# adae adae # Adverse Events Analysis Structure: `One record per subject per adverse event` ``` python from pharmadata import pharmaverseadam meta = pharmaverseadam.meta('adae') print(f"Rows: {meta.number_rows:,} Columns: {meta.number_columns}") ``` Rows: 1,191 Columns: 107 ## 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 ``` python 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