from pharmadata import pharmaverseadam
meta = pharmaverseadam.meta('adae')
print(f"Rows: {meta.number_rows:,} Columns: {meta.number_columns}")Rows: 1,191 Columns: 107adae
adae
Adverse Events Analysis
Structure: One record per subject per adverse event
Variables
Show variable specs
shape: (107, 5)
| variable | label | type | mandatory | role |
|---|---|---|---|---|
| str | str | str | str | str |
| "STUDYID" | "Study Identifier" | "String" | "Yes" | "OCCDS Identifier Variables" |
| "USUBJID" | "Unique Subject Identifier" | "String" | "Yes" | "OCCDS Identifier Variables" |
| "SUBJID" | "Subject Identifier for the Study" | "String" | "No" | "OCCDS Identifier Variables" |
| "SITEID" | "Study Site Identifier" | "String" | "No" | "OCCDS Identifier Variables" |
| "COUNTRY" | "Country" | "String" | "No" | null |
| "DOMAIN" | "Domain Abbreviation" | "String" | "No" | null |
| "RFSTDTC" | "Subject Reference Start Date/Time" | "String" | "No" | null |
| "RFENDTC" | "Subject Reference End Date/Time" | "String" | "No" | null |
| "RFXSTDTC" | "Date/Time of First Study Treatment" | "String" | "No" | null |
| "RFXENDTC" | "Date/Time of Last Study Treatment" | "String" | "No" | null |
| "RFPENDTC" | "Date/Time of End of Participation" | "String" | "No" | null |
| "SCRFDT" | "Screen Failure Date" | "Date" | "No" | null |
| "FRVDT" | "Final Retrieval Visit Date" | "Date" | "No" | null |
| "DTHDTC" | "Date/Time of Death" | "String" | "No" | null |
| "DTHADY" | "Relative Day of Death" | "Float64" | "No" | null |
| "DTHFL" | "Subject Death Flag" | "String" | "No" | null |
| "LDDTHELD" | "Elapsed Days from Last Dose to Death" | "Float64" | "No" | null |
| "LDDTHGR1" | "Last Dose to Death - Days Elapsed Grp 1" | "String" | "No" | null |
| "DTH30FL" | "Death Within 30 Days of Last Trt Flag" | "String" | "No" | null |
| "DTHA30FL" | "Death After 30 Days from Last Trt Flag" | "String" | "No" | null |
| "DTHDOM" | "Domain for Date of Death Collection" | "String" | "No" | null |
| "DTHB30FL" | "Death Within 30 Days of First Trt Flag" | "String" | "No" | null |
| "REGION1" | "Geographic Region 1" | "String" | "No" | null |
| "DMDTC" | "Date/Time of Collection" | "String" | "No" | null |
| "DMDY" | "Study Day of Collection" | "Float64" | "No" | null |
| "AGE" | "Age" | "Float64" | "No" | "ADSL Subject Demographics Variables" |
| "AGEU" | "Age Units" | "String" | "No" | "ADSL Subject Demographics Variables" |
| "AGEGR1" | "Pooled Age Group 1" | "String" | "No" | null |
| "SEX" | "Sex" | "String" | "No" | "ADSL Subject Demographics Variables" |
| "RACE" | "Race" | "String" | "No" | "ADSL Subject Demographics Variables" |
| "RACEGR1" | "Pooled Race Group 1" | "String" | "No" | null |
| "ETHNIC" | "Ethnicity" | "String" | "No" | null |
| "SAFFL" | "Safety Population Flag" | "String" | "No" | "ADSL Population Indicator Variables" |
| "ARM" | "Description of Planned Arm" | "String" | "No" | "ADSL Treatment Variables" |
| "ARMCD" | "Planned Arm Code" | "String" | "No" | null |
| "ACTARM" | "Description of Actual Arm" | "String" | "No" | "ADSL Treatment Variables" |
| "ACTARMCD" | "Actual Arm Code" | "String" | "No" | null |
