticaria,systemic,,0,130-03
None,2.0,1,4,Day 2,0,urtic,Urticaria,systemic,,0,130-03
None,2.0,1,5,Day 3,0,urtic,Urticaria,systemic,,0,130-03
None,9.0,2,0,Baseline,1,ery,Erythema,local,left arm,0,130-03
None,9.0,2,1,Early,0,ery,Erythema,local,left arm,0,130-03
None,9.0,2,2,Day 0,0,ery,Erythema,local,left arm,0,130-03
None,9.0,2,3,Day 1,0,ery,Erythema,local,left arm,0,130-03
None,9.0,2,4,Day 2,0,ery,Erythema,local,left arm,0,130-03
None,9.0,2,5,Day 3,0,ery,Erythema,local,left arm,0,130-03
None,9.0,2,0,Baseline,1,ind,Induration,local,left arm,0,130-03
None,9.0,2,1,Early,0,ind,Induration,local,left arm,0,130-03
None,9.0,2,2,Day 0,0,ind,Induration,local,left arm,0,130-03
None,9.0,2,3,Day 1,0,ind,Induration,local,left arm,0,130-03
None,9.0,2,4,Day 2,0,ind,Induration,local,left arm,0,130-03
None,9.0,2,5,Day 3,0,ind,Induration,local,left arm,0,130-03
None,9.0,2,0,Baseline,1,pain,Pain or Tenderness,local,left arm,0,130-03
None,9.0,2,1,Early,0,pain,Pain or Tenderness,local,left arm,0,130-03
None,9.0,2,2,Day 0,0,pain,Pain or Tenderness,local,left arm,0,130-03
None,9.0,2,3,Day 1,0,pain,Pain or Tenderness,local,left arm,0,130-03
None,9.0,2,4,Day 2,0,pain,Pain or Tenderness,local,left arm,0,130-03
None,9.0,2,5,Day 3,0,pain,Pain or Tenderness,local,left arm,0,130-03
None,9.0,2,0,Baseline,1,arth,Arthralgia,systemic,,0,130-03
None,9.0,2,1,Early,0,arth,Arthralgia,systemic,,0,130-03
None,9.0,2,2,Day 0,0,arth,Arthralgia,systemic,,0,130-03
None,9.0,2,3,Day 1,0,arth,Arthralgia,systemic,,0,130-03
None,9.0,2,4,Day 2,0,arth,Arthralgia,systemic,,0,130-03
None,9.0,2,5,Day 3,0,arth,Arthralgia,systemic,,0,130-03
None,9.0,2,0,Baseline,1,chill,Chills,systemic,,0,130-03
None,9.0,2,1,Early,0,chill,Chills,systemic,,0,130-03
None,9.0,2,2,Day 0,0,chill,Chills,systemic,,0,130-03
None,9.0,2,3,Day 1,0,chill,Chills,systemic,,0,130-03
None,9.0,2,4,Day 2,0,chill,Chills,systemic,,0,130-03
None,9.0,2,5,Day 3,0,chill,Chills,systemic,,0,130-03
None,9.0,2,0,Baseline,1,flush,Facial Flushing,systemic,,0,130-03
None,9.0,2,1,Early,0,flush,Facial Flushing,systemic,,0,130-03
None,9.0,2,2,Day 0,0,flush,Facial Flushing,systemic,,0,130-03
None,9.0,2,3,Day 1,0,flush,Facial Flushing,systemic,,0,130-03
None,9.0,2,4,Day 2,0,flush,Facial Flushing,systemic,,0,130-03
None,9.0,2,5,Day 3,0,flush,Facial Flushing,systemic,,0,130-03
None,9.0,2,0,Baseline,1,gprur,Generalized Pruritis,systemic,,0,130-03
None,9.0,2,1,Early,0,gprur,Generalized Pruritis,systemic,,0,130-03
None,9.0,2,2,Day 0,0,gprur,Generalized Pruritis,systemic,,0,130-03
None,9.0,2,3,Day 1,0,gprur,Generalized Pruritis,systemic,,0,130-03
None,9.0,2,4,Day 2,0,gprur,Generalized Pruritis,systemic,,0,130-03
None,9.0,2,5,Day 3,0,gprur,Generalized Pruritis,systemic,,0,130-03
None,9.0,2,0,Baseline,1,head,Headache,systemic,,0,130-03
None,9.0,2,1,Early,0,head,Headache,systemic,,0,130-03
None,9.0,2,2,Day 0,0,head,Headache,systemic,,0,130-03
None,9.0,2,3,Day 1,0,head,Headache,systemic,,0,130-03
None,9.0,2,4,Day 2,0,head,Headache,systemic,,0,130-03
None,9.0,2,5,Day 3,0,head,Headache,systemic,,0,130-03
None,9.0,2,0,Baseline,1,mf,Malaise/fatigue,systemic,,0,130-03
None,9.0,2,1,Early,0,mf,Malaise/fatigue,systemic,,0,130-03
None,9.0,2,2,Day 0,0,mf,Malaise/fatigue,systemic,,0,130-03
None,9.0,2,3,Day 1,0,mf,Malaise/fatigue,systemic,,0,130-03
None,9.0,2,4,Day 2,0,mf,Malaise/fatigue,systemic,,0,130-03
None,9.0,2,5,Day 3,0,mf,Malaise/fatigue,systemic,,0,130-03
None,9.0,2,0,Baseline,1,myal,Myalgia,systemic,,0,130-03
None,9.0,2,1,Early,0,myal,Myalgia,systemic,,0,130-03
None,9.0,2,2,Day 0,0,myal,Myalgia,systemic,,0,130-03
None,9.0,2,3,Day 1,0,myal,Myalgia,systemic,,0,130-03
None,9.0,2,4,Day 2,0,myal,Myalgia,systemic,,0,130-03
None,9.0,2,5,Day 3,0,myal,Myalgia,systemic,,0,130-03
None,9.0,2,0,Baseline,1,naus,Nausea,systemic,,0,130-03
None,9.0,2,1,Early,0,naus,Nausea,systemic,,0,130-03
None,9.0,2,2,Day 0,0,naus,Nausea,systemic,,0,130-03
None,9.0,2,3,Day 1,0,naus,Nausea,systemic,,0,130-03
None,9.0,2,4,Day 2,0,naus,Nausea,systemic,,0,130-03
None,9.0,2,5,Day 3,0,naus,Nausea,systemic,,0,130-03
None,9.0,2,0,Baseline,1,ndysp,Non-exertional Dyspnea,systemic,,0,130-03
None,9.0,2,1,Early,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-03
None,9.0,2,2,Day 0,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-03
None,9.0,2,3,Day 1,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-03
None,9.0,2,4,Day 2,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-03
None,9.0,2,5,Day 3,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-03
None,9.0,2,0,Baseline,1,ntach,Non-exertional Tachycardia,systemic,,0,130-03
None,9.0,2,1,Early,0,ntach,Non-exertional Tachycardia,systemic,,0,130-03
None,9.0,2,2,Day 0,0,ntach,Non-exertional Tachycardia,systemic,,0,130-03
None,9.0,2,3,Day 1,0,ntach,Non-exertional Tachycardia,systemic,,0,130-03
None,9.0,2,4,Day 2,0,ntach,Non-exertional Tachycardia,systemic,,0,130-03
None,9.0,2,5,Day 3,0,ntach,Non-exertional Tachycardia,systemic,,0,130-03
< 37.9C (None),9.0,2,0,Baseline,1,tempc,Temperature (C),systemic,,0,130-03
< 37.9C (None),9.0,2,1,Early,0,tempc,Temperature (C),systemic,,0,130-03
< 37.9C (None),9.0,2,2,Day 0,0,tempc,Temperature (C),systemic,,0,130-03
< 37.9C (None),9.0,2,3,Day 1,0,tempc,Temperature (C),systemic,,0,130-03
< 37.9C (None),9.0,2,4,Day 2,0,tempc,Temperature (C),systemic,,0,130-03
< 37.9C (None),9.0,2,5,Day 3,0,tempc,Temperature (C),systemic,,0,130-03
None,9.0,2,0,Baseline,1,udiap,Unexplained Diaphoresis,systemic,,0,130-03
None,9.0,2,1,Early,0,udiap,Unexplained Diaphoresis,systemic,,0,130-03
None,9.0,2,2,Day 0,0,udiap,Unexplained Diaphoresis,systemic,,0,130-03
None,9.0,2,3,Day 1,0,udiap,Unexplained Diaphoresis,systemic,,0,130-03
None,9.0,2,4,Day 2,0,udiap,Unexplained Diaphoresis,systemic,,0,130-03
None,9.0,2,5,Day 3,0,udiap,Unexplained Diaphoresis,systemic,,0,130-03
None,9.0,2,0,Baseline,1,urtic,Urticaria,systemic,,0,130-03
None,9.0,2,1,Early,0,urtic,Urticaria,systemic,,0,130-03
None,9.0,2,2,Day 0,0,urtic,Urticaria,systemic,,0,130-03
None,9.0,2,3,Day 1,0,urtic,Urticaria,systemic,,0,130-03
None,9.0,2,4,Day 2,0,urtic,Urticaria,systemic,,0,130-03
None,9.0,2,5,Day 3,0,urtic,Urticaria,systemic,,0,130-03
None,2.0,1,0,Baseline,1,ery,Erythema,local,left arm,0,130-04
None,2.0,1,1,Early,0,ery,Erythema,local,left arm,0,130-04
None,2.0,1,2,Day 0,0,ery,Erythema,local,left arm,0,130-04
None,2.0,1,3,Day 1,0,ery,Erythema,local,left arm,0,130-04
None,2.0,1,4,Day 2,0,ery,Erythema,local,left arm,0,130-04
None,2.0,1,5,Day 3,0,ery,Erythema,local,left arm,0,130-04
None,2.0,1,0,Baseline,1,ind,Induration,local,left arm,0,130-04
None,2.0,1,1,Early,0,ind,Induration,local,left arm,0,130-04
None,2.0,1,2,Day 0,0,ind,Induration,local,left arm,0,130-04
None,2.0,1,3,Day 1,0,ind,Induration,local,left arm,0,130-04
None,2.0,1,4,Day 2,0,ind,Induration,local,left arm,0,130-04
None,2.0,1,5,Day 3,0,ind,Induration,local,left arm,0,130-04
None,2.0,1,0,Baseline,1,pain,Pain or Tenderness,local,left arm,0,130-04
None,2.0,1,1,Early,0,pain,Pain or Tenderness,local,left arm,0,130-04
None,2.0,1,2,Day 0,0,pain,Pain or Tenderness,local,left arm,0,130-04
None,2.0,1,3,Day 1,0,pain,Pain or Tenderness,local,left arm,0,130-04
None,2.0,1,4,Day 2,0,pain,Pain or Tenderness,local,left arm,0,130-04
None,2.0,1,5,Day 3,0,pain,Pain or Tenderness,local,left arm,0,130-04
None,2.0,1,0,Baseline,1,arth,Arthralgia,systemic,,0,130-04
None,2.0,1,1,Early,0,arth,Arthralgia,systemic,,0,130-04
None,2.0,1,2,Day 0,0,arth,Arthralgia,systemic,,0,130-04
None,2.0,1,3,Day 1,0,arth,Arthralgia,systemic,,0,130-04
None,2.0,1,4,Day 2,0,arth,Arthralgia,systemic,,0,130-04
None,2.0,1,5,Day 3,0,arth,Arthralgia,systemic,,0,130-04
None,2.0,1,0,Baseline,1,chill,Chills,systemic,,0,130-04
None,2.0,1,1,Early,0,chill,Chills,systemic,,0,130-04
None,2.0,1,2,Day 0,0,chill,Chills,systemic,,0,130-04
None,2.0,1,3,Day 1,0,chill,Chills,systemic,,0,130-04
None,2.0,1,4,Day 2,0,chill,Chills,systemic,,0,130-04
None,2.0,1,5,Day 3,0,chill,Chills,systemic,,0,130-04
None,2.0,1,0,Baseline,1,flush,Facial Flushing,systemic,,0,130-04
None,2.0,1,1,Early,0,flush,Facial Flushing,systemic,,0,130-04
None,2.0,1,2,Day 0,0,flush,Facial Flushing,systemic,,0,130-04
None,2.0,1,3,Day 1,0,flush,Facial Flushing,systemic,,0,130-04
None,2.0,1,4,Day 2,0,flush,Facial Flushing,systemic,,0,130-04
None,2.0,1,5,Day 3,0,flush,Facial Flushing,systemic,,0,130-04
None,2.0,1,0,Baseline,1,gprur,Generalized Pruritis,systemic,,0,130-04
None,2.0,1,1,Early,0,gprur,Generalized Pruritis,systemic,,0,130-04
None,2.0,1,2,Day 0,0,gprur,Generalized Pruritis,systemic,,0,130-04
None,2.0,1,3,Day 1,0,gprur,Generalized Pruritis,systemic,,0,130-04
None,2.0,1,4,Day 2,0,gprur,Generalized Pruritis,systemic,,0,130-04
None,2.0,1,5,Day 3,0,gprur,Generalized Pruritis,systemic,,0,130-04
None,2.0,1,0,Baseline,1,head,Headache,systemic,,0,130-04
None,2.0,1,1,Early,0,head,Headache,systemic,,0,130-04
None,2.0,1,2,Day 0,0,head,Headache,systemic,,0,130-04
None,2.0,1,3,Day 1,0,head,Headache,systemic,,0,130-04
None,2.0,1,4,Day 2,0,head,Headache,systemic,,0,130-04
None,2.0,1,5,Day 3,0,head,Headache,systemic,,0,130-04
None,2.0,1,0,Baseline,1,mf,Malaise/fatigue,systemic,,0,130-04
None,2.0,1,1,Early,0,mf,Malaise/fatigue,systemic,,0,130-04
None,2.0,1,2,Day 0,0,mf,Malaise/fatigue,systemic,,0,130-04
Moderate,2.0,1,3,Day 1,0,mf,Malaise/fatigue,systemic,,2,130-04
Moderate,2.0,1,4,Day 2,0,mf,Malaise/fatigue,systemic,,2,130-04
None,2.0,1,5,Day 3,0,mf,Malaise/fatigue,systemic,,0,130-04
None,2.0,1,0,Baseline,1,myal,Myalgia,systemic,,0,130-04
None,2.0,1,1,Early,0,myal,Myalgia,systemic,,0,130-04
None,2.0,1,2,Day 0,0,myal,Myalgia,systemic,,0,130-04
None,2.0,1,3,Day 1,0,myal,Myalgia,systemic,,0,130-04
None,2.0,1,4,Day 2,0,myal,Myalgia,systemic,,0,130-04
None,2.0,1,5,Day 3,0,myal,Myalgia,systemic,,0,130-04
None,2.0,1,0,Baseline,1,naus,Nausea,systemic,,0,130-04
None,2.0,1,1,Early,0,naus,Nausea,systemic,,0,130-04
None,2.0,1,2,Day 0,0,naus,Nausea,systemic,,0,130-04
None,2.0,1,3,Day 1,0,naus,Nausea,systemic,,0,130-04
None,2.0,1,4,Day 2,0,naus,Nausea,systemic,,0,130-04
None,2.0,1,5,Day 3,0,naus,Nausea,systemic,,0,130-04
None,2.0,1,0,Baseline,1,ndysp,Non-exertional Dyspnea,systemic,,0,130-04
None,2.0,1,1,Early,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-04
None,2.0,1,2,Day 0,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-04
None,2.0,1,3,Day 1,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-04
None,2.0,1,4,Day 2,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-04
None,2.0,1,5,Day 3,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-04
None,2.0,1,0,Baseline,1,ntach,Non-exertional Tachycardia,systemic,,0,130-04
None,2.0,1,1,Early,0,ntach,Non-exertional Tachycardia,systemic,,0,130-04
None,2.0,1,2,Day 0,0,ntach,Non-exertional Tachycardia,systemic,,0,130-04
None,2.0,1,3,Day 1,0,ntach,Non-exertional Tachycardia,systemic,,0,130-04
None,2.0,1,4,Day 2,0,ntach,Non-exertional Tachycardia,systemic,,0,130-04
None,2.0,1,5,Day 3,0,ntach,Non-exertional Tachycardia,systemic,,0,130-04
< 37.9C (None),2.0,1,0,Baseline,1,tempc,Temperature (C),systemic,,0,130-04
< 37.9C (None),2.0,1,1,Early,0,tempc,Temperature (C),systemic,,0,130-04
< 37.9C (None),2.0,1,2,Day 0,0,tempc,Temperature (C),systemic,,0,130-04
< 37.9C (None),2.0,1,3,Day 1,0,tempc,Temperature (C),systemic,,0,130-04
< 37.9C (None),2.0,1,4,Day 2,0,tempc,Temperature (C),systemic,,0,130-04
< 37.9C (None),2.0,1,5,Day 3,0,tempc,Temperature (C),systemic,,0,130-04
None,2.0,1,0,Baseline,1,udiap,Unexplained Diaphoresis,systemic,,0,130-04
None,2.0,1,1,Early,0,udiap,Unexplained Diaphoresis,systemic,,0,130-04
None,2.0,1,2,Day 0,0,udiap,Unexplained Diaphoresis,systemic,,0,130-04
None,2.0,1,3,Day 1,0,udiap,Unexplained Diaphoresis,systemic,,0,130-04
None,2.0,1,4,Day 2,0,udiap,Unexplained Diaphoresis,systemic,,0,130-04
None,2.0,1,5,Day 3,0,udiap,Unexplained Diaphoresis,systemic,,0,130-04
None,2.0,1,0,Baseline,1,urtic,Urticaria,systemic,,0,130-04
None,2.0,1,1,Early,0,urtic,Urticaria,systemic,,0,130-04
None,2.0,1,2,Day 0,0,urtic,Urticaria,systemic,,0,130-04
None,2.0,1,3,Day 1,0,urtic,Urticaria,systemic,,0,130-04
None,2.0,1,4,Day 2,0,urtic,Urticaria,systemic,,0,130-04
None,2.0,1,5,Day 3,0,urtic,Urticaria,systemic,,0,130-04
None,2.0,1,0,Baseline,1,ery,Erythema,local,left arm,0,130-05
None,2.0,1,1,Early,0,ery,Erythema,local,left arm,0,130-05
None,2.0,1,2,Day 0,0,ery,Erythema,local,left arm,0,130-05
None,2.0,1,3,Day 1,0,ery,Erythema,local,left arm,0,130-05
None,2.0,1,4,Day 2,0,ery,Erythema,local,left arm,0,130-05
None,2.0,1,5,Day 3,0,ery,Erythema,local,left arm,0,130-05
None,2.0,1,0,Baseline,1,ind,Induration,local,left arm,0,130-05
None,2.0,1,1,Early,0,ind,Induration,local,left arm,0,130-05
None,2.0,1,2,Day 0,0,ind,Induration,local,left arm,0,130-05
None,2.0,1,3,Day 1,0,ind,Induration,local,left arm,0,130-05
None,2.0,1,4,Day 2,0,ind,Induration,local,left arm,0,130-05
None,2.0,1,5,Day 3,0,ind,Induration,local,left arm,0,130-05
None,2.0,1,0,Baseline,1,pain,Pain or Tenderness,local,left arm,0,130-05
None,2.0,1,1,Early,0,pain,Pain or Tenderness,local,left arm,0,130-05
None,2.0,1,2,Day 0,0,pain,Pain or Tenderness,local,left arm,0,130-05
None,2.0,1,3,Day 1,0,pain,Pain or Tenderness,local,left arm,0,130-05
None,2.0,1,4,Day 2,0,pain,Pain or Tenderness,local,left arm,0,130-05
None,2.0,1,5,Day 3,0,pain,Pain or Tenderness,local,left arm,0,130-05
None,2.0,1,0,Baseline,1,arth,Arthralgia,systemic,,0,130-05
None,2.0,1,1,Early,0,arth,Arthralgia,systemic,,0,130-05
Mild,2.0,1,2,Day 0,0,arth,Arthralgia,systemic,,1,130-05
Mild,2.0,1,3,Day 1,0,arth,Arthralgia,systemic,,1,130-05
None,2.0,1,4,Day 2,0,arth,Arthralgia,systemic,,0,130-05
None,2.0,1,5,Day 3,0,arth,Arthralgia,systemic,,0,130-05
None,2.0,1,0,Baseline,1,chill,Chills,systemic,,0,130-05
None,2.0,1,1,Early,0,chill,Chills,systemic,,0,130-05
None,2.0,1,2,Day 0,0,chill,Chills,systemic,,0,130-05
None,2.0,1,3,Day 1,0,chill,Chills,systemic,,0,130-05
None,2.0,1,4,Day 2,0,chill,Chills,systemic,,0,130-05
None,2.0,1,5,Day 3,0,chill,Chills,systemic,,0,130-05
None,2.0,1,0,Baseline,1,flush,Facial Flushing,systemic,,0,130-05
None,2.0,1,1,Early,0,flush,Facial Flushing,systemic,,0,130-05
None,2.0,1,2,Day 0,0,flush,Facial Flushing,systemic,,0,130-05
None,2.0,1,3,Day 1,0,flush,Facial Flushing,systemic,,0,130-05
None,2.0,1,4,Day 2,0,flush,Facial Flushing,systemic,,0,130-05
None,2.0,1,5,Day 3,0,flush,Facial Flushing,systemic,,0,130-05
None,2.0,1,0,Baseline,1,gprur,Generalized Pruritis,systemic,,0,130-05
None,2.0,1,1,Early,0,gprur,Generalized Pruritis,systemic,,0,130-05
None,2.0,1,2,Day 0,0,gprur,Generalized Pruritis,systemic,,0,130-05
None,2.0,1,3,Day 1,0,gprur,Generalized Pruritis,systemic,,0,130-05
None,2.0,1,4,Day 2,0,gprur,Generalized Pruritis,systemic,,0,130-05
None,2.0,1,5,Day 3,0,gprur,Generalized Pruritis,systemic,,0,130-05
None,2.0,1,0,Baseline,1,head,Headache,systemic,,0,130-05
None,2.0,1,1,Early,0,head,Headache,systemic,,0,130-05
None,2.0,1,2,Day 0,0,head,Headache,systemic,,0,130-05
None,2.0,1,3,Day 1,0,head,Headache,systemic,,0,130-05
None,2.0,1,4,Day 2,0,head,Headache,systemic,,0,130-05
None,2.0,1,5,Day 3,0,head,Headache,systemic,,0,130-05
None,2.0,1,0,Baseline,1,mf,Malaise/fatigue,systemic,,0,130-05
None,2.0,1,1,Early,0,mf,Malaise/fatigue,systemic,,0,130-05
None,2.0,1,2,Day 0,0,mf,Malaise/fatigue,systemic,,0,130-05
None,2.0,1,3,Day 1,0,mf,Malaise/fatigue,systemic,,0,130-05
None,2.0,1,4,Day 2,0,mf,Malaise/fatigue,systemic,,0,130-05
None,2.0,1,5,Day 3,0,mf,Malaise/fatigue,systemic,,0,130-05
None,2.0,1,0,Baseline,1,myal,Myalgia,systemic,,0,130-05
None,2.0,1,1,Early,0,myal,Myalgia,systemic,,0,130-05
None,2.0,1,2,Day 0,0,myal,Myalgia,systemic,,0,130-05
None,2.0,1,3,Day 1,0,myal,Myalgia,systemic,,0,130-05
None,2.0,1,4,Day 2,0,myal,Myalgia,systemic,,0,130-05
None,2.0,1,5,Day 3,0,myal,Myalgia,systemic,,0,130-05
None,2.0,1,0,Baseline,1,naus,Nausea,systemic,,0,130-05
None,2.0,1,1,Early,0,naus,Nausea,systemic,,0,130-05
Mild,2.0,1,2,Day 0,0,naus,Nausea,systemic,,1,130-05
Mild,2.0,1,3,Day 1,0,naus,Nausea,systemic,,1,130-05
None,2.0,1,4,Day 2,0,naus,Nausea,systemic,,0,130-05
None,2.0,1,5,Day 3,0,naus,Nausea,systemic,,0,130-05
None,2.0,1,0,Baseline,1,ndysp,Non-exertional Dyspnea,systemic,,0,130-05
None,2.0,1,1,Early,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-05
None,2.0,1,2,Day 0,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-05
None,2.0,1,3,Day 1,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-05
None,2.0,1,4,Day 2,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-05
None,2.0,1,5,Day 3,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-05
None,2.0,1,0,Baseline,1,ntach,Non-exertional Tachycardia,systemic,,0,130-05
None,2.0,1,1,Early,0,ntach,Non-exertional Tachycardia,systemic,,0,130-05
None,2.0,1,2,Day 0,0,ntach,Non-exertional Tachycardia,systemic,,0,130-05
None,2.0,1,3,Day 1,0,ntach,Non-exertional Tachycardia,systemic,,0,130-05
None,2.0,1,4,Day 2,0,ntach,Non-exertional Tachycardia,systemic,,0,130-05
None,2.0,1,5,Day 3,0,ntach,Non-exertional Tachycardia,systemic,,0,130-05
< 37.9C (None),2.0,1,0,Baseline,1,tempc,Temperature (C),systemic,,0,130-05
< 37.9C (None),2.0,1,1,Early,0,tempc,Temperature (C),systemic,,0,130-05
< 37.9C (None),2.0,1,2,Day 0,0,tempc,Temperature (C),systemic,,0,130-05
< 37.9C (None),2.0,1,3,Day 1,0,tempc,Temperature (C),systemic,,0,130-05
< 37.9C (None),2.0,1,4,Day 2,0,tempc,Temperature (C),systemic,,0,130-05
< 37.9C (None),2.0,1,5,Day 3,0,tempc,Temperature (C),systemic,,0,130-05
None,2.0,1,0,Baseline,1,udiap,Unexplained Diaphoresis,systemic,,0,130-05
None,2.0,1,1,Early,0,udiap,Unexplained Diaphoresis,systemic,,0,130-05
None,2.0,1,2,Day 0,0,udiap,Unexplained Diaphoresis,systemic,,0,130-05
None,2.0,1,3,Day 1,0,udiap,Unexplained Diaphoresis,systemic,,0,130-05
None,2.0,1,4,Day 2,0,udiap,Unexplained Diaphoresis,systemic,,0,130-05
None,2.0,1,5,Day 3,0,udiap,Unexplained Diaphoresis,systemic,,0,130-05
None,2.0,1,0,Baseline,1,urtic,Urticaria,systemic,,0,130-05
None,2.0,1,1,Early,0,urtic,Urticaria,systemic,,0,130-05
None,2.0,1,2,Day 0,0,urtic,Urticaria,systemic,,0,130-05
None,2.0,1,3,Day 1,0,urtic,Urticaria,systemic,,0,130-05
None,2.0,1,4,Day 2,0,urtic,Urticaria,systemic,,0,130-05
None,2.0,1,5,Day 3,0,urtic,Urticaria,systemic,,0,130-05
None,2.0,1,0,Baseline,1,ery,Erythema,local,right arm,0,130-06
None,2.0,1,1,Early,0,ery,Erythema,local,right arm,0,130-06
None,2.0,1,2,Day 0,0,ery,Erythema,local,right arm,0,130-06
None,2.0,1,3,Day 1,0,ery,Erythema,local,right arm,0,130-06
None,2.0,1,4,Day 2,0,ery,Erythema,local,right arm,0,130-06
None,2.0,1,5,Day 3,0,ery,Erythema,local,right arm,0,130-06
None,2.0,1,0,Baseline,1,ind,Induration,local,right arm,0,130-06
None,2.0,1,1,Early,0,ind,Induration,local,right arm,0,130-06
None,2.0,1,2,Day 0,0,ind,Induration,local,right arm,0,130-06
None,2.0,1,3,Day 1,0,ind,Induration,local,right arm,0,130-06
None,2.0,1,4,Day 2,0,ind,Induration,local,right arm,0,130-06
None,2.0,1,5,Day 3,0,ind,Induration,local,right arm,0,130-06
None,2.0,1,0,Baseline,1,pain,Pain or Tenderness,local,right arm,0,130-06
None,2.0,1,1,Early,0,pain,Pain or Tenderness,local,right arm,0,130-06
None,2.0,1,2,Day 0,0,pain,Pain or Tenderness,local,right arm,0,130-06
None,2.0,1,3,Day 1,0,pain,Pain or Tenderness,local,right arm,0,130-06
None,2.0,1,4,Day 2,0,pain,Pain or Tenderness,local,right arm,0,130-06
None,2.0,1,5,Day 3,0,pain,Pain or Tenderness,local,right arm,0,130-06
None,2.0,1,0,Baseline,1,arth,Arthralgia,systemic,,0,130-06
None,2.0,1,1,Early,0,arth,Arthralgia,systemic,,0,130-06
None,2.0,1,2,Day 0,0,arth,Arthralgia,systemic,,0,130-06
None,2.0,1,3,Day 1,0,arth,Arthralgia,systemic,,0,130-06
None,2.0,1,4,Day 2,0,arth,Arthralgia,systemic,,0,130-06
None,2.0,1,5,Day 3,0,arth,Arthralgia,systemic,,0,130-06
None,2.0,1,0,Baseline,1,chill,Chills,systemic,,0,130-06
None,2.0,1,1,Early,0,chill,Chills,systemic,,0,130-06
Mild,2.0,1,2,Day 0,0,chill,Chills,systemic,,1,130-06
None,2.0,1,3,Day 1,0,chill,Chills,systemic,,0,130-06
None,2.0,1,4,Day 2,0,chill,Chills,systemic,,0,130-06
None,2.0,1,5,Day 3,0,chill,Chills,systemic,,0,130-06
None,2.0,1,0,Baseline,1,flush,Facial Flushing,systemic,,0,130-06
None,2.0,1,1,Early,0,flush,Facial Flushing,systemic,,0,130-06
Mild,2.0,1,2,Day 0,0,flush,Facial Flushing,systemic,,1,130-06
None,2.0,1,3,Day 1,0,flush,Facial Flushing,systemic,,0,130-06
None,2.0,1,4,Day 2,0,flush,Facial Flushing,systemic,,0,130-06
None,2.0,1,5,Day 3,0,flush,Facial Flushing,systemic,,0,130-06
None,2.0,1,0,Baseline,1,gprur,Generalized Pruritis,systemic,,0,130-06
None,2.0,1,1,Early,0,gprur,Generalized Pruritis,systemic,,0,130-06
None,2.0,1,2,Day 0,0,gprur,Generalized Pruritis,systemic,,0,130-06
None,2.0,1,3,Day 1,0,gprur,Generalized Pruritis,systemic,,0,130-06
None,2.0,1,4,Day 2,0,gprur,Generalized Pruritis,systemic,,0,130-06
None,2.0,1,5,Day 3,0,gprur,Generalized Pruritis,systemic,,0,130-06
None,2.0,1,0,Baseline,1,head,Headache,systemic,,0,130-06
None,2.0,1,1,Early,0,head,Headache,systemic,,0,130-06
None,2.0,1,2,Day 0,0,head,Headache,systemic,,0,130-06
None,2.0,1,3,Day 1,0,head,Headache,systemic,,0,130-06
None,2.0,1,4,Day 2,0,head,Headache,systemic,,0,130-06
None,2.0,1,5,Day 3,0,head,Headache,systemic,,0,130-06
None,2.0,1,0,Baseline,1,mf,Malaise/fatigue,systemic,,0,130-06
None,2.0,1,1,Early,0,mf,Malaise/fatigue,systemic,,0,130-06
Mild,2.0,1,2,Day 0,0,mf,Malaise/fatigue,systemic,,1,130-06
None,2.0,1,3,Day 1,0,mf,Malaise/fatigue,systemic,,0,130-06
None,2.0,1,4,Day 2,0,mf,Malaise/fatigue,systemic,,0,130-06
None,2.0,1,5,Day 3,0,mf,Malaise/fatigue,systemic,,0,130-06
None,2.0,1,0,Baseline,1,myal,Myalgia,systemic,,0,130-06
None,2.0,1,1,Early,0,myal,Myalgia,systemic,,0,130-06
None,2.0,1,2,Day 0,0,myal,Myalgia,systemic,,0,130-06
None,2.0,1,3,Day 1,0,myal,Myalgia,systemic,,0,130-06
None,2.0,1,4,Day 2,0,myal,Myalgia,systemic,,0,130-06
None,2.0,1,5,Day 3,0,myal,Myalgia,systemic,,0,130-06
None,2.0,1,0,Baseline,1,naus,Nausea,systemic,,0,130-06
None,2.0,1,1,Early,0,naus,Nausea,systemic,,0,130-06
None,2.0,1,2,Day 0,0,naus,Nausea,systemic,,0,130-06
None,2.0,1,3,Day 1,0,naus,Nausea,systemic,,0,130-06
None,2.0,1,4,Day 2,0,naus,Nausea,systemic,,0,130-06
None,2.0,1,5,Day 3,0,naus,Nausea,systemic,,0,130-06
None,2.0,1,0,Baseline,1,ndysp,Non-exertional Dyspnea,systemic,,0,130-06
None,2.0,1,1,Early,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-06
None,2.0,1,2,Day 0,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-06
None,2.0,1,3,Day 1,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-06
