Kyle Marshall
Kyle Marshall
2020-01-10T22:50:04Z
2020-01-14T20:09:54Z
16.00
18270
32767
32767
32767
3
False
False
| Tab |
Description |
Structure |
File |
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| SUBJECT_MASTER |
Baseline Subject Characteristics |
One record per subject |
subject_master.csv |
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| AE_LIST |
Adverse Events |
One record per adverse event per subject |
ae_list.csv |
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| REACTO_EVAL |
Reactogenicity Events |
One record per reactogenicity event per time point per subject |
reacto_list.csv |
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600
600
3
24
8
False
False
| Variable |
Type |
Len |
Label |
Key |
Derivation |
| AGE |
Num |
4 |
Age at Enrollment |
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| DISC_FL |
Char |
3 |
Discontinued Vaccination Flag |
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No" if TERM_RSN = "Scheduled exit visit/end of study"; "Yes" otherwise |
| DISC_RSN |
Char |
60 |
Reason Vaccine Discontinued |
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| DISC_RSN_O |
Char |
100 |
Reason Vaccine Discontinued for "Other, specify" |
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| EARLY_TERM_FL |
Char |
3 |
Early Termination Flag |
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| HISPANIC |
Char |
3 |
Latino/a or of Hispanic origin? |
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| NUM_VAC_RECD |
Num |
8 |
Number of Vaccination Received |
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| PROTOCOL |
Char |
3 |
Protocol Number |
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| PUB_ID |
Char |
8 |
Publication ID |
1 |
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| RACE |
Char |
35 |
Race |
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| RX_CODE |
Char |
8 |
Treatment arm |
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| RX_LABEL |
Char |
100 |
Treatment Label |
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| SEX |
Char |
8 |
Sex at Birth |
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| TERM_AE |
Char |
3 |
Termination due to AE |
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| TERM_RSN |
Char |
60 |
Reason for Termination |
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| Observations |
132 |
| Variables |
15 |
| Indexes |
0 |
| Observation Length |
408 |
| Deleted Observations |
0 |
| Compressed |
NO |
| Sorted |
YES |
300
300
3
4
6
False
False
| Variable |
Type |
Len |
Format |
Label |
Key |
Derivation |
| AEDAIDSC |
Char |
13 |
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AE to be reported as an EAE |
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| AEDRADC |
Char |
24 |
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Study Product Administration |
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| AEICHC |
Char |
13 |
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SAE according to ICH |
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| AEOUTCC |
Char |
26 |
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Status/Outcome |
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| AESAERCTC |
Char |
13 |
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AE reported on a Reactogenicity form |
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| AEdaids |
Num |
4 |
1=Y 2=N |
Reported as an EAE |
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| AEdiag |
Char |
100 |
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Adverse Experience (AE) |
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| AEdrad |
Num |
4 |
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Study Product Administration |
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| AEich |
Num |
4 |
1=Y 2=N |
SAE according to ICH |
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| AEmdra |
Char |
120 |
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Preferred Term |
2 |
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| AEocdate |
Num |
8 |
DATE9. |
AE Outcome Date (derived) |
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If Day of Outcome is missing, it is imputed as 15th day of the Month, If Month of Outcome is missing, it is imputed as 1st month of the Year |
| AEocdt_dsp |
Char |
9 |
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AE Outcome Date (character) |
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| AEondate |
Num |
8 |
DATE9. |
AE Onset Date (derived) |
3 |
If Day of Onset is missing, it is imputed as 15th day of the Month, If Month of Onset is missing, it is imputed as 1st month of the Year |
| AEondt_dsp |
Char |
9 |
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AE Onset Date (character) |
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| AEoutc |
Num |
4 |
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Status/Outcome |
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| AEpagenum |
Num |
8 |
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AE Page Number |
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| AErel |
Num |
4 |
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Relationship to Study Product |
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| AErel_txt |
Char |
30 |
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Relationship to Study Product (Character) |
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| AEsaerct |
Num |
4 |
1=Y 2=N |
AE reported on a Reactogenicity form |
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| AEseve |
Num |
4 |
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Severity |
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| AEseve_txt |
Char |
30 |
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Severity (Character) |
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| AEsoc |
Char |
120 |
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SOC |
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| AEtreatment |
Char |
70 |
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AE Treatment |
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| AEvisit |
Num |
8 |
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At which visit was this AE first reported |
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| hl_name |
Char |
120 |
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Higher Level Term, full name |
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| hlg_name |
Char |
120 |
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Higher Level Group Term, full name |
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| ll_name |
Char |
120 |
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Low Level Term Name |
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| pub_id |
Char |
8 |
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Publication ID |
1 |
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| visit |
Num |
4 |
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Visit Number |
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| Observations |
140 |
| Variables |
29 |
| Indexes |
0 |
| Observation Length |
1016 |
| Deleted Observations |
0 |
| Compressed |
NO |
| Sorted |
NO |
300
300
3
5
R1C6:R2C7
False
False
| Variable |
Type |
Len |
Label |
Key |
Derivation |
| PUB_ID |
Char |
8 |
Publication ID |
1 |
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| RGBASEFLAG |
Num |
8 |
1=Baseline |
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| RGDGRADE |
Num |
8 |
Severity Grade for IND Annual Reports |
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| RGDGRADE_TXT |
Char |
30 |
Severity Grade (DAIDS Severity Definitions) |
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Severity grades are determined using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events: https://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf |
| RGEVAL |
Num |
8 |
Reactogenicity Evaluation |
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| RGEVALC |
Char |
30 |
Reactogenicity Evaluation |
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| RGLOC |
Char |
20 |
Reactogenicity Location |
4 |
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| RGPARAM |
Char |
10 |
Reactogenicity Parameter |
3 |
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| RGPARAMC |
Char |
32 |
Reactogenicity Parameter |
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| RGTYPE |
Char |
8 |
Type of symptom |
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| VACN |
Num |
8 |
Study Product Administration Number |
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| VISIT |
Num |
4 |
Visit Number |
2 |
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| Observations |
51155 |
| Variables |
12 |
| Indexes |
0 |
| Observation Length |
176 |
| Deleted Observations |
0 |
| Compressed |
NO |
0 |
| Sorted |
NO |
300
300
3
17
5
False
False
gasmus
gasmus
2020-01-10T13:40:39
2020-01-10T13:40:39
SAS Institute Inc. http://www.sas.com
9.04.01M2P07232014