| "TRT01P" | "Planned Treatment for Period 01" | "String" | "No" | null |
| "TRT01A" | "Actual Treatment for Period 01" | "String" | "No" | null |
| "TRTSDT" | "Date of First Exposure to Treatment" | "Date" | "No" | "ADSL Treatment Timing Variables" |
| "TRTSDTM" | "Datetime of First Exposure to Treatment" | "Datetime" | "No" | "ADSL Treatment Timing Variables" |
| "TRTSTMF" | "Time of First Exposure Imput. Flag" | "String" | "No" | "ADSL Treatment Timing Variables" |
| "TRTEDT" | "Date of Last Exposure to Treatment" | "Date" | "No" | "ADSL Treatment Timing Variables" |
| "TRTEDTM" | "Datetime of Last Exposure to Treatment" | "Datetime" | "No" | "ADSL Treatment Timing Variables" |
| "TRTETMF" | "Time of Last Exposure Imput. Flag" | "String" | "No" | "ADSL Treatment Timing Variables" |
| "EOSSTT" | "End of Study Status" | "String" | "No" | "ADSL Subject-Level Trial Experience Variables" |
| "EOSDT" | "End of Study Date" | "Date" | "No" | "ADSL Subject-Level Trial Experience Variables" |
| "RFICDTC" | "Date/Time of Informed Consent" | "String" | "No" | null |
| "RANDDT" | "Date of Randomization" | "Date" | "No" | "ADSL Subject-Level Trial Experience Variables" |
| "LSTALVDT" | "Date Last Known Alive" | "Date" | "No" | "ADSL Subject-Level Trial Experience Variables" |
| "TRTDURD" | "Total Treatment Duration (Days)" | "Float64" | "No" | "ADSL Subject-Level Trial Experience Variables" |
| "DTHDT" | "Date of Death" | "Date" | "No" | "ADSL Subject-Level Trial Experience Variables" |
| "DTHDTF" | "Date of Death Imputation Flag" | "String" | "No" | "ADSL Subject-Level Trial Experience Variables" |
| "DTHCAUS" | "Cause of Death" | "String" | "No" | null |
| "DTHCGR1" | "Cause of Death Reason 1" | "String" | "No" | null |
| "AESEQ" | "Sequence Number" | "Float64" | "Yes" | "OCCDS Identifier Variables" |
| "AETERM" | "Reported Term for the Adverse Event" | "String" | "Yes" | "MedDRA Dictionary Coding Variables" |
| "AEDECOD" | "Dictionary-Derived Term" | "String" | "No" | "MedDRA Dictionary Coding Variables" |
| "AEBODSYS" | "Body System or Organ Class" | "String" | "No" | "MedDRA Dictionary Coding Variables" |
| "AEBDSYCD" | "Body System or Organ Class Code" | "Float64" | "No" | "MedDRA Dictionary Coding Variables" |
| "AELLT" | "Lowest Level Term" | "String" | "No" | "MedDRA Dictionary Coding Variables" |
| "AELLTCD" | "Lowest Level Term Code" | "Float64" | "No" | "MedDRA Dictionary Coding Variables" |
| "AEPTCD" | "Preferred Term Code" | "Float64" | "No" | "MedDRA Dictionary Coding Variables" |
| "AEHLT" | "High Level Term" | "String" | "No" | "MedDRA Dictionary Coding Variables" |
| "AEHLTCD" | "High Level Term Code" | "Float64" | "No" | "MedDRA Dictionary Coding Variables" |
| "AEHLGT" | "High Level Group Term" | "String" | "No" | "MedDRA Dictionary Coding Variables" |
| "AEHLGTCD" | "High Level Group Term Code" | "Float64" | "No" | "MedDRA Dictionary Coding Variables" |
| "AESOC" | "Primary System Organ Class" | "String" | "No" | "MedDRA Dictionary Coding Variables" |
| "AESOCCD" | "Primary System Organ Class Code" | "Float64" | "No" | "MedDRA Dictionary Coding Variables" |