None,2.0,1,4,Day 2,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-06
None,2.0,1,5,Day 3,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-06
None,2.0,1,0,Baseline,1,ntach,Non-exertional Tachycardia,systemic,,0,130-06
None,2.0,1,1,Early,0,ntach,Non-exertional Tachycardia,systemic,,0,130-06
None,2.0,1,2,Day 0,0,ntach,Non-exertional Tachycardia,systemic,,0,130-06
None,2.0,1,3,Day 1,0,ntach,Non-exertional Tachycardia,systemic,,0,130-06
None,2.0,1,4,Day 2,0,ntach,Non-exertional Tachycardia,systemic,,0,130-06
None,2.0,1,5,Day 3,0,ntach,Non-exertional Tachycardia,systemic,,0,130-06
< 37.9C (None),2.0,1,0,Baseline,1,tempc,Temperature (C),systemic,,0,130-06
< 37.9C (None),2.0,1,1,Early,0,tempc,Temperature (C),systemic,,0,130-06
< 37.9C (None),2.0,1,2,Day 0,0,tempc,Temperature (C),systemic,,0,130-06
< 37.9C (None),2.0,1,3,Day 1,0,tempc,Temperature (C),systemic,,0,130-06
< 37.9C (None),2.0,1,4,Day 2,0,tempc,Temperature (C),systemic,,0,130-06
< 37.9C (None),2.0,1,5,Day 3,0,tempc,Temperature (C),systemic,,0,130-06
None,2.0,1,0,Baseline,1,udiap,Unexplained Diaphoresis,systemic,,0,130-06
None,2.0,1,1,Early,0,udiap,Unexplained Diaphoresis,systemic,,0,130-06
None,2.0,1,2,Day 0,0,udiap,Unexplained Diaphoresis,systemic,,0,130-06
None,2.0,1,3,Day 1,0,udiap,Unexplained Diaphoresis,systemic,,0,130-06
None,2.0,1,4,Day 2,0,udiap,Unexplained Diaphoresis,systemic,,0,130-06
None,2.0,1,5,Day 3,0,udiap,Unexplained Diaphoresis,systemic,,0,130-06
None,2.0,1,0,Baseline,1,urtic,Urticaria,systemic,,0,130-06
None,2.0,1,1,Early,0,urtic,Urticaria,systemic,,0,130-06
None,2.0,1,2,Day 0,0,urtic,Urticaria,systemic,,0,130-06
None,2.0,1,3,Day 1,0,urtic,Urticaria,systemic,,0,130-06
None,2.0,1,4,Day 2,0,urtic,Urticaria,systemic,,0,130-06
None,2.0,1,5,Day 3,0,urtic,Urticaria,systemic,,0,130-06
None,2.0,1,0,Baseline,1,ery,Erythema,local,right arm,0,130-07
None,2.0,1,1,Early,0,ery,Erythema,local,right arm,0,130-07
None,2.0,1,2,Day 0,0,ery,Erythema,local,right arm,0,130-07
None,2.0,1,3,Day 1,0,ery,Erythema,local,right arm,0,130-07
None,2.0,1,4,Day 2,0,ery,Erythema,local,right arm,0,130-07
None,2.0,1,5,Day 3,0,ery,Erythema,local,right arm,0,130-07
None,2.0,1,0,Baseline,1,ind,Induration,local,right arm,0,130-07
None,2.0,1,1,Early,0,ind,Induration,local,right arm,0,130-07
None,2.0,1,2,Day 0,0,ind,Induration,local,right arm,0,130-07
None,2.0,1,3,Day 1,0,ind,Induration,local,right arm,0,130-07
None,2.0,1,4,Day 2,0,ind,Induration,local,right arm,0,130-07
None,2.0,1,5,Day 3,0,ind,Induration,local,right arm,0,130-07
None,2.0,1,0,Baseline,1,pain,Pain or Tenderness,local,right arm,0,130-07
None,2.0,1,1,Early,0,pain,Pain or Tenderness,local,right arm,0,130-07
None,2.0,1,2,Day 0,0,pain,Pain or Tenderness,local,right arm,0,130-07
None,2.0,1,3,Day 1,0,pain,Pain or Tenderness,local,right arm,0,130-07
None,2.0,1,4,Day 2,0,pain,Pain or Tenderness,local,right arm,0,130-07
None,2.0,1,5,Day 3,0,pain,Pain or Tenderness,local,right arm,0,130-07
None,2.0,1,0,Baseline,1,arth,Arthralgia,systemic,,0,130-07
None,2.0,1,1,Early,0,arth,Arthralgia,systemic,,0,130-07
None,2.0,1,2,Day 0,0,arth,Arthralgia,systemic,,0,130-07
None,2.0,1,3,Day 1,0,arth,Arthralgia,systemic,,0,130-07
None,2.0,1,4,Day 2,0,arth,Arthralgia,systemic,,0,130-07
None,2.0,1,5,Day 3,0,arth,Arthralgia,systemic,,0,130-07
None,2.0,1,0,Baseline,1,chill,Chills,systemic,,0,130-07
None,2.0,1,1,Early,0,chill,Chills,systemic,,0,130-07
None,2.0,1,2,Day 0,0,chill,Chills,systemic,,0,130-07
None,2.0,1,3,Day 1,0,chill,Chills,systemic,,0,130-07
None,2.0,1,4,Day 2,0,chill,Chills,systemic,,0,130-07
None,2.0,1,5,Day 3,0,chill,Chills,systemic,,0,130-07
None,2.0,1,0,Baseline,1,flush,Facial Flushing,systemic,,0,130-07
None,2.0,1,1,Early,0,flush,Facial Flushing,systemic,,0,130-07
None,2.0,1,2,Day 0,0,flush,Facial Flushing,systemic,,0,130-07
None,2.0,1,3,Day 1,0,flush,Facial Flushing,systemic,,0,130-07
None,2.0,1,4,Day 2,0,flush,Facial Flushing,systemic,,0,130-07
None,2.0,1,5,Day 3,0,flush,Facial Flushing,systemic,,0,130-07
None,2.0,1,0,Baseline,1,gprur,Generalized Pruritis,systemic,,0,130-07
None,2.0,1,1,Early,0,gprur,Generalized Pruritis,systemic,,0,130-07
None,2.0,1,2,Day 0,0,gprur,Generalized Pruritis,systemic,,0,130-07
None,2.0,1,3,Day 1,0,gprur,Generalized Pruritis,systemic,,0,130-07
None,2.0,1,4,Day 2,0,gprur,Generalized Pruritis,systemic,,0,130-07
None,2.0,1,5,Day 3,0,gprur,Generalized Pruritis,systemic,,0,130-07
None,2.0,1,0,Baseline,1,head,Headache,systemic,,0,130-07
None,2.0,1,1,Early,0,head,Headache,systemic,,0,130-07
None,2.0,1,2,Day 0,0,head,Headache,systemic,,0,130-07
None,2.0,1,3,Day 1,0,head,Headache,systemic,,0,130-07
None,2.0,1,4,Day 2,0,head,Headache,systemic,,0,130-07
None,2.0,1,5,Day 3,0,head,Headache,systemic,,0,130-07
None,2.0,1,0,Baseline,1,mf,Malaise/fatigue,systemic,,0,130-07
None,2.0,1,1,Early,0,mf,Malaise/fatigue,systemic,,0,130-07
None,2.0,1,2,Day 0,0,mf,Malaise/fatigue,systemic,,0,130-07
None,2.0,1,3,Day 1,0,mf,Malaise/fatigue,systemic,,0,130-07
None,2.0,1,4,Day 2,0,mf,Malaise/fatigue,systemic,,0,130-07
None,2.0,1,5,Day 3,0,mf,Malaise/fatigue,systemic,,0,130-07
None,2.0,1,0,Baseline,1,myal,Myalgia,systemic,,0,130-07
None,2.0,1,1,Early,0,myal,Myalgia,systemic,,0,130-07
None,2.0,1,2,Day 0,0,myal,Myalgia,systemic,,0,130-07
None,2.0,1,3,Day 1,0,myal,Myalgia,systemic,,0,130-07
None,2.0,1,4,Day 2,0,myal,Myalgia,systemic,,0,130-07
None,2.0,1,5,Day 3,0,myal,Myalgia,systemic,,0,130-07
None,2.0,1,0,Baseline,1,naus,Nausea,systemic,,0,130-07
None,2.0,1,1,Early,0,naus,Nausea,systemic,,0,130-07
None,2.0,1,2,Day 0,0,naus,Nausea,systemic,,0,130-07
None,2.0,1,3,Day 1,0,naus,Nausea,systemic,,0,130-07
None,2.0,1,4,Day 2,0,naus,Nausea,systemic,,0,130-07
None,2.0,1,5,Day 3,0,naus,Nausea,systemic,,0,130-07
None,2.0,1,0,Baseline,1,ndysp,Non-exertional Dyspnea,systemic,,0,130-07
None,2.0,1,1,Early,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-07
None,2.0,1,2,Day 0,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-07
None,2.0,1,3,Day 1,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-07
None,2.0,1,4,Day 2,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-07
None,2.0,1,5,Day 3,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-07
None,2.0,1,0,Baseline,1,ntach,Non-exertional Tachycardia,systemic,,0,130-07
None,2.0,1,1,Early,0,ntach,Non-exertional Tachycardia,systemic,,0,130-07
None,2.0,1,2,Day 0,0,ntach,Non-exertional Tachycardia,systemic,,0,130-07
None,2.0,1,3,Day 1,0,ntach,Non-exertional Tachycardia,systemic,,0,130-07
None,2.0,1,4,Day 2,0,ntach,Non-exertional Tachycardia,systemic,,0,130-07
None,2.0,1,5,Day 3,0,ntach,Non-exertional Tachycardia,systemic,,0,130-07
< 37.9C (None),2.0,1,0,Baseline,1,tempc,Temperature (C),systemic,,0,130-07
< 37.9C (None),2.0,1,1,Early,0,tempc,Temperature (C),systemic,,0,130-07
< 37.9C (None),2.0,1,2,Day 0,0,tempc,Temperature (C),systemic,,0,130-07
< 37.9C (None),2.0,1,3,Day 1,0,tempc,Temperature (C),systemic,,0,130-07
< 37.9C (None),2.0,1,4,Day 2,0,tempc,Temperature (C),systemic,,0,130-07
< 37.9C (None),2.0,1,5,Day 3,0,tempc,Temperature (C),systemic,,0,130-07
None,2.0,1,0,Baseline,1,udiap,Unexplained Diaphoresis,systemic,,0,130-07
None,2.0,1,1,Early,0,udiap,Unexplained Diaphoresis,systemic,,0,130-07
None,2.0,1,2,Day 0,0,udiap,Unexplained Diaphoresis,systemic,,0,130-07
None,2.0,1,3,Day 1,0,udiap,Unexplained Diaphoresis,systemic,,0,130-07
None,2.0,1,4,Day 2,0,udiap,Unexplained Diaphoresis,systemic,,0,130-07
None,2.0,1,5,Day 3,0,udiap,Unexplained Diaphoresis,systemic,,0,130-07
None,2.0,1,0,Baseline,1,urtic,Urticaria,systemic,,0,130-07
None,2.0,1,1,Early,0,urtic,Urticaria,systemic,,0,130-07
None,2.0,1,2,Day 0,0,urtic,Urticaria,systemic,,0,130-07
None,2.0,1,3,Day 1,0,urtic,Urticaria,systemic,,0,130-07
None,2.0,1,4,Day 2,0,urtic,Urticaria,systemic,,0,130-07
None,2.0,1,5,Day 3,0,urtic,Urticaria,systemic,,0,130-07
None,2.0,1,0,Baseline,1,ery,Erythema,local,right arm,0,130-08
None,2.0,1,1,Early,0,ery,Erythema,local,right arm,0,130-08
None,2.0,1,2,Day 0,0,ery,Erythema,local,right arm,0,130-08
None,2.0,1,3,Day 1,0,ery,Erythema,local,right arm,0,130-08
None,2.0,1,4,Day 2,0,ery,Erythema,local,right arm,0,130-08
None,2.0,1,5,Day 3,0,ery,Erythema,local,right arm,0,130-08
None,2.0,1,6,Resolution,0,ery,Erythema,local,right arm,0,130-08
None,2.0,1,0,Baseline,1,ind,Induration,local,right arm,0,130-08
None,2.0,1,1,Early,0,ind,Induration,local,right arm,0,130-08
None,2.0,1,2,Day 0,0,ind,Induration,local,right arm,0,130-08
None,2.0,1,3,Day 1,0,ind,Induration,local,right arm,0,130-08
None,2.0,1,4,Day 2,0,ind,Induration,local,right arm,0,130-08
None,2.0,1,5,Day 3,0,ind,Induration,local,right arm,0,130-08
None,2.0,1,6,Resolution,0,ind,Induration,local,right arm,0,130-08
None,2.0,1,0,Baseline,1,pain,Pain or Tenderness,local,right arm,0,130-08
None,2.0,1,1,Early,0,pain,Pain or Tenderness,local,right arm,0,130-08
None,2.0,1,2,Day 0,0,pain,Pain or Tenderness,local,right arm,0,130-08
None,2.0,1,3,Day 1,0,pain,Pain or Tenderness,local,right arm,0,130-08
None,2.0,1,4,Day 2,0,pain,Pain or Tenderness,local,right arm,0,130-08
None,2.0,1,5,Day 3,0,pain,Pain or Tenderness,local,right arm,0,130-08
None,2.0,1,5,Day 3,0,pain,Pain or Tenderness,local,unknown,0,130-08
None,2.0,1,0,Baseline,1,arth,Arthralgia,systemic,,0,130-08
None,2.0,1,1,Early,0,arth,Arthralgia,systemic,,0,130-08
None,2.0,1,2,Day 0,0,arth,Arthralgia,systemic,,0,130-08
None,2.0,1,3,Day 1,0,arth,Arthralgia,systemic,,0,130-08
None,2.0,1,4,Day 2,0,arth,Arthralgia,systemic,,0,130-08
None,2.0,1,5,Day 3,0,arth,Arthralgia,systemic,,0,130-08
None,2.0,1,6,Resolution,0,arth,Arthralgia,systemic,,0,130-08
None,2.0,1,0,Baseline,1,chill,Chills,systemic,,0,130-08
None,2.0,1,1,Early,0,chill,Chills,systemic,,0,130-08
None,2.0,1,2,Day 0,0,chill,Chills,systemic,,0,130-08
None,2.0,1,3,Day 1,0,chill,Chills,systemic,,0,130-08
None,2.0,1,4,Day 2,0,chill,Chills,systemic,,0,130-08
None,2.0,1,5,Day 3,0,chill,Chills,systemic,,0,130-08
None,2.0,1,6,Resolution,0,chill,Chills,systemic,,0,130-08
None,2.0,1,0,Baseline,1,flush,Facial Flushing,systemic,,0,130-08
None,2.0,1,1,Early,0,flush,Facial Flushing,systemic,,0,130-08
None,2.0,1,2,Day 0,0,flush,Facial Flushing,systemic,,0,130-08
None,2.0,1,3,Day 1,0,flush,Facial Flushing,systemic,,0,130-08
None,2.0,1,4,Day 2,0,flush,Facial Flushing,systemic,,0,130-08
None,2.0,1,5,Day 3,0,flush,Facial Flushing,systemic,,0,130-08
None,2.0,1,6,Resolution,0,flush,Facial Flushing,systemic,,0,130-08
None,2.0,1,0,Baseline,1,gprur,Generalized Pruritis,systemic,,0,130-08
None,2.0,1,1,Early,0,gprur,Generalized Pruritis,systemic,,0,130-08
None,2.0,1,2,Day 0,0,gprur,Generalized Pruritis,systemic,,0,130-08
Mild,2.0,1,3,Day 1,0,gprur,Generalized Pruritis,systemic,,1,130-08
None,2.0,1,4,Day 2,0,gprur,Generalized Pruritis,systemic,,0,130-08
None,2.0,1,5,Day 3,0,gprur,Generalized Pruritis,systemic,,0,130-08
None,2.0,1,6,Resolution,0,gprur,Generalized Pruritis,systemic,,0,130-08
None,2.0,1,0,Baseline,1,head,Headache,systemic,,0,130-08
None,2.0,1,1,Early,0,head,Headache,systemic,,0,130-08
None,2.0,1,2,Day 0,0,head,Headache,systemic,,0,130-08
None,2.0,1,3,Day 1,0,head,Headache,systemic,,0,130-08
None,2.0,1,4,Day 2,0,head,Headache,systemic,,0,130-08
None,2.0,1,5,Day 3,0,head,Headache,systemic,,0,130-08
None,2.0,1,6,Resolution,0,head,Headache,systemic,,0,130-08
None,2.0,1,0,Baseline,1,mf,Malaise/fatigue,systemic,,0,130-08
None,2.0,1,1,Early,0,mf,Malaise/fatigue,systemic,,0,130-08
Mild,2.0,1,2,Day 0,0,mf,Malaise/fatigue,systemic,,1,130-08
Mild,2.0,1,3,Day 1,0,mf,Malaise/fatigue,systemic,,1,130-08
None,2.0,1,4,Day 2,0,mf,Malaise/fatigue,systemic,,0,130-08
Moderate,2.0,1,5,Day 3,0,mf,Malaise/fatigue,systemic,,2,130-08
Moderate,2.0,1,6,Resolution,0,mf,Malaise/fatigue,systemic,,2,130-08
None,2.0,1,0,Baseline,1,myal,Myalgia,systemic,,0,130-08
None,2.0,1,1,Early,0,myal,Myalgia,systemic,,0,130-08
None,2.0,1,2,Day 0,0,myal,Myalgia,systemic,,0,130-08
None,2.0,1,3,Day 1,0,myal,Myalgia,systemic,,0,130-08
None,2.0,1,4,Day 2,0,myal,Myalgia,systemic,,0,130-08
None,2.0,1,5,Day 3,0,myal,Myalgia,systemic,,0,130-08
None,2.0,1,6,Resolution,0,myal,Myalgia,systemic,,0,130-08
None,2.0,1,0,Baseline,1,naus,Nausea,systemic,,0,130-08
None,2.0,1,1,Early,0,naus,Nausea,systemic,,0,130-08
Mild,2.0,1,2,Day 0,0,naus,Nausea,systemic,,1,130-08
None,2.0,1,3,Day 1,0,naus,Nausea,systemic,,0,130-08
None,2.0,1,4,Day 2,0,naus,Nausea,systemic,,0,130-08
None,2.0,1,5,Day 3,0,naus,Nausea,systemic,,0,130-08
None,2.0,1,6,Resolution,0,naus,Nausea,systemic,,0,130-08
None,2.0,1,0,Baseline,1,ndysp,Non-exertional Dyspnea,systemic,,0,130-08
None,2.0,1,1,Early,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-08
None,2.0,1,2,Day 0,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-08
None,2.0,1,3,Day 1,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-08
None,2.0,1,4,Day 2,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-08
None,2.0,1,5,Day 3,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-08
None,2.0,1,6,Resolution,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-08
None,2.0,1,0,Baseline,1,ntach,Non-exertional Tachycardia,systemic,,0,130-08
None,2.0,1,1,Early,0,ntach,Non-exertional Tachycardia,systemic,,0,130-08
None,2.0,1,2,Day 0,0,ntach,Non-exertional Tachycardia,systemic,,0,130-08
None,2.0,1,3,Day 1,0,ntach,Non-exertional Tachycardia,systemic,,0,130-08
None,2.0,1,4,Day 2,0,ntach,Non-exertional Tachycardia,systemic,,0,130-08
None,2.0,1,5,Day 3,0,ntach,Non-exertional Tachycardia,systemic,,0,130-08
None,2.0,1,6,Resolution,0,ntach,Non-exertional Tachycardia,systemic,,0,130-08
< 37.9C (None),2.0,1,0,Baseline,1,tempc,Temperature (C),systemic,,0,130-08
< 37.9C (None),2.0,1,1,Early,0,tempc,Temperature (C),systemic,,0,130-08
< 37.9C (None),2.0,1,2,Day 0,0,tempc,Temperature (C),systemic,,0,130-08
< 37.9C (None),2.0,1,3,Day 1,0,tempc,Temperature (C),systemic,,0,130-08
< 37.9C (None),2.0,1,4,Day 2,0,tempc,Temperature (C),systemic,,0,130-08
< 37.9C (None),2.0,1,5,Day 3,0,tempc,Temperature (C),systemic,,0,130-08
< 37.9C (None),2.0,1,6,Resolution,0,tempc,Temperature (C),systemic,,0,130-08
None,2.0,1,0,Baseline,1,udiap,Unexplained Diaphoresis,systemic,,0,130-08
None,2.0,1,1,Early,0,udiap,Unexplained Diaphoresis,systemic,,0,130-08
None,2.0,1,2,Day 0,0,udiap,Unexplained Diaphoresis,systemic,,0,130-08
None,2.0,1,3,Day 1,0,udiap,Unexplained Diaphoresis,systemic,,0,130-08
None,2.0,1,4,Day 2,0,udiap,Unexplained Diaphoresis,systemic,,0,130-08
None,2.0,1,5,Day 3,0,udiap,Unexplained Diaphoresis,systemic,,0,130-08
None,2.0,1,6,Resolution,0,udiap,Unexplained Diaphoresis,systemic,,0,130-08
None,2.0,1,0,Baseline,1,urtic,Urticaria,systemic,,0,130-08
None,2.0,1,1,Early,0,urtic,Urticaria,systemic,,0,130-08
None,2.0,1,2,Day 0,0,urtic,Urticaria,systemic,,0,130-08
None,2.0,1,3,Day 1,0,urtic,Urticaria,systemic,,0,130-08
None,2.0,1,4,Day 2,0,urtic,Urticaria,systemic,,0,130-08
None,2.0,1,5,Day 3,0,urtic,Urticaria,systemic,,0,130-08
None,2.0,1,6,Resolution,0,urtic,Urticaria,systemic,,0,130-08
None,2.0,1,0,Baseline,1,ery,Erythema,local,right arm,0,130-09
None,2.0,1,1,Early,0,ery,Erythema,local,right arm,0,130-09
None,2.0,1,2,Day 0,0,ery,Erythema,local,right arm,0,130-09
None,2.0,1,3,Day 1,0,ery,Erythema,local,right arm,0,130-09
None,2.0,1,4,Day 2,0,ery,Erythema,local,right arm,0,130-09
None,2.0,1,5,Day 3,0,ery,Erythema,local,right arm,0,130-09
None,2.0,1,0,Baseline,1,ind,Induration,local,right arm,0,130-09
None,2.0,1,1,Early,0,ind,Induration,local,right arm,0,130-09
None,2.0,1,2,Day 0,0,ind,Induration,local,right arm,0,130-09
None,2.0,1,3,Day 1,0,ind,Induration,local,right arm,0,130-09
None,2.0,1,4,Day 2,0,ind,Induration,local,right arm,0,130-09
None,2.0,1,5,Day 3,0,ind,Induration,local,right arm,0,130-09
None,2.0,1,0,Baseline,1,pain,Pain or Tenderness,local,right arm,0,130-09
None,2.0,1,1,Early,0,pain,Pain or Tenderness,local,right arm,0,130-09
None,2.0,1,2,Day 0,0,pain,Pain or Tenderness,local,right arm,0,130-09
None,2.0,1,3,Day 1,0,pain,Pain or Tenderness,local,right arm,0,130-09
None,2.0,1,4,Day 2,0,pain,Pain or Tenderness,local,right arm,0,130-09
None,2.0,1,5,Day 3,0,pain,Pain or Tenderness,local,right arm,0,130-09
None,2.0,1,0,Baseline,1,arth,Arthralgia,systemic,,0,130-09
None,2.0,1,1,Early,0,arth,Arthralgia,systemic,,0,130-09
None,2.0,1,2,Day 0,0,arth,Arthralgia,systemic,,0,130-09
None,2.0,1,3,Day 1,0,arth,Arthralgia,systemic,,0,130-09
None,2.0,1,4,Day 2,0,arth,Arthralgia,systemic,,0,130-09
None,2.0,1,5,Day 3,0,arth,Arthralgia,systemic,,0,130-09
None,2.0,1,0,Baseline,1,chill,Chills,systemic,,0,130-09
None,2.0,1,1,Early,0,chill,Chills,systemic,,0,130-09
None,2.0,1,2,Day 0,0,chill,Chills,systemic,,0,130-09
None,2.0,1,3,Day 1,0,chill,Chills,systemic,,0,130-09
None,2.0,1,4,Day 2,0,chill,Chills,systemic,,0,130-09
None,2.0,1,5,Day 3,0,chill,Chills,systemic,,0,130-09
None,2.0,1,0,Baseline,1,flush,Facial Flushing,systemic,,0,130-09
None,2.0,1,1,Early,0,flush,Facial Flushing,systemic,,0,130-09
None,2.0,1,2,Day 0,0,flush,Facial Flushing,systemic,,0,130-09
None,2.0,1,3,Day 1,0,flush,Facial Flushing,systemic,,0,130-09
None,2.0,1,4,Day 2,0,flush,Facial Flushing,systemic,,0,130-09
None,2.0,1,5,Day 3,0,flush,Facial Flushing,systemic,,0,130-09
None,2.0,1,0,Baseline,1,gprur,Generalized Pruritis,systemic,,0,130-09
None,2.0,1,1,Early,0,gprur,Generalized Pruritis,systemic,,0,130-09
None,2.0,1,2,Day 0,0,gprur,Generalized Pruritis,systemic,,0,130-09
None,2.0,1,3,Day 1,0,gprur,Generalized Pruritis,systemic,,0,130-09
None,2.0,1,4,Day 2,0,gprur,Generalized Pruritis,systemic,,0,130-09
None,2.0,1,5,Day 3,0,gprur,Generalized Pruritis,systemic,,0,130-09
None,2.0,1,0,Baseline,1,head,Headache,systemic,,0,130-09
None,2.0,1,1,Early,0,head,Headache,systemic,,0,130-09
Mild,2.0,1,2,Day 0,0,head,Headache,systemic,,1,130-09
None,2.0,1,3,Day 1,0,head,Headache,systemic,,0,130-09
None,2.0,1,4,Day 2,0,head,Headache,systemic,,0,130-09
None,2.0,1,5,Day 3,0,head,Headache,systemic,,0,130-09
None,2.0,1,0,Baseline,1,mf,Malaise/fatigue,systemic,,0,130-09
None,2.0,1,1,Early,0,mf,Malaise/fatigue,systemic,,0,130-09
None,2.0,1,2,Day 0,0,mf,Malaise/fatigue,systemic,,0,130-09
None,2.0,1,3,Day 1,0,mf,Malaise/fatigue,systemic,,0,130-09
None,2.0,1,4,Day 2,0,mf,Malaise/fatigue,systemic,,0,130-09
None,2.0,1,5,Day 3,0,mf,Malaise/fatigue,systemic,,0,130-09
None,2.0,1,0,Baseline,1,myal,Myalgia,systemic,,0,130-09
None,2.0,1,1,Early,0,myal,Myalgia,systemic,,0,130-09
None,2.0,1,2,Day 0,0,myal,Myalgia,systemic,,0,130-09
None,2.0,1,3,Day 1,0,myal,Myalgia,systemic,,0,130-09
None,2.0,1,4,Day 2,0,myal,Myalgia,systemic,,0,130-09
None,2.0,1,5,Day 3,0,myal,Myalgia,systemic,,0,130-09
None,2.0,1,0,Baseline,1,naus,Nausea,systemic,,0,130-09
None,2.0,1,1,Early,0,naus,Nausea,systemic,,0,130-09
None,2.0,1,2,Day 0,0,naus,Nausea,systemic,,0,130-09
None,2.0,1,3,Day 1,0,naus,Nausea,systemic,,0,130-09
None,2.0,1,4,Day 2,0,naus,Nausea,systemic,,0,130-09
None,2.0,1,5,Day 3,0,naus,Nausea,systemic,,0,130-09
None,2.0,1,0,Baseline,1,ndysp,Non-exertional Dyspnea,systemic,,0,130-09
None,2.0,1,1,Early,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-09
None,2.0,1,2,Day 0,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-09
None,2.0,1,3,Day 1,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-09
None,2.0,1,4,Day 2,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-09
None,2.0,1,5,Day 3,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-09
None,2.0,1,0,Baseline,1,ntach,Non-exertional Tachycardia,systemic,,0,130-09
None,2.0,1,1,Early,0,ntach,Non-exertional Tachycardia,systemic,,0,130-09
None,2.0,1,2,Day 0,0,ntach,Non-exertional Tachycardia,systemic,,0,130-09
None,2.0,1,3,Day 1,0,ntach,Non-exertional Tachycardia,systemic,,0,130-09
None,2.0,1,4,Day 2,0,ntach,Non-exertional Tachycardia,systemic,,0,130-09
None,2.0,1,5,Day 3,0,ntach,Non-exertional Tachycardia,systemic,,0,130-09
< 37.9C (None),2.0,1,0,Baseline,1,tempc,Temperature (C),systemic,,0,130-09
< 37.9C (None),2.0,1,1,Early,0,tempc,Temperature (C),systemic,,0,130-09
< 37.9C (None),2.0,1,2,Day 0,0,tempc,Temperature (C),systemic,,0,130-09
< 37.9C (None),2.0,1,3,Day 1,0,tempc,Temperature (C),systemic,,0,130-09
< 37.9C (None),2.0,1,4,Day 2,0,tempc,Temperature (C),systemic,,0,130-09
< 37.9C (None),2.0,1,5,Day 3,0,tempc,Temperature (C),systemic,,0,130-09
None,2.0,1,0,Baseline,1,udiap,Unexplained Diaphoresis,systemic,,0,130-09
None,2.0,1,1,Early,0,udiap,Unexplained Diaphoresis,systemic,,0,130-09
None,2.0,1,2,Day 0,0,udiap,Unexplained Diaphoresis,systemic,,0,130-09
None,2.0,1,3,Day 1,0,udiap,Unexplained Diaphoresis,systemic,,0,130-09
None,2.0,1,4,Day 2,0,udiap,Unexplained Diaphoresis,systemic,,0,130-09
None,2.0,1,5,Day 3,0,udiap,Unexplained Diaphoresis,systemic,,0,130-09
None,2.0,1,0,Baseline,1,urtic,Urticaria,systemic,,0,130-09
None,2.0,1,1,Early,0,urtic,Urticaria,systemic,,0,130-09
None,2.0,1,2,Day 0,0,urtic,Urticaria,systemic,,0,130-09
None,2.0,1,3,Day 1,0,urtic,Urticaria,systemic,,0,130-09
None,2.0,1,4,Day 2,0,urtic,Urticaria,systemic,,0,130-09
None,2.0,1,5,Day 3,0,urtic,Urticaria,systemic,,0,130-09
None,2.0,1,0,Baseline,1,ery,Erythema,local,right arm,0,130-10
None,2.0,1,1,Early,0,ery,Erythema,local,right arm,0,130-10
None,2.0,1,2,Day 0,0,ery,Erythema,local,right arm,0,130-10
None,2.0,1,3,Day 1,0,ery,Erythema,local,right arm,0,130-10
None,2.0,1,4,Day 2,0,ery,Erythema,local,right arm,0,130-10
None,2.0,1,5,Day 3,0,ery,Erythema,local,right arm,0,130-10
None,2.0,1,0,Baseline,1,ind,Induration,local,right arm,0,130-10
None,2.0,1,1,Early,0,ind,Induration,local,right arm,0,130-10
None,2.0,1,2,Day 0,0,ind,Induration,local,right arm,0,130-10
None,2.0,1,3,Day 1,0,ind,Induration,local,right arm,0,130-10
None,2.0,1,4,Day 2,0,ind,Induration,local,right arm,0,130-10
None,2.0,1,5,Day 3,0,ind,Induration,local,right arm,0,130-10
None,2.0,1,0,Baseline,1,pain,Pain or Tenderness,local,right arm,0,130-10
None,2.0,1,1,Early,0,pain,Pain or Tenderness,local,right arm,0,130-10
None,2.0,1,2,Day 0,0,pain,Pain or Tenderness,local,right arm,0,130-10
None,2.0,1,3,Day 1,0,pain,Pain or Tenderness,local,right arm,0,130-10
None,2.0,1,4,Day 2,0,pain,Pain or Tenderness,local,right arm,0,130-10
None,2.0,1,5,Day 3,0,pain,Pain or Tenderness,local,right arm,0,130-10
None,2.0,1,0,Baseline,1,arth,Arthralgia,systemic,,0,130-10
None,2.0,1,1,Early,0,arth,Arthralgia,systemic,,0,130-10
None,2.0,1,2,Day 0,0,arth,Arthralgia,systemic,,0,130-10
None,2.0,1,3,Day 1,0,arth,Arthralgia,systemic,,0,130-10
None,2.0,1,4,Day 2,0,arth,Arthralgia,systemic,,0,130-10
