from pharmadata import cdiscpilotadam
meta = cdiscpilotadam.meta('adae')
print(f"Rows: {meta.number_rows:,} Columns: {meta.number_columns}")Rows: 1,191 Columns: 55adae
adae
Adverse Events Analysis Dataset
Structure: one record per subject per adverse event
Variables
Show variable specs
shape: (55, 5)
| variable | label | type | mandatory | role |
|---|---|---|---|---|
| str | str | str | str | null |
| "STUDYID" | "Study Identifier" | "String" | "No" | null |
| "SITEID" | "Study Site Identifier" | "String" | "No" | null |
| "USUBJID" | "Unique Subject Identifier" | "String" | "No" | null |
| "TRTA" | "Actual Treatment" | "String" | "No" | null |
| "TRTAN" | "Actual Treatment (N)" | "Float64" | "No" | null |
| "AGE" | "Age" | "Float64" | "No" | null |
| "AGEGR1" | "Pooled Age Group 1" | "String" | "No" | null |
| "AGEGR1N" | "Pooled Age Group 1 (N)" | "Float64" | "No" | null |
| "RACE" | "Race" | "String" | "No" | null |
| "RACEN" | "Race (N)" | "Float64" | "No" | null |
| "SEX" | "Sex" | "String" | "No" | null |
| "SAFFL" | "Safety Population Flag" | "String" | "No" | null |
| "TRTSDT" | "Date of First Exposure to Treatment" | "Date" | "No" | null |
| "TRTEDT" | "Date of Last Exposure to Treatment" | "Date" | "No" | null |
| "ASTDT" | "Analysis Start Date" | "Date" | "No" | null |
| "ASTDTF" | "Analysis Start Date Imputation Flag" | "String" | "No" | null |
| "ASTDY" | "Analysis Start Relative Day" | "Float64" | "No" | null |
| "AENDT" | "Analysis End Date" | "Date" | "No" | null |
| "AENDY" | "Analysis End Relative Day" | "Float64" | "No" | null |
| "ADURN" | "AE Duration (N)" | "Float64" | "No" | null |
| "ADURU" | "AE Duration Units" | "String" | "No" | null |
| "AETERM" | "Reported Term for the Adverse Event" | "String" | "No" | null |
| "AELLT" | "Lowest Level Term" | "String" | "No" | null |
| "AELLTCD" | "Lowest Level Term Code" | "Float64" | "No" | null |
| "AEDECOD" | "Dictionary-Derived Term" | "String" | "No" | null |
| "AEPTCD" | "Preferred Term Code" | "Float64" | "No" | null |
| "AEHLT" | "High Level Term" | "String" | "No" | null |
| "AEHLTCD" | "High Level Term Code" | "Float64" | "No" | null |
| "AEHLGT" | "High Level Group Term" | "String" | "No" | null |
| "AEHLGTCD" | "High Level Group Term Code" | "Float64" | "No" | null |
| "AEBODSYS" | "Body System or Organ Class" | "String" | "No" | null |
| "AESOC" | "Primary System Organ Class" | "String" | "No" | null |
| "AESOCCD" | "Primary System Organ Class Code" | "Float64" | "No" | null |
| "AESEV" | "Severity/Intensity" | "String" | "No" | null |
| "AESER" | "Serious Event" | "String" | "No" | null |
| "AESCAN" | "Involves Cancer" | "String" | "No" | null |
| "AESCONG" | "Congenital Anomaly or Birth Defect" | "String" | "No" | null |
| "AESDISAB" | "Persist or Signif Disability/Incapacity" | "String" | "No" | null |
| "AESDTH" | "Results in Death" | "String" | "No" | null |
| "AESHOSP" | "Requires or Prolongs Hospitalization" | "String" | "No" | null |
| "AESLIFE" | "Is Life Threatening" | "String" | "No" | null |
| "AESOD" | "Occurred with Overdose" | "String" | "No" | null |
| "AEREL" | "Causality" | "String" | "No" | null |
| "AEACN" | "Action Taken with Study Treatment" | "String" | "No" | null |
| "AEOUT" | "Outcome of Adverse Event" | "String" | "No" | null |
| "AESEQ" | "Sequence Number" | "Float64" | "No" | null |