| "AESTDTC" | "Start Date/Time of Adverse Event" | "String" | "No" | "Timing Variables" |
| "ASTDT" | "Analysis Start Date" | "Date" | "No" | "Timing Variables" |
| "ASTDTM" | "Analysis Start Date/Time" | "Datetime" | "No" | "Timing Variables" |
| "ASTDTF" | "Analysis Start Date Imputation Flag" | "String" | "No" | "Timing Variables" |
| "ASTTMF" | "Analysis Start Time Imputation Flag" | "String" | "No" | "Timing Variables" |
| "AEENDTC" | "End Date/Time of Adverse Event" | "String" | "No" | "Timing Variables" |
| "AENDT" | "Analysis End Date" | "Date" | "No" | "Timing Variables" |
| "AENDTM" | "Analysis End Date/Time" | "Datetime" | "No" | "Timing Variables" |
| "AENDTF" | "Analysis End Date Imputation Flag" | "String" | "No" | "Timing Variables" |
| "AENTMF" | "Analysis End Time Imputation Flag" | "String" | "No" | "Timing Variables" |
| "ASTDY" | "Analysis Start Relative Day" | "Float64" | "No" | "Timing Variables" |
| "AESTDY" | "Study Day of Start of Adverse Event" | "Float64" | "No" | "Timing Variables" |
| "AENDY" | "Analysis End Relative Day" | "Float64" | "No" | "Timing Variables" |
| "AEENDY" | "Study Day of End of Adverse Event" | "Float64" | "No" | "Timing Variables" |
| "ADURN" | "Analysis Duration (N)" | "Float64" | "No" | "Timing Variables" |
| "ADURU" | "Analysis Duration Units" | "String" | "No" | "Timing Variables" |
| "TRTEMFL" | "Treatment Emergent Analysis Flag" | "String" | "No" | "Adverse Events Indicator Variables" |
| "AOCCIFL" | "1st Max Sev./Int. Occurrence Flag" | "String" | "No" | "OCCDS Occurrence Flag Variables" |
| "AESER" | "Serious Event" | "String" | "Yes" | "Adverse Event Descriptive Variables" |
| "AESDTH" | "Results in Death" | "String" | "No" | null |
| "AESLIFE" | "Is Life Threatening" | "String" | "No" | null |
| "AESHOSP" | "Requires or Prolongs Hospitalization" | "String" | "No" | null |
| "AESDISAB" | "Persist or Signif Disability/Incapacity" | "String" | "No" | null |
| "AESCONG" | "Congenital Anomaly or Birth Defect" | "String" | "No" | null |
| "AESEV" | "Severity/Intensity" | "String" | "No" | "Adverse Event Descriptive Variables" |
| "ASEV" | "Analysis Severity/Intensity" | "String" | "No" | "Adverse Event Descriptive Variables" |
| "ASEVN" | "Analysis Severity/Intensity (N)" | "Int32" | "No" | "Adverse Event Descriptive Variables" |
| "AEREL" | "Causality" | "String" | "No" | "Adverse Event Descriptive Variables" |
| "AREL" | "Analysis Causality" | "String" | "No" | "Adverse Event Descriptive Variables" |
| "AEACN" | "Action Taken with Study Treatment" | "String" | "No" | "Adverse Event Descriptive Variables" |
| "AESPID" | "Sponsor-Defined Identifier" | "String" | "No" | null |
| "AEOUT" | "Outcome of Adverse Event" | "String" | "No" | null |
| "AESCAN" | "Involves Cancer" | "String" | "No" | null |
| "AESOD" | "Occurred with Overdose" | "String" | "No" | null |
| "AEDTC" | "Date/Time of Collection" | "String" | "No" | null |
| "LDOSEDTM" | "End Date/Time of Last Dose" | "Datetime" | "No" | null |
| "DOSEON" | "Treatment Dose" | "Float64" | "No" | null |
| "DOSEU" | "Treatment Dose Unit" | "String" | "No" | null |
Examples
from great_docs import tbl_explorer