None,2.0,1,5,Day 3,0,arth,Arthralgia,systemic,,0,130-10
None,2.0,1,0,Baseline,1,chill,Chills,systemic,,0,130-10
None,2.0,1,1,Early,0,chill,Chills,systemic,,0,130-10
None,2.0,1,2,Day 0,0,chill,Chills,systemic,,0,130-10
None,2.0,1,3,Day 1,0,chill,Chills,systemic,,0,130-10
None,2.0,1,4,Day 2,0,chill,Chills,systemic,,0,130-10
None,2.0,1,5,Day 3,0,chill,Chills,systemic,,0,130-10
None,2.0,1,0,Baseline,1,flush,Facial Flushing,systemic,,0,130-10
None,2.0,1,1,Early,0,flush,Facial Flushing,systemic,,0,130-10
None,2.0,1,2,Day 0,0,flush,Facial Flushing,systemic,,0,130-10
None,2.0,1,3,Day 1,0,flush,Facial Flushing,systemic,,0,130-10
None,2.0,1,4,Day 2,0,flush,Facial Flushing,systemic,,0,130-10
None,2.0,1,5,Day 3,0,flush,Facial Flushing,systemic,,0,130-10
None,2.0,1,0,Baseline,1,gprur,Generalized Pruritis,systemic,,0,130-10
None,2.0,1,1,Early,0,gprur,Generalized Pruritis,systemic,,0,130-10
None,2.0,1,2,Day 0,0,gprur,Generalized Pruritis,systemic,,0,130-10
None,2.0,1,3,Day 1,0,gprur,Generalized Pruritis,systemic,,0,130-10
None,2.0,1,4,Day 2,0,gprur,Generalized Pruritis,systemic,,0,130-10
None,2.0,1,5,Day 3,0,gprur,Generalized Pruritis,systemic,,0,130-10
None,2.0,1,0,Baseline,1,head,Headache,systemic,,0,130-10
None,2.0,1,1,Early,0,head,Headache,systemic,,0,130-10
None,2.0,1,2,Day 0,0,head,Headache,systemic,,0,130-10
None,2.0,1,3,Day 1,0,head,Headache,systemic,,0,130-10
None,2.0,1,4,Day 2,0,head,Headache,systemic,,0,130-10
None,2.0,1,5,Day 3,0,head,Headache,systemic,,0,130-10
None,2.0,1,0,Baseline,1,mf,Malaise/fatigue,systemic,,0,130-10
None,2.0,1,1,Early,0,mf,Malaise/fatigue,systemic,,0,130-10
None,2.0,1,2,Day 0,0,mf,Malaise/fatigue,systemic,,0,130-10
None,2.0,1,3,Day 1,0,mf,Malaise/fatigue,systemic,,0,130-10
None,2.0,1,4,Day 2,0,mf,Malaise/fatigue,systemic,,0,130-10
None,2.0,1,5,Day 3,0,mf,Malaise/fatigue,systemic,,0,130-10
None,2.0,1,0,Baseline,1,myal,Myalgia,systemic,,0,130-10
None,2.0,1,1,Early,0,myal,Myalgia,systemic,,0,130-10
None,2.0,1,2,Day 0,0,myal,Myalgia,systemic,,0,130-10
None,2.0,1,3,Day 1,0,myal,Myalgia,systemic,,0,130-10
None,2.0,1,4,Day 2,0,myal,Myalgia,systemic,,0,130-10
None,2.0,1,5,Day 3,0,myal,Myalgia,systemic,,0,130-10
None,2.0,1,0,Baseline,1,naus,Nausea,systemic,,0,130-10
None,2.0,1,1,Early,0,naus,Nausea,systemic,,0,130-10
None,2.0,1,2,Day 0,0,naus,Nausea,systemic,,0,130-10
None,2.0,1,3,Day 1,0,naus,Nausea,systemic,,0,130-10
None,2.0,1,4,Day 2,0,naus,Nausea,systemic,,0,130-10
None,2.0,1,5,Day 3,0,naus,Nausea,systemic,,0,130-10
None,2.0,1,0,Baseline,1,ndysp,Non-exertional Dyspnea,systemic,,0,130-10
None,2.0,1,1,Early,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-10
None,2.0,1,2,Day 0,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-10
None,2.0,1,3,Day 1,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-10
None,2.0,1,4,Day 2,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-10
None,2.0,1,5,Day 3,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-10
None,2.0,1,0,Baseline,1,ntach,Non-exertional Tachycardia,systemic,,0,130-10
None,2.0,1,1,Early,0,ntach,Non-exertional Tachycardia,systemic,,0,130-10
None,2.0,1,2,Day 0,0,ntach,Non-exertional Tachycardia,systemic,,0,130-10
None,2.0,1,3,Day 1,0,ntach,Non-exertional Tachycardia,systemic,,0,130-10
None,2.0,1,4,Day 2,0,ntach,Non-exertional Tachycardia,systemic,,0,130-10
None,2.0,1,5,Day 3,0,ntach,Non-exertional Tachycardia,systemic,,0,130-10
< 37.9C (None),2.0,1,0,Baseline,1,tempc,Temperature (C),systemic,,0,130-10
< 37.9C (None),2.0,1,1,Early,0,tempc,Temperature (C),systemic,,0,130-10
< 37.9C (None),2.0,1,2,Day 0,0,tempc,Temperature (C),systemic,,0,130-10
< 37.9C (None),2.0,1,3,Day 1,0,tempc,Temperature (C),systemic,,0,130-10
< 37.9C (None),2.0,1,4,Day 2,0,tempc,Temperature (C),systemic,,0,130-10
< 37.9C (None),2.0,1,5,Day 3,0,tempc,Temperature (C),systemic,,0,130-10
None,2.0,1,0,Baseline,1,udiap,Unexplained Diaphoresis,systemic,,0,130-10
None,2.0,1,1,Early,0,udiap,Unexplained Diaphoresis,systemic,,0,130-10
None,2.0,1,2,Day 0,0,udiap,Unexplained Diaphoresis,systemic,,0,130-10
None,2.0,1,3,Day 1,0,udiap,Unexplained Diaphoresis,systemic,,0,130-10
None,2.0,1,4,Day 2,0,udiap,Unexplained Diaphoresis,systemic,,0,130-10
None,2.0,1,5,Day 3,0,udiap,Unexplained Diaphoresis,systemic,,0,130-10
None,2.0,1,0,Baseline,1,urtic,Urticaria,systemic,,0,130-10
None,2.0,1,1,Early,0,urtic,Urticaria,systemic,,0,130-10
None,2.0,1,2,Day 0,0,urtic,Urticaria,systemic,,0,130-10
None,2.0,1,3,Day 1,0,urtic,Urticaria,systemic,,0,130-10
None,2.0,1,4,Day 2,0,urtic,Urticaria,systemic,,0,130-10
None,2.0,1,5,Day 3,0,urtic,Urticaria,systemic,,0,130-10
None,2.0,1,0,Baseline,1,ery,Erythema,local,left arm,0,130-11
None,2.0,1,1,Early,0,ery,Erythema,local,left arm,0,130-11
None,2.0,1,2,Day 0,0,ery,Erythema,local,left arm,0,130-11
None,2.0,1,3,Day 1,0,ery,Erythema,local,left arm,0,130-11
None,2.0,1,4,Day 2,0,ery,Erythema,local,left arm,0,130-11
None,2.0,1,5,Day 3,0,ery,Erythema,local,left arm,0,130-11
None,2.0,1,0,Baseline,1,ind,Induration,local,left arm,0,130-11
None,2.0,1,1,Early,0,ind,Induration,local,left arm,0,130-11
None,2.0,1,2,Day 0,0,ind,Induration,local,left arm,0,130-11
None,2.0,1,3,Day 1,0,ind,Induration,local,left arm,0,130-11
None,2.0,1,4,Day 2,0,ind,Induration,local,left arm,0,130-11
None,2.0,1,5,Day 3,0,ind,Induration,local,left arm,0,130-11
None,2.0,1,0,Baseline,1,pain,Pain or Tenderness,local,left arm,0,130-11
None,2.0,1,1,Early,0,pain,Pain or Tenderness,local,left arm,0,130-11
None,2.0,1,2,Day 0,0,pain,Pain or Tenderness,local,left arm,0,130-11
None,2.0,1,3,Day 1,0,pain,Pain or Tenderness,local,left arm,0,130-11
None,2.0,1,4,Day 2,0,pain,Pain or Tenderness,local,left arm,0,130-11
None,2.0,1,5,Day 3,0,pain,Pain or Tenderness,local,left arm,0,130-11
None,2.0,1,0,Baseline,1,arth,Arthralgia,systemic,,0,130-11
None,2.0,1,1,Early,0,arth,Arthralgia,systemic,,0,130-11
None,2.0,1,2,Day 0,0,arth,Arthralgia,systemic,,0,130-11
None,2.0,1,3,Day 1,0,arth,Arthralgia,systemic,,0,130-11
None,2.0,1,4,Day 2,0,arth,Arthralgia,systemic,,0,130-11
None,2.0,1,5,Day 3,0,arth,Arthralgia,systemic,,0,130-11
None,2.0,1,0,Baseline,1,chill,Chills,systemic,,0,130-11
None,2.0,1,1,Early,0,chill,Chills,systemic,,0,130-11
None,2.0,1,2,Day 0,0,chill,Chills,systemic,,0,130-11
None,2.0,1,3,Day 1,0,chill,Chills,systemic,,0,130-11
None,2.0,1,4,Day 2,0,chill,Chills,systemic,,0,130-11
None,2.0,1,5,Day 3,0,chill,Chills,systemic,,0,130-11
None,2.0,1,0,Baseline,1,flush,Facial Flushing,systemic,,0,130-11
None,2.0,1,1,Early,0,flush,Facial Flushing,systemic,,0,130-11
None,2.0,1,2,Day 0,0,flush,Facial Flushing,systemic,,0,130-11
None,2.0,1,3,Day 1,0,flush,Facial Flushing,systemic,,0,130-11
None,2.0,1,4,Day 2,0,flush,Facial Flushing,systemic,,0,130-11
None,2.0,1,5,Day 3,0,flush,Facial Flushing,systemic,,0,130-11
None,2.0,1,0,Baseline,1,gprur,Generalized Pruritis,systemic,,0,130-11
None,2.0,1,1,Early,0,gprur,Generalized Pruritis,systemic,,0,130-11
None,2.0,1,2,Day 0,0,gprur,Generalized Pruritis,systemic,,0,130-11
None,2.0,1,3,Day 1,0,gprur,Generalized Pruritis,systemic,,0,130-11
None,2.0,1,4,Day 2,0,gprur,Generalized Pruritis,systemic,,0,130-11
None,2.0,1,5,Day 3,0,gprur,Generalized Pruritis,systemic,,0,130-11
None,2.0,1,0,Baseline,1,head,Headache,systemic,,0,130-11
None,2.0,1,1,Early,0,head,Headache,systemic,,0,130-11
None,2.0,1,2,Day 0,0,head,Headache,systemic,,0,130-11
None,2.0,1,3,Day 1,0,head,Headache,systemic,,0,130-11
None,2.0,1,4,Day 2,0,head,Headache,systemic,,0,130-11
None,2.0,1,5,Day 3,0,head,Headache,systemic,,0,130-11
None,2.0,1,0,Baseline,1,mf,Malaise/fatigue,systemic,,0,130-11
None,2.0,1,1,Early,0,mf,Malaise/fatigue,systemic,,0,130-11
None,2.0,1,2,Day 0,0,mf,Malaise/fatigue,systemic,,0,130-11
None,2.0,1,3,Day 1,0,mf,Malaise/fatigue,systemic,,0,130-11
None,2.0,1,4,Day 2,0,mf,Malaise/fatigue,systemic,,0,130-11
None,2.0,1,5,Day 3,0,mf,Malaise/fatigue,systemic,,0,130-11
None,2.0,1,0,Baseline,1,myal,Myalgia,systemic,,0,130-11
None,2.0,1,1,Early,0,myal,Myalgia,systemic,,0,130-11
None,2.0,1,2,Day 0,0,myal,Myalgia,systemic,,0,130-11
None,2.0,1,3,Day 1,0,myal,Myalgia,systemic,,0,130-11
None,2.0,1,4,Day 2,0,myal,Myalgia,systemic,,0,130-11
None,2.0,1,5,Day 3,0,myal,Myalgia,systemic,,0,130-11
None,2.0,1,0,Baseline,1,naus,Nausea,systemic,,0,130-11
None,2.0,1,1,Early,0,naus,Nausea,systemic,,0,130-11
None,2.0,1,2,Day 0,0,naus,Nausea,systemic,,0,130-11
None,2.0,1,3,Day 1,0,naus,Nausea,systemic,,0,130-11
None,2.0,1,4,Day 2,0,naus,Nausea,systemic,,0,130-11
None,2.0,1,5,Day 3,0,naus,Nausea,systemic,,0,130-11
None,2.0,1,0,Baseline,1,ndysp,Non-exertional Dyspnea,systemic,,0,130-11
None,2.0,1,1,Early,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-11
None,2.0,1,2,Day 0,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-11
None,2.0,1,3,Day 1,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-11
None,2.0,1,4,Day 2,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-11
None,2.0,1,5,Day 3,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-11
None,2.0,1,0,Baseline,1,ntach,Non-exertional Tachycardia,systemic,,0,130-11
None,2.0,1,1,Early,0,ntach,Non-exertional Tachycardia,systemic,,0,130-11
None,2.0,1,2,Day 0,0,ntach,Non-exertional Tachycardia,systemic,,0,130-11
None,2.0,1,3,Day 1,0,ntach,Non-exertional Tachycardia,systemic,,0,130-11
None,2.0,1,4,Day 2,0,ntach,Non-exertional Tachycardia,systemic,,0,130-11
None,2.0,1,5,Day 3,0,ntach,Non-exertional Tachycardia,systemic,,0,130-11
< 37.9C (None),2.0,1,0,Baseline,1,tempc,Temperature (C),systemic,,0,130-11
< 37.9C (None),2.0,1,1,Early,0,tempc,Temperature (C),systemic,,0,130-11
< 37.9C (None),2.0,1,2,Day 0,0,tempc,Temperature (C),systemic,,0,130-11
< 37.9C (None),2.0,1,3,Day 1,0,tempc,Temperature (C),systemic,,0,130-11
< 37.9C (None),2.0,1,4,Day 2,0,tempc,Temperature (C),systemic,,0,130-11
< 37.9C (None),2.0,1,5,Day 3,0,tempc,Temperature (C),systemic,,0,130-11
None,2.0,1,0,Baseline,1,udiap,Unexplained Diaphoresis,systemic,,0,130-11
None,2.0,1,1,Early,0,udiap,Unexplained Diaphoresis,systemic,,0,130-11
None,2.0,1,2,Day 0,0,udiap,Unexplained Diaphoresis,systemic,,0,130-11
None,2.0,1,3,Day 1,0,udiap,Unexplained Diaphoresis,systemic,,0,130-11
None,2.0,1,4,Day 2,0,udiap,Unexplained Diaphoresis,systemic,,0,130-11
None,2.0,1,5,Day 3,0,udiap,Unexplained Diaphoresis,systemic,,0,130-11
None,2.0,1,0,Baseline,1,urtic,Urticaria,systemic,,0,130-11
None,2.0,1,1,Early,0,urtic,Urticaria,systemic,,0,130-11
None,2.0,1,2,Day 0,0,urtic,Urticaria,systemic,,0,130-11
None,2.0,1,3,Day 1,0,urtic,Urticaria,systemic,,0,130-11
None,2.0,1,4,Day 2,0,urtic,Urticaria,systemic,,0,130-11
None,2.0,1,5,Day 3,0,urtic,Urticaria,systemic,,0,130-11
None,2.0,1,0,Baseline,1,ery,Erythema,local,right arm,0,130-12
None,2.0,1,1,Early,0,ery,Erythema,local,right arm,0,130-12
None,2.0,1,2,Day 0,0,ery,Erythema,local,right arm,0,130-12
None,2.0,1,3,Day 1,0,ery,Erythema,local,right arm,0,130-12
None,2.0,1,4,Day 2,0,ery,Erythema,local,right arm,0,130-12
None,2.0,1,5,Day 3,0,ery,Erythema,local,right arm,0,130-12
None,2.0,1,0,Baseline,1,ind,Induration,local,right arm,0,130-12
None,2.0,1,1,Early,0,ind,Induration,local,right arm,0,130-12
None,2.0,1,2,Day 0,0,ind,Induration,local,right arm,0,130-12
None,2.0,1,3,Day 1,0,ind,Induration,local,right arm,0,130-12
None,2.0,1,4,Day 2,0,ind,Induration,local,right arm,0,130-12
None,2.0,1,5,Day 3,0,ind,Induration,local,right arm,0,130-12
None,2.0,1,0,Baseline,1,pain,Pain or Tenderness,local,right arm,0,130-12
None,2.0,1,1,Early,0,pain,Pain or Tenderness,local,right arm,0,130-12
None,2.0,1,2,Day 0,0,pain,Pain or Tenderness,local,right arm,0,130-12
None,2.0,1,3,Day 1,0,pain,Pain or Tenderness,local,right arm,0,130-12
None,2.0,1,4,Day 2,0,pain,Pain or Tenderness,local,right arm,0,130-12
None,2.0,1,5,Day 3,0,pain,Pain or Tenderness,local,right arm,0,130-12
None,2.0,1,0,Baseline,1,arth,Arthralgia,systemic,,0,130-12
None,2.0,1,1,Early,0,arth,Arthralgia,systemic,,0,130-12
None,2.0,1,2,Day 0,0,arth,Arthralgia,systemic,,0,130-12
None,2.0,1,3,Day 1,0,arth,Arthralgia,systemic,,0,130-12
None,2.0,1,4,Day 2,0,arth,Arthralgia,systemic,,0,130-12
None,2.0,1,5,Day 3,0,arth,Arthralgia,systemic,,0,130-12
None,2.0,1,0,Baseline,1,chill,Chills,systemic,,0,130-12
None,2.0,1,1,Early,0,chill,Chills,systemic,,0,130-12
None,2.0,1,2,Day 0,0,chill,Chills,systemic,,0,130-12
None,2.0,1,3,Day 1,0,chill,Chills,systemic,,0,130-12
None,2.0,1,4,Day 2,0,chill,Chills,systemic,,0,130-12
None,2.0,1,5,Day 3,0,chill,Chills,systemic,,0,130-12
None,2.0,1,0,Baseline,1,flush,Facial Flushing,systemic,,0,130-12
None,2.0,1,1,Early,0,flush,Facial Flushing,systemic,,0,130-12
None,2.0,1,2,Day 0,0,flush,Facial Flushing,systemic,,0,130-12
None,2.0,1,3,Day 1,0,flush,Facial Flushing,systemic,,0,130-12
None,2.0,1,4,Day 2,0,flush,Facial Flushing,systemic,,0,130-12
None,2.0,1,5,Day 3,0,flush,Facial Flushing,systemic,,0,130-12
None,2.0,1,0,Baseline,1,gprur,Generalized Pruritis,systemic,,0,130-12
None,2.0,1,1,Early,0,gprur,Generalized Pruritis,systemic,,0,130-12
None,2.0,1,2,Day 0,0,gprur,Generalized Pruritis,systemic,,0,130-12
None,2.0,1,3,Day 1,0,gprur,Generalized Pruritis,systemic,,0,130-12
None,2.0,1,4,Day 2,0,gprur,Generalized Pruritis,systemic,,0,130-12
None,2.0,1,5,Day 3,0,gprur,Generalized Pruritis,systemic,,0,130-12
None,2.0,1,0,Baseline,1,head,Headache,systemic,,0,130-12
None,2.0,1,1,Early,0,head,Headache,systemic,,0,130-12
None,2.0,1,2,Day 0,0,head,Headache,systemic,,0,130-12
None,2.0,1,3,Day 1,0,head,Headache,systemic,,0,130-12
None,2.0,1,4,Day 2,0,head,Headache,systemic,,0,130-12
None,2.0,1,5,Day 3,0,head,Headache,systemic,,0,130-12
None,2.0,1,0,Baseline,1,mf,Malaise/fatigue,systemic,,0,130-12
None,2.0,1,1,Early,0,mf,Malaise/fatigue,systemic,,0,130-12
Mild,2.0,1,2,Day 0,0,mf,Malaise/fatigue,systemic,,1,130-12
Moderate,2.0,1,3,Day 1,0,mf,Malaise/fatigue,systemic,,2,130-12
None,2.0,1,4,Day 2,0,mf,Malaise/fatigue,systemic,,0,130-12
None,2.0,1,5,Day 3,0,mf,Malaise/fatigue,systemic,,0,130-12
None,2.0,1,0,Baseline,1,myal,Myalgia,systemic,,0,130-12
None,2.0,1,1,Early,0,myal,Myalgia,systemic,,0,130-12
None,2.0,1,2,Day 0,0,myal,Myalgia,systemic,,0,130-12
None,2.0,1,3,Day 1,0,myal,Myalgia,systemic,,0,130-12
None,2.0,1,4,Day 2,0,myal,Myalgia,systemic,,0,130-12
None,2.0,1,5,Day 3,0,myal,Myalgia,systemic,,0,130-12
None,2.0,1,0,Baseline,1,naus,Nausea,systemic,,0,130-12
Mild,2.0,1,1,Early,0,naus,Nausea,systemic,,1,130-12
None,2.0,1,2,Day 0,0,naus,Nausea,systemic,,0,130-12
Mild,2.0,1,3,Day 1,0,naus,Nausea,systemic,,1,130-12
None,2.0,1,4,Day 2,0,naus,Nausea,systemic,,0,130-12
None,2.0,1,5,Day 3,0,naus,Nausea,systemic,,0,130-12
None,2.0,1,0,Baseline,1,ndysp,Non-exertional Dyspnea,systemic,,0,130-12
None,2.0,1,1,Early,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-12
None,2.0,1,2,Day 0,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-12
None,2.0,1,3,Day 1,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-12
None,2.0,1,4,Day 2,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-12
None,2.0,1,5,Day 3,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-12
None,2.0,1,0,Baseline,1,ntach,Non-exertional Tachycardia,systemic,,0,130-12
None,2.0,1,1,Early,0,ntach,Non-exertional Tachycardia,systemic,,0,130-12
None,2.0,1,2,Day 0,0,ntach,Non-exertional Tachycardia,systemic,,0,130-12
None,2.0,1,3,Day 1,0,ntach,Non-exertional Tachycardia,systemic,,0,130-12
None,2.0,1,4,Day 2,0,ntach,Non-exertional Tachycardia,systemic,,0,130-12
None,2.0,1,5,Day 3,0,ntach,Non-exertional Tachycardia,systemic,,0,130-12
< 37.9C (None),2.0,1,0,Baseline,1,tempc,Temperature (C),systemic,,0,130-12
< 37.9C (None),2.0,1,1,Early,0,tempc,Temperature (C),systemic,,0,130-12
< 37.9C (None),2.0,1,2,Day 0,0,tempc,Temperature (C),systemic,,0,130-12
< 37.9C (None),2.0,1,3,Day 1,0,tempc,Temperature (C),systemic,,0,130-12
< 37.9C (None),2.0,1,4,Day 2,0,tempc,Temperature (C),systemic,,0,130-12
< 37.9C (None),2.0,1,5,Day 3,0,tempc,Temperature (C),systemic,,0,130-12
None,2.0,1,0,Baseline,1,udiap,Unexplained Diaphoresis,systemic,,0,130-12
None,2.0,1,1,Early,0,udiap,Unexplained Diaphoresis,systemic,,0,130-12
None,2.0,1,2,Day 0,0,udiap,Unexplained Diaphoresis,systemic,,0,130-12
None,2.0,1,3,Day 1,0,udiap,Unexplained Diaphoresis,systemic,,0,130-12
None,2.0,1,4,Day 2,0,udiap,Unexplained Diaphoresis,systemic,,0,130-12
None,2.0,1,5,Day 3,0,udiap,Unexplained Diaphoresis,systemic,,0,130-12
None,2.0,1,0,Baseline,1,urtic,Urticaria,systemic,,0,130-12
None,2.0,1,1,Early,0,urtic,Urticaria,systemic,,0,130-12
None,2.0,1,2,Day 0,0,urtic,Urticaria,systemic,,0,130-12
None,2.0,1,3,Day 1,0,urtic,Urticaria,systemic,,0,130-12
None,2.0,1,4,Day 2,0,urtic,Urticaria,systemic,,0,130-12
None,2.0,1,5,Day 3,0,urtic,Urticaria,systemic,,0,130-12
None,2.0,1,0,Baseline,1,ery,Erythema,local,right arm,0,130-13
None,2.0,1,1,Early,0,ery,Erythema,local,right arm,0,130-13
None,2.0,1,2,Day 0,0,ery,Erythema,local,right arm,0,130-13
None,2.0,1,3,Day 1,0,ery,Erythema,local,right arm,0,130-13
None,2.0,1,4,Day 2,0,ery,Erythema,local,right arm,0,130-13
None,2.0,1,5,Day 3,0,ery,Erythema,local,right arm,0,130-13
None,2.0,1,0,Baseline,1,ind,Induration,local,right arm,0,130-13
None,2.0,1,1,Early,0,ind,Induration,local,right arm,0,130-13
None,2.0,1,2,Day 0,0,ind,Induration,local,right arm,0,130-13
None,2.0,1,3,Day 1,0,ind,Induration,local,right arm,0,130-13
None,2.0,1,4,Day 2,0,ind,Induration,local,right arm,0,130-13
None,2.0,1,5,Day 3,0,ind,Induration,local,right arm,0,130-13
None,2.0,1,0,Baseline,1,pain,Pain or Tenderness,local,right arm,0,130-13
Mild,2.0,1,1,Early,0,pain,Pain or Tenderness,local,right arm,1,130-13
None,2.0,1,2,Day 0,0,pain,Pain or Tenderness,local,right arm,0,130-13
None,2.0,1,3,Day 1,0,pain,Pain or Tenderness,local,right arm,0,130-13
None,2.0,1,4,Day 2,0,pain,Pain or Tenderness,local,right arm,0,130-13
None,2.0,1,5,Day 3,0,pain,Pain or Tenderness,local,right arm,0,130-13
None,2.0,1,0,Baseline,1,arth,Arthralgia,systemic,,0,130-13
None,2.0,1,1,Early,0,arth,Arthralgia,systemic,,0,130-13
None,2.0,1,2,Day 0,0,arth,Arthralgia,systemic,,0,130-13
None,2.0,1,3,Day 1,0,arth,Arthralgia,systemic,,0,130-13
None,2.0,1,4,Day 2,0,arth,Arthralgia,systemic,,0,130-13
None,2.0,1,5,Day 3,0,arth,Arthralgia,systemic,,0,130-13
None,2.0,1,0,Baseline,1,chill,Chills,systemic,,0,130-13
None,2.0,1,1,Early,0,chill,Chills,systemic,,0,130-13
None,2.0,1,2,Day 0,0,chill,Chills,systemic,,0,130-13
None,2.0,1,3,Day 1,0,chill,Chills,systemic,,0,130-13
None,2.0,1,4,Day 2,0,chill,Chills,systemic,,0,130-13
None,2.0,1,5,Day 3,0,chill,Chills,systemic,,0,130-13
None,2.0,1,0,Baseline,1,flush,Facial Flushing,systemic,,0,130-13
None,2.0,1,1,Early,0,flush,Facial Flushing,systemic,,0,130-13
None,2.0,1,2,Day 0,0,flush,Facial Flushing,systemic,,0,130-13
None,2.0,1,3,Day 1,0,flush,Facial Flushing,systemic,,0,130-13
None,2.0,1,4,Day 2,0,flush,Facial Flushing,systemic,,0,130-13
None,2.0,1,5,Day 3,0,flush,Facial Flushing,systemic,,0,130-13
None,2.0,1,0,Baseline,1,gprur,Generalized Pruritis,systemic,,0,130-13
None,2.0,1,1,Early,0,gprur,Generalized Pruritis,systemic,,0,130-13
None,2.0,1,2,Day 0,0,gprur,Generalized Pruritis,systemic,,0,130-13
None,2.0,1,3,Day 1,0,gprur,Generalized Pruritis,systemic,,0,130-13
None,2.0,1,4,Day 2,0,gprur,Generalized Pruritis,systemic,,0,130-13
None,2.0,1,5,Day 3,0,gprur,Generalized Pruritis,systemic,,0,130-13
None,2.0,1,0,Baseline,1,head,Headache,systemic,,0,130-13
None,2.0,1,1,Early,0,head,Headache,systemic,,0,130-13
None,2.0,1,2,Day 0,0,head,Headache,systemic,,0,130-13
None,2.0,1,3,Day 1,0,head,Headache,systemic,,0,130-13
None,2.0,1,4,Day 2,0,head,Headache,systemic,,0,130-13
None,2.0,1,5,Day 3,0,head,Headache,systemic,,0,130-13
Mild,2.0,1,0,Baseline,1,mf,Malaise/fatigue,systemic,,1,130-13
None,2.0,1,1,Early,0,mf,Malaise/fatigue,systemic,,0,130-13
Mild,2.0,1,2,Day 0,0,mf,Malaise/fatigue,systemic,,1,130-13
None,2.0,1,3,Day 1,0,mf,Malaise/fatigue,systemic,,0,130-13
None,2.0,1,4,Day 2,0,mf,Malaise/fatigue,systemic,,0,130-13
None,2.0,1,5,Day 3,0,mf,Malaise/fatigue,systemic,,0,130-13
None,2.0,1,0,Baseline,1,myal,Myalgia,systemic,,0,130-13
None,2.0,1,1,Early,0,myal,Myalgia,systemic,,0,130-13
None,2.0,1,2,Day 0,0,myal,Myalgia,systemic,,0,130-13
None,2.0,1,3,Day 1,0,myal,Myalgia,systemic,,0,130-13
None,2.0,1,4,Day 2,0,myal,Myalgia,systemic,,0,130-13
None,2.0,1,5,Day 3,0,myal,Myalgia,systemic,,0,130-13
None,2.0,1,0,Baseline,1,naus,Nausea,systemic,,0,130-13
None,2.0,1,1,Early,0,naus,Nausea,systemic,,0,130-13
None,2.0,1,2,Day 0,0,naus,Nausea,systemic,,0,130-13
None,2.0,1,3,Day 1,0,naus,Nausea,systemic,,0,130-13
None,2.0,1,4,Day 2,0,naus,Nausea,systemic,,0,130-13
None,2.0,1,5,Day 3,0,naus,Nausea,systemic,,0,130-13
None,2.0,1,0,Baseline,1,ndysp,Non-exertional Dyspnea,systemic,,0,130-13
None,2.0,1,1,Early,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-13
None,2.0,1,2,Day 0,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-13
None,2.0,1,3,Day 1,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-13
None,2.0,1,4,Day 2,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-13
None,2.0,1,5,Day 3,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-13
None,2.0,1,0,Baseline,1,ntach,Non-exertional Tachycardia,systemic,,0,130-13
None,2.0,1,1,Early,0,ntach,Non-exertional Tachycardia,systemic,,0,130-13
None,2.0,1,2,Day 0,0,ntach,Non-exertional Tachycardia,systemic,,0,130-13
None,2.0,1,3,Day 1,0,ntach,Non-exertional Tachycardia,systemic,,0,130-13
None,2.0,1,4,Day 2,0,ntach,Non-exertional Tachycardia,systemic,,0,130-13
None,2.0,1,5,Day 3,0,ntach,Non-exertional Tachycardia,systemic,,0,130-13
< 37.9C (None),2.0,1,0,Baseline,1,tempc,Temperature (C),systemic,,0,130-13
< 37.9C (None),2.0,1,1,Early,0,tempc,Temperature (C),systemic,,0,130-13
< 37.9C (None),2.0,1,2,Day 0,0,tempc,Temperature (C),systemic,,0,130-13
< 37.9C (None),2.0,1,3,Day 1,0,tempc,Temperature (C),systemic,,0,130-13
< 37.9C (None),2.0,1,4,Day 2,0,tempc,Temperature (C),systemic,,0,130-13
< 37.9C (None),2.0,1,5,Day 3,0,tempc,Temperature (C),systemic,,0,130-13
None,2.0,1,0,Baseline,1,udiap,Unexplained Diaphoresis,systemic,,0,130-13
None,2.0,1,1,Early,0,udiap,Unexplained Diaphoresis,systemic,,0,130-13
None,2.0,1,2,Day 0,0,udiap,Unexplained Diaphoresis,systemic,,0,130-13
None,2.0,1,3,Day 1,0,udiap,Unexplained Diaphoresis,systemic,,0,130-13
None,2.0,1,4,Day 2,0,udiap,Unexplained Diaphoresis,systemic,,0,130-13
None,2.0,1,5,Day 3,0,udiap,Unexplained Diaphoresis,systemic,,0,130-13
None,2.0,1,0,Baseline,1,urtic,Urticaria,systemic,,0,130-13
None,2.0,1,1,Early,0,urtic,Urticaria,systemic,,0,130-13