| "TRTEMFL" | "Treatment Emergent Analysis Flag" | "String" | "No" | null |
| "AOCCFL" | "1st Occurrence of Any AE Flag" | "String" | "No" | null |
| "AOCCSFL" | "1st Occurrence of SOC Flag" | "String" | "No" | null |
| "AOCCPFL" | "1st Occurrence of Preferred Term Flag" | "String" | "No" | null |
| "AOCC02FL" | "1st Occurrence 02 Flag for Serious" | "String" | "No" | null |
| "AOCC03FL" | "1st Occurrence 03 Flag for Serious SOC" | "String" | "No" | null |
| "AOCC04FL" | "1st Occurrence 04 Flag for Serious PT" | "String" | "No" | null |
| "CQ01NAM" | "Customized Query 01 Name" | "String" | "No" | null |
| "AOCC01FL" | "1st Occurrence 01 Flag for CQ01" | "String" | "No" | null |
Examples
from great_docs import tbl_explorer
from pharmadata import cdiscpilotadam
tbl_explorer(cdiscpilotadam.adae.head(10))PolarsRows10Columns55 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
STUDYID str |
SITEID str |
USUBJID str |
TRTA str |
TRTAN f64 |
AGE f64 |
AGEGR1 str |
AGEGR1N f64 |
RACE str |
RACEN f64 |
SEX str |
SAFFL str |
TRTSDT date |
TRTEDT date |
ASTDT date |
ASTDTF str |
ASTDY f64 |
AENDT date |
AENDY f64 |
ADURN f64 |
ADURU str |
AETERM str |
AELLT str |
AELLTCD f64 |
AEDECOD str |
AEPTCD f64 |
AEHLT str |
AEHLTCD f64 |
AEHLGT str |
AEHLGTCD f64 |
AEBODSYS str |
AESOC str |
AESOCCD f64 |
AESEV str |
AESER str |
AESCAN str |
AESCONG str |
AESDISAB str |
AESDTH str |
AESHOSP str |
AESLIFE str |
AESOD str |
AEREL str |
AEACN str |
AEOUT str |
AESEQ f64 |
TRTEMFL str |
AOCCFL str |
AOCCSFL str |
AOCCPFL str |
AOCC02FL str |
AOCC03FL str |
AOCC04FL str |
CQ01NAM str |
AOCC01FL str |
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0 | CDISCPILOT01 | 701 | 01-701-1015 | Placebo | 0 | 63 | <65 | 1 | WHITE | 1 | F | Y | 2014-01-02 | 2014-07-02 | 2014-01-03 | None | 2 | None | None | None | None | APPLICATION SITE ERYTHEMA | APPLICATION SITE REDNESS | None | APPLICATION SITE ERYTHEMA | None | HLT_0617 | None | HLGT_0152 | None | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | None | MILD | N | N | N | N | N | N | N | N | PROBABLE | None | NOT RECOVERED/NOT RESOLVED | 1 | Y | Y | Y | Y | None | None | None | DERMATOLOGIC EVENTS | Y |
| 1 | CDISCPILOT01 | 701 | 01-701-1015 | Placebo | 0 | 63 | <65 | 1 | WHITE | 1 | F | Y | 2014-01-02 | 2014-07-02 | 2014-01-03 | None | 2 | None | None | None | None | APPLICATION SITE PRURITUS | APPLICATION SITE ITCHING | None | APPLICATION SITE PRURITUS | None | HLT_0317 | None | HLGT_0338 | None | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | None | MILD | N | N | N | N | N | N | N | N | PROBABLE | None | NOT RECOVERED/NOT RESOLVED | 2 | Y | None | None | Y | None | None | None | DERMATOLOGIC EVENTS | None |
| 2 | CDISCPILOT01 | 701 | 01-701-1015 | Placebo | 0 | 63 | <65 | 1 | WHITE | 1 | F | Y | 2014-01-02 | 2014-07-02 | 2014-01-09 | None | 8 | 2014-01-11 | 10 | 3 | DAY | DIARRHOEA | DIARRHEA | None | DIARRHOEA | None | HLT_0148 | None | HLGT_0588 | None | GASTROINTESTINAL DISORDERS | GASTROINTESTINAL DISORDERS | None | MILD | N | N | N | N | N | N | N | N | REMOTE | None | RECOVERED/RESOLVED | 3 | Y | None | Y | Y | None | None | None | None | None |