from pharmadata import pharmaverseadam
tbl_explorer(pharmaverseadam.adae.head(10))PolarsRows10Columns107 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
STUDYID str |
USUBJID str |
SUBJID str |
SITEID str |
COUNTRY str |
DOMAIN str |
RFSTDTC str |
RFENDTC str |
RFXSTDTC str |
RFXENDTC str |
RFPENDTC str |
SCRFDT date |
FRVDT date |
DTHDTC str |
DTHADY f64 |
DTHFL str |
LDDTHELD f64 |
LDDTHGR1 str |
DTH30FL str |
DTHA30FL str |
DTHDOM str |
DTHB30FL str |
REGION1 str |
DMDTC str |
DMDY f64 |
AGE f64 |
AGEU str |
AGEGR1 str |
SEX str |
RACE str |
RACEGR1 str |
ETHNIC str |
SAFFL str |
ARM str |
ARMCD str |
ACTARM str |
ACTARMCD str |
TRT01P str |
TRT01A str |
TRTSDT date |
TRTSDTM dtime |
TRTSTMF str |
TRTEDT date |
TRTEDTM dtime |
TRTETMF str |
EOSSTT str |
EOSDT date |
RFICDTC str |
RANDDT date |
LSTALVDT date |
TRTDURD f64 |
DTHDT date |
DTHDTF str |
DTHCAUS str |
DTHCGR1 str |
AESEQ f64 |
AETERM str |
AEDECOD str |
AEBODSYS str |
AEBDSYCD f64 |
AELLT str |
AELLTCD f64 |
AEPTCD f64 |
AEHLT str |
AEHLTCD f64 |
AEHLGT str |
AEHLGTCD f64 |
AESOC str |
AESOCCD f64 |
AESTDTC str |
ASTDT date |
ASTDTM dtime |
ASTDTF str |
ASTTMF str |
AEENDTC str |
AENDT date |
AENDTM dtime |
AENDTF str |
AENTMF str |
ASTDY f64 |
AESTDY f64 |
AENDY f64 |
AEENDY f64 |
ADURN f64 |
ADURU str |
TRTEMFL str |
AOCCIFL str |
AESER str |
AESDTH str |
AESLIFE str |
AESHOSP str |
AESDISAB str |
AESCONG str |
AESEV str |
ASEV str |
ASEVN i32 |
AEREL str |
AREL str |
AEACN str |
AESPID str |
AEOUT str |
AESCAN str |
AESOD str |
AEDTC str |
LDOSEDTM dtime |
DOSEON f64 |
DOSEU str |
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0 | CDISCPILOT01 | 01-701-1015 | 1015 | 701 | USA | AE | 2014-01-02 | 2014-07-02 | 2014-01-02 | 2014-07-02 | 2014-07-02T11:45 | None | None | None | None | None | None | None | None | None | None | None | NA | 2013-12-26 | -7 | 63 | YEARS | 18-64 | F | WHITE | White | HISPANIC OR LATINO | Y | Placebo | Pbo | Placebo | Pbo | Placebo | Placebo | 2014-01-02 | 2014-01-02 00:00:00+00:00 | H | 2014-07-02 | 2014-07-02 23:59:59+00:00 | H | COMPLETED | 2014-07-02 | None | 2014-01-02 | 2014-07-02 | 182 | None | None | None | None | 1 | APPLICATION SITE ERYTHEMA | APPLICATION SITE ERYTHEMA | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | None | APPLICATION SITE REDNESS | None | None | HLT_0617 | None | HLGT_0152 | None | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | None | 2014-01-03 | 2014-01-03 | 2014-01-03 00:00:00+00:00 | None | H | None | None | None | None | None | 2 | 2 | None | None | None | None | Y | Y | N | N | N | N | N | N | MILD | MILD | 1 | PROBABLE | PROBABLE | None | E07 | NOT RECOVERED/NOT RESOLVED | N | N | 2014-01-16 | 2014-01-03 00:00:00+00:00 | 0 | mg |