None,2.0,1,2,Day 0,0,urtic,Urticaria,systemic,,0,130-13
None,2.0,1,3,Day 1,0,urtic,Urticaria,systemic,,0,130-13
None,2.0,1,4,Day 2,0,urtic,Urticaria,systemic,,0,130-13
None,2.0,1,5,Day 3,0,urtic,Urticaria,systemic,,0,130-13
None,9.0,2,0,Baseline,1,ery,Erythema,local,right arm,0,130-13
None,9.0,2,1,Early,0,ery,Erythema,local,right arm,0,130-13
None,9.0,2,2,Day 0,0,ery,Erythema,local,right arm,0,130-13
None,9.0,2,3,Day 1,0,ery,Erythema,local,right arm,0,130-13
None,9.0,2,4,Day 2,0,ery,Erythema,local,right arm,0,130-13
None,9.0,2,5,Day 3,0,ery,Erythema,local,right arm,0,130-13
None,9.0,2,0,Baseline,1,ind,Induration,local,right arm,0,130-13
None,9.0,2,1,Early,0,ind,Induration,local,right arm,0,130-13
None,9.0,2,2,Day 0,0,ind,Induration,local,right arm,0,130-13
None,9.0,2,3,Day 1,0,ind,Induration,local,right arm,0,130-13
None,9.0,2,4,Day 2,0,ind,Induration,local,right arm,0,130-13
None,9.0,2,5,Day 3,0,ind,Induration,local,right arm,0,130-13
None,9.0,2,0,Baseline,1,pain,Pain or Tenderness,local,right arm,0,130-13
None,9.0,2,1,Early,0,pain,Pain or Tenderness,local,right arm,0,130-13
None,9.0,2,2,Day 0,0,pain,Pain or Tenderness,local,right arm,0,130-13
None,9.0,2,0,Baseline,1,arth,Arthralgia,systemic,,0,130-13
None,9.0,2,1,Early,0,arth,Arthralgia,systemic,,0,130-13
None,9.0,2,2,Day 0,0,arth,Arthralgia,systemic,,0,130-13
None,9.0,2,0,Baseline,1,chill,Chills,systemic,,0,130-13
None,9.0,2,1,Early,0,chill,Chills,systemic,,0,130-13
Mild,9.0,2,2,Day 0,0,chill,Chills,systemic,,1,130-13
None,9.0,2,0,Baseline,1,flush,Facial Flushing,systemic,,0,130-13
None,9.0,2,1,Early,0,flush,Facial Flushing,systemic,,0,130-13
None,9.0,2,2,Day 0,0,flush,Facial Flushing,systemic,,0,130-13
None,9.0,2,0,Baseline,1,gprur,Generalized Pruritis,systemic,,0,130-13
None,9.0,2,1,Early,0,gprur,Generalized Pruritis,systemic,,0,130-13
None,9.0,2,2,Day 0,0,gprur,Generalized Pruritis,systemic,,0,130-13
None,9.0,2,0,Baseline,1,head,Headache,systemic,,0,130-13
None,9.0,2,1,Early,0,head,Headache,systemic,,0,130-13
None,9.0,2,2,Day 0,0,head,Headache,systemic,,0,130-13
None,9.0,2,0,Baseline,1,mf,Malaise/fatigue,systemic,,0,130-13
None,9.0,2,1,Early,0,mf,Malaise/fatigue,systemic,,0,130-13
Mild,9.0,2,2,Day 0,0,mf,Malaise/fatigue,systemic,,1,130-13
None,9.0,2,0,Baseline,1,myal,Myalgia,systemic,,0,130-13
None,9.0,2,1,Early,0,myal,Myalgia,systemic,,0,130-13
Mild,9.0,2,2,Day 0,0,myal,Myalgia,systemic,,1,130-13
None,9.0,2,0,Baseline,1,naus,Nausea,systemic,,0,130-13
None,9.0,2,1,Early,0,naus,Nausea,systemic,,0,130-13
None,9.0,2,2,Day 0,0,naus,Nausea,systemic,,0,130-13
None,9.0,2,0,Baseline,1,ndysp,Non-exertional Dyspnea,systemic,,0,130-13
None,9.0,2,1,Early,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-13
None,9.0,2,2,Day 0,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-13
None,9.0,2,0,Baseline,1,ntach,Non-exertional Tachycardia,systemic,,0,130-13
None,9.0,2,1,Early,0,ntach,Non-exertional Tachycardia,systemic,,0,130-13
None,9.0,2,2,Day 0,0,ntach,Non-exertional Tachycardia,systemic,,0,130-13
< 37.9C (None),9.0,2,0,Baseline,1,tempc,Temperature (C),systemic,,0,130-13
< 37.9C (None),9.0,2,1,Early,0,tempc,Temperature (C),systemic,,0,130-13
< 37.9C (None),9.0,2,2,Day 0,0,tempc,Temperature (C),systemic,,0,130-13
None,9.0,2,0,Baseline,1,udiap,Unexplained Diaphoresis,systemic,,0,130-13
None,9.0,2,1,Early,0,udiap,Unexplained Diaphoresis,systemic,,0,130-13
None,9.0,2,2,Day 0,0,udiap,Unexplained Diaphoresis,systemic,,0,130-13
None,9.0,2,0,Baseline,1,urtic,Urticaria,systemic,,0,130-13
None,9.0,2,1,Early,0,urtic,Urticaria,systemic,,0,130-13
None,9.0,2,2,Day 0,0,urtic,Urticaria,systemic,,0,130-13
None,2.0,1,0,Baseline,1,ery,Erythema,local,left arm,0,130-14
None,2.0,1,1,Early,0,ery,Erythema,local,left arm,0,130-14
None,2.0,1,2,Day 0,0,ery,Erythema,local,left arm,0,130-14
None,2.0,1,3,Day 1,0,ery,Erythema,local,left arm,0,130-14
None,2.0,1,4,Day 2,0,ery,Erythema,local,left arm,0,130-14
None,2.0,1,5,Day 3,0,ery,Erythema,local,left arm,0,130-14
None,2.0,1,0,Baseline,1,ind,Induration,local,left arm,0,130-14
None,2.0,1,1,Early,0,ind,Induration,local,left arm,0,130-14
None,2.0,1,2,Day 0,0,ind,Induration,local,left arm,0,130-14
None,2.0,1,3,Day 1,0,ind,Induration,local,left arm,0,130-14
None,2.0,1,4,Day 2,0,ind,Induration,local,left arm,0,130-14
None,2.0,1,5,Day 3,0,ind,Induration,local,left arm,0,130-14
None,2.0,1,0,Baseline,1,pain,Pain or Tenderness,local,left arm,0,130-14
None,2.0,1,1,Early,0,pain,Pain or Tenderness,local,left arm,0,130-14
None,2.0,1,2,Day 0,0,pain,Pain or Tenderness,local,left arm,0,130-14
None,2.0,1,3,Day 1,0,pain,Pain or Tenderness,local,left arm,0,130-14
None,2.0,1,4,Day 2,0,pain,Pain or Tenderness,local,left arm,0,130-14
None,2.0,1,5,Day 3,0,pain,Pain or Tenderness,local,left arm,0,130-14
None,2.0,1,0,Baseline,1,arth,Arthralgia,systemic,,0,130-14
Mild,2.0,1,1,Early,0,arth,Arthralgia,systemic,,1,130-14
Mild,2.0,1,2,Day 0,0,arth,Arthralgia,systemic,,1,130-14
None,2.0,1,3,Day 1,0,arth,Arthralgia,systemic,,0,130-14
None,2.0,1,4,Day 2,0,arth,Arthralgia,systemic,,0,130-14
None,2.0,1,5,Day 3,0,arth,Arthralgia,systemic,,0,130-14
None,2.0,1,0,Baseline,1,chill,Chills,systemic,,0,130-14
Moderate,2.0,1,1,Early,0,chill,Chills,systemic,,2,130-14
None,2.0,1,2,Day 0,0,chill,Chills,systemic,,0,130-14
None,2.0,1,3,Day 1,0,chill,Chills,systemic,,0,130-14
None,2.0,1,4,Day 2,0,chill,Chills,systemic,,0,130-14
None,2.0,1,5,Day 3,0,chill,Chills,systemic,,0,130-14
None,2.0,1,0,Baseline,1,flush,Facial Flushing,systemic,,0,130-14
None,2.0,1,1,Early,0,flush,Facial Flushing,systemic,,0,130-14
None,2.0,1,2,Day 0,0,flush,Facial Flushing,systemic,,0,130-14
None,2.0,1,3,Day 1,0,flush,Facial Flushing,systemic,,0,130-14
None,2.0,1,4,Day 2,0,flush,Facial Flushing,systemic,,0,130-14
None,2.0,1,5,Day 3,0,flush,Facial Flushing,systemic,,0,130-14
None,2.0,1,0,Baseline,1,gprur,Generalized Pruritis,systemic,,0,130-14
None,2.0,1,1,Early,0,gprur,Generalized Pruritis,systemic,,0,130-14
None,2.0,1,2,Day 0,0,gprur,Generalized Pruritis,systemic,,0,130-14
None,2.0,1,3,Day 1,0,gprur,Generalized Pruritis,systemic,,0,130-14
None,2.0,1,4,Day 2,0,gprur,Generalized Pruritis,systemic,,0,130-14
None,2.0,1,5,Day 3,0,gprur,Generalized Pruritis,systemic,,0,130-14
None,2.0,1,0,Baseline,1,head,Headache,systemic,,0,130-14
Mild,2.0,1,1,Early,0,head,Headache,systemic,,1,130-14
Mild,2.0,1,2,Day 0,0,head,Headache,systemic,,1,130-14
None,2.0,1,3,Day 1,0,head,Headache,systemic,,0,130-14
None,2.0,1,4,Day 2,0,head,Headache,systemic,,0,130-14
None,2.0,1,5,Day 3,0,head,Headache,systemic,,0,130-14
None,2.0,1,0,Baseline,1,mf,Malaise/fatigue,systemic,,0,130-14
None,2.0,1,1,Early,0,mf,Malaise/fatigue,systemic,,0,130-14
None,2.0,1,2,Day 0,0,mf,Malaise/fatigue,systemic,,0,130-14
None,2.0,1,3,Day 1,0,mf,Malaise/fatigue,systemic,,0,130-14
None,2.0,1,4,Day 2,0,mf,Malaise/fatigue,systemic,,0,130-14
None,2.0,1,5,Day 3,0,mf,Malaise/fatigue,systemic,,0,130-14
None,2.0,1,0,Baseline,1,myal,Myalgia,systemic,,0,130-14
Mild,2.0,1,1,Early,0,myal,Myalgia,systemic,,1,130-14
None,2.0,1,2,Day 0,0,myal,Myalgia,systemic,,0,130-14
None,2.0,1,3,Day 1,0,myal,Myalgia,systemic,,0,130-14
None,2.0,1,4,Day 2,0,myal,Myalgia,systemic,,0,130-14
None,2.0,1,5,Day 3,0,myal,Myalgia,systemic,,0,130-14
None,2.0,1,0,Baseline,1,naus,Nausea,systemic,,0,130-14
None,2.0,1,1,Early,0,naus,Nausea,systemic,,0,130-14
None,2.0,1,2,Day 0,0,naus,Nausea,systemic,,0,130-14
None,2.0,1,3,Day 1,0,naus,Nausea,systemic,,0,130-14
None,2.0,1,4,Day 2,0,naus,Nausea,systemic,,0,130-14
None,2.0,1,5,Day 3,0,naus,Nausea,systemic,,0,130-14
None,2.0,1,0,Baseline,1,ndysp,Non-exertional Dyspnea,systemic,,0,130-14
None,2.0,1,1,Early,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-14
None,2.0,1,2,Day 0,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-14
None,2.0,1,3,Day 1,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-14
None,2.0,1,4,Day 2,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-14
None,2.0,1,5,Day 3,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-14
None,2.0,1,0,Baseline,1,ntach,Non-exertional Tachycardia,systemic,,0,130-14
None,2.0,1,1,Early,0,ntach,Non-exertional Tachycardia,systemic,,0,130-14
None,2.0,1,2,Day 0,0,ntach,Non-exertional Tachycardia,systemic,,0,130-14
None,2.0,1,3,Day 1,0,ntach,Non-exertional Tachycardia,systemic,,0,130-14
None,2.0,1,4,Day 2,0,ntach,Non-exertional Tachycardia,systemic,,0,130-14
None,2.0,1,5,Day 3,0,ntach,Non-exertional Tachycardia,systemic,,0,130-14
< 37.9C (None),2.0,1,0,Baseline,1,tempc,Temperature (C),systemic,,0,130-14
< 37.9C (None),2.0,1,1,Early,0,tempc,Temperature (C),systemic,,0,130-14
< 37.9C (None),2.0,1,2,Day 0,0,tempc,Temperature (C),systemic,,0,130-14
< 37.9C (None),2.0,1,3,Day 1,0,tempc,Temperature (C),systemic,,0,130-14
< 37.9C (None),2.0,1,4,Day 2,0,tempc,Temperature (C),systemic,,0,130-14
< 37.9C (None),2.0,1,5,Day 3,0,tempc,Temperature (C),systemic,,0,130-14
None,2.0,1,0,Baseline,1,udiap,Unexplained Diaphoresis,systemic,,0,130-14
None,2.0,1,1,Early,0,udiap,Unexplained Diaphoresis,systemic,,0,130-14
None,2.0,1,2,Day 0,0,udiap,Unexplained Diaphoresis,systemic,,0,130-14
None,2.0,1,3,Day 1,0,udiap,Unexplained Diaphoresis,systemic,,0,130-14
None,2.0,1,4,Day 2,0,udiap,Unexplained Diaphoresis,systemic,,0,130-14
None,2.0,1,5,Day 3,0,udiap,Unexplained Diaphoresis,systemic,,0,130-14
None,2.0,1,0,Baseline,1,urtic,Urticaria,systemic,,0,130-14
None,2.0,1,1,Early,0,urtic,Urticaria,systemic,,0,130-14
None,2.0,1,2,Day 0,0,urtic,Urticaria,systemic,,0,130-14
None,2.0,1,3,Day 1,0,urtic,Urticaria,systemic,,0,130-14
None,2.0,1,4,Day 2,0,urtic,Urticaria,systemic,,0,130-14
None,2.0,1,5,Day 3,0,urtic,Urticaria,systemic,,0,130-14
None,2.0,1,0,Baseline,1,ery,Erythema,local,left arm,0,130-15
None,2.0,1,1,Early,0,ery,Erythema,local,left arm,0,130-15
None,2.0,1,2,Day 0,0,ery,Erythema,local,left arm,0,130-15
None,2.0,1,3,Day 1,0,ery,Erythema,local,left arm,0,130-15
None,2.0,1,4,Day 2,0,ery,Erythema,local,left arm,0,130-15
None,2.0,1,5,Day 3,0,ery,Erythema,local,left arm,0,130-15
None,2.0,1,0,Baseline,1,ind,Induration,local,left arm,0,130-15
None,2.0,1,1,Early,0,ind,Induration,local,left arm,0,130-15
None,2.0,1,2,Day 0,0,ind,Induration,local,left arm,0,130-15
None,2.0,1,3,Day 1,0,ind,Induration,local,left arm,0,130-15
None,2.0,1,4,Day 2,0,ind,Induration,local,left arm,0,130-15
None,2.0,1,5,Day 3,0,ind,Induration,local,left arm,0,130-15
None,2.0,1,0,Baseline,1,pain,Pain or Tenderness,local,left arm,0,130-15
None,2.0,1,1,Early,0,pain,Pain or Tenderness,local,left arm,0,130-15
None,2.0,1,2,Day 0,0,pain,Pain or Tenderness,local,left arm,0,130-15
None,2.0,1,3,Day 1,0,pain,Pain or Tenderness,local,left arm,0,130-15
None,2.0,1,4,Day 2,0,pain,Pain or Tenderness,local,left arm,0,130-15
None,2.0,1,5,Day 3,0,pain,Pain or Tenderness,local,left arm,0,130-15
None,2.0,1,0,Baseline,1,arth,Arthralgia,systemic,,0,130-15
None,2.0,1,1,Early,0,arth,Arthralgia,systemic,,0,130-15
None,2.0,1,2,Day 0,0,arth,Arthralgia,systemic,,0,130-15
None,2.0,1,3,Day 1,0,arth,Arthralgia,systemic,,0,130-15
None,2.0,1,4,Day 2,0,arth,Arthralgia,systemic,,0,130-15
None,2.0,1,5,Day 3,0,arth,Arthralgia,systemic,,0,130-15
None,2.0,1,0,Baseline,1,chill,Chills,systemic,,0,130-15
None,2.0,1,1,Early,0,chill,Chills,systemic,,0,130-15
None,2.0,1,2,Day 0,0,chill,Chills,systemic,,0,130-15
None,2.0,1,3,Day 1,0,chill,Chills,systemic,,0,130-15
None,2.0,1,4,Day 2,0,chill,Chills,systemic,,0,130-15
None,2.0,1,5,Day 3,0,chill,Chills,systemic,,0,130-15
None,2.0,1,0,Baseline,1,flush,Facial Flushing,systemic,,0,130-15
None,2.0,1,1,Early,0,flush,Facial Flushing,systemic,,0,130-15
None,2.0,1,2,Day 0,0,flush,Facial Flushing,systemic,,0,130-15
None,2.0,1,3,Day 1,0,flush,Facial Flushing,systemic,,0,130-15
None,2.0,1,4,Day 2,0,flush,Facial Flushing,systemic,,0,130-15
None,2.0,1,5,Day 3,0,flush,Facial Flushing,systemic,,0,130-15
None,2.0,1,0,Baseline,1,gprur,Generalized Pruritis,systemic,,0,130-15
None,2.0,1,1,Early,0,gprur,Generalized Pruritis,systemic,,0,130-15
None,2.0,1,2,Day 0,0,gprur,Generalized Pruritis,systemic,,0,130-15
None,2.0,1,3,Day 1,0,gprur,Generalized Pruritis,systemic,,0,130-15
None,2.0,1,4,Day 2,0,gprur,Generalized Pruritis,systemic,,0,130-15
None,2.0,1,5,Day 3,0,gprur,Generalized Pruritis,systemic,,0,130-15
None,2.0,1,0,Baseline,1,head,Headache,systemic,,0,130-15
None,2.0,1,1,Early,0,head,Headache,systemic,,0,130-15
None,2.0,1,2,Day 0,0,head,Headache,systemic,,0,130-15
None,2.0,1,3,Day 1,0,head,Headache,systemic,,0,130-15
None,2.0,1,4,Day 2,0,head,Headache,systemic,,0,130-15
None,2.0,1,5,Day 3,0,head,Headache,systemic,,0,130-15
None,2.0,1,0,Baseline,1,mf,Malaise/fatigue,systemic,,0,130-15
None,2.0,1,1,Early,0,mf,Malaise/fatigue,systemic,,0,130-15
Mild,2.0,1,2,Day 0,0,mf,Malaise/fatigue,systemic,,1,130-15
None,2.0,1,3,Day 1,0,mf,Malaise/fatigue,systemic,,0,130-15
None,2.0,1,4,Day 2,0,mf,Malaise/fatigue,systemic,,0,130-15
None,2.0,1,5,Day 3,0,mf,Malaise/fatigue,systemic,,0,130-15
None,2.0,1,0,Baseline,1,myal,Myalgia,systemic,,0,130-15
None,2.0,1,1,Early,0,myal,Myalgia,systemic,,0,130-15
None,2.0,1,2,Day 0,0,myal,Myalgia,systemic,,0,130-15
None,2.0,1,3,Day 1,0,myal,Myalgia,systemic,,0,130-15
None,2.0,1,4,Day 2,0,myal,Myalgia,systemic,,0,130-15
None,2.0,1,5,Day 3,0,myal,Myalgia,systemic,,0,130-15
None,2.0,1,0,Baseline,1,naus,Nausea,systemic,,0,130-15
None,2.0,1,1,Early,0,naus,Nausea,systemic,,0,130-15
None,2.0,1,2,Day 0,0,naus,Nausea,systemic,,0,130-15
None,2.0,1,3,Day 1,0,naus,Nausea,systemic,,0,130-15
None,2.0,1,4,Day 2,0,naus,Nausea,systemic,,0,130-15
None,2.0,1,5,Day 3,0,naus,Nausea,systemic,,0,130-15
None,2.0,1,0,Baseline,1,ndysp,Non-exertional Dyspnea,systemic,,0,130-15
None,2.0,1,1,Early,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-15
None,2.0,1,2,Day 0,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-15
None,2.0,1,3,Day 1,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-15
None,2.0,1,4,Day 2,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-15
None,2.0,1,5,Day 3,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-15
None,2.0,1,0,Baseline,1,ntach,Non-exertional Tachycardia,systemic,,0,130-15
None,2.0,1,1,Early,0,ntach,Non-exertional Tachycardia,systemic,,0,130-15
None,2.0,1,2,Day 0,0,ntach,Non-exertional Tachycardia,systemic,,0,130-15
None,2.0,1,3,Day 1,0,ntach,Non-exertional Tachycardia,systemic,,0,130-15
None,2.0,1,4,Day 2,0,ntach,Non-exertional Tachycardia,systemic,,0,130-15
None,2.0,1,5,Day 3,0,ntach,Non-exertional Tachycardia,systemic,,0,130-15
< 37.9C (None),2.0,1,0,Baseline,1,tempc,Temperature (C),systemic,,0,130-15
< 37.9C (None),2.0,1,1,Early,0,tempc,Temperature (C),systemic,,0,130-15
< 37.9C (None),2.0,1,2,Day 0,0,tempc,Temperature (C),systemic,,0,130-15
< 37.9C (None),2.0,1,3,Day 1,0,tempc,Temperature (C),systemic,,0,130-15
< 37.9C (None),2.0,1,4,Day 2,0,tempc,Temperature (C),systemic,,0,130-15
< 37.9C (None),2.0,1,5,Day 3,0,tempc,Temperature (C),systemic,,0,130-15
None,2.0,1,0,Baseline,1,udiap,Unexplained Diaphoresis,systemic,,0,130-15
None,2.0,1,1,Early,0,udiap,Unexplained Diaphoresis,systemic,,0,130-15
None,2.0,1,2,Day 0,0,udiap,Unexplained Diaphoresis,systemic,,0,130-15
None,2.0,1,3,Day 1,0,udiap,Unexplained Diaphoresis,systemic,,0,130-15
None,2.0,1,4,Day 2,0,udiap,Unexplained Diaphoresis,systemic,,0,130-15
None,2.0,1,5,Day 3,0,udiap,Unexplained Diaphoresis,systemic,,0,130-15
None,2.0,1,0,Baseline,1,urtic,Urticaria,systemic,,0,130-15
None,2.0,1,1,Early,0,urtic,Urticaria,systemic,,0,130-15
None,2.0,1,2,Day 0,0,urtic,Urticaria,systemic,,0,130-15
None,2.0,1,3,Day 1,0,urtic,Urticaria,systemic,,0,130-15
None,2.0,1,4,Day 2,0,urtic,Urticaria,systemic,,0,130-15
None,2.0,1,5,Day 3,0,urtic,Urticaria,systemic,,0,130-15
None,9.0,2,0,Baseline,1,ery,Erythema,local,right arm,0,130-15
None,9.0,2,1,Early,0,ery,Erythema,local,right arm,0,130-15
None,9.0,2,2,Day 0,0,ery,Erythema,local,right arm,0,130-15
None,9.0,2,3,Day 1,0,ery,Erythema,local,right arm,0,130-15
None,9.0,2,4,Day 2,0,ery,Erythema,local,right arm,0,130-15
None,9.0,2,5,Day 3,0,ery,Erythema,local,right arm,0,130-15
None,9.0,2,0,Baseline,1,ind,Induration,local,right arm,0,130-15
None,9.0,2,1,Early,0,ind,Induration,local,right arm,0,130-15
None,9.0,2,2,Day 0,0,ind,Induration,local,right arm,0,130-15
None,9.0,2,3,Day 1,0,ind,Induration,local,right arm,0,130-15
None,9.0,2,4,Day 2,0,ind,Induration,local,right arm,0,130-15
None,9.0,2,5,Day 3,0,ind,Induration,local,right arm,0,130-15
None,9.0,2,0,Baseline,1,pain,Pain or Tenderness,local,right arm,0,130-15
None,9.0,2,1,Early,0,pain,Pain or Tenderness,local,right arm,0,130-15
None,9.0,2,2,Day 0,0,pain,Pain or Tenderness,local,right arm,0,130-15
None,9.0,2,3,Day 1,0,pain,Pain or Tenderness,local,right arm,0,130-15
None,9.0,2,3,Day 1,0,pain,Pain or Tenderness,local,unknown,0,130-15
None,9.0,2,4,Day 2,0,pain,Pain or Tenderness,local,right arm,0,130-15
None,9.0,2,5,Day 3,0,pain,Pain or Tenderness,local,right arm,0,130-15
None,9.0,2,0,Baseline,1,arth,Arthralgia,systemic,,0,130-15
None,9.0,2,1,Early,0,arth,Arthralgia,systemic,,0,130-15
None,9.0,2,2,Day 0,0,arth,Arthralgia,systemic,,0,130-15
None,9.0,2,3,Day 1,0,arth,Arthralgia,systemic,,0,130-15
None,9.0,2,4,Day 2,0,arth,Arthralgia,systemic,,0,130-15
None,9.0,2,5,Day 3,0,arth,Arthralgia,systemic,,0,130-15
None,9.0,2,0,Baseline,1,chill,Chills,systemic,,0,130-15
None,9.0,2,1,Early,0,chill,Chills,systemic,,0,130-15
None,9.0,2,2,Day 0,0,chill,Chills,systemic,,0,130-15
None,9.0,2,3,Day 1,0,chill,Chills,systemic,,0,130-15
None,9.0,2,4,Day 2,0,chill,Chills,systemic,,0,130-15
None,9.0,2,5,Day 3,0,chill,Chills,systemic,,0,130-15
None,9.0,2,0,Baseline,1,flush,Facial Flushing,systemic,,0,130-15
None,9.0,2,1,Early,0,flush,Facial Flushing,systemic,,0,130-15
None,9.0,2,2,Day 0,0,flush,Facial Flushing,systemic,,0,130-15
None,9.0,2,3,Day 1,0,flush,Facial Flushing,systemic,,0,130-15
None,9.0,2,4,Day 2,0,flush,Facial Flushing,systemic,,0,130-15
None,9.0,2,5,Day 3,0,flush,Facial Flushing,systemic,,0,130-15
None,9.0,2,0,Baseline,1,gprur,Generalized Pruritis,systemic,,0,130-15
None,9.0,2,1,Early,0,gprur,Generalized Pruritis,systemic,,0,130-15
None,9.0,2,2,Day 0,0,gprur,Generalized Pruritis,systemic,,0,130-15
None,9.0,2,3,Day 1,0,gprur,Generalized Pruritis,systemic,,0,130-15
None,9.0,2,4,Day 2,0,gprur,Generalized Pruritis,systemic,,0,130-15
None,9.0,2,5,Day 3,0,gprur,Generalized Pruritis,systemic,,0,130-15
None,9.0,2,0,Baseline,1,head,Headache,systemic,,0,130-15
None,9.0,2,1,Early,0,head,Headache,systemic,,0,130-15
None,9.0,2,2,Day 0,0,head,Headache,systemic,,0,130-15
None,9.0,2,3,Day 1,0,head,Headache,systemic,,0,130-15
None,9.0,2,4,Day 2,0,head,Headache,systemic,,0,130-15
None,9.0,2,5,Day 3,0,head,Headache,systemic,,0,130-15
None,9.0,2,0,Baseline,1,mf,Malaise/fatigue,systemic,,0,130-15
None,9.0,2,1,Early,0,mf,Malaise/fatigue,systemic,,0,130-15
None,9.0,2,2,Day 0,0,mf,Malaise/fatigue,systemic,,0,130-15
None,9.0,2,3,Day 1,0,mf,Malaise/fatigue,systemic,,0,130-15
None,9.0,2,4,Day 2,0,mf,Malaise/fatigue,systemic,,0,130-15
None,9.0,2,5,Day 3,0,mf,Malaise/fatigue,systemic,,0,130-15
None,9.0,2,0,Baseline,1,myal,Myalgia,systemic,,0,130-15
None,9.0,2,1,Early,0,myal,Myalgia,systemic,,0,130-15
None,9.0,2,2,Day 0,0,myal,Myalgia,systemic,,0,130-15
None,9.0,2,3,Day 1,0,myal,Myalgia,systemic,,0,130-15
None,9.0,2,4,Day 2,0,myal,Myalgia,systemic,,0,130-15
None,9.0,2,5,Day 3,0,myal,Myalgia,systemic,,0,130-15
None,9.0,2,0,Baseline,1,naus,Nausea,systemic,,0,130-15
None,9.0,2,1,Early,0,naus,Nausea,systemic,,0,130-15
None,9.0,2,2,Day 0,0,naus,Nausea,systemic,,0,130-15
None,9.0,2,3,Day 1,0,naus,Nausea,systemic,,0,130-15
None,9.0,2,4,Day 2,0,naus,Nausea,systemic,,0,130-15
None,9.0,2,5,Day 3,0,naus,Nausea,systemic,,0,130-15
None,9.0,2,0,Baseline,1,ndysp,Non-exertional Dyspnea,systemic,,0,130-15
None,9.0,2,1,Early,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-15
None,9.0,2,2,Day 0,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-15
None,9.0,2,3,Day 1,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-15
None,9.0,2,4,Day 2,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-15
None,9.0,2,5,Day 3,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-15
None,9.0,2,0,Baseline,1,ntach,Non-exertional Tachycardia,systemic,,0,130-15
None,9.0,2,1,Early,0,ntach,Non-exertional Tachycardia,systemic,,0,130-15
None,9.0,2,2,Day 0,0,ntach,Non-exertional Tachycardia,systemic,,0,130-15
None,9.0,2,3,Day 1,0,ntach,Non-exertional Tachycardia,systemic,,0,130-15
None,9.0,2,4,Day 2,0,ntach,Non-exertional Tachycardia,systemic,,0,130-15
None,9.0,2,5,Day 3,0,ntach,Non-exertional Tachycardia,systemic,,0,130-15
< 37.9C (None),9.0,2,0,Baseline,1,tempc,Temperature (C),systemic,,0,130-15
< 37.9C (None),9.0,2,1,Early,0,tempc,Temperature (C),systemic,,0,130-15
< 37.9C (None),9.0,2,2,Day 0,0,tempc,Temperature (C),systemic,,0,130-15
< 37.9C (None),9.0,2,3,Day 1,0,tempc,Temperature (C),systemic,,0,130-15
< 37.9C (None),9.0,2,4,Day 2,0,tempc,Temperature (C),systemic,,0,130-15
< 37.9C (None),9.0,2,5,Day 3,0,tempc,Temperature (C),systemic,,0,130-15
None,9.0,2,0,Baseline,1,udiap,Unexplained Diaphoresis,systemic,,0,130-15
None,9.0,2,1,Early,0,udiap,Unexplained Diaphoresis,systemic,,0,130-15
None,9.0,2,2,Day 0,0,udiap,Unexplained Diaphoresis,systemic,,0,130-15
None,9.0,2,3,Day 1,0,udiap,Unexplained Diaphoresis,systemic,,0,130-15
None,9.0,2,4,Day 2,0,udiap,Unexplained Diaphoresis,systemic,,0,130-15
None,9.0,2,5,Day 3,0,udiap,Unexplained Diaphoresis,systemic,,0,130-15
None,9.0,2,0,Baseline,1,urtic,Urticaria,systemic,,0,130-15
None,9.0,2,1,Early,0,urtic,Urticaria,systemic,,0,130-15
None,9.0,2,2,Day 0,0,urtic,Urticaria,systemic,,0,130-15
None,9.0,2,3,Day 1,0,urtic,Urticaria,systemic,,0,130-15
None,9.0,2,4,Day 2,0,urtic,Urticaria,systemic,,0,130-15
None,9.0,2,5,Day 3,0,urtic,Urticaria,systemic,,0,130-15
None,2.0,1,0,Baseline,1,ery,Erythema,local,left arm,0,130-16
None,2.0,1,1,Early,0,ery,Erythema,local,left arm,0,130-16
None,2.0,1,2,Day 0,0,ery,Erythema,local,left arm,0,130-16
None,2.0,1,3,Day 1,0,ery,Erythema,local,left arm,0,130-16
None,2.0,1,4,Day 2,0,ery,Erythema,local,left arm,0,130-16
None,2.0,1,5,Day 3,0,ery,Erythema,local,left arm,0,130-16
None,2.0,1,0,Baseline,1,ind,Induration,local,left arm,0,130-16
None,2.0,1,1,Early,0,ind,Induration,local,left arm,0,130-16
None,2.0,1,2,Day 0,0,ind,Induration,local,left arm,0,130-16
None,2.0,1,3,Day 1,0,ind,Induration,local,left arm,0,130-16
None,2.0,1,4,Day 2,0,ind,Induration,local,left arm,0,130-16