| 3 | CDISCPILOT01 | 701 | 01-701-1023 | Placebo | 0 | 64 | <65 | 1 | WHITE | 1 | M | Y | 2012-08-05 | 2012-09-01 | 2012-08-07 | None | 3 | 2012-08-30 | 26 | 24 | DAY | ERYTHEMA | ERYTHEMA | None | ERYTHEMA | None | HLT_0284 | None | HLGT_0192 | None | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | None | MILD | N | N | N | N | N | N | N | N | POSSIBLE | None | NOT RECOVERED/NOT RESOLVED | 1 | Y | Y | Y | Y | None | None | None | DERMATOLOGIC EVENTS | Y |
| 4 | CDISCPILOT01 | 701 | 01-701-1023 | Placebo | 0 | 64 | <65 | 1 | WHITE | 1 | M | Y | 2012-08-05 | 2012-09-01 | 2012-08-07 | None | 3 | None | None | None | None | ERYTHEMA | LOCALIZED ERYTHEMA | None | ERYTHEMA | None | HLT_0284 | None | HLGT_0192 | None | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | None | MODERATE | N | N | N | N | N | N | N | N | PROBABLE | None | NOT RECOVERED/NOT RESOLVED | 2 | Y | None | None | None | None | None | None | DERMATOLOGIC EVENTS | None |
| 5 | CDISCPILOT01 | 701 | 01-701-1023 | Placebo | 0 | 64 | <65 | 1 | WHITE | 1 | M | Y | 2012-08-05 | 2012-09-01 | 2012-08-26 | None | 22 | None | None | None | None | ATRIOVENTRICULAR BLOCK SECOND DEGREE | AV BLOCK SECOND DEGREE | None | ATRIOVENTRICULAR BLOCK SECOND DEGREE | None | HLT_0415 | None | HLGT_0086 | None | CARDIAC DISORDERS | CARDIAC DISORDERS | None | MILD | N | N | N | N | N | N | N | N | POSSIBLE | None | NOT RECOVERED/NOT RESOLVED | 3 | Y | None | Y | Y | None | None | None | None | None |
| 6 | CDISCPILOT01 | 701 | 01-701-1023 | Placebo | 0 | 64 | <65 | 1 | WHITE | 1 | M | Y | 2012-08-05 | 2012-09-01 | 2012-08-07 | None | 3 | 2012-08-30 | 26 | 24 | DAY | ERYTHEMA | ERYTHEMA | None | ERYTHEMA | None | HLT_0284 | None | HLGT_0192 | None | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | None | MILD | N | N | N | N | N | N | N | N | POSSIBLE | None | RECOVERED/RESOLVED | 4 | Y | None | None | None | None | None | None | DERMATOLOGIC EVENTS | None |
| 7 | CDISCPILOT01 | 701 | 01-701-1028 | Xanomeline High Dose | 81 | 71 | 65-80 | 2 | WHITE | 1 | M | Y | 2013-07-19 | 2014-01-14 | 2013-07-21 | None | 3 | None | None | None | None | APPLICATION SITE ERYTHEMA | APPLICATION SITE ERYTHEMA | None | APPLICATION SITE ERYTHEMA | None | HLT_0617 | None | HLGT_0152 | None | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | None | MILD | N | N | N | N | N | N | N | N | POSSIBLE | None | NOT RECOVERED/NOT RESOLVED | 1 | Y | Y | Y | Y | None | None | None | DERMATOLOGIC EVENTS | Y |
| 8 | CDISCPILOT01 | 701 | 01-701-1028 | Xanomeline High Dose | 81 | 71 | 65-80 | 2 | WHITE | 1 | M | Y | 2013-07-19 | 2014-01-14 | 2013-08-08 | None | 21 | None | None | None | None | APPLICATION SITE PRURITUS | APPLICATION SITE ITCHING | None | APPLICATION SITE PRURITUS | None | HLT_0317 | None | HLGT_0338 | None | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | None | MILD | N | N | N | N | N | N | N | N | PROBABLE | None | NOT RECOVERED/NOT RESOLVED | 2 | Y | None | None | Y | None | None | None | DERMATOLOGIC EVENTS | None |
| 9 | CDISCPILOT01 | 701 | 01-701-1034 | Xanomeline High Dose | 81 | 77 | 65-80 | 2 | WHITE | 1 | F | Y | 2014-07-01 | 2014-12-30 | 2014-08-27 | None | 58 | None | None | None | None | APPLICATION SITE PRURITUS | APPLICATION SITE ITCHING | None | APPLICATION SITE PRURITUS | None | HLT_0317 | None | HLGT_0338 | None | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | None | MILD | N | N | N | N | N | N | N | N | PROBABLE | None | NOT RECOVERED/NOT RESOLVED | 1 | Y | Y | Y | Y | None | None | None | DERMATOLOGIC EVENTS | Y |