| 1 | CDISCPILOT01 | 01-701-1015 | 1015 | 701 | USA | AE | 2014-01-02 | 2014-07-02 | 2014-01-02 | 2014-07-02 | 2014-07-02T11:45 | None | None | None | None | None | None | None | None | None | None | None | NA | 2013-12-26 | -7 | 63 | YEARS | 18-64 | F | WHITE | White | HISPANIC OR LATINO | Y | Placebo | Pbo | Placebo | Pbo | Placebo | Placebo | 2014-01-02 | 2014-01-02 00:00:00+00:00 | H | 2014-07-02 | 2014-07-02 23:59:59+00:00 | H | COMPLETED | 2014-07-02 | None | 2014-01-02 | 2014-07-02 | 182 | None | None | None | None | 2 | APPLICATION SITE PRURITUS | APPLICATION SITE PRURITUS | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | None | APPLICATION SITE ITCHING | None | None | HLT_0317 | None | HLGT_0338 | None | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | None | 2014-01-03 | 2014-01-03 | 2014-01-03 00:00:00+00:00 | None | H | None | None | None | None | None | 2 | 2 | None | None | None | None | Y | None | N | N | N | N | N | N | MILD | MILD | 1 | PROBABLE | PROBABLE | None | E08 | NOT RECOVERED/NOT RESOLVED | N | N | 2014-01-16 | 2014-01-03 00:00:00+00:00 | 0 | mg |
| 2 | CDISCPILOT01 | 01-701-1015 | 1015 | 701 | USA | AE | 2014-01-02 | 2014-07-02 | 2014-01-02 | 2014-07-02 | 2014-07-02T11:45 | None | None | None | None | None | None | None | None | None | None | None | NA | 2013-12-26 | -7 | 63 | YEARS | 18-64 | F | WHITE | White | HISPANIC OR LATINO | Y | Placebo | Pbo | Placebo | Pbo | Placebo | Placebo | 2014-01-02 | 2014-01-02 00:00:00+00:00 | H | 2014-07-02 | 2014-07-02 23:59:59+00:00 | H | COMPLETED | 2014-07-02 | None | 2014-01-02 | 2014-07-02 | 182 | None | None | None | None | 3 | DIARRHOEA | DIARRHOEA | GASTROINTESTINAL DISORDERS | None | DIARRHEA | None | None | HLT_0148 | None | HLGT_0588 | None | GASTROINTESTINAL DISORDERS | None | 2014-01-09 | 2014-01-09 | 2014-01-09 00:00:00+00:00 | None | H | 2014-01-11 | 2014-01-11 | 2014-01-11 23:59:59+00:00 | None | H | 8 | 8 | 10 | 10 | 3 | days | Y | None | N | N | N | N | N | N | MILD | MILD | 1 | REMOTE | REMOTE | None | E06 | RECOVERED/RESOLVED | N | N | 2014-01-16 | 2014-01-09 00:00:00+00:00 | 0 | mg |
| 3 | CDISCPILOT01 | 01-701-1023 | 1023 | 701 | USA | AE | 2012-08-05 | 2012-09-02 | 2012-08-05 | 2012-09-01 | 2013-02-18 | None | 2013-02-18 | None | None | None | None | None | None | None | None | None | NA | 2012-07-22 | -14 | 64 | YEARS | 18-64 | M | WHITE | White | HISPANIC OR LATINO | Y | Placebo | Pbo | Placebo | Pbo | Placebo | Placebo | 2012-08-05 | 2012-08-05 00:00:00+00:00 | H | 2012-09-01 | 2012-09-01 23:59:59+00:00 | H | DISCONTINUED | 2012-09-02 | None | 2012-08-05 | 2012-09-02 | 28 | None | None | None | None | 2 | ERYTHEMA | ERYTHEMA | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | None | LOCALIZED ERYTHEMA | None | None | HLT_0284 | None | HLGT_0192 | None | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | None | 2012-08-07 | 2012-08-07 | 2012-08-07 00:00:00+00:00 | None | H | None | None | None | None | None | 3 | 3 | None | None | None | None | Y | Y | N | N | N | N | N | N | MODERATE | MODERATE | 2 | PROBABLE | PROBABLE | None | E09 | NOT RECOVERED/NOT RESOLVED | N | N | 2012-08-27 | 2012-08-07 00:00:00+00:00 | 0 | mg |