None,2.0,1,5,Day 3,0,ind,Induration,local,left arm,0,130-16
None,2.0,1,0,Baseline,1,pain,Pain or Tenderness,local,left arm,0,130-16
None,2.0,1,1,Early,0,pain,Pain or Tenderness,local,left arm,0,130-16
None,2.0,1,2,Day 0,0,pain,Pain or Tenderness,local,left arm,0,130-16
None,2.0,1,3,Day 1,0,pain,Pain or Tenderness,local,left arm,0,130-16
None,2.0,1,4,Day 2,0,pain,Pain or Tenderness,local,left arm,0,130-16
None,2.0,1,5,Day 3,0,pain,Pain or Tenderness,local,left arm,0,130-16
None,2.0,1,0,Baseline,1,arth,Arthralgia,systemic,,0,130-16
None,2.0,1,1,Early,0,arth,Arthralgia,systemic,,0,130-16
None,2.0,1,2,Day 0,0,arth,Arthralgia,systemic,,0,130-16
None,2.0,1,3,Day 1,0,arth,Arthralgia,systemic,,0,130-16
None,2.0,1,4,Day 2,0,arth,Arthralgia,systemic,,0,130-16
None,2.0,1,5,Day 3,0,arth,Arthralgia,systemic,,0,130-16
None,2.0,1,0,Baseline,1,chill,Chills,systemic,,0,130-16
None,2.0,1,1,Early,0,chill,Chills,systemic,,0,130-16
None,2.0,1,2,Day 0,0,chill,Chills,systemic,,0,130-16
None,2.0,1,3,Day 1,0,chill,Chills,systemic,,0,130-16
None,2.0,1,4,Day 2,0,chill,Chills,systemic,,0,130-16
None,2.0,1,5,Day 3,0,chill,Chills,systemic,,0,130-16
None,2.0,1,0,Baseline,1,flush,Facial Flushing,systemic,,0,130-16
None,2.0,1,1,Early,0,flush,Facial Flushing,systemic,,0,130-16
None,2.0,1,2,Day 0,0,flush,Facial Flushing,systemic,,0,130-16
None,2.0,1,3,Day 1,0,flush,Facial Flushing,systemic,,0,130-16
None,2.0,1,4,Day 2,0,flush,Facial Flushing,systemic,,0,130-16
None,2.0,1,5,Day 3,0,flush,Facial Flushing,systemic,,0,130-16
None,2.0,1,0,Baseline,1,gprur,Generalized Pruritis,systemic,,0,130-16
None,2.0,1,1,Early,0,gprur,Generalized Pruritis,systemic,,0,130-16
None,2.0,1,2,Day 0,0,gprur,Generalized Pruritis,systemic,,0,130-16
None,2.0,1,3,Day 1,0,gprur,Generalized Pruritis,systemic,,0,130-16
None,2.0,1,4,Day 2,0,gprur,Generalized Pruritis,systemic,,0,130-16
None,2.0,1,5,Day 3,0,gprur,Generalized Pruritis,systemic,,0,130-16
None,2.0,1,0,Baseline,1,head,Headache,systemic,,0,130-16
None,2.0,1,1,Early,0,head,Headache,systemic,,0,130-16
None,2.0,1,2,Day 0,0,head,Headache,systemic,,0,130-16
None,2.0,1,3,Day 1,0,head,Headache,systemic,,0,130-16
None,2.0,1,4,Day 2,0,head,Headache,systemic,,0,130-16
None,2.0,1,5,Day 3,0,head,Headache,systemic,,0,130-16
None,2.0,1,0,Baseline,1,mf,Malaise/fatigue,systemic,,0,130-16
None,2.0,1,1,Early,0,mf,Malaise/fatigue,systemic,,0,130-16
None,2.0,1,2,Day 0,0,mf,Malaise/fatigue,systemic,,0,130-16
None,2.0,1,3,Day 1,0,mf,Malaise/fatigue,systemic,,0,130-16
None,2.0,1,4,Day 2,0,mf,Malaise/fatigue,systemic,,0,130-16
None,2.0,1,5,Day 3,0,mf,Malaise/fatigue,systemic,,0,130-16
None,2.0,1,0,Baseline,1,myal,Myalgia,systemic,,0,130-16
None,2.0,1,1,Early,0,myal,Myalgia,systemic,,0,130-16
None,2.0,1,2,Day 0,0,myal,Myalgia,systemic,,0,130-16
None,2.0,1,3,Day 1,0,myal,Myalgia,systemic,,0,130-16
None,2.0,1,4,Day 2,0,myal,Myalgia,systemic,,0,130-16
None,2.0,1,5,Day 3,0,myal,Myalgia,systemic,,0,130-16
None,2.0,1,0,Baseline,1,naus,Nausea,systemic,,0,130-16
None,2.0,1,1,Early,0,naus,Nausea,systemic,,0,130-16
None,2.0,1,2,Day 0,0,naus,Nausea,systemic,,0,130-16
None,2.0,1,3,Day 1,0,naus,Nausea,systemic,,0,130-16
None,2.0,1,4,Day 2,0,naus,Nausea,systemic,,0,130-16
None,2.0,1,5,Day 3,0,naus,Nausea,systemic,,0,130-16
None,2.0,1,0,Baseline,1,ndysp,Non-exertional Dyspnea,systemic,,0,130-16
None,2.0,1,1,Early,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-16
None,2.0,1,2,Day 0,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-16
None,2.0,1,3,Day 1,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-16
None,2.0,1,4,Day 2,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-16
None,2.0,1,5,Day 3,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-16
None,2.0,1,0,Baseline,1,ntach,Non-exertional Tachycardia,systemic,,0,130-16
None,2.0,1,1,Early,0,ntach,Non-exertional Tachycardia,systemic,,0,130-16
None,2.0,1,2,Day 0,0,ntach,Non-exertional Tachycardia,systemic,,0,130-16
None,2.0,1,3,Day 1,0,ntach,Non-exertional Tachycardia,systemic,,0,130-16
None,2.0,1,4,Day 2,0,ntach,Non-exertional Tachycardia,systemic,,0,130-16
None,2.0,1,5,Day 3,0,ntach,Non-exertional Tachycardia,systemic,,0,130-16
< 37.9C (None),2.0,1,0,Baseline,1,tempc,Temperature (C),systemic,,0,130-16
< 37.9C (None),2.0,1,1,Early,0,tempc,Temperature (C),systemic,,0,130-16
< 37.9C (None),2.0,1,2,Day 0,0,tempc,Temperature (C),systemic,,0,130-16
< 37.9C (None),2.0,1,3,Day 1,0,tempc,Temperature (C),systemic,,0,130-16
< 37.9C (None),2.0,1,4,Day 2,0,tempc,Temperature (C),systemic,,0,130-16
< 37.9C (None),2.0,1,5,Day 3,0,tempc,Temperature (C),systemic,,0,130-16
None,2.0,1,0,Baseline,1,udiap,Unexplained Diaphoresis,systemic,,0,130-16
None,2.0,1,1,Early,0,udiap,Unexplained Diaphoresis,systemic,,0,130-16
None,2.0,1,2,Day 0,0,udiap,Unexplained Diaphoresis,systemic,,0,130-16
None,2.0,1,3,Day 1,0,udiap,Unexplained Diaphoresis,systemic,,0,130-16
None,2.0,1,4,Day 2,0,udiap,Unexplained Diaphoresis,systemic,,0,130-16
None,2.0,1,5,Day 3,0,udiap,Unexplained Diaphoresis,systemic,,0,130-16
None,2.0,1,0,Baseline,1,urtic,Urticaria,systemic,,0,130-16
None,2.0,1,1,Early,0,urtic,Urticaria,systemic,,0,130-16
None,2.0,1,2,Day 0,0,urtic,Urticaria,systemic,,0,130-16
None,2.0,1,3,Day 1,0,urtic,Urticaria,systemic,,0,130-16
None,2.0,1,4,Day 2,0,urtic,Urticaria,systemic,,0,130-16
None,2.0,1,5,Day 3,0,urtic,Urticaria,systemic,,0,130-16
None,9.0,2,0,Baseline,1,ery,Erythema,local,left arm,0,130-16
None,9.0,2,1,Early,0,ery,Erythema,local,left arm,0,130-16
None,9.0,2,2,Day 0,0,ery,Erythema,local,left arm,0,130-16
None,9.0,2,3,Day 1,0,ery,Erythema,local,left arm,0,130-16
None,9.0,2,4,Day 2,0,ery,Erythema,local,left arm,0,130-16
None,9.0,2,5,Day 3,0,ery,Erythema,local,left arm,0,130-16
None,9.0,2,0,Baseline,1,ind,Induration,local,left arm,0,130-16
None,9.0,2,1,Early,0,ind,Induration,local,left arm,0,130-16
None,9.0,2,2,Day 0,0,ind,Induration,local,left arm,0,130-16
None,9.0,2,3,Day 1,0,ind,Induration,local,left arm,0,130-16
None,9.0,2,4,Day 2,0,ind,Induration,local,left arm,0,130-16
None,9.0,2,5,Day 3,0,ind,Induration,local,left arm,0,130-16
None,9.0,2,0,Baseline,1,pain,Pain or Tenderness,local,left arm,0,130-16
None,9.0,2,1,Early,0,pain,Pain or Tenderness,local,left arm,0,130-16
None,9.0,2,1,Early,0,pain,Pain or Tenderness,local,unknown,0,130-16
None,9.0,2,2,Day 0,0,pain,Pain or Tenderness,local,left arm,0,130-16
None,9.0,2,3,Day 1,0,pain,Pain or Tenderness,local,left arm,0,130-16
None,9.0,2,4,Day 2,0,pain,Pain or Tenderness,local,left arm,0,130-16
None,9.0,2,5,Day 3,0,pain,Pain or Tenderness,local,left arm,0,130-16
None,9.0,2,0,Baseline,1,arth,Arthralgia,systemic,,0,130-16
None,9.0,2,1,Early,0,arth,Arthralgia,systemic,,0,130-16
None,9.0,2,2,Day 0,0,arth,Arthralgia,systemic,,0,130-16
None,9.0,2,3,Day 1,0,arth,Arthralgia,systemic,,0,130-16
None,9.0,2,4,Day 2,0,arth,Arthralgia,systemic,,0,130-16
None,9.0,2,5,Day 3,0,arth,Arthralgia,systemic,,0,130-16
None,9.0,2,0,Baseline,1,chill,Chills,systemic,,0,130-16
None,9.0,2,1,Early,0,chill,Chills,systemic,,0,130-16
None,9.0,2,2,Day 0,0,chill,Chills,systemic,,0,130-16
None,9.0,2,3,Day 1,0,chill,Chills,systemic,,0,130-16
None,9.0,2,4,Day 2,0,chill,Chills,systemic,,0,130-16
None,9.0,2,5,Day 3,0,chill,Chills,systemic,,0,130-16
None,9.0,2,0,Baseline,1,flush,Facial Flushing,systemic,,0,130-16
None,9.0,2,1,Early,0,flush,Facial Flushing,systemic,,0,130-16
None,9.0,2,2,Day 0,0,flush,Facial Flushing,systemic,,0,130-16
None,9.0,2,3,Day 1,0,flush,Facial Flushing,systemic,,0,130-16
None,9.0,2,4,Day 2,0,flush,Facial Flushing,systemic,,0,130-16
None,9.0,2,5,Day 3,0,flush,Facial Flushing,systemic,,0,130-16
None,9.0,2,0,Baseline,1,gprur,Generalized Pruritis,systemic,,0,130-16
None,9.0,2,1,Early,0,gprur,Generalized Pruritis,systemic,,0,130-16
None,9.0,2,2,Day 0,0,gprur,Generalized Pruritis,systemic,,0,130-16
None,9.0,2,3,Day 1,0,gprur,Generalized Pruritis,systemic,,0,130-16
None,9.0,2,4,Day 2,0,gprur,Generalized Pruritis,systemic,,0,130-16
None,9.0,2,5,Day 3,0,gprur,Generalized Pruritis,systemic,,0,130-16
None,9.0,2,0,Baseline,1,head,Headache,systemic,,0,130-16
None,9.0,2,1,Early,0,head,Headache,systemic,,0,130-16
None,9.0,2,2,Day 0,0,head,Headache,systemic,,0,130-16
None,9.0,2,3,Day 1,0,head,Headache,systemic,,0,130-16
None,9.0,2,4,Day 2,0,head,Headache,systemic,,0,130-16
None,9.0,2,5,Day 3,0,head,Headache,systemic,,0,130-16
None,9.0,2,0,Baseline,1,mf,Malaise/fatigue,systemic,,0,130-16
None,9.0,2,1,Early,0,mf,Malaise/fatigue,systemic,,0,130-16
None,9.0,2,2,Day 0,0,mf,Malaise/fatigue,systemic,,0,130-16
None,9.0,2,3,Day 1,0,mf,Malaise/fatigue,systemic,,0,130-16
None,9.0,2,4,Day 2,0,mf,Malaise/fatigue,systemic,,0,130-16
None,9.0,2,5,Day 3,0,mf,Malaise/fatigue,systemic,,0,130-16
None,9.0,2,0,Baseline,1,myal,Myalgia,systemic,,0,130-16
None,9.0,2,1,Early,0,myal,Myalgia,systemic,,0,130-16
None,9.0,2,2,Day 0,0,myal,Myalgia,systemic,,0,130-16
None,9.0,2,3,Day 1,0,myal,Myalgia,systemic,,0,130-16
None,9.0,2,4,Day 2,0,myal,Myalgia,systemic,,0,130-16
None,9.0,2,5,Day 3,0,myal,Myalgia,systemic,,0,130-16
None,9.0,2,0,Baseline,1,naus,Nausea,systemic,,0,130-16
None,9.0,2,1,Early,0,naus,Nausea,systemic,,0,130-16
None,9.0,2,2,Day 0,0,naus,Nausea,systemic,,0,130-16
None,9.0,2,3,Day 1,0,naus,Nausea,systemic,,0,130-16
None,9.0,2,4,Day 2,0,naus,Nausea,systemic,,0,130-16
None,9.0,2,5,Day 3,0,naus,Nausea,systemic,,0,130-16
None,9.0,2,0,Baseline,1,ndysp,Non-exertional Dyspnea,systemic,,0,130-16
None,9.0,2,1,Early,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-16
None,9.0,2,2,Day 0,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-16
None,9.0,2,3,Day 1,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-16
None,9.0,2,4,Day 2,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-16
None,9.0,2,5,Day 3,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-16
None,9.0,2,0,Baseline,1,ntach,Non-exertional Tachycardia,systemic,,0,130-16
None,9.0,2,1,Early,0,ntach,Non-exertional Tachycardia,systemic,,0,130-16
None,9.0,2,2,Day 0,0,ntach,Non-exertional Tachycardia,systemic,,0,130-16
None,9.0,2,3,Day 1,0,ntach,Non-exertional Tachycardia,systemic,,0,130-16
None,9.0,2,4,Day 2,0,ntach,Non-exertional Tachycardia,systemic,,0,130-16
None,9.0,2,5,Day 3,0,ntach,Non-exertional Tachycardia,systemic,,0,130-16
< 37.9C (None),9.0,2,0,Baseline,1,tempc,Temperature (C),systemic,,0,130-16
< 37.9C (None),9.0,2,1,Early,0,tempc,Temperature (C),systemic,,0,130-16
< 37.9C (None),9.0,2,2,Day 0,0,tempc,Temperature (C),systemic,,0,130-16
< 37.9C (None),9.0,2,3,Day 1,0,tempc,Temperature (C),systemic,,0,130-16
< 37.9C (None),9.0,2,4,Day 2,0,tempc,Temperature (C),systemic,,0,130-16
< 37.9C (None),9.0,2,5,Day 3,0,tempc,Temperature (C),systemic,,0,130-16
None,9.0,2,0,Baseline,1,udiap,Unexplained Diaphoresis,systemic,,0,130-16
None,9.0,2,1,Early,0,udiap,Unexplained Diaphoresis,systemic,,0,130-16
None,9.0,2,2,Day 0,0,udiap,Unexplained Diaphoresis,systemic,,0,130-16
None,9.0,2,3,Day 1,0,udiap,Unexplained Diaphoresis,systemic,,0,130-16
None,9.0,2,4,Day 2,0,udiap,Unexplained Diaphoresis,systemic,,0,130-16
None,9.0,2,5,Day 3,0,udiap,Unexplained Diaphoresis,systemic,,0,130-16
None,9.0,2,0,Baseline,1,urtic,Urticaria,systemic,,0,130-16
None,9.0,2,1,Early,0,urtic,Urticaria,systemic,,0,130-16
None,9.0,2,2,Day 0,0,urtic,Urticaria,systemic,,0,130-16
None,9.0,2,3,Day 1,0,urtic,Urticaria,systemic,,0,130-16
None,9.0,2,4,Day 2,0,urtic,Urticaria,systemic,,0,130-16
None,9.0,2,5,Day 3,0,urtic,Urticaria,systemic,,0,130-16
None,2.0,1,0,Baseline,1,ery,Erythema,local,right arm,0,130-17
None,2.0,1,1,Early,0,ery,Erythema,local,right arm,0,130-17
None,2.0,1,2,Day 0,0,ery,Erythema,local,right arm,0,130-17
None,2.0,1,3,Day 1,0,ery,Erythema,local,right arm,0,130-17
None,2.0,1,4,Day 2,0,ery,Erythema,local,right arm,0,130-17
None,2.0,1,5,Day 3,0,ery,Erythema,local,right arm,0,130-17
None,2.0,1,0,Baseline,1,ind,Induration,local,right arm,0,130-17
None,2.0,1,1,Early,0,ind,Induration,local,right arm,0,130-17
None,2.0,1,2,Day 0,0,ind,Induration,local,right arm,0,130-17
None,2.0,1,3,Day 1,0,ind,Induration,local,right arm,0,130-17
None,2.0,1,4,Day 2,0,ind,Induration,local,right arm,0,130-17
None,2.0,1,5,Day 3,0,ind,Induration,local,right arm,0,130-17
None,2.0,1,0,Baseline,1,pain,Pain or Tenderness,local,right arm,0,130-17
None,2.0,1,1,Early,0,pain,Pain or Tenderness,local,right arm,0,130-17
None,2.0,1,2,Day 0,0,pain,Pain or Tenderness,local,right arm,0,130-17
None,2.0,1,3,Day 1,0,pain,Pain or Tenderness,local,right arm,0,130-17
None,2.0,1,4,Day 2,0,pain,Pain or Tenderness,local,right arm,0,130-17
None,2.0,1,5,Day 3,0,pain,Pain or Tenderness,local,right arm,0,130-17
None,2.0,1,0,Baseline,1,arth,Arthralgia,systemic,,0,130-17
None,2.0,1,1,Early,0,arth,Arthralgia,systemic,,0,130-17
None,2.0,1,2,Day 0,0,arth,Arthralgia,systemic,,0,130-17
None,2.0,1,3,Day 1,0,arth,Arthralgia,systemic,,0,130-17
None,2.0,1,4,Day 2,0,arth,Arthralgia,systemic,,0,130-17
None,2.0,1,5,Day 3,0,arth,Arthralgia,systemic,,0,130-17
None,2.0,1,0,Baseline,1,chill,Chills,systemic,,0,130-17
None,2.0,1,1,Early,0,chill,Chills,systemic,,0,130-17
Mild,2.0,1,2,Day 0,0,chill,Chills,systemic,,1,130-17
None,2.0,1,3,Day 1,0,chill,Chills,systemic,,0,130-17
None,2.0,1,4,Day 2,0,chill,Chills,systemic,,0,130-17
None,2.0,1,5,Day 3,0,chill,Chills,systemic,,0,130-17
None,2.0,1,0,Baseline,1,flush,Facial Flushing,systemic,,0,130-17
None,2.0,1,1,Early,0,flush,Facial Flushing,systemic,,0,130-17
None,2.0,1,2,Day 0,0,flush,Facial Flushing,systemic,,0,130-17
None,2.0,1,3,Day 1,0,flush,Facial Flushing,systemic,,0,130-17
None,2.0,1,4,Day 2,0,flush,Facial Flushing,systemic,,0,130-17
None,2.0,1,5,Day 3,0,flush,Facial Flushing,systemic,,0,130-17
None,2.0,1,0,Baseline,1,gprur,Generalized Pruritis,systemic,,0,130-17
None,2.0,1,1,Early,0,gprur,Generalized Pruritis,systemic,,0,130-17
None,2.0,1,2,Day 0,0,gprur,Generalized Pruritis,systemic,,0,130-17
None,2.0,1,3,Day 1,0,gprur,Generalized Pruritis,systemic,,0,130-17
None,2.0,1,4,Day 2,0,gprur,Generalized Pruritis,systemic,,0,130-17
None,2.0,1,5,Day 3,0,gprur,Generalized Pruritis,systemic,,0,130-17
None,2.0,1,0,Baseline,1,head,Headache,systemic,,0,130-17
None,2.0,1,1,Early,0,head,Headache,systemic,,0,130-17
None,2.0,1,2,Day 0,0,head,Headache,systemic,,0,130-17
None,2.0,1,3,Day 1,0,head,Headache,systemic,,0,130-17
None,2.0,1,4,Day 2,0,head,Headache,systemic,,0,130-17
None,2.0,1,5,Day 3,0,head,Headache,systemic,,0,130-17
None,2.0,1,0,Baseline,1,mf,Malaise/fatigue,systemic,,0,130-17
Mild,2.0,1,1,Early,0,mf,Malaise/fatigue,systemic,,1,130-17
None,2.0,1,2,Day 0,0,mf,Malaise/fatigue,systemic,,0,130-17
None,2.0,1,3,Day 1,0,mf,Malaise/fatigue,systemic,,0,130-17
None,2.0,1,4,Day 2,0,mf,Malaise/fatigue,systemic,,0,130-17
None,2.0,1,5,Day 3,0,mf,Malaise/fatigue,systemic,,0,130-17
None,2.0,1,0,Baseline,1,myal,Myalgia,systemic,,0,130-17
Mild,2.0,1,1,Early,0,myal,Myalgia,systemic,,1,130-17
Mild,2.0,1,2,Day 0,0,myal,Myalgia,systemic,,1,130-17
None,2.0,1,3,Day 1,0,myal,Myalgia,systemic,,0,130-17
None,2.0,1,4,Day 2,0,myal,Myalgia,systemic,,0,130-17
None,2.0,1,5,Day 3,0,myal,Myalgia,systemic,,0,130-17
None,2.0,1,0,Baseline,1,naus,Nausea,systemic,,0,130-17
None,2.0,1,1,Early,0,naus,Nausea,systemic,,0,130-17
None,2.0,1,2,Day 0,0,naus,Nausea,systemic,,0,130-17
None,2.0,1,3,Day 1,0,naus,Nausea,systemic,,0,130-17
None,2.0,1,4,Day 2,0,naus,Nausea,systemic,,0,130-17
None,2.0,1,5,Day 3,0,naus,Nausea,systemic,,0,130-17
None,2.0,1,0,Baseline,1,ndysp,Non-exertional Dyspnea,systemic,,0,130-17
None,2.0,1,1,Early,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-17
None,2.0,1,2,Day 0,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-17
None,2.0,1,3,Day 1,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-17
None,2.0,1,4,Day 2,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-17
None,2.0,1,5,Day 3,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-17
None,2.0,1,0,Baseline,1,ntach,Non-exertional Tachycardia,systemic,,0,130-17
None,2.0,1,1,Early,0,ntach,Non-exertional Tachycardia,systemic,,0,130-17
None,2.0,1,2,Day 0,0,ntach,Non-exertional Tachycardia,systemic,,0,130-17
None,2.0,1,3,Day 1,0,ntach,Non-exertional Tachycardia,systemic,,0,130-17
None,2.0,1,4,Day 2,0,ntach,Non-exertional Tachycardia,systemic,,0,130-17
None,2.0,1,5,Day 3,0,ntach,Non-exertional Tachycardia,systemic,,0,130-17
< 37.9C (None),2.0,1,0,Baseline,1,tempc,Temperature (C),systemic,,0,130-17
< 37.9C (None),2.0,1,1,Early,0,tempc,Temperature (C),systemic,,0,130-17
< 37.9C (None),2.0,1,2,Day 0,0,tempc,Temperature (C),systemic,,0,130-17
< 37.9C (None),2.0,1,3,Day 1,0,tempc,Temperature (C),systemic,,0,130-17
< 37.9C (None),2.0,1,4,Day 2,0,tempc,Temperature (C),systemic,,0,130-17
< 37.9C (None),2.0,1,5,Day 3,0,tempc,Temperature (C),systemic,,0,130-17
None,2.0,1,0,Baseline,1,udiap,Unexplained Diaphoresis,systemic,,0,130-17
None,2.0,1,1,Early,0,udiap,Unexplained Diaphoresis,systemic,,0,130-17
None,2.0,1,2,Day 0,0,udiap,Unexplained Diaphoresis,systemic,,0,130-17
None,2.0,1,3,Day 1,0,udiap,Unexplained Diaphoresis,systemic,,0,130-17
None,2.0,1,4,Day 2,0,udiap,Unexplained Diaphoresis,systemic,,0,130-17
None,2.0,1,5,Day 3,0,udiap,Unexplained Diaphoresis,systemic,,0,130-17
None,2.0,1,0,Baseline,1,urtic,Urticaria,systemic,,0,130-17
None,2.0,1,1,Early,0,urtic,Urticaria,systemic,,0,130-17
None,2.0,1,2,Day 0,0,urtic,Urticaria,systemic,,0,130-17
None,2.0,1,3,Day 1,0,urtic,Urticaria,systemic,,0,130-17
None,2.0,1,4,Day 2,0,urtic,Urticaria,systemic,,0,130-17
None,2.0,1,5,Day 3,0,urtic,Urticaria,systemic,,0,130-17
None,2.0,1,0,Baseline,1,ery,Erythema,local,left arm,0,130-18
None,2.0,1,1,Early,0,ery,Erythema,local,left arm,0,130-18
None,2.0,1,2,Day 0,0,ery,Erythema,local,left arm,0,130-18
None,2.0,1,3,Day 1,0,ery,Erythema,local,left arm,0,130-18
None,2.0,1,4,Day 2,0,ery,Erythema,local,left arm,0,130-18
None,2.0,1,5,Day 3,0,ery,Erythema,local,left arm,0,130-18
None,2.0,1,0,Baseline,1,ind,Induration,local,left arm,0,130-18
None,2.0,1,1,Early,0,ind,Induration,local,left arm,0,130-18
None,2.0,1,2,Day 0,0,ind,Induration,local,left arm,0,130-18
None,2.0,1,3,Day 1,0,ind,Induration,local,left arm,0,130-18
None,2.0,1,4,Day 2,0,ind,Induration,local,left arm,0,130-18
None,2.0,1,5,Day 3,0,ind,Induration,local,left arm,0,130-18
None,2.0,1,0,Baseline,1,pain,Pain or Tenderness,local,left arm,0,130-18
None,2.0,1,1,Early,0,pain,Pain or Tenderness,local,left arm,0,130-18
None,2.0,1,2,Day 0,0,pain,Pain or Tenderness,local,left arm,0,130-18
None,2.0,1,3,Day 1,0,pain,Pain or Tenderness,local,left arm,0,130-18
None,2.0,1,4,Day 2,0,pain,Pain or Tenderness,local,left arm,0,130-18
None,2.0,1,5,Day 3,0,pain,Pain or Tenderness,local,left arm,0,130-18
None,2.0,1,0,Baseline,1,arth,Arthralgia,systemic,,0,130-18
None,2.0,1,1,Early,0,arth,Arthralgia,systemic,,0,130-18
None,2.0,1,2,Day 0,0,arth,Arthralgia,systemic,,0,130-18
None,2.0,1,3,Day 1,0,arth,Arthralgia,systemic,,0,130-18
None,2.0,1,4,Day 2,0,arth,Arthralgia,systemic,,0,130-18
None,2.0,1,5,Day 3,0,arth,Arthralgia,systemic,,0,130-18
None,2.0,1,0,Baseline,1,chill,Chills,systemic,,0,130-18
None,2.0,1,1,Early,0,chill,Chills,systemic,,0,130-18
None,2.0,1,2,Day 0,0,chill,Chills,systemic,,0,130-18
None,2.0,1,3,Day 1,0,chill,Chills,systemic,,0,130-18
None,2.0,1,4,Day 2,0,chill,Chills,systemic,,0,130-18
None,2.0,1,5,Day 3,0,chill,Chills,systemic,,0,130-18
None,2.0,1,0,Baseline,1,flush,Facial Flushing,systemic,,0,130-18
None,2.0,1,1,Early,0,flush,Facial Flushing,systemic,,0,130-18
None,2.0,1,2,Day 0,0,flush,Facial Flushing,systemic,,0,130-18
None,2.0,1,3,Day 1,0,flush,Facial Flushing,systemic,,0,130-18
None,2.0,1,4,Day 2,0,flush,Facial Flushing,systemic,,0,130-18
None,2.0,1,5,Day 3,0,flush,Facial Flushing,systemic,,0,130-18
None,2.0,1,0,Baseline,1,gprur,Generalized Pruritis,systemic,,0,130-18
None,2.0,1,1,Early,0,gprur,Generalized Pruritis,systemic,,0,130-18
None,2.0,1,2,Day 0,0,gprur,Generalized Pruritis,systemic,,0,130-18
None,2.0,1,3,Day 1,0,gprur,Generalized Pruritis,systemic,,0,130-18
None,2.0,1,4,Day 2,0,gprur,Generalized Pruritis,systemic,,0,130-18
None,2.0,1,5,Day 3,0,gprur,Generalized Pruritis,systemic,,0,130-18
None,2.0,1,0,Baseline,1,head,Headache,systemic,,0,130-18
None,2.0,1,1,Early,0,head,Headache,systemic,,0,130-18
None,2.0,1,2,Day 0,0,head,Headache,systemic,,0,130-18
None,2.0,1,3,Day 1,0,head,Headache,systemic,,0,130-18
None,2.0,1,4,Day 2,0,head,Headache,systemic,,0,130-18
None,2.0,1,5,Day 3,0,head,Headache,systemic,,0,130-18
None,2.0,1,0,Baseline,1,mf,Malaise/fatigue,systemic,,0,130-18
None,2.0,1,1,Early,0,mf,Malaise/fatigue,systemic,,0,130-18
None,2.0,1,2,Day 0,0,mf,Malaise/fatigue,systemic,,0,130-18
None,2.0,1,3,Day 1,0,mf,Malaise/fatigue,systemic,,0,130-18
None,2.0,1,4,Day 2,0,mf,Malaise/fatigue,systemic,,0,130-18
None,2.0,1,5,Day 3,0,mf,Malaise/fatigue,systemic,,0,130-18
None,2.0,1,0,Baseline,1,myal,Myalgia,systemic,,0,130-18
None,2.0,1,1,Early,0,myal,Myalgia,systemic,,0,130-18
None,2.0,1,2,Day 0,0,myal,Myalgia,systemic,,0,130-18
None,2.0,1,3,Day 1,0,myal,Myalgia,systemic,,0,130-18
None,2.0,1,4,Day 2,0,myal,Myalgia,systemic,,0,130-18
None,2.0,1,5,Day 3,0,myal,Myalgia,systemic,,0,130-18
None,2.0,1,0,Baseline,1,naus,Nausea,systemic,,0,130-18
None,2.0,1,1,Early,0,naus,Nausea,systemic,,0,130-18
None,2.0,1,2,Day 0,0,naus,Nausea,systemic,,0,130-18
None,2.0,1,3,Day 1,0,naus,Nausea,systemic,,0,130-18
None,2.0,1,4,Day 2,0,naus,Nausea,systemic,,0,130-18
None,2.0,1,5,Day 3,0,naus,Nausea,systemic,,0,130-18
None,2.0,1,0,Baseline,1,ndysp,Non-exertional Dyspnea,systemic,,0,130-18
None,2.0,1,1,Early,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-18
None,2.0,1,2,Day 0,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-18
None,2.0,1,3,Day 1,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-18
None,2.0,1,4,Day 2,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-18
None,2.0,1,5,Day 3,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-18
None,2.0,1,0,Baseline,1,ntach,Non-exertional Tachycardia,systemic,,0,130-18
None,2.0,1,1,Early,0,ntach,Non-exertional Tachycardia,systemic,,0,130-18
None,2.0,1,2,Day 0,0,ntach,Non-exertional Tachycardia,systemic,,0,130-18
None,2.0,1,3,Day 1,0,ntach,Non-exertional Tachycardia,systemic,,0,130-18
None,2.0,1,4,Day 2,0,ntach,Non-exertional Tachycardia,systemic,,0,130-18
None,2.0,1,5,Day 3,0,ntach,Non-exertional Tachycardia,systemic,,0,130-18
< 37.9C (None),2.0,1,0,Baseline,1,tempc,Temperature (C),systemic,,0,130-18
< 37.9C (None),2.0,1,1,Early,0,tempc,Temperature (C),systemic,,0,130-18
< 37.9C (None),2.0,1,2,Day 0,0,tempc,Temperature (C),systemic,,0,130-18
< 37.9C (None),2.0,1,3,Day 1,0,tempc,Temperature (C),systemic,,0,130-18
< 37.9C (None),2.0,1,4,Day 2,0,tempc,Temperature (C),systemic,,0,130-18
< 37.9C (None),2.0,1,5,Day 3,0,tempc,Temperature (C),systemic,,0,130-18
None,2.0,1,0,Baseline,1,udiap,Unexplained Diaphoresis,systemic,,0,130-18
None,2.0,1,1,Early,0,udiap,Unexplained Diaphoresis,systemic,,0,130-18
None,2.0,1,2,Day 0,0,udiap,Unexplained Diaphoresis,systemic,,0,130-18
None,2.0,1,3,Day 1,0,udiap,Unexplained Diaphoresis,systemic,,0,130-18
None,2.0,1,4,Day 2,0,udiap,Unexplained Diaphoresis,systemic,,0,130-18
None,2.0,1,5,Day 3,0,udiap,Unexplained Diaphoresis,systemic,,0,130-18
None,2.0,1,0,Baseline,1,urtic,Urticaria,systemic,,0,130-18
None,2.0,1,1,Early,0,urtic,Urticaria,systemic,,0,130-18
None,2.0,1,2,Day 0,0,urtic,Urticaria,systemic,,0,130-18
None,2.0,1,3,Day 1,0,urtic,Urticaria,systemic,,0,130-18
None,2.0,1,4,Day 2,0,urtic,Urticaria,systemic,,0,130-18
None,2.0,1,5,Day 3,0,urtic,Urticaria,systemic,,0,130-18
None,2.0,1,0,Baseline,1,ery,Erythema,local,left arm,0,130-19
None,2.0,1,1,Early,0,ery,Erythema,local,left arm,0,130-19
None,2.0,1,2,Day 0,0,ery,Erythema,local,left arm,0,130-19
None,2.0,1,3,Day 1,0,ery,Erythema,local,left arm,0,130-19
None,2.0,1,4,Day 2,0,ery,Erythema,local,left arm,0,130-19
None,2.0,1,5,Day 3,0,ery,Erythema,local,left arm,0,130-19
None,2.0,1,0,Baseline,1,ind,Induration,local,left arm,0,130-19
None,2.0,1,1,Early,0,ind,Induration,local,left arm,0,130-19
None,2.0,1,2,Day 0,0,ind,Induration,local,left arm,0,130-19
None,2.0,1,3,Day 1,0,ind,Induration,local,left arm,0,130-19
None,2.0,1,4,Day 2,0,ind,Induration,local,left arm,0,130-19
None,2.0,1,5,Day 3,0,ind,Induration,local,left arm,0,130-19
None,2.0,1,0,Baseline,1,pain,Pain or Tenderness,local,left arm,0,130-19
None,2.0,1,1,Early,0,pain,Pain or Tenderness,local,left arm,0,130-19
None,2.0,1,2,Day 0,0,pain,Pain or Tenderness,local,left arm,0,130-19
None,2.0,1,3,Day 1,0,pain,Pain or Tenderness,local,left arm,0,130-19
None,2.0,1,4,Day 2,0,pain,Pain or Tenderness,local,left arm,0,130-19
None,2.0,1,5,Day 3,0,pain,Pain or Tenderness,local,left arm,0,130-19
None,2.0,1,0,Baseline,1,arth,Arthralgia,systemic,,0,130-19
None,2.0,1,1,Early,0,arth,Arthralgia,systemic,,0,130-19
None,2.0,1,2,Day 0,0,arth,Arthralgia,systemic,,0,130-19
None,2.0,1,3,Day 1,0,arth,Arthralgia,systemic,,0,130-19
None,2.0,1,4,Day 2,0,arth,Arthralgia,systemic,,0,130-19
None,2.0,1,5,Day 3,0,arth,Arthralgia,systemic,,0,130-19
None,2.0,1,0,Baseline,1,chill,Chills,systemic,,0,130-19
None,2.0,1,1,Early,0,chill,Chills,systemic,,0,130-19
None,2.0,1,2,Day 0,0,chill,Chills,systemic,,0,130-19
None,2.0,1,3,Day 1,0,chill,Chills,systemic,,0,130-19
None,2.0,1,4,Day 2,0,chill,Chills,systemic,,0,130-19
None,2.0,1,5,Day 3,0,chill,Chills,systemic,,0,130-19
None,2.0,1,0,Baseline,1,flush,Facial Flushing,systemic,,0,130-19
None,2.0,1,1,Early,0,flush,Facial Flushing,systemic,,0,130-19
None,2.0,1,2,Day 0,0,flush,Facial Flushing,systemic,,0,130-19
None,2.0,1,3,Day 1,0,flush,Facial Flushing,systemic,,0,130-19
None,2.0,1,4,Day 2,0,flush,Facial Flushing,systemic,,0,130-19
None,2.0,1,5,Day 3,0,flush,Facial Flushing,systemic,,0,130-19
None,2.0,1,0,Baseline,1,gprur,Generalized Pruritis,systemic,,0,130-19
None,2.0,1,1,Early,0,gprur,Generalized Pruritis,systemic,,0,130-19
None,2.0,1,2,Day 0,0,gprur,Generalized Pruritis,systemic,,0,130-19
None,2.0,1,3,Day 1,0,gprur,Generalized Pruritis,systemic,,0,130-19
None,2.0,1,4,Day 2,0,gprur,Generalized Pruritis,systemic,,0,130-19
None,2.0,1,5,Day 3,0,gprur,Generalized Pruritis,systemic,,0,130-19
None,2.0,1,0,Baseline,1,head,Headache,systemic,,0,130-19
None,2.0,1,1,Early,0,head,Headache,systemic,,0,130-19
None,2.0,1,2,Day 0,0,head,Headache,systemic,,0,130-19
None,2.0,1,3,Day 1,0,head,Headache,systemic,,0,130-19
None,2.0,1,4,Day 2,0,head,Headache,systemic,,0,130-19
None,2.0,1,5,Day 3,0,head,Headache,systemic,,0,130-19
None,2.0,1,0,Baseline,1,mf,Malaise/fatigue,systemic,,0,130-19
None,2.0,1,1,Early,0,mf,Malaise/fatigue,systemic,,0,130-19
None,2.0,1,2,Day 0,0,mf,Malaise/fatigue,systemic,,0,130-19
None,2.0,1,3,Day 1,0,mf,Malaise/fatigue,systemic,,0,130-19
None,2.0,1,4,Day 2,0,mf,Malaise/fatigue,systemic,,0,130-19
None,2.0,1,5,Day 3,0,mf,Malaise/fatigue,systemic,,0,130-19
None,2.0,1,0,Baseline,1,myal,Myalgia,systemic,,0,130-19
None,2.0,1,1,Early,0,myal,Myalgia,systemic,,0,130-19
None,2.0,1,2,Day 0,0,myal,Myalgia,systemic,,0,130-19
None,2.0,1,3,Day 1,0,myal,Myalgia,systemic,,0,130-19
None,2.0,1,4,Day 2,0,myal,Myalgia,systemic,,0,130-19
None,2.0,1,5,Day 3,0,myal,Myalgia,systemic,,0,130-19
None,2.0,1,0,Baseline,1,naus,Nausea,systemic,,0,130-19
None,2.0,1,1,Early,0,naus,Nausea,systemic,,0,130-19
None,2.0,1,2,Day 0,0,naus,Nausea,systemic,,0,130-19
None,2.0,1,3,Day 1,0,naus,Nausea,systemic,,0,130-19
None,2.0,1,4,Day 2,0,naus,Nausea,systemic,,0,130-19
None,2.0,1,5,Day 3,0,naus,Nausea,systemic,,0,130-19
None,2.0,1,0,Baseline,1,ndysp,Non-exertional Dyspnea,systemic,,0,130-19
None,2.0,1,1,Early,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-19
None,2.0,1,2,Day 0,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-19
None,2.0,1,3,Day 1,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-19
None,2.0,1,4,Day 2,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-19
None,2.0,1,5,Day 3,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-19
None,2.0,1,0,Baseline,1,ntach,Non-exertional Tachycardia,systemic,,0,130-19
None,2.0,1,1,Early,0,ntach,Non-exertional Tachycardia,systemic,,0,130-19
None,2.0,1,2,Day 0,0,ntach,Non-exertional Tachycardia,systemic,,0,130-19
None,2.0,1,3,Day 1,0,ntach,Non-exertional Tachycardia,systemic,,0,130-19
None,2.0,1,4,Day 2,0,ntach,Non-exertional Tachycardia,systemic,,0,130-19
None,2.0,1,5,Day 3,0,ntach,Non-exertional Tachycardia,systemic,,0,130-19
< 37.9C (None),2.0,1,0,Baseline,1,tempc,Temperature (C),systemic,,0,130-19
< 37.9C (None),2.0,1,1,Early,0,tempc,Temperature (C),systemic,,0,130-19
< 37.9C (None),2.0,1,2,Day 0,0,tempc,Temperature (C),systemic,,0,130-19
< 37.9C (None),2.0,1,3,Day 1,0,tempc,Temperature (C),systemic,,0,130-19
< 37.9C (None),2.0,1,4,Day 2,0,tempc,Temperature (C),systemic,,0,130-19
< 37.9C (None),2.0,1,5,Day 3,0,tempc,Temperature (C),systemic,,0,130-19
None,2.0,1,0,Baseline,1,udiap,Unexplained Diaphoresis,systemic,,0,130-19
None,2.0,1,1,Early,0,udiap,Unexplained Diaphoresis,systemic,,0,130-19
None,2.0,1,2,Day 0,0,udiap,Unexplained Diaphoresis,systemic,,0,130-19
None,2.0,1,3,Day 1,0,udiap,Unexplained Diaphoresis,systemic,,0,130-19
None,2.0,1,4,Day 2,0,udiap,Unexplained Diaphoresis,systemic,,0,130-19
None,2.0,1,5,Day 3,0,udiap,Unexplained Diaphoresis,systemic,,0,130-19
None,2.0,1,0,Baseline,1,urtic,Urticaria,systemic,,0,130-19
None,2.0,1,1,Early,0,urtic,Urticaria,systemic,,0,130-19
None,2.0,1,2,Day 0,0,urtic,Urticaria,systemic,,0,130-19
None,2.0,1,3,Day 1,0,urtic,Urticaria,systemic,,0,130-19
None,2.0,1,4,Day 2,0,urtic,Urticaria,systemic,,0,130-19
None,2.0,1,5,Day 3,0,urtic,Urticaria,systemic,,0,130-19
None,9.0,2,0,Baseline,1,ery,Erythema,local,left arm,0,130-19
None,9.0,2,1,Early,0,ery,Erythema,local,left arm,0,130-19
None,9.0,2,2,Day 0,0,ery,Erythema,local,left arm,0,130-19
None,9.0,2,3,Day 1,0,ery,Erythema,local,left arm,0,130-19
None,9.0,2,4,Day 2,0,ery,Erythema,local,left arm,0,130-19
None,9.0,2,5,Day 3,0,ery,Erythema,local,left arm,0,130-19
None,9.0,2,0,Baseline,1,ind,Induration,local,left arm,0,130-19
None,9.0,2,1,Early,0,ind,Induration,local,left arm,0,130-19
None,9.0,2,2,Day 0,0,ind,Induration,local,left arm,0,130-19
None,9.0,2,3,Day 1,0,ind,Induration,local,left arm,0,130-19
None,9.0,2,4,Day 2,0,ind,Induration,local,left arm,0,130-19
None,9.0,2,5,Day 3,0,ind,Induration,local,left arm,0,130-19
None,9.0,2,0,Baseline,1,pain,Pain or Tenderness,local,left arm,0,130-19
None,9.0,2,1,Early,0,pain,Pain or Tenderness,local,left arm,0,130-19
None,9.0,2,2,Day 0,0,pain,Pain or Tenderness,local,left arm,0,130-19
None,9.0,2,3,Day 1,0,pain,Pain or Tenderness,local,left arm,0,130-19
None,9.0,2,4,Day 2,0,pain,Pain or Tenderness,local,left arm,0,130-19
None,9.0,2,5,Day 3,0,pain,Pain or Tenderness,local,left arm,0,130-19
None,9.0,2,0,Baseline,1,arth,Arthralgia,systemic,,0,130-19
None,9.0,2,1,Early,0,arth,Arthralgia,systemic,,0,130-19
None,9.0,2,2,Day 0,0,arth,Arthralgia,systemic,,0,130-19
None,9.0,2,3,Day 1,0,arth,Arthralgia,systemic,,0,130-19
None,9.0,2,4,Day 2,0,arth,Arthralgia,systemic,,0,130-19
None,9.0,2,5,Day 3,0,arth,Arthralgia,systemic,,0,130-19
None,9.0,2,0,Baseline,1,chill,Chills,systemic,,0,130-19
None,9.0,2,1,Early,0,chill,Chills,systemic,,0,130-19
None,9.0,2,2,Day 0,0,chill,Chills,systemic,,0,130-19
None,9.0,2,3,Day 1,0,chill,Chills,systemic,,0,130-19
None,9.0,2,4,Day 2,0,chill,Chills,systemic,,0,130-19
None,9.0,2,5,Day 3,0,chill,Chills,systemic,,0,130-19
None,9.0,2,0,Baseline,1,flush,Facial Flushing,systemic,,0,130-19
None,9.0,2,1,Early,0,flush,Facial Flushing,systemic,,0,130-19
None,9.0,2,2,Day 0,0,flush,Facial Flushing,systemic,,0,130-19
None,9.0,2,3,Day 1,0,flush,Facial Flushing,systemic,,0,130-19
None,9.0,2,4,Day 2,0,flush,Facial Flushing,systemic,,0,130-19
None,9.0,2,5,Day 3,0,flush,Facial Flushing,systemic,,0,130-19
None,9.0,2,0,Baseline,1,gprur,Generalized Pruritis,systemic,,0,130-19
None,9.0,2,1,Early,0,gprur,Generalized Pruritis,systemic,,0,130-19
None,9.0,2,2,Day 0,0,gprur,Generalized Pruritis,systemic,,0,130-19
None,9.0,2,3,Day 1,0,gprur,Generalized Pruritis,systemic,,0,130-19
None,9.0,2,4,Day 2,0,gprur,Generalized Pruritis,systemic,,0,130-19
None,9.0,2,5,Day 3,0,gprur,Generalized Pruritis,systemic,,0,130-19
None,9.0,2,0,Baseline,1,head,Headache,systemic,,0,130-19
None,9.0,2,1,Early,0,head,Headache,systemic,,0,130-19
None,9.0,2,2,Day 0,0,head,Headache,systemic,,0,130-19
None,9.0,2,3,Day 1,0,head,Headache,systemic,,0,130-19
None,9.0,2,4,Day 2,0,head,Headache,systemic,,0,130-19
None,9.0,2,5,Day 3,0,head,Headache,systemic,,0,130-19
None,9.0,2,0,Baseline,1,mf,Malaise/fatigue,systemic,,0,130-19
None,9.0,2,1,Early,0,mf,Malaise/fatigue,systemic,,0,130-19
None,9.0,2,2,Day 0,0,mf,Malaise/fatigue,systemic,,0,130-19
None,9.0,2,3,Day 1,0,mf,Malaise/fatigue,systemic,,0,130-19
None,9.0,2,4,Day 2,0,mf,Malaise/fatigue,systemic,,0,130-19
None,9.0,2,5,Day 3,0,mf,Malaise/fatigue,systemic,,0,130-19
None,9.0,2,0,Baseline,1,myal,Myalgia,systemic,,0,130-19
None,9.0,2,1,Early,0,myal,Myalgia,systemic,,0,130-19
None,9.0,2,2,Day 0,0,myal,Myalgia,systemic,,0,130-19
None,9.0,2,3,Day 1,0,myal,Myalgia,systemic,,0,130-19
None,9.0,2,4,Day 2,0,myal,Myalgia,systemic,,0,130-19
None,9.0,2,5,Day 3,0,myal,Myalgia,systemic,,0,130-19
None,9.0,2,0,Baseline,1,naus,Nausea,systemic,,0,130-19
None,9.0,2,1,Early,0,naus,Nausea,systemic,,0,130-19
None,9.0,2,2,Day 0,0,naus,Nausea,systemic,,0,130-19
None,9.0,2,3,Day 1,0,naus,Nausea,systemic,,0,130-19
None,9.0,2,4,Day 2,0,naus,Nausea,systemic,,0,130-19
None,9.0,2,5,Day 3,0,naus,Nausea,systemic,,0,130-19
None,9.0,2,0,Baseline,1,ndysp,Non-exertional Dyspnea,systemic,,0,130-19
None,9.0,2,1,Early,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-19
None,9.0,2,2,Day 0,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-19
None,9.0,2,3,Day 1,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-19
None,9.0,2,4,Day 2,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-19
None,9.0,2,5,Day 3,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-19
None,9.0,2,0,Baseline,1,ntach,Non-exertional Tachycardia,systemic,,0,130-19
None,9.0,2,1,Early,0,ntach,Non-exertional Tachycardia,systemic,,0,130-19
None,9.0,2,2,Day 0,0,ntach,Non-exertional Tachycardia,systemic,,0,130-19
None,9.0,2,3,Day 1,0,ntach,Non-exertional Tachycardia,systemic,,0,130-19
None,9.0,2,4,Day 2,0,ntach,Non-exertional Tachycardia,systemic,,0,130-19
None,9.0,2,5,Day 3,0,ntach,Non-exertional Tachycardia,systemic,,0,130-19
< 37.9C (None),9.0,2,0,Baseline,1,tempc,Temperature (C),systemic,,0,130-19
< 37.9C (None),9.0,2,1,Early,0,tempc,Temperature (C),systemic,,0,130-19
< 37.9C (None),9.0,2,2,Day 0,0,tempc,Temperature (C),systemic,,0,130-19
< 37.9C (None),9.0,2,3,Day 1,0,tempc,Temperature (C),systemic,,0,130-19
< 37.9C (None),9.0,2,4,Day 2,0,tempc,Temperature (C),systemic,,0,130-19
< 37.9C (None),9.0,2,5,Day 3,0,tempc,Temperature (C),systemic,,0,130-19
None,9.0,2,0,Baseline,1,udiap,Unexplained Diaphoresis,systemic,,0,130-19
None,9.0,2,1,Early,0,udiap,Unexplained Diaphoresis,systemic,,0,130-19
None,9.0,2,2,Day 0,0,udiap,Unexplained Diaphoresis,systemic,,0,130-19
None,9.0,2,3,Day 1,0,udiap,Unexplained Diaphoresis,systemic,,0,130-19
None,9.0,2,4,Day 2,0,udiap,Unexplained Diaphoresis,systemic,,0,130-19
None,9.0,2,5,Day 3,0,udiap,Unexplained Diaphoresis,systemic,,0,130-19
None,9.0,2,0,Baseline,1,urtic,Urticaria,systemic,,0,130-19
None,9.0,2,1,Early,0,urtic,Urticaria,systemic,,0,130-19
None,9.0,2,2,Day 0,0,urtic,Urticaria,systemic,,0,130-19
None,9.0,2,3,Day 1,0,urtic,Urticaria,systemic,,0,130-19
None,9.0,2,4,Day 2,0,urtic,Urticaria,systemic,,0,130-19
None,9.0,2,5,Day 3,0,urtic,Urticaria,systemic,,0,130-19
None,2.0,1,0,Baseline,1,ery,Erythema,local,right arm,0,130-20
None,2.0,1,1,Early,0,ery,Erythema,local,right arm,0,130-20
None,2.0,1,2,Day 0,0,ery,Erythema,local,right arm,0,130-20
None,2.0,1,3,Day 1,0,ery,Erythema,local,right arm,0,130-20
None,2.0,1,4,Day 2,0,ery,Erythema,local,right arm,0,130-20
None,2.0,1,5,Day 3,0,ery,Erythema,local,right arm,0,130-20
None,2.0,1,0,Baseline,1,ind,Induration,local,right arm,0,130-20
None,2.0,1,1,Early,0,ind,Induration,local,right arm,0,130-20
None,2.0,1,2,Day 0,0,ind,Induration,local,right arm,0,130-20
None,2.0,1,3,Day 1,0,ind,Induration,local,right arm,0,130-20
None,2.0,1,4,Day 2,0,ind,Induration,local,right arm,0,130-20
None,2.0,1,5,Day 3,0,ind,Induration,local,right arm,0,130-20
None,2.0,1,0,Baseline,1,pain,Pain or Tenderness,local,right arm,0,130-20
None,2.0,1,1,Early,0,pain,Pain or Tenderness,local,right arm,0,130-20
None,2.0,1,2,Day 0,0,pain,Pain or Tenderness,local,right arm,0,130-20
None,2.0,1,3,Day 1,0,pain,Pain or Tenderness,local,right arm,0,130-20
None,2.0,1,4,Day 2,0,pain,Pain or Tenderness,local,right arm,0,130-20
None,2.0,1,5,Day 3,0,pain,Pain or Tenderness,local,right arm,0,130-20
None,2.0,1,5,Day 3,0,pain,Pain or Tenderness,local,unknown,0,130-20
None,2.0,1,0,Baseline,1,arth,Arthralgia,systemic,,0,130-20
None,2.0,1,1,Early,0,arth,Arthralgia,systemic,,0,130-20
None,2.0,1,2,Day 0,0,arth,Arthralgia,systemic,,0,130-20
None,2.0,1,3,Day 1,0,arth,Arthralgia,systemic,,0,130-20
None,2.0,1,4,Day 2,0,arth,Arthralgia,systemic,,0,130-20
None,2.0,1,5,Day 3,0,arth,Arthralgia,systemic,,0,130-20
None,2.0,1,0,Baseline,1,chill,Chills,systemic,,0,130-20
None,2.0,1,1,Early,0,chill,Chills,systemic,,0,130-20
None,2.0,1,2,Day 0,0,chill,Chills,systemic,,0,130-20
None,2.0,1,3,Day 1,0,chill,Chills,systemic,,0,130-20
None,2.0,1,4,Day 2,0,chill,Chills,systemic,,0,130-20
None,2.0,1,5,Day 3,0,chill,Chills,systemic,,0,130-20
None,2.0,1,0,Baseline,1,flush,Facial Flushing,systemic,,0,130-20
None,2.0,1,1,Early,0,flush,Facial Flushing,systemic,,0,130-20
None,2.0,1,2,Day 0,0,flush,Facial Flushing,systemic,,0,130-20
None,2.0,1,3,Day 1,0,flush,Facial Flushing,systemic,,0,130-20
None,2.0,1,4,Day 2,0,flush,Facial Flushing,systemic,,0,130-20
None,2.0,1,5,Day 3,0,flush,Facial Flushing,systemic,,0,130-20
None,2.0,1,0,Baseline,1,gprur,Generalized Pruritis,systemic,,0,130-20
None,2.0,1,1,Early,0,gprur,Generalized Pruritis,systemic,,0,130-20
None,2.0,1,2,Day 0,0,gprur,Generalized Pruritis,systemic,,0,130-20
None,2.0,1,3,Day 1,0,gprur,Generalized Pruritis,systemic,,0,130-20
None,2.0,1,4,Day 2,0,gprur,Generalized Pruritis,systemic,,0,130-20
None,2.0,1,5,Day 3,0,gprur,Generalized Pruritis,systemic,,0,130-20
None,2.0,1,0,Baseline,1,head,Headache,systemic,,0,130-20
None,2.0,1,1,Early,0,head,Headache,systemic,,0,130-20
None,2.0,1,2,Day 0,0,head,Headache,systemic,,0,130-20
Mild,2.0,1,3,Day 1,0,head,Headache,systemic,,1,130-20
None,2.0,1,4,Day 2,0,head,Headache,systemic,,0,130-20
None,2.0,1,5,Day 3,0,head,Headache,systemic,,0,130-20
None,2.0,1,0,Baseline,1,mf,Malaise/fatigue,systemic,,0,130-20
None,2.0,1,1,Early,0,mf,Malaise/fatigue,systemic,,0,130-20
None,2.0,1,2,Day 0,0,mf,Malaise/fatigue,systemic,,0,130-20
None,2.0,1,3,Day 1,0,mf,Malaise/fatigue,systemic,,0,130-20
None,2.0,1,4,Day 2,0,mf,Malaise/fatigue,systemic,,0,130-20
None,2.0,1,5,Day 3,0,mf,Malaise/fatigue,systemic,,0,130-20
None,2.0,1,0,Baseline,1,myal,Myalgia,systemic,,0,130-20
None,2.0,1,1,Early,0,myal,Myalgia,systemic,,0,130-20
None,2.0,1,2,Day 0,0,myal,Myalgia,systemic,,0,130-20
None,2.0,1,3,Day 1,0,myal,Myalgia,systemic,,0,130-20
None,2.0,1,4,Day 2,0,myal,Myalgia,systemic,,0,130-20
None,2.0,1,5,Day 3,0,myal,Myalgia,systemic,,0,130-20
None,2.0,1,0,Baseline,1,naus,Nausea,systemic,,0,130-20
None,2.0,1,1,Early,0,naus,Nausea,systemic,,0,130-20
None,2.0,1,2,Day 0,0,naus,Nausea,systemic,,0,130-20
None,2.0,1,3,Day 1,0,naus,Nausea,systemic,,0,130-20
None,2.0,1,4,Day 2,0,naus,Nausea,systemic,,0,130-20
None,2.0,1,5,Day 3,0,naus,Nausea,systemic,,0,130-20
None,2.0,1,0,Baseline,1,ndysp,Non-exertional Dyspnea,systemic,,0,130-20
None,2.0,1,1,Early,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-20
None,2.0,1,2,Day 0,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-20
None,2.0,1,3,Day 1,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-20
None,2.0,1,4,Day 2,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-20
None,2.0,1,5,Day 3,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-20
None,2.0,1,0,Baseline,1,ntach,Non-exertional Tachycardia,systemic,,0,130-20
None,2.0,1,1,Early,0,ntach,Non-exertional Tachycardia,systemic,,0,130-20
None,2.0,1,2,Day 0,0,ntach,Non-exertional Tachycardia,systemic,,0,130-20
None,2.0,1,3,Day 1,0,ntach,Non-exertional Tachycardia,systemic,,0,130-20
None,2.0,1,4,Day 2,0,ntach,Non-exertional Tachycardia,systemic,,0,130-20
None,2.0,1,5,Day 3,0,ntach,Non-exertional Tachycardia,systemic,,0,130-20
< 37.9C (None),2.0,1,0,Baseline,1,tempc,Temperature (C),systemic,,0,130-20
< 37.9C (None),2.0,1,1,Early,0,tempc,Temperature (C),systemic,,0,130-20
< 37.9C (None),2.0,1,2,Day 0,0,tempc,Temperature (C),systemic,,0,130-20
< 37.9C (None),2.0,1,3,Day 1,0,tempc,Temperature (C),systemic,,0,130-20
< 37.9C (None),2.0,1,4,Day 2,0,tempc,Temperature (C),systemic,,0,130-20
< 37.9C (None),2.0,1,5,Day 3,0,tempc,Temperature (C),systemic,,0,130-20
None,2.0,1,0,Baseline,1,udiap,Unexplained Diaphoresis,systemic,,0,130-20
None,2.0,1,1,Early,0,udiap,Unexplained Diaphoresis,systemic,,0,130-20
None,2.0,1,2,Day 0,0,udiap,Unexplained Diaphoresis,systemic,,0,130-20
None,2.0,1,3,Day 1,0,udiap,Unexplained Diaphoresis,systemic,,0,130-20
None,2.0,1,4,Day 2,0,udiap,Unexplained Diaphoresis,systemic,,0,130-20
None,2.0,1,5,Day 3,0,udiap,Unexplained Diaphoresis,systemic,,0,130-20
None,2.0,1,0,Baseline,1,urtic,Urticaria,systemic,,0,130-20
None,2.0,1,1,Early,0,urtic,Urticaria,systemic,,0,130-20
None,2.0,1,2,Day 0,0,urtic,Urticaria,systemic,,0,130-20
None,2.0,1,3,Day 1,0,urtic,Urticaria,systemic,,0,130-20
None,2.0,1,4,Day 2,0,urtic,Urticaria,systemic,,0,130-20
None,2.0,1,5,Day 3,0,urtic,Urticaria,systemic,,0,130-20
None,2.0,1,0,Baseline,1,ery,Erythema,local,left arm,0,130-21
None,2.0,1,1,Early,0,ery,Erythema,local,left arm,0,130-21
None,2.0,1,2,Day 0,0,ery,Erythema,local,left arm,0,130-21
None,2.0,1,3,Day 1,0,ery,Erythema,local,left arm,0,130-21
None,2.0,1,4,Day 2,0,ery,Erythema,local,left arm,0,130-21
None,2.0,1,5,Day 3,0,ery,Erythema,local,left arm,0,130-21
None,2.0,1,0,Baseline,1,ind,Induration,local,left arm,0,130-21
None,2.0,1,1,Early,0,ind,Induration,local,left arm,0,130-21
Not gradable,2.0,1,2,Day 0,0,ind,Induration,local,left arm,0.5,130-21
None,2.0,1,3,Day 1,0,ind,Induration,local,left arm,0,130-21
None,2.0,1,4,Day 2,0,ind,Induration,local,left arm,0,130-21
None,2.0,1,5,Day 3,0,ind,Induration,local,left arm,0,130-21
None,2.0,1,0,Baseline,1,pain,Pain or Tenderness,local,left arm,0,130-21
None,2.0,1,1,Early,0,pain,Pain or Tenderness,local,left arm,0,130-21
None,2.0,1,2,Day 0,0,pain,Pain or Tenderness,local,left arm,0,130-21
Mild,2.0,1,3,Day 1,0,pain,Pain or Tenderness,local,left arm,1,130-21
None,2.0,1,4,Day 2,0,pain,Pain or Tenderness,local,left arm,0,130-21
None,2.0,1,5,Day 3,0,pain,Pain or Tenderness,local,left arm,0,130-21
None,2.0,1,0,Baseline,1,arth,Arthralgia,systemic,,0,130-21
None,2.0,1,1,Early,0,arth,Arthralgia,systemic,,0,130-21
None,2.0,1,2,Day 0,0,arth,Arthralgia,systemic,,0,130-21
None,2.0,1,3,Day 1,0,arth,Arthralgia,systemic,,0,130-21
None,2.0,1,4,Day 2,0,arth,Arthralgia,systemic,,0,130-21
None,2.0,1,5,Day 3,0,arth,Arthralgia,systemic,,0,130-21
None,2.0,1,0,Baseline,1,chill,Chills,systemic,,0,130-21
None,2.0,1,1,Early,0,chill,Chills,systemic,,0,130-21
None,2.0,1,2,Day 0,0,chill,Chills,systemic,,0,130-21
None,2.0,1,3,Day 1,0,chill,Chills,systemic,,0,130-21
None,2.0,1,4,Day 2,0,chill,Chills,systemic,,0,130-21
None,2.0,1,5,Day 3,0,chill,Chills,systemic,,0,130-21
None,2.0,1,0,Baseline,1,flush,Facial Flushing,systemic,,0,130-21
None,2.0,1,1,Early,0,flush,Facial Flushing,systemic,,0,130-21
None,2.0,1,2,Day 0,0,flush,Facial Flushing,systemic,,0,130-21
None,2.0,1,3,Day 1,0,flush,Facial Flushing,systemic,,0,130-21
None,2.0,1,4,Day 2,0,flush,Facial Flushing,systemic,,0,130-21
None,2.0,1,5,Day 3,0,flush,Facial Flushing,systemic,,0,130-21
None,2.0,1,0,Baseline,1,gprur,Generalized Pruritis,systemic,,0,130-21
None,2.0,1,1,Early,0,gprur,Generalized Pruritis,systemic,,0,130-21
None,2.0,1,2,Day 0,0,gprur,Generalized Pruritis,systemic,,0,130-21
None,2.0,1,3,Day 1,0,gprur,Generalized Pruritis,systemic,,0,130-21
None,2.0,1,4,Day 2,0,gprur,Generalized Pruritis,systemic,,0,130-21
None,2.0,1,5,Day 3,0,gprur,Generalized Pruritis,systemic,,0,130-21
None,2.0,1,0,Baseline,1,head,Headache,systemic,,0,130-21
None,2.0,1,1,Early,0,head,Headache,systemic,,0,130-21
Mild,2.0,1,2,Day 0,0,head,Headache,systemic,,1,130-21
None,2.0,1,3,Day 1,0,head,Headache,systemic,,0,130-21
None,2.0,1,4,Day 2,0,head,Headache,systemic,,0,130-21
None,2.0,1,5,Day 3,0,head,Headache,systemic,,0,130-21
None,2.0,1,0,Baseline,1,mf,Malaise/fatigue,systemic,,0,130-21
None,2.0,1,1,Early,0,mf,Malaise/fatigue,systemic,,0,130-21
None,2.0,1,2,Day 0,0,mf,Malaise/fatigue,systemic,,0,130-21
None,2.0,1,3,Day 1,0,mf,Malaise/fatigue,systemic,,0,130-21
None,2.0,1,4,Day 2,0,mf,Malaise/fatigue,systemic,,0,130-21