| 4 | CDISCPILOT01 | 01-701-1023 | 1023 | 701 | USA | AE | 2012-08-05 | 2012-09-02 | 2012-08-05 | 2012-09-01 | 2013-02-18 | None | 2013-02-18 | None | None | None | None | None | None | None | None | None | NA | 2012-07-22 | -14 | 64 | YEARS | 18-64 | M | WHITE | White | HISPANIC OR LATINO | Y | Placebo | Pbo | Placebo | Pbo | Placebo | Placebo | 2012-08-05 | 2012-08-05 00:00:00+00:00 | H | 2012-09-01 | 2012-09-01 23:59:59+00:00 | H | DISCONTINUED | 2012-09-02 | None | 2012-08-05 | 2012-09-02 | 28 | None | None | None | None | 1 | ERYTHEMA | ERYTHEMA | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | None | ERYTHEMA | None | None | HLT_0284 | None | HLGT_0192 | None | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | None | 2012-08-07 | 2012-08-07 | 2012-08-07 00:00:00+00:00 | None | H | 2012-08-30 | 2012-08-30 | 2012-08-30 23:59:59+00:00 | None | H | 3 | 3 | 26 | 26 | 24 | days | Y | None | N | N | N | N | N | N | MILD | MILD | 1 | POSSIBLE | POSSIBLE | None | E08 | NOT RECOVERED/NOT RESOLVED | N | N | 2012-08-27 | 2012-08-07 00:00:00+00:00 | 0 | mg |
| 5 | CDISCPILOT01 | 01-701-1023 | 1023 | 701 | USA | AE | 2012-08-05 | 2012-09-02 | 2012-08-05 | 2012-09-01 | 2013-02-18 | None | 2013-02-18 | None | None | None | None | None | None | None | None | None | NA | 2012-07-22 | -14 | 64 | YEARS | 18-64 | M | WHITE | White | HISPANIC OR LATINO | Y | Placebo | Pbo | Placebo | Pbo | Placebo | Placebo | 2012-08-05 | 2012-08-05 00:00:00+00:00 | H | 2012-09-01 | 2012-09-01 23:59:59+00:00 | H | DISCONTINUED | 2012-09-02 | None | 2012-08-05 | 2012-09-02 | 28 | None | None | None | None | 4 | ERYTHEMA | ERYTHEMA | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | None | ERYTHEMA | None | None | HLT_0284 | None | HLGT_0192 | None | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | None | 2012-08-07 | 2012-08-07 | 2012-08-07 00:00:00+00:00 | None | H | 2012-08-30 | 2012-08-30 | 2012-08-30 23:59:59+00:00 | None | H | 3 | 3 | 26 | 26 | 24 | days | Y | None | N | N | N | N | N | N | MILD | MILD | 1 | POSSIBLE | POSSIBLE | None | E08 | RECOVERED/RESOLVED | N | N | 2012-09-02 | 2012-08-07 00:00:00+00:00 | 0 | mg |
| 6 | CDISCPILOT01 | 01-701-1023 | 1023 | 701 | USA | AE | 2012-08-05 | 2012-09-02 | 2012-08-05 | 2012-09-01 | 2013-02-18 | None | 2013-02-18 | None | None | None | None | None | None | None | None | None | NA | 2012-07-22 | -14 | 64 | YEARS | 18-64 | M | WHITE | White | HISPANIC OR LATINO | Y | Placebo | Pbo | Placebo | Pbo | Placebo | Placebo | 2012-08-05 | 2012-08-05 00:00:00+00:00 | H | 2012-09-01 | 2012-09-01 23:59:59+00:00 | H | DISCONTINUED | 2012-09-02 | None | 2012-08-05 | 2012-09-02 | 28 | None | None | None | None | 3 | ATRIOVENTRICULAR BLOCK SECOND DEGREE | ATRIOVENTRICULAR BLOCK SECOND DEGREE | CARDIAC DISORDERS | None | AV BLOCK SECOND DEGREE | None | None | HLT_0415 | None | HLGT_0086 | None | CARDIAC DISORDERS | None | 2012-08-26 | 2012-08-26 | 2012-08-26 00:00:00+00:00 | None | H | None | None | None | None | None | 22 | 22 | None | None | None | None | Y | None | N | N | N | N | N | N | MILD | MILD | 1 | POSSIBLE | POSSIBLE | None | E10 | NOT RECOVERED/NOT RESOLVED | N | N | 2012-08-27 | 2012-08-26 00:00:00+00:00 | 0 | mg |