None,2.0,1,5,Day 3,0,mf,Malaise/fatigue,systemic,,0,130-21
None,2.0,1,0,Baseline,1,myal,Myalgia,systemic,,0,130-21
None,2.0,1,1,Early,0,myal,Myalgia,systemic,,0,130-21
None,2.0,1,2,Day 0,0,myal,Myalgia,systemic,,0,130-21
None,2.0,1,3,Day 1,0,myal,Myalgia,systemic,,0,130-21
None,2.0,1,4,Day 2,0,myal,Myalgia,systemic,,0,130-21
None,2.0,1,5,Day 3,0,myal,Myalgia,systemic,,0,130-21
None,2.0,1,0,Baseline,1,naus,Nausea,systemic,,0,130-21
None,2.0,1,1,Early,0,naus,Nausea,systemic,,0,130-21
None,2.0,1,2,Day 0,0,naus,Nausea,systemic,,0,130-21
None,2.0,1,3,Day 1,0,naus,Nausea,systemic,,0,130-21
None,2.0,1,4,Day 2,0,naus,Nausea,systemic,,0,130-21
None,2.0,1,5,Day 3,0,naus,Nausea,systemic,,0,130-21
None,2.0,1,0,Baseline,1,ndysp,Non-exertional Dyspnea,systemic,,0,130-21
None,2.0,1,1,Early,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-21
None,2.0,1,2,Day 0,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-21
None,2.0,1,3,Day 1,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-21
None,2.0,1,4,Day 2,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-21
None,2.0,1,5,Day 3,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-21
None,2.0,1,0,Baseline,1,ntach,Non-exertional Tachycardia,systemic,,0,130-21
None,2.0,1,1,Early,0,ntach,Non-exertional Tachycardia,systemic,,0,130-21
None,2.0,1,2,Day 0,0,ntach,Non-exertional Tachycardia,systemic,,0,130-21
None,2.0,1,3,Day 1,0,ntach,Non-exertional Tachycardia,systemic,,0,130-21
None,2.0,1,4,Day 2,0,ntach,Non-exertional Tachycardia,systemic,,0,130-21
None,2.0,1,5,Day 3,0,ntach,Non-exertional Tachycardia,systemic,,0,130-21
< 37.9C (None),2.0,1,0,Baseline,1,tempc,Temperature (C),systemic,,0,130-21
< 37.9C (None),2.0,1,1,Early,0,tempc,Temperature (C),systemic,,0,130-21
< 37.9C (None),2.0,1,2,Day 0,0,tempc,Temperature (C),systemic,,0,130-21
< 37.9C (None),2.0,1,3,Day 1,0,tempc,Temperature (C),systemic,,0,130-21
< 37.9C (None),2.0,1,4,Day 2,0,tempc,Temperature (C),systemic,,0,130-21
< 37.9C (None),2.0,1,5,Day 3,0,tempc,Temperature (C),systemic,,0,130-21
None,2.0,1,0,Baseline,1,udiap,Unexplained Diaphoresis,systemic,,0,130-21
None,2.0,1,1,Early,0,udiap,Unexplained Diaphoresis,systemic,,0,130-21
None,2.0,1,2,Day 0,0,udiap,Unexplained Diaphoresis,systemic,,0,130-21
None,2.0,1,3,Day 1,0,udiap,Unexplained Diaphoresis,systemic,,0,130-21
None,2.0,1,4,Day 2,0,udiap,Unexplained Diaphoresis,systemic,,0,130-21
None,2.0,1,5,Day 3,0,udiap,Unexplained Diaphoresis,systemic,,0,130-21
None,2.0,1,0,Baseline,1,urtic,Urticaria,systemic,,0,130-21
None,2.0,1,1,Early,0,urtic,Urticaria,systemic,,0,130-21
None,2.0,1,2,Day 0,0,urtic,Urticaria,systemic,,0,130-21
None,2.0,1,3,Day 1,0,urtic,Urticaria,systemic,,0,130-21
None,2.0,1,4,Day 2,0,urtic,Urticaria,systemic,,0,130-21
None,2.0,1,5,Day 3,0,urtic,Urticaria,systemic,,0,130-21
None,2.0,1,0,Baseline,1,ery,Erythema,local,left arm,0,130-22
None,2.0,1,1,Early,0,ery,Erythema,local,left arm,0,130-22
None,2.0,1,2,Day 0,0,ery,Erythema,local,left arm,0,130-22
None,2.0,1,3,Day 1,0,ery,Erythema,local,left arm,0,130-22
None,2.0,1,4,Day 2,0,ery,Erythema,local,left arm,0,130-22
None,2.0,1,5,Day 3,0,ery,Erythema,local,left arm,0,130-22
None,2.0,1,0,Baseline,1,ind,Induration,local,left arm,0,130-22
None,2.0,1,1,Early,0,ind,Induration,local,left arm,0,130-22
None,2.0,1,2,Day 0,0,ind,Induration,local,left arm,0,130-22
None,2.0,1,3,Day 1,0,ind,Induration,local,left arm,0,130-22
None,2.0,1,4,Day 2,0,ind,Induration,local,left arm,0,130-22
None,2.0,1,5,Day 3,0,ind,Induration,local,left arm,0,130-22
None,2.0,1,0,Baseline,1,pain,Pain or Tenderness,local,left arm,0,130-22
None,2.0,1,1,Early,0,pain,Pain or Tenderness,local,left arm,0,130-22
None,2.0,1,2,Day 0,0,pain,Pain or Tenderness,local,left arm,0,130-22
None,2.0,1,3,Day 1,0,pain,Pain or Tenderness,local,left arm,0,130-22
None,2.0,1,4,Day 2,0,pain,Pain or Tenderness,local,left arm,0,130-22
None,2.0,1,5,Day 3,0,pain,Pain or Tenderness,local,left arm,0,130-22
None,2.0,1,0,Baseline,1,arth,Arthralgia,systemic,,0,130-22
None,2.0,1,1,Early,0,arth,Arthralgia,systemic,,0,130-22
None,2.0,1,2,Day 0,0,arth,Arthralgia,systemic,,0,130-22
None,2.0,1,3,Day 1,0,arth,Arthralgia,systemic,,0,130-22
None,2.0,1,4,Day 2,0,arth,Arthralgia,systemic,,0,130-22
None,2.0,1,5,Day 3,0,arth,Arthralgia,systemic,,0,130-22
None,2.0,1,0,Baseline,1,chill,Chills,systemic,,0,130-22
None,2.0,1,1,Early,0,chill,Chills,systemic,,0,130-22
None,2.0,1,2,Day 0,0,chill,Chills,systemic,,0,130-22
None,2.0,1,3,Day 1,0,chill,Chills,systemic,,0,130-22
None,2.0,1,4,Day 2,0,chill,Chills,systemic,,0,130-22
None,2.0,1,5,Day 3,0,chill,Chills,systemic,,0,130-22
None,2.0,1,0,Baseline,1,flush,Facial Flushing,systemic,,0,130-22
None,2.0,1,1,Early,0,flush,Facial Flushing,systemic,,0,130-22
None,2.0,1,2,Day 0,0,flush,Facial Flushing,systemic,,0,130-22
None,2.0,1,3,Day 1,0,flush,Facial Flushing,systemic,,0,130-22
None,2.0,1,4,Day 2,0,flush,Facial Flushing,systemic,,0,130-22
None,2.0,1,5,Day 3,0,flush,Facial Flushing,systemic,,0,130-22
None,2.0,1,0,Baseline,1,gprur,Generalized Pruritis,systemic,,0,130-22
None,2.0,1,1,Early,0,gprur,Generalized Pruritis,systemic,,0,130-22
None,2.0,1,2,Day 0,0,gprur,Generalized Pruritis,systemic,,0,130-22
None,2.0,1,3,Day 1,0,gprur,Generalized Pruritis,systemic,,0,130-22
None,2.0,1,4,Day 2,0,gprur,Generalized Pruritis,systemic,,0,130-22
None,2.0,1,5,Day 3,0,gprur,Generalized Pruritis,systemic,,0,130-22
None,2.0,1,0,Baseline,1,head,Headache,systemic,,0,130-22
None,2.0,1,1,Early,0,head,Headache,systemic,,0,130-22
None,2.0,1,2,Day 0,0,head,Headache,systemic,,0,130-22
None,2.0,1,3,Day 1,0,head,Headache,systemic,,0,130-22
None,2.0,1,4,Day 2,0,head,Headache,systemic,,0,130-22
None,2.0,1,5,Day 3,0,head,Headache,systemic,,0,130-22
None,2.0,1,0,Baseline,1,mf,Malaise/fatigue,systemic,,0,130-22
None,2.0,1,1,Early,0,mf,Malaise/fatigue,systemic,,0,130-22
None,2.0,1,2,Day 0,0,mf,Malaise/fatigue,systemic,,0,130-22
None,2.0,1,3,Day 1,0,mf,Malaise/fatigue,systemic,,0,130-22
None,2.0,1,4,Day 2,0,mf,Malaise/fatigue,systemic,,0,130-22
None,2.0,1,5,Day 3,0,mf,Malaise/fatigue,systemic,,0,130-22
None,2.0,1,0,Baseline,1,myal,Myalgia,systemic,,0,130-22
None,2.0,1,1,Early,0,myal,Myalgia,systemic,,0,130-22
None,2.0,1,2,Day 0,0,myal,Myalgia,systemic,,0,130-22
None,2.0,1,3,Day 1,0,myal,Myalgia,systemic,,0,130-22
None,2.0,1,4,Day 2,0,myal,Myalgia,systemic,,0,130-22
None,2.0,1,5,Day 3,0,myal,Myalgia,systemic,,0,130-22
None,2.0,1,0,Baseline,1,naus,Nausea,systemic,,0,130-22
None,2.0,1,1,Early,0,naus,Nausea,systemic,,0,130-22
None,2.0,1,2,Day 0,0,naus,Nausea,systemic,,0,130-22
None,2.0,1,3,Day 1,0,naus,Nausea,systemic,,0,130-22
None,2.0,1,4,Day 2,0,naus,Nausea,systemic,,0,130-22
None,2.0,1,5,Day 3,0,naus,Nausea,systemic,,0,130-22
None,2.0,1,0,Baseline,1,ndysp,Non-exertional Dyspnea,systemic,,0,130-22
None,2.0,1,1,Early,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-22
None,2.0,1,2,Day 0,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-22
None,2.0,1,3,Day 1,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-22
None,2.0,1,4,Day 2,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-22
None,2.0,1,5,Day 3,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-22
None,2.0,1,0,Baseline,1,ntach,Non-exertional Tachycardia,systemic,,0,130-22
None,2.0,1,1,Early,0,ntach,Non-exertional Tachycardia,systemic,,0,130-22
None,2.0,1,2,Day 0,0,ntach,Non-exertional Tachycardia,systemic,,0,130-22
None,2.0,1,3,Day 1,0,ntach,Non-exertional Tachycardia,systemic,,0,130-22
None,2.0,1,4,Day 2,0,ntach,Non-exertional Tachycardia,systemic,,0,130-22
None,2.0,1,5,Day 3,0,ntach,Non-exertional Tachycardia,systemic,,0,130-22
< 37.9C (None),2.0,1,0,Baseline,1,tempc,Temperature (C),systemic,,0,130-22
< 37.9C (None),2.0,1,1,Early,0,tempc,Temperature (C),systemic,,0,130-22
< 37.9C (None),2.0,1,2,Day 0,0,tempc,Temperature (C),systemic,,0,130-22
< 37.9C (None),2.0,1,3,Day 1,0,tempc,Temperature (C),systemic,,0,130-22
< 37.9C (None),2.0,1,4,Day 2,0,tempc,Temperature (C),systemic,,0,130-22
< 37.9C (None),2.0,1,5,Day 3,0,tempc,Temperature (C),systemic,,0,130-22
None,2.0,1,0,Baseline,1,udiap,Unexplained Diaphoresis,systemic,,0,130-22
None,2.0,1,1,Early,0,udiap,Unexplained Diaphoresis,systemic,,0,130-22
None,2.0,1,2,Day 0,0,udiap,Unexplained Diaphoresis,systemic,,0,130-22
None,2.0,1,3,Day 1,0,udiap,Unexplained Diaphoresis,systemic,,0,130-22
None,2.0,1,4,Day 2,0,udiap,Unexplained Diaphoresis,systemic,,0,130-22
None,2.0,1,5,Day 3,0,udiap,Unexplained Diaphoresis,systemic,,0,130-22
None,2.0,1,0,Baseline,1,urtic,Urticaria,systemic,,0,130-22
None,2.0,1,1,Early,0,urtic,Urticaria,systemic,,0,130-22
None,2.0,1,2,Day 0,0,urtic,Urticaria,systemic,,0,130-22
None,2.0,1,3,Day 1,0,urtic,Urticaria,systemic,,0,130-22
None,2.0,1,4,Day 2,0,urtic,Urticaria,systemic,,0,130-22
None,2.0,1,5,Day 3,0,urtic,Urticaria,systemic,,0,130-22
None,2.0,1,0,Baseline,1,ery,Erythema,local,left arm,0,130-23
None,2.0,1,1,Early,0,ery,Erythema,local,left arm,0,130-23
None,2.0,1,2,Day 0,0,ery,Erythema,local,left arm,0,130-23
None,2.0,1,3,Day 1,0,ery,Erythema,local,left arm,0,130-23
None,2.0,1,4,Day 2,0,ery,Erythema,local,left arm,0,130-23
None,2.0,1,5,Day 3,0,ery,Erythema,local,left arm,0,130-23
None,2.0,1,0,Baseline,1,ind,Induration,local,left arm,0,130-23
None,2.0,1,1,Early,0,ind,Induration,local,left arm,0,130-23
None,2.0,1,2,Day 0,0,ind,Induration,local,left arm,0,130-23
None,2.0,1,3,Day 1,0,ind,Induration,local,left arm,0,130-23
None,2.0,1,4,Day 2,0,ind,Induration,local,left arm,0,130-23
None,2.0,1,5,Day 3,0,ind,Induration,local,left arm,0,130-23
None,2.0,1,0,Baseline,1,pain,Pain or Tenderness,local,left arm,0,130-23
None,2.0,1,1,Early,0,pain,Pain or Tenderness,local,left arm,0,130-23
None,2.0,1,2,Day 0,0,pain,Pain or Tenderness,local,left arm,0,130-23
None,2.0,1,3,Day 1,0,pain,Pain or Tenderness,local,left arm,0,130-23
None,2.0,1,4,Day 2,0,pain,Pain or Tenderness,local,left arm,0,130-23
None,2.0,1,5,Day 3,0,pain,Pain or Tenderness,local,left arm,0,130-23
None,2.0,1,0,Baseline,1,arth,Arthralgia,systemic,,0,130-23
None,2.0,1,1,Early,0,arth,Arthralgia,systemic,,0,130-23
None,2.0,1,2,Day 0,0,arth,Arthralgia,systemic,,0,130-23
None,2.0,1,3,Day 1,0,arth,Arthralgia,systemic,,0,130-23
None,2.0,1,4,Day 2,0,arth,Arthralgia,systemic,,0,130-23
None,2.0,1,5,Day 3,0,arth,Arthralgia,systemic,,0,130-23
None,2.0,1,0,Baseline,1,chill,Chills,systemic,,0,130-23
None,2.0,1,1,Early,0,chill,Chills,systemic,,0,130-23
None,2.0,1,2,Day 0,0,chill,Chills,systemic,,0,130-23
None,2.0,1,3,Day 1,0,chill,Chills,systemic,,0,130-23
None,2.0,1,4,Day 2,0,chill,Chills,systemic,,0,130-23
None,2.0,1,5,Day 3,0,chill,Chills,systemic,,0,130-23
None,2.0,1,0,Baseline,1,flush,Facial Flushing,systemic,,0,130-23
None,2.0,1,1,Early,0,flush,Facial Flushing,systemic,,0,130-23
None,2.0,1,2,Day 0,0,flush,Facial Flushing,systemic,,0,130-23
None,2.0,1,3,Day 1,0,flush,Facial Flushing,systemic,,0,130-23
None,2.0,1,4,Day 2,0,flush,Facial Flushing,systemic,,0,130-23
None,2.0,1,5,Day 3,0,flush,Facial Flushing,systemic,,0,130-23
None,2.0,1,0,Baseline,1,gprur,Generalized Pruritis,systemic,,0,130-23
None,2.0,1,1,Early,0,gprur,Generalized Pruritis,systemic,,0,130-23
None,2.0,1,2,Day 0,0,gprur,Generalized Pruritis,systemic,,0,130-23
None,2.0,1,3,Day 1,0,gprur,Generalized Pruritis,systemic,,0,130-23
None,2.0,1,4,Day 2,0,gprur,Generalized Pruritis,systemic,,0,130-23
None,2.0,1,5,Day 3,0,gprur,Generalized Pruritis,systemic,,0,130-23
Mild,2.0,1,0,Baseline,1,head,Headache,systemic,,1,130-23
Mild,2.0,1,1,Early,0,head,Headache,systemic,,1,130-23
Mild,2.0,1,2,Day 0,0,head,Headache,systemic,,1,130-23
Mild,2.0,1,3,Day 1,0,head,Headache,systemic,,1,130-23
Mild,2.0,1,4,Day 2,0,head,Headache,systemic,,1,130-23
None,2.0,1,5,Day 3,0,head,Headache,systemic,,0,130-23
None,2.0,1,0,Baseline,1,mf,Malaise/fatigue,systemic,,0,130-23
None,2.0,1,1,Early,0,mf,Malaise/fatigue,systemic,,0,130-23
Mild,2.0,1,2,Day 0,0,mf,Malaise/fatigue,systemic,,1,130-23
Mild,2.0,1,3,Day 1,0,mf,Malaise/fatigue,systemic,,1,130-23
Mild,2.0,1,4,Day 2,0,mf,Malaise/fatigue,systemic,,1,130-23
None,2.0,1,5,Day 3,0,mf,Malaise/fatigue,systemic,,0,130-23
None,2.0,1,0,Baseline,1,myal,Myalgia,systemic,,0,130-23
None,2.0,1,1,Early,0,myal,Myalgia,systemic,,0,130-23
None,2.0,1,2,Day 0,0,myal,Myalgia,systemic,,0,130-23
None,2.0,1,3,Day 1,0,myal,Myalgia,systemic,,0,130-23
None,2.0,1,4,Day 2,0,myal,Myalgia,systemic,,0,130-23
None,2.0,1,5,Day 3,0,myal,Myalgia,systemic,,0,130-23
None,2.0,1,0,Baseline,1,naus,Nausea,systemic,,0,130-23
None,2.0,1,1,Early,0,naus,Nausea,systemic,,0,130-23
None,2.0,1,2,Day 0,0,naus,Nausea,systemic,,0,130-23
None,2.0,1,3,Day 1,0,naus,Nausea,systemic,,0,130-23
None,2.0,1,4,Day 2,0,naus,Nausea,systemic,,0,130-23
None,2.0,1,5,Day 3,0,naus,Nausea,systemic,,0,130-23
None,2.0,1,0,Baseline,1,ndysp,Non-exertional Dyspnea,systemic,,0,130-23
None,2.0,1,1,Early,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-23
None,2.0,1,2,Day 0,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-23
None,2.0,1,3,Day 1,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-23
None,2.0,1,4,Day 2,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-23
None,2.0,1,5,Day 3,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-23
None,2.0,1,0,Baseline,1,ntach,Non-exertional Tachycardia,systemic,,0,130-23
None,2.0,1,1,Early,0,ntach,Non-exertional Tachycardia,systemic,,0,130-23
None,2.0,1,2,Day 0,0,ntach,Non-exertional Tachycardia,systemic,,0,130-23
None,2.0,1,3,Day 1,0,ntach,Non-exertional Tachycardia,systemic,,0,130-23
None,2.0,1,4,Day 2,0,ntach,Non-exertional Tachycardia,systemic,,0,130-23
None,2.0,1,5,Day 3,0,ntach,Non-exertional Tachycardia,systemic,,0,130-23
< 37.9C (None),2.0,1,0,Baseline,1,tempc,Temperature (C),systemic,,0,130-23
< 37.9C (None),2.0,1,1,Early,0,tempc,Temperature (C),systemic,,0,130-23
< 37.9C (None),2.0,1,2,Day 0,0,tempc,Temperature (C),systemic,,0,130-23
< 37.9C (None),2.0,1,3,Day 1,0,tempc,Temperature (C),systemic,,0,130-23
< 37.9C (None),2.0,1,4,Day 2,0,tempc,Temperature (C),systemic,,0,130-23
< 37.9C (None),2.0,1,5,Day 3,0,tempc,Temperature (C),systemic,,0,130-23
None,2.0,1,0,Baseline,1,udiap,Unexplained Diaphoresis,systemic,,0,130-23
None,2.0,1,1,Early,0,udiap,Unexplained Diaphoresis,systemic,,0,130-23
None,2.0,1,2,Day 0,0,udiap,Unexplained Diaphoresis,systemic,,0,130-23
None,2.0,1,3,Day 1,0,udiap,Unexplained Diaphoresis,systemic,,0,130-23
None,2.0,1,4,Day 2,0,udiap,Unexplained Diaphoresis,systemic,,0,130-23
None,2.0,1,5,Day 3,0,udiap,Unexplained Diaphoresis,systemic,,0,130-23
None,2.0,1,0,Baseline,1,urtic,Urticaria,systemic,,0,130-23
None,2.0,1,1,Early,0,urtic,Urticaria,systemic,,0,130-23
None,2.0,1,2,Day 0,0,urtic,Urticaria,systemic,,0,130-23
None,2.0,1,3,Day 1,0,urtic,Urticaria,systemic,,0,130-23
None,2.0,1,4,Day 2,0,urtic,Urticaria,systemic,,0,130-23
None,2.0,1,5,Day 3,0,urtic,Urticaria,systemic,,0,130-23
None,2.0,1,0,Baseline,1,ery,Erythema,local,right arm,0,130-24
None,2.0,1,1,Early,0,ery,Erythema,local,right arm,0,130-24
None,2.0,1,2,Day 0,0,ery,Erythema,local,right arm,0,130-24
None,2.0,1,3,Day 1,0,ery,Erythema,local,right arm,0,130-24
None,2.0,1,4,Day 2,0,ery,Erythema,local,right arm,0,130-24
None,2.0,1,5,Day 3,0,ery,Erythema,local,right arm,0,130-24
None,2.0,1,0,Baseline,1,ind,Induration,local,right arm,0,130-24
None,2.0,1,1,Early,0,ind,Induration,local,right arm,0,130-24
None,2.0,1,2,Day 0,0,ind,Induration,local,right arm,0,130-24
None,2.0,1,3,Day 1,0,ind,Induration,local,right arm,0,130-24
None,2.0,1,4,Day 2,0,ind,Induration,local,right arm,0,130-24
None,2.0,1,5,Day 3,0,ind,Induration,local,right arm,0,130-24
None,2.0,1,0,Baseline,1,pain,Pain or Tenderness,local,right arm,0,130-24
None,2.0,1,1,Early,0,pain,Pain or Tenderness,local,right arm,0,130-24
None,2.0,1,2,Day 0,0,pain,Pain or Tenderness,local,right arm,0,130-24
None,2.0,1,3,Day 1,0,pain,Pain or Tenderness,local,right arm,0,130-24
None,2.0,1,4,Day 2,0,pain,Pain or Tenderness,local,right arm,0,130-24
None,2.0,1,5,Day 3,0,pain,Pain or Tenderness,local,right arm,0,130-24
None,2.0,1,0,Baseline,1,arth,Arthralgia,systemic,,0,130-24
None,2.0,1,1,Early,0,arth,Arthralgia,systemic,,0,130-24
None,2.0,1,2,Day 0,0,arth,Arthralgia,systemic,,0,130-24
None,2.0,1,3,Day 1,0,arth,Arthralgia,systemic,,0,130-24
None,2.0,1,4,Day 2,0,arth,Arthralgia,systemic,,0,130-24
Mild,2.0,1,5,Day 3,0,arth,Arthralgia,systemic,,1,130-24
None,2.0,1,0,Baseline,1,chill,Chills,systemic,,0,130-24
None,2.0,1,1,Early,0,chill,Chills,systemic,,0,130-24
None,2.0,1,2,Day 0,0,chill,Chills,systemic,,0,130-24
None,2.0,1,3,Day 1,0,chill,Chills,systemic,,0,130-24
None,2.0,1,4,Day 2,0,chill,Chills,systemic,,0,130-24
None,2.0,1,5,Day 3,0,chill,Chills,systemic,,0,130-24
None,2.0,1,0,Baseline,1,flush,Facial Flushing,systemic,,0,130-24
None,2.0,1,1,Early,0,flush,Facial Flushing,systemic,,0,130-24
None,2.0,1,2,Day 0,0,flush,Facial Flushing,systemic,,0,130-24
None,2.0,1,3,Day 1,0,flush,Facial Flushing,systemic,,0,130-24
None,2.0,1,4,Day 2,0,flush,Facial Flushing,systemic,,0,130-24
None,2.0,1,5,Day 3,0,flush,Facial Flushing,systemic,,0,130-24
None,2.0,1,0,Baseline,1,gprur,Generalized Pruritis,systemic,,0,130-24
None,2.0,1,1,Early,0,gprur,Generalized Pruritis,systemic,,0,130-24
None,2.0,1,2,Day 0,0,gprur,Generalized Pruritis,systemic,,0,130-24
None,2.0,1,3,Day 1,0,gprur,Generalized Pruritis,systemic,,0,130-24
None,2.0,1,4,Day 2,0,gprur,Generalized Pruritis,systemic,,0,130-24
None,2.0,1,5,Day 3,0,gprur,Generalized Pruritis,systemic,,0,130-24
None,2.0,1,0,Baseline,1,head,Headache,systemic,,0,130-24
None,2.0,1,1,Early,0,head,Headache,systemic,,0,130-24
None,2.0,1,2,Day 0,0,head,Headache,systemic,,0,130-24
None,2.0,1,3,Day 1,0,head,Headache,systemic,,0,130-24
None,2.0,1,4,Day 2,0,head,Headache,systemic,,0,130-24
Mild,2.0,1,5,Day 3,0,head,Headache,systemic,,1,130-24
None,2.0,1,0,Baseline,1,mf,Malaise/fatigue,systemic,,0,130-24
None,2.0,1,1,Early,0,mf,Malaise/fatigue,systemic,,0,130-24
Mild,2.0,1,2,Day 0,0,mf,Malaise/fatigue,systemic,,1,130-24
None,2.0,1,3,Day 1,0,mf,Malaise/fatigue,systemic,,0,130-24
Mild,2.0,1,4,Day 2,0,mf,Malaise/fatigue,systemic,,1,130-24
None,2.0,1,5,Day 3,0,mf,Malaise/fatigue,systemic,,0,130-24
None,2.0,1,0,Baseline,1,myal,Myalgia,systemic,,0,130-24
None,2.0,1,1,Early,0,myal,Myalgia,systemic,,0,130-24
None,2.0,1,2,Day 0,0,myal,Myalgia,systemic,,0,130-24
None,2.0,1,3,Day 1,0,myal,Myalgia,systemic,,0,130-24
None,2.0,1,4,Day 2,0,myal,Myalgia,systemic,,0,130-24
Moderate,2.0,1,5,Day 3,0,myal,Myalgia,systemic,,2,130-24
None,2.0,1,0,Baseline,1,naus,Nausea,systemic,,0,130-24
None,2.0,1,1,Early,0,naus,Nausea,systemic,,0,130-24
None,2.0,1,2,Day 0,0,naus,Nausea,systemic,,0,130-24
None,2.0,1,3,Day 1,0,naus,Nausea,systemic,,0,130-24
None,2.0,1,4,Day 2,0,naus,Nausea,systemic,,0,130-24
None,2.0,1,5,Day 3,0,naus,Nausea,systemic,,0,130-24
None,2.0,1,0,Baseline,1,ndysp,Non-exertional Dyspnea,systemic,,0,130-24
None,2.0,1,1,Early,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-24
None,2.0,1,2,Day 0,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-24
None,2.0,1,3,Day 1,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-24
None,2.0,1,4,Day 2,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-24
None,2.0,1,5,Day 3,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-24
None,2.0,1,0,Baseline,1,ntach,Non-exertional Tachycardia,systemic,,0,130-24
None,2.0,1,1,Early,0,ntach,Non-exertional Tachycardia,systemic,,0,130-24
None,2.0,1,2,Day 0,0,ntach,Non-exertional Tachycardia,systemic,,0,130-24
None,2.0,1,3,Day 1,0,ntach,Non-exertional Tachycardia,systemic,,0,130-24
None,2.0,1,4,Day 2,0,ntach,Non-exertional Tachycardia,systemic,,0,130-24
None,2.0,1,5,Day 3,0,ntach,Non-exertional Tachycardia,systemic,,0,130-24
< 37.9C (None),2.0,1,0,Baseline,1,tempc,Temperature (C),systemic,,0,130-24
< 37.9C (None),2.0,1,1,Early,0,tempc,Temperature (C),systemic,,0,130-24
< 37.9C (None),2.0,1,2,Day 0,0,tempc,Temperature (C),systemic,,0,130-24
< 37.9C (None),2.0,1,3,Day 1,0,tempc,Temperature (C),systemic,,0,130-24
< 37.9C (None),2.0,1,5,Day 3,0,tempc,Temperature (C),systemic,,0,130-24
None,2.0,1,0,Baseline,1,udiap,Unexplained Diaphoresis,systemic,,0,130-24
None,2.0,1,1,Early,0,udiap,Unexplained Diaphoresis,systemic,,0,130-24
None,2.0,1,2,Day 0,0,udiap,Unexplained Diaphoresis,systemic,,0,130-24
None,2.0,1,3,Day 1,0,udiap,Unexplained Diaphoresis,systemic,,0,130-24
None,2.0,1,4,Day 2,0,udiap,Unexplained Diaphoresis,systemic,,0,130-24
None,2.0,1,5,Day 3,0,udiap,Unexplained Diaphoresis,systemic,,0,130-24
None,2.0,1,0,Baseline,1,urtic,Urticaria,systemic,,0,130-24
None,2.0,1,1,Early,0,urtic,Urticaria,systemic,,0,130-24
None,2.0,1,2,Day 0,0,urtic,Urticaria,systemic,,0,130-24
None,2.0,1,3,Day 1,0,urtic,Urticaria,systemic,,0,130-24
None,2.0,1,4,Day 2,0,urtic,Urticaria,systemic,,0,130-24
None,2.0,1,5,Day 3,0,urtic,Urticaria,systemic,,0,130-24
None,2.0,1,0,Baseline,1,ery,Erythema,local,right arm,0,130-25
None,2.0,1,1,Early,0,ery,Erythema,local,right arm,0,130-25
None,2.0,1,2,Day 0,0,ery,Erythema,local,right arm,0,130-25
None,2.0,1,3,Day 1,0,ery,Erythema,local,right arm,0,130-25
None,2.0,1,4,Day 2,0,ery,Erythema,local,right arm,0,130-25
None,2.0,1,5,Day 3,0,ery,Erythema,local,right arm,0,130-25
None,2.0,1,0,Baseline,1,ind,Induration,local,right arm,0,130-25
None,2.0,1,1,Early,0,ind,Induration,local,right arm,0,130-25
None,2.0,1,2,Day 0,0,ind,Induration,local,right arm,0,130-25
None,2.0,1,3,Day 1,0,ind,Induration,local,right arm,0,130-25
None,2.0,1,4,Day 2,0,ind,Induration,local,right arm,0,130-25
None,2.0,1,5,Day 3,0,ind,Induration,local,right arm,0,130-25
None,2.0,1,0,Baseline,1,pain,Pain or Tenderness,local,right arm,0,130-25
None,2.0,1,1,Early,0,pain,Pain or Tenderness,local,right arm,0,130-25
None,2.0,1,2,Day 0,0,pain,Pain or Tenderness,local,right arm,0,130-25
None,2.0,1,3,Day 1,0,pain,Pain or Tenderness,local,right arm,0,130-25
None,2.0,1,4,Day 2,0,pain,Pain or Tenderness,local,right arm,0,130-25
None,2.0,1,5,Day 3,0,pain,Pain or Tenderness,local,right arm,0,130-25
None,2.0,1,0,Baseline,1,arth,Arthralgia,systemic,,0,130-25
None,2.0,1,1,Early,0,arth,Arthralgia,systemic,,0,130-25
None,2.0,1,2,Day 0,0,arth,Arthralgia,systemic,,0,130-25
None,2.0,1,3,Day 1,0,arth,Arthralgia,systemic,,0,130-25
None,2.0,1,4,Day 2,0,arth,Arthralgia,systemic,,0,130-25
None,2.0,1,5,Day 3,0,arth,Arthralgia,systemic,,0,130-25
None,2.0,1,0,Baseline,1,chill,Chills,systemic,,0,130-25
None,2.0,1,1,Early,0,chill,Chills,systemic,,0,130-25
None,2.0,1,2,Day 0,0,chill,Chills,systemic,,0,130-25
None,2.0,1,3,Day 1,0,chill,Chills,systemic,,0,130-25
None,2.0,1,4,Day 2,0,chill,Chills,systemic,,0,130-25
None,2.0,1,5,Day 3,0,chill,Chills,systemic,,0,130-25
None,2.0,1,0,Baseline,1,flush,Facial Flushing,systemic,,0,130-25
None,2.0,1,1,Early,0,flush,Facial Flushing,systemic,,0,130-25
None,2.0,1,2,Day 0,0,flush,Facial Flushing,systemic,,0,130-25
None,2.0,1,3,Day 1,0,flush,Facial Flushing,systemic,,0,130-25
None,2.0,1,4,Day 2,0,flush,Facial Flushing,systemic,,0,130-25
None,2.0,1,5,Day 3,0,flush,Facial Flushing,systemic,,0,130-25
None,2.0,1,0,Baseline,1,gprur,Generalized Pruritis,systemic,,0,130-25
None,2.0,1,1,Early,0,gprur,Generalized Pruritis,systemic,,0,130-25
None,2.0,1,2,Day 0,0,gprur,Generalized Pruritis,systemic,,0,130-25
None,2.0,1,3,Day 1,0,gprur,Generalized Pruritis,systemic,,0,130-25
None,2.0,1,4,Day 2,0,gprur,Generalized Pruritis,systemic,,0,130-25
None,2.0,1,5,Day 3,0,gprur,Generalized Pruritis,systemic,,0,130-25
None,2.0,1,0,Baseline,1,head,Headache,systemic,,0,130-25
None,2.0,1,1,Early,0,head,Headache,systemic,,0,130-25
None,2.0,1,2,Day 0,0,head,Headache,systemic,,0,130-25
None,2.0,1,3,Day 1,0,head,Headache,systemic,,0,130-25
None,2.0,1,4,Day 2,0,head,Headache,systemic,,0,130-25
None,2.0,1,5,Day 3,0,head,Headache,systemic,,0,130-25
None,2.0,1,0,Baseline,1,mf,Malaise/fatigue,systemic,,0,130-25
None,2.0,1,1,Early,0,mf,Malaise/fatigue,systemic,,0,130-25
None,2.0,1,2,Day 0,0,mf,Malaise/fatigue,systemic,,0,130-25
None,2.0,1,3,Day 1,0,mf,Malaise/fatigue,systemic,,0,130-25
None,2.0,1,4,Day 2,0,mf,Malaise/fatigue,systemic,,0,130-25
None,2.0,1,5,Day 3,0,mf,Malaise/fatigue,systemic,,0,130-25
None,2.0,1,0,Baseline,1,myal,Myalgia,systemic,,0,130-25
None,2.0,1,1,Early,0,myal,Myalgia,systemic,,0,130-25
None,2.0,1,2,Day 0,0,myal,Myalgia,systemic,,0,130-25
None,2.0,1,3,Day 1,0,myal,Myalgia,systemic,,0,130-25
None,2.0,1,4,Day 2,0,myal,Myalgia,systemic,,0,130-25
None,2.0,1,5,Day 3,0,myal,Myalgia,systemic,,0,130-25
None,2.0,1,0,Baseline,1,naus,Nausea,systemic,,0,130-25
None,2.0,1,1,Early,0,naus,Nausea,systemic,,0,130-25
None,2.0,1,2,Day 0,0,naus,Nausea,systemic,,0,130-25
None,2.0,1,3,Day 1,0,naus,Nausea,systemic,,0,130-25
None,2.0,1,4,Day 2,0,naus,Nausea,systemic,,0,130-25
None,2.0,1,5,Day 3,0,naus,Nausea,systemic,,0,130-25
None,2.0,1,0,Baseline,1,ndysp,Non-exertional Dyspnea,systemic,,0,130-25
None,2.0,1,1,Early,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-25
None,2.0,1,2,Day 0,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-25
None,2.0,1,3,Day 1,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-25
None,2.0,1,4,Day 2,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-25
None,2.0,1,5,Day 3,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-25
None,2.0,1,0,Baseline,1,ntach,Non-exertional Tachycardia,systemic,,0,130-25
None,2.0,1,1,Early,0,ntach,Non-exertional Tachycardia,systemic,,0,130-25
None,2.0,1,2,Day 0,0,ntach,Non-exertional Tachycardia,systemic,,0,130-25
None,2.0,1,3,Day 1,0,ntach,Non-exertional Tachycardia,systemic,,0,130-25
None,2.0,1,4,Day 2,0,ntach,Non-exertional Tachycardia,systemic,,0,130-25
None,2.0,1,5,Day 3,0,ntach,Non-exertional Tachycardia,systemic,,0,130-25
< 37.9C (None),2.0,1,0,Baseline,1,tempc,Temperature (C),systemic,,0,130-25
< 37.9C (None),2.0,1,1,Early,0,tempc,Temperature (C),systemic,,0,130-25
< 37.9C (None),2.0,1,2,Day 0,0,tempc,Temperature (C),systemic,,0,130-25
< 37.9C (None),2.0,1,3,Day 1,0,tempc,Temperature (C),systemic,,0,130-25
< 37.9C (None),2.0,1,4,Day 2,0,tempc,Temperature (C),systemic,,0,130-25
< 37.9C (None),2.0,1,5,Day 3,0,tempc,Temperature (C),systemic,,0,130-25
None,2.0,1,0,Baseline,1,udiap,Unexplained Diaphoresis,systemic,,0,130-25
None,2.0,1,1,Early,0,udiap,Unexplained Diaphoresis,systemic,,0,130-25
None,2.0,1,2,Day 0,0,udiap,Unexplained Diaphoresis,systemic,,0,130-25
None,2.0,1,3,Day 1,0,udiap,Unexplained Diaphoresis,systemic,,0,130-25
None,2.0,1,4,Day 2,0,udiap,Unexplained Diaphoresis,systemic,,0,130-25
None,2.0,1,5,Day 3,0,udiap,Unexplained Diaphoresis,systemic,,0,130-25
None,2.0,1,0,Baseline,1,urtic,Urticaria,systemic,,0,130-25
None,2.0,1,1,Early,0,urtic,Urticaria,systemic,,0,130-25
None,2.0,1,2,Day 0,0,urtic,Urticaria,systemic,,0,130-25
None,2.0,1,3,Day 1,0,urtic,Urticaria,systemic,,0,130-25
None,2.0,1,4,Day 2,0,urtic,Urticaria,systemic,,0,130-25
None,2.0,1,5,Day 3,0,urtic,Urticaria,systemic,,0,130-25
None,2.0,1,0,Baseline,1,ery,Erythema,local,right arm,0,130-26
None,2.0,1,1,Early,0,ery,Erythema,local,right arm,0,130-26
None,2.0,1,2,Day 0,0,ery,Erythema,local,right arm,0,130-26
None,2.0,1,3,Day 1,0,ery,Erythema,local,right arm,0,130-26
None,2.0,1,4,Day 2,0,ery,Erythema,local,right arm,0,130-26
None,2.0,1,5,Day 3,0,ery,Erythema,local,right arm,0,130-26
None,2.0,1,0,Baseline,1,ind,Induration,local,right arm,0,130-26
None,2.0,1,1,Early,0,ind,Induration,local,right arm,0,130-26
None,2.0,1,2,Day 0,0,ind,Induration,local,right arm,0,130-26
None,2.0,1,3,Day 1,0,ind,Induration,local,right arm,0,130-26
None,2.0,1,4,Day 2,0,ind,Induration,local,right arm,0,130-26
None,2.0,1,5,Day 3,0,ind,Induration,local,right arm,0,130-26
None,2.0,1,0,Baseline,1,pain,Pain or Tenderness,local,right arm,0,130-26
None,2.0,1,1,Early,0,pain,Pain or Tenderness,local,right arm,0,130-26
Mild,2.0,1,2,Day 0,0,pain,Pain or Tenderness,local,right arm,1,130-26
None,2.0,1,3,Day 1,0,pain,Pain or Tenderness,local,right arm,0,130-26
None,2.0,1,4,Day 2,0,pain,Pain or Tenderness,local,right arm,0,130-26
None,2.0,1,5,Day 3,0,pain,Pain or Tenderness,local,right arm,0,130-26
None,2.0,1,0,Baseline,1,arth,Arthralgia,systemic,,0,130-26
None,2.0,1,1,Early,0,arth,Arthralgia,systemic,,0,130-26
None,2.0,1,2,Day 0,0,arth,Arthralgia,systemic,,0,130-26
None,2.0,1,3,Day 1,0,arth,Arthralgia,systemic,,0,130-26
None,2.0,1,4,Day 2,0,arth,Arthralgia,systemic,,0,130-26
None,2.0,1,5,Day 3,0,arth,Arthralgia,systemic,,0,130-26
None,2.0,1,0,Baseline,1,chill,Chills,systemic,,0,130-26
None,2.0,1,1,Early,0,chill,Chills,systemic,,0,130-26
None,2.0,1,2,Day 0,0,chill,Chills,systemic,,0,130-26
None,2.0,1,3,Day 1,0,chill,Chills,systemic,,0,130-26
None,2.0,1,4,Day 2,0,chill,Chills,systemic,,0,130-26
None,2.0,1,5,Day 3,0,chill,Chills,systemic,,0,130-26
None,2.0,1,0,Baseline,1,flush,Facial Flushing,systemic,,0,130-26
None,2.0,1,1,Early,0,flush,Facial Flushing,systemic,,0,130-26
None,2.0,1,2,Day 0,0,flush,Facial Flushing,systemic,,0,130-26
None,2.0,1,3,Day 1,0,flush,Facial Flushing,systemic,,0,130-26
None,2.0,1,4,Day 2,0,flush,Facial Flushing,systemic,,0,130-26
None,2.0,1,5,Day 3,0,flush,Facial Flushing,systemic,,0,130-26
None,2.0,1,0,Baseline,1,gprur,Generalized Pruritis,systemic,,0,130-26
None,2.0,1,1,Early,0,gprur,Generalized Pruritis,systemic,,0,130-26
None,2.0,1,2,Day 0,0,gprur,Generalized Pruritis,systemic,,0,130-26
None,2.0,1,3,Day 1,0,gprur,Generalized Pruritis,systemic,,0,130-26
None,2.0,1,4,Day 2,0,gprur,Generalized Pruritis,systemic,,0,130-26
None,2.0,1,5,Day 3,0,gprur,Generalized Pruritis,systemic,,0,130-26
None,2.0,1,0,Baseline,1,head,Headache,systemic,,0,130-26
None,2.0,1,1,Early,0,head,Headache,systemic,,0,130-26
None,2.0,1,2,Day 0,0,head,Headache,systemic,,0,130-26
None,2.0,1,3,Day 1,0,head,Headache,systemic,,0,130-26
None,2.0,1,4,Day 2,0,head,Headache,systemic,,0,130-26
None,2.0,1,5,Day 3,0,head,Headache,systemic,,0,130-26
None,2.0,1,0,Baseline,1,mf,Malaise/fatigue,systemic,,0,130-26
None,2.0,1,1,Early,0,mf,Malaise/fatigue,systemic,,0,130-26
None,2.0,1,2,Day 0,0,mf,Malaise/fatigue,systemic,,0,130-26
Mild,2.0,1,3,Day 1,0,mf,Malaise/fatigue,systemic,,1,130-26
None,2.0,1,4,Day 2,0,mf,Malaise/fatigue,systemic,,0,130-26
None,2.0,1,5,Day 3,0,mf,Malaise/fatigue,systemic,,0,130-26
None,2.0,1,0,Baseline,1,myal,Myalgia,systemic,,0,130-26
None,2.0,1,1,Early,0,myal,Myalgia,systemic,,0,130-26
None,2.0,1,2,Day 0,0,myal,Myalgia,systemic,,0,130-26
None,2.0,1,3,Day 1,0,myal,Myalgia,systemic,,0,130-26
None,2.0,1,4,Day 2,0,myal,Myalgia,systemic,,0,130-26
None,2.0,1,5,Day 3,0,myal,Myalgia,systemic,,0,130-26
None,2.0,1,0,Baseline,1,naus,Nausea,systemic,,0,130-26
None,2.0,1,1,Early,0,naus,Nausea,systemic,,0,130-26
None,2.0,1,2,Day 0,0,naus,Nausea,systemic,,0,130-26
None,2.0,1,3,Day 1,0,naus,Nausea,systemic,,0,130-26
None,2.0,1,4,Day 2,0,naus,Nausea,systemic,,0,130-26
None,2.0,1,5,Day 3,0,naus,Nausea,systemic,,0,130-26
None,2.0,1,0,Baseline,1,ndysp,Non-exertional Dyspnea,systemic,,0,130-26
None,2.0,1,1,Early,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-26
None,2.0,1,2,Day 0,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-26
None,2.0,1,3,Day 1,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-26
None,2.0,1,4,Day 2,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-26
None,2.0,1,5,Day 3,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-26
None,2.0,1,0,Baseline,1,ntach,Non-exertional Tachycardia,systemic,,0,130-26
None,2.0,1,1,Early,0,ntach,Non-exertional Tachycardia,systemic,,0,130-26
None,2.0,1,2,Day 0,0,ntach,Non-exertional Tachycardia,systemic,,0,130-26
None,2.0,1,3,Day 1,0,ntach,Non-exertional Tachycardia,systemic,,0,130-26
None,2.0,1,4,Day 2,0,ntach,Non-exertional Tachycardia,systemic,,0,130-26
None,2.0,1,5,Day 3,0,ntach,Non-exertional Tachycardia,systemic,,0,130-26
< 37.9C (None),2.0,1,0,Baseline,1,tempc,Temperature (C),systemic,,0,130-26
< 37.9C (None),2.0,1,1,Early,0,tempc,Temperature (C),systemic,,0,130-26
< 37.9C (None),2.0,1,2,Day 0,0,tempc,Temperature (C),systemic,,0,130-26
< 37.9C (None),2.0,1,3,Day 1,0,tempc,Temperature (C),systemic,,0,130-26
< 37.9C (None),2.0,1,4,Day 2,0,tempc,Temperature (C),systemic,,0,130-26
< 37.9C (None),2.0,1,5,Day 3,0,tempc,Temperature (C),systemic,,0,130-26
None,2.0,1,0,Baseline,1,udiap,Unexplained Diaphoresis,systemic,,0,130-26
None,2.0,1,1,Early,0,udiap,Unexplained Diaphoresis,systemic,,0,130-26
None,2.0,1,2,Day 0,0,udiap,Unexplained Diaphoresis,systemic,,0,130-26
None,2.0,1,3,Day 1,0,udiap,Unexplained Diaphoresis,systemic,,0,130-26
None,2.0,1,4,Day 2,0,udiap,Unexplained Diaphoresis,systemic,,0,130-26
None,2.0,1,5,Day 3,0,udiap,Unexplained Diaphoresis,systemic,,0,130-26
None,2.0,1,0,Baseline,1,urtic,Urticaria,systemic,,0,130-26
None,2.0,1,1,Early,0,urtic,Urticaria,systemic,,0,130-26
None,2.0,1,2,Day 0,0,urtic,Urticaria,systemic,,0,130-26
None,2.0,1,3,Day 1,0,urtic,Urticaria,systemic,,0,130-26
None,2.0,1,4,Day 2,0,urtic,Urticaria,systemic,,0,130-26
None,2.0,1,5,Day 3,0,urtic,Urticaria,systemic,,0,130-26
None,9.0,2,0,Baseline,1,ery,Erythema,local,right arm,0,130-26
None,9.0,2,1,Early,0,ery,Erythema,local,right arm,0,130-26
None,9.0,2,2,Day 0,0,ery,Erythema,local,right arm,0,130-26
None,9.0,2,3,Day 1,0,ery,Erythema,local,right arm,0,130-26
None,9.0,2,4,Day 2,0,ery,Erythema,local,right arm,0,130-26
None,9.0,2,5,Day 3,0,ery,Erythema,local,right arm,0,130-26
None,9.0,2,0,Baseline,1,ind,Induration,local,right arm,0,130-26
None,9.0,2,1,Early,0,ind,Induration,local,right arm,0,130-26
None,9.0,2,2,Day 0,0,ind,Induration,local,right arm,0,130-26
None,9.0,2,3,Day 1,0,ind,Induration,local,right arm,0,130-26
None,9.0,2,4,Day 2,0,ind,Induration,local,right arm,0,130-26
None,9.0,2,5,Day 3,0,ind,Induration,local,right arm,0,130-26
None,9.0,2,0,Baseline,1,pain,Pain or Tenderness,local,right arm,0,130-26
None,9.0,2,1,Early,0,pain,Pain or Tenderness,local,right arm,0,130-26
None,9.0,2,2,Day 0,0,pain,Pain or Tenderness,local,right arm,0,130-26
None,9.0,2,3,Day 1,0,pain,Pain or Tenderness,local,right arm,0,130-26
None,9.0,2,4,Day 2,0,pain,Pain or Tenderness,local,right arm,0,130-26
None,9.0,2,5,Day 3,0,pain,Pain or Tenderness,local,right arm,0,130-26
None,9.0,2,0,Baseline,1,arth,Arthralgia,systemic,,0,130-26
None,9.0,2,1,Early,0,arth,Arthralgia,systemic,,0,130-26
None,9.0,2,2,Day 0,0,arth,Arthralgia,systemic,,0,130-26
None,9.0,2,3,Day 1,0,arth,Arthralgia,systemic,,0,130-26
None,9.0,2,4,Day 2,0,arth,Arthralgia,systemic,,0,130-26
None,9.0,2,5,Day 3,0,arth,Arthralgia,systemic,,0,130-26
None,9.0,2,0,Baseline,1,chill,Chills,systemic,,0,130-26
None,9.0,2,1,Early,0,chill,Chills,systemic,,0,130-26
None,9.0,2,2,Day 0,0,chill,Chills,systemic,,0,130-26
None,9.0,2,3,Day 1,0,chill,Chills,systemic,,0,130-26
None,9.0,2,4,Day 2,0,chill,Chills,systemic,,0,130-26
None,9.0,2,5,Day 3,0,chill,Chills,systemic,,0,130-26
None,9.0,2,0,Baseline,1,flush,Facial Flushing,systemic,,0,130-26
None,9.0,2,1,Early,0,flush,Facial Flushing,systemic,,0,130-26
None,9.0,2,2,Day 0,0,flush,Facial Flushing,systemic,,0,130-26
None,9.0,2,3,Day 1,0,flush,Facial Flushing,systemic,,0,130-26
None,9.0,2,4,Day 2,0,flush,Facial Flushing,systemic,,0,130-26
None,9.0,2,5,Day 3,0,flush,Facial Flushing,systemic,,0,130-26
None,9.0,2,0,Baseline,1,gprur,Generalized Pruritis,systemic,,0,130-26
None,9.0,2,1,Early,0,gprur,Generalized Pruritis,systemic,,0,130-26
None,9.0,2,2,Day 0,0,gprur,Generalized Pruritis,systemic,,0,130-26
None,9.0,2,3,Day 1,0,gprur,Generalized Pruritis,systemic,,0,130-26
None,9.0,2,4,Day 2,0,gprur,Generalized Pruritis,systemic,,0,130-26
None,9.0,2,5,Day 3,0,gprur,Generalized Pruritis,systemic,,0,130-26
None,9.0,2,0,Baseline,1,head,Headache,systemic,,0,130-26
None,9.0,2,1,Early,0,head,Headache,systemic,,0,130-26
None,9.0,2,2,Day 0,0,head,Headache,systemic,,0,130-26
None,9.0,2,3,Day 1,0,head,Headache,systemic,,0,130-26
None,9.0,2,4,Day 2,0,head,Headache,systemic,,0,130-26
None,9.0,2,5,Day 3,0,head,Headache,systemic,,0,130-26
None,9.0,2,0,Baseline,1,mf,Malaise/fatigue,systemic,,0,130-26
None,9.0,2,1,Early,0,mf,Malaise/fatigue,systemic,,0,130-26
None,9.0,2,2,Day 0,0,mf,Malaise/fatigue,systemic,,0,130-26
None,9.0,2,3,Day 1,0,mf,Malaise/fatigue,systemic,,0,130-26
None,9.0,2,4,Day 2,0,mf,Malaise/fatigue,systemic,,0,130-26
None,9.0,2,5,Day 3,0,mf,Malaise/fatigue,systemic,,0,130-26
None,9.0,2,0,Baseline,1,myal,Myalgia,systemic,,0,130-26
None,9.0,2,1,Early,0,myal,Myalgia,systemic,,0,130-26
None,9.0,2,2,Day 0,0,myal,Myalgia,systemic,,0,130-26
None,9.0,2,3,Day 1,0,myal,Myalgia,systemic,,0,130-26
None,9.0,2,4,Day 2,0,myal,Myalgia,systemic,,0,130-26
None,9.0,2,5,Day 3,0,myal,Myalgia,systemic,,0,130-26
None,9.0,2,0,Baseline,1,naus,Nausea,systemic,,0,130-26
None,9.0,2,1,Early,0,naus,Nausea,systemic,,0,130-26
None,9.0,2,2,Day 0,0,naus,Nausea,systemic,,0,130-26
None,9.0,2,3,Day 1,0,naus,Nausea,systemic,,0,130-26
None,9.0,2,4,Day 2,0,naus,Nausea,systemic,,0,130-26
None,9.0,2,5,Day 3,0,naus,Nausea,systemic,,0,130-26
None,9.0,2,0,Baseline,1,ndysp,Non-exertional Dyspnea,systemic,,0,130-26
None,9.0,2,1,Early,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-26
None,9.0,2,2,Day 0,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-26
None,9.0,2,3,Day 1,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-26
None,9.0,2,4,Day 2,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-26
None,9.0,2,5,Day 3,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-26
None,9.0,2,0,Baseline,1,ntach,Non-exertional Tachycardia,systemic,,0,130-26
None,9.0,2,1,Early,0,ntach,Non-exertional Tachycardia,systemic,,0,130-26
None,9.0,2,2,Day 0,0,ntach,Non-exertional Tachycardia,systemic,,0,130-26
None,9.0,2,3,Day 1,0,ntach,Non-exertional Tachycardia,systemic,,0,130-26
None,9.0,2,4,Day 2,0,ntach,Non-exertional Tachycardia,systemic,,0,130-26
None,9.0,2,5,Day 3,0,ntach,Non-exertional Tachycardia,systemic,,0,130-26
< 37.9C (None),9.0,2,0,Baseline,1,tempc,Temperature (C),systemic,,0,130-26
< 37.9C (None),9.0,2,1,Early,0,tempc,Temperature (C),systemic,,0,130-26
< 37.9C (None),9.0,2,3,Day 1,0,tempc,Temperature (C),systemic,,0,130-26
< 37.9C (None),9.0,2,4,Day 2,0,tempc,Temperature (C),systemic,,0,130-26
< 37.9C (None),9.0,2,5,Day 3,0,tempc,Temperature (C),systemic,,0,130-26
None,9.0,2,0,Baseline,1,udiap,Unexplained Diaphoresis,systemic,,0,130-26
None,9.0,2,1,Early,0,udiap,Unexplained Diaphoresis,systemic,,0,130-26
None,9.0,2,2,Day 0,0,udiap,Unexplained Diaphoresis,systemic,,0,130-26
None,9.0,2,3,Day 1,0,udiap,Unexplained Diaphoresis,systemic,,0,130-26
None,9.0,2,4,Day 2,0,udiap,Unexplained Diaphoresis,systemic,,0,130-26
None,9.0,2,5,Day 3,0,udiap,Unexplained Diaphoresis,systemic,,0,130-26
None,9.0,2,0,Baseline,1,urtic,Urticaria,systemic,,0,130-26
None,9.0,2,1,Early,0,urtic,Urticaria,systemic,,0,130-26
None,9.0,2,2,Day 0,0,urtic,Urticaria,systemic,,0,130-26
None,9.0,2,3,Day 1,0,urtic,Urticaria,systemic,,0,130-26
None,9.0,2,4,Day 2,0,urtic,Urticaria,systemic,,0,130-26
None,9.0,2,5,Day 3,0,urtic,Urticaria,systemic,,0,130-26
None,2.0,1,0,Baseline,1,ery,Erythema,local,left arm,0,130-27
None,2.0,1,1,Early,0,ery,Erythema,local,left arm,0,130-27
None,2.0,1,2,Day 0,0,ery,Erythema,local,left arm,0,130-27
None,2.0,1,3,Day 1,0,ery,Erythema,local,left arm,0,130-27
None,2.0,1,4,Day 2,0,ery,Erythema,local,left arm,0,130-27
None,2.0,1,5,Day 3,0,ery,Erythema,local,left arm,0,130-27
None,2.0,1,0,Baseline,1,ind,Induration,local,left arm,0,130-27
None,2.0,1,1,Early,0,ind,Induration,local,left arm,0,130-27
None,2.0,1,2,Day 0,0,ind,Induration,local,left arm,0,130-27
None,2.0,1,3,Day 1,0,ind,Induration,local,left arm,0,130-27
None,2.0,1,4,Day 2,0,ind,Induration,local,left arm,0,130-27
None,2.0,1,5,Day 3,0,ind,Induration,local,left arm,0,130-27
None,2.0,1,0,Baseline,1,pain,Pain or Tenderness,local,left arm,0,130-27
None,2.0,1,1,Early,0,pain,Pain or Tenderness,local,left arm,0,130-27
None,2.0,1,2,Day 0,0,pain,Pain or Tenderness,local,left arm,0,130-27
None,2.0,1,3,Day 1,0,pain,Pain or Tenderness,local,left arm,0,130-27
None,2.0,1,4,Day 2,0,pain,Pain or Tenderness,local,left arm,0,130-27
None,2.0,1,5,Day 3,0,pain,Pain or Tenderness,local,left arm,0,130-27
None,2.0,1,0,Baseline,1,arth,Arthralgia,systemic,,0,130-27
None,2.0,1,1,Early,0,arth,Arthralgia,systemic,,0,130-27
None,2.0,1,2,Day 0,0,arth,Arthralgia,systemic,,0,130-27
None,2.0,1,3,Day 1,0,arth,Arthralgia,systemic,,0,130-27
None,2.0,1,4,Day 2,0,arth,Arthralgia,systemic,,0,130-27
None,2.0,1,5,Day 3,0,arth,Arthralgia,systemic,,0,130-27
None,2.0,1,0,Baseline,1,chill,Chills,systemic,,0,130-27
None,2.0,1,1,Early,0,chill,Chills,systemic,,0,130-27
None,2.0,1,2,Day 0,0,chill,Chills,systemic,,0,130-27
None,2.0,1,3,Day 1,0,chill,Chills,systemic,,0,130-27
None,2.0,1,4,Day 2,0,chill,Chills,systemic,,0,130-27
None,2.0,1,5,Day 3,0,chill,Chills,systemic,,0,130-27
None,2.0,1,0,Baseline,1,flush,Facial Flushing,systemic,,0,130-27
None,2.0,1,1,Early,0,flush,Facial Flushing,systemic,,0,130-27
None,2.0,1,2,Day 0,0,flush,Facial Flushing,systemic,,0,130-27
None,2.0,1,3,Day 1,0,flush,Facial Flushing,systemic,,0,130-27
None,2.0,1,4,Day 2,0,flush,Facial Flushing,systemic,,0,130-27
None,2.0,1,5,Day 3,0,flush,Facial Flushing,systemic,,0,130-27
None,2.0,1,0,Baseline,1,gprur,Generalized Pruritis,systemic,,0,130-27
None,2.0,1,1,Early,0,gprur,Generalized Pruritis,systemic,,0,130-27
None,2.0,1,2,Day 0,0,gprur,Generalized Pruritis,systemic,,0,130-27
None,2.0,1,3,Day 1,0,gprur,Generalized Pruritis,systemic,,0,130-27
None,2.0,1,4,Day 2,0,gprur,Generalized Pruritis,systemic,,0,130-27
None,2.0,1,5,Day 3,0,gprur,Generalized Pruritis,systemic,,0,130-27
None,2.0,1,0,Baseline,1,head,Headache,systemic,,0,130-27
None,2.0,1,1,Early,0,head,Headache,systemic,,0,130-27
None,2.0,1,2,Day 0,0,head,Headache,systemic,,0,130-27
None,2.0,1,3,Day 1,0,head,Headache,systemic,,0,130-27
None,2.0,1,4,Day 2,0,head,Headache,systemic,,0,130-27
None,2.0,1,5,Day 3,0,head,Headache,systemic,,0,130-27
None,2.0,1,0,Baseline,1,mf,Malaise/fatigue,systemic,,0,130-27
None,2.0,1,1,Early,0,mf,Malaise/fatigue,systemic,,0,130-27
None,2.0,1,2,Day 0,0,mf,Malaise/fatigue,systemic,,0,130-27
Mild,2.0,1,3,Day 1,0,mf,Malaise/fatigue,systemic,,1,130-27
None,2.0,1,4,Day 2,0,mf,Malaise/fatigue,systemic,,0,130-27
None,2.0,1,5,Day 3,0,mf,Malaise/fatigue,systemic,,0,130-27
None,2.0,1,0,Baseline,1,myal,Myalgia,systemic,,0,130-27
None,2.0,1,1,Early,0,myal,Myalgia,systemic,,0,130-27
None,2.0,1,2,Day 0,0,myal,Myalgia,systemic,,0,130-27
None,2.0,1,3,Day 1,0,myal,Myalgia,systemic,,0,130-27
None,2.0,1,4,Day 2,0,myal,Myalgia,systemic,,0,130-27
None,2.0,1,5,Day 3,0,myal,Myalgia,systemic,,0,130-27
None,2.0,1,0,Baseline,1,naus,Nausea,systemic,,0,130-27
None,2.0,1,1,Early,0,naus,Nausea,systemic,,0,130-27
None,2.0,1,2,Day 0,0,naus,Nausea,systemic,,0,130-27
None,2.0,1,3,Day 1,0,naus,Nausea,systemic,,0,130-27
None,2.0,1,4,Day 2,0,naus,Nausea,systemic,,0,130-27
None,2.0,1,5,Day 3,0,naus,Nausea,systemic,,0,130-27
None,2.0,1,0,Baseline,1,ndysp,Non-exertional Dyspnea,systemic,,0,130-27
None,2.0,1,1,Early,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-27
None,2.0,1,2,Day 0,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-27
None,2.0,1,3,Day 1,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-27
None,2.0,1,4,Day 2,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-27
None,2.0,1,5,Day 3,0,ndysp,Non-exertional Dyspnea,systemic,,0,130-27
None,2.0,1,0,Baseline,1,ntach,Non-exertional Tachycardia,systemic,,0,130-27
None,2.0,1,1,Early,0,ntach,Non-exertional Tachycardia,systemic,,0,130-27
None,2.0,1,2,Day 0,0,ntach,Non-exertional Tachycardia,systemic,,0,130-27
None,2.0,1,3,Day 1,0,ntach,Non-exertional Tachycardia,systemic,,0,130-27
None,2.0,1,4,Day 2,0,ntach,Non-exertional Tachycardia,systemic,,0,130-27
None,2.0,1,5,Day 3,0,ntach,Non-exertional Tachycardia,systemic,,0,130-27
< 37.9C (None),2.0,1,0,Baseline,1,tempc,Temperature (C),systemic,,0,130-27
< 37.9C (None),2.0,1,1,Early,0,tempc,Temperature (C),systemic,,0,130-27
< 37.9C (None),2.0,1,2,Day 0,0,tempc,Temperature (C),systemic,,0,130-27
< 37.9C (None),2.0,1,3,Day 1,0,tempc,Temperature (C),systemic,,0,130-27
< 37.9C (None),2.0,1,4,Day 2,0,tempc,Temperature (C),systemic,,0,130-27
< 37.9C (None),2.0,1,5,Day 3,0,tempc,Temperature (C),systemic,,0,130-27
None,2.0,1,0,Baseline,1,udiap,Unexplained Diaphoresis,systemic,,0,130-27
None,2.0,1,1,Early,0,udiap,Unexplained Diaphoresis,systemic,,0,130-27
None,2.0,1,2,Day 0,0,udiap,Unexplained Diaphoresis,systemic,,0,130-27
None,2.0,1,3,Day 1,0,udiap,Unexplained Diaphoresis,systemic,,0,130-27
None,2.0,1,4,Day 2,0,udiap,Unexplained Diaphoresis,systemic,,0,130-27
None,2.0,1,5,Day 3,0,udiap,Unexplained Diaphoresis,systemic,,0,130-27
None,2.0,1,0,Baseline,1,urtic,Urticaria,systemic,,0,130-27
None,2.0,1,1,Early,0,urtic,Urticaria,systemic,,0,130-27
None,2.0,1,2,Day 0,0,urtic,Urticaria,systemic,,0,130-27
None,2.0,1,3,Day 1,0,urtic,Urticaria,systemic,,0,130-27
None,2.0,1,4,Day 2,0,urtic,Urticaria,systemic,,0,130-27
None,2.0,1,5,Day 3,0,urtic,Urticaria,systemic,,0,130-27