| 7 | CDISCPILOT01 | 01-701-1028 | 1028 | 701 | USA | AE | 2013-07-19 | 2014-01-14 | 2013-07-19 | 2014-01-14 | 2014-01-14T11:10 | None | None | None | None | None | None | None | None | None | None | None | NA | 2013-07-11 | -8 | 71 | YEARS | >64 | M | WHITE | White | NOT HISPANIC OR LATINO | Y | Xanomeline High Dose | Xan_Hi | Xanomeline High Dose | Xan_Hi | Xanomeline High Dose | Xanomeline High Dose | 2013-07-19 | 2013-07-19 00:00:00+00:00 | H | 2014-01-14 | 2014-01-14 23:59:59+00:00 | H | COMPLETED | 2014-01-14 | None | 2013-07-19 | 2014-01-14 | 180 | None | None | None | None | 1 | APPLICATION SITE ERYTHEMA | APPLICATION SITE ERYTHEMA | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | None | APPLICATION SITE ERYTHEMA | None | None | HLT_0617 | None | HLGT_0152 | None | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | None | 2013-07-21 | 2013-07-21 | 2013-07-21 00:00:00+00:00 | None | H | None | None | None | None | None | 3 | 3 | None | None | None | None | Y | Y | N | N | N | N | N | N | MILD | MILD | 1 | POSSIBLE | POSSIBLE | None | E04 | NOT RECOVERED/NOT RESOLVED | N | N | 2013-08-01 | 2013-07-21 00:00:00+00:00 | 54 | mg |
| 8 | CDISCPILOT01 | 01-701-1028 | 1028 | 701 | USA | AE | 2013-07-19 | 2014-01-14 | 2013-07-19 | 2014-01-14 | 2014-01-14T11:10 | None | None | None | None | None | None | None | None | None | None | None | NA | 2013-07-11 | -8 | 71 | YEARS | >64 | M | WHITE | White | NOT HISPANIC OR LATINO | Y | Xanomeline High Dose | Xan_Hi | Xanomeline High Dose | Xan_Hi | Xanomeline High Dose | Xanomeline High Dose | 2013-07-19 | 2013-07-19 00:00:00+00:00 | H | 2014-01-14 | 2014-01-14 23:59:59+00:00 | H | COMPLETED | 2014-01-14 | None | 2013-07-19 | 2014-01-14 | 180 | None | None | None | None | 2 | APPLICATION SITE PRURITUS | APPLICATION SITE PRURITUS | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | None | APPLICATION SITE ITCHING | None | None | HLT_0317 | None | HLGT_0338 | None | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | None | 2013-08-08 | 2013-08-08 | 2013-08-08 00:00:00+00:00 | None | H | None | None | None | None | None | 21 | 21 | None | None | None | None | Y | None | N | N | N | N | N | N | MILD | MILD | 1 | PROBABLE | PROBABLE | None | E05 | NOT RECOVERED/NOT RESOLVED | N | N | 2013-08-14 | 2013-08-01 00:00:00+00:00 | None | None |
| 9 | CDISCPILOT01 | 01-701-1034 | 1034 | 701 | USA | AE | 2014-07-01 | 2014-12-30 | 2014-07-01 | 2014-12-30 | 2014-12-30T09:50 | None | None | None | None | None | None | None | None | None | None | None | NA | 2014-06-24 | -7 | 77 | YEARS | >64 | F | WHITE | White | NOT HISPANIC OR LATINO | Y | Xanomeline High Dose | Xan_Hi | Xanomeline High Dose | Xan_Hi | Xanomeline High Dose | Xanomeline High Dose | 2014-07-01 | 2014-07-01 00:00:00+00:00 | H | 2014-12-30 | 2014-12-30 23:59:59+00:00 | H | COMPLETED | 2014-12-30 | None | 2014-07-01 | 2014-12-30 | 183 | None | None | None | None | 1 | APPLICATION SITE PRURITUS | APPLICATION SITE PRURITUS | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | None | APPLICATION SITE ITCHING | None | None | HLT_0317 | None | HLGT_0338 | None | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | None | 2014-08-27 | 2014-08-27 | 2014-08-27 00:00:00+00:00 | None | H | None | None | None | None | None | 58 | 58 | None | None | None | None | Y | Y | N | N | N | N | N | N | MILD | MILD | 1 | PROBABLE | PROBABLE | None | E08 | NOT RECOVERED/NOT RESOLVED | N | N | 2014-09-25 | 2014-07-15 00:00:00+00:00 | None | None |