from pharmadata import pharmaverseadam
meta = pharmaverseadam.meta('adex')
print(f"Rows: {meta.number_rows:,} Columns: {meta.number_columns}")Rows: 6,315 Columns: 92adex
adex
Exposure Analysis
Structure: One or more records per subject per analysis parameter per analysis timepoint
Variables
Show variable specs
shape: (92, 5)
| variable | label | type | mandatory | role |
|---|---|---|---|---|
| str | str | str | str | str |
| "STUDYID" | "Study Identifier" | "String" | "Yes" | "Identifier Variables for BDS Datasets" |
| "USUBJID" | "Unique Subject Identifier" | "String" | "Yes" | "Identifier Variables for BDS Datasets" |
| "SUBJID" | "Subject Identifier for the Study" | "String" | "No" | "Identifier Variables for BDS Datasets" |
| "SITEID" | "Study Site Identifier" | "String" | "No" | "Identifier Variables for BDS Datasets" |
| "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 |
| "ASEQ" | "Analysis Sequence Number" | "Int32" | "No" | "Identifier Variables for BDS Datasets" |
| "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 |
| "EXTRT" | "Name of Treatment" | "String" | "No" | null |
| "EXDOSE" | "Dose" | "Float64" | "No" | null |
| "EXDOSFRM" | "Dose Form" | "String" | "No" | null |
| "EXDOSFRQ" | "Dosing Frequency per Interval" | "String" | "No" | null |
| "EXROUTE" | "Route of Administration" | "String" | "No" | null |
| "EXADJ" | "Reason for Dose Adjustment" | "String" | "No" | null |
| "EXSTDTC" | "Start Date/Time of Treatment" | "String" | "No" | null |
| "EXENDTC" | "End Date/Time of Treatment" | "String" | "No" | null |
| "EXSTDY" | "Study Day of Start of Treatment" | "Float64" | "No" | null |
| "EXENDY" | "Study Day of End of Treatment" | "Float64" | "No" | null |
| "EXSEQ" | "Sequence Number" | "Float64" | "No" | null |
| "ASTDT" | "Analysis Start Date" | "Date" | "No" | "Timing Variables for BDS Datasets" |
| "AENDT" | "Analysis End Date" | "Date" | "No" | "Timing Variables for BDS Datasets" |
| "EXDURD" | "Duration of Treatment (Days)" | "Float64" | "No" | null |
| "EXDOSU" | "Dose Units" | "String" | "No" | null |
| "VISITNUM" | "Visit Number" | "Float64" | "No" | null |
| "VISIT" | "Visit Name" | "String" | "No" | null |
| "VISITDY" | "Planned Study Day of Visit" | "Float64" | "No" | null |
| "EXPLDOS" | "Planned Dose" | "Float64" | "No" | null |
| "ASTDTM" | "Analysis Start Datetime" | "Datetime" | "No" | "Timing Variables for BDS Datasets" |
| "ASTDTF" | "Analysis Start Date Imputation Flag" | "String" | "No" | "Timing Variables for BDS Datasets" |
| "ASTTMF" | "Analysis Start Time Imputation Flag" | "String" | "No" | "Timing Variables for BDS Datasets" |
| "AENDTM" | "Analysis End Datetime" | "Datetime" | "No" | "Timing Variables for BDS Datasets" |
| "AENDTF" | "Analysis End Date Imputation Flag" | "String" | "No" | "Timing Variables for BDS Datasets" |
| "AENTMF" | "Analysis End Time Imputation Flag" | "String" | "No" | "Timing Variables for BDS Datasets" |
| "ASTDY" | "Analysis Start Relative Day" | "Float64" | "No" | "Timing Variables for BDS Datasets" |
| "AENDY" | "Analysis End Relative Day" | "Float64" | "No" | "Timing Variables for BDS Datasets" |
| "DOSEO" | "Dose O" | "Float64" | "No" | null |
| "PDOSEO" | "PDose O" | "Float64" | "No" | null |
| "PARAMCD" | "Parameter Code" | "String" | "Yes" | "Analysis Parameter Variables for BDS Datasets" |
| "AVAL" | "Analysis Value" | "Float64" | "No" | "Analysis Parameter Variables for BDS Datasets" |
| "AVALC" | "Analysis Value (C)" | "String" | "No" | "Analysis Parameter Variables for BDS Datasets" |
| "PARCAT1" | "Parameter Category 1" | "String" | "No" | null |
| "PARAM" | "Parameter" | "String" | "Yes" | "Analysis Parameter Variables for BDS Datasets" |
| "PARAMN" | "Parameter (N)" | "Float64" | "No" | "Analysis Parameter Variables for BDS Datasets" |
| "AVALCAT1" | "Analysis Value Category 1" | "String" | "No" | null |
Examples
from great_docs import tbl_explorer
from pharmadata import pharmaverseadam
tbl_explorer(pharmaverseadam.adex.head(10))PolarsRows10Columns92 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 |
ASEQ i32 |
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 |
EXTRT str |
EXDOSE f64 |
EXDOSFRM str |
EXDOSFRQ str |
EXROUTE str |
EXADJ str |
EXSTDTC str |
EXENDTC str |
EXSTDY f64 |
EXENDY f64 |
EXSEQ f64 |
ASTDT date |
AENDT date |
EXDURD f64 |
EXDOSU str |
VISITNUM f64 |
VISIT str |
VISITDY f64 |
EXPLDOS f64 |
ASTDTM dtime |
ASTDTF str |
ASTTMF str |
AENDTM dtime |
AENDTF str |
AENTMF str |
ASTDY f64 |
AENDY f64 |
DOSEO f64 |
PDOSEO f64 |
PARAMCD str |
AVAL f64 |
AVALC str |
PARCAT1 str |
PARAM str |
PARAMN f64 |
AVALCAT1 str |
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0 | CDISCPILOT01 | 01-701-1015 | 1015 | 701 | USA | EX | 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 | 1 | 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 | PLACEBO | 0 | PATCH | QD | TRANSDERMAL | None | 2014-01-02 | 2014-01-16 | 1 | 15 | 1 | 2014-01-02 | 2014-01-16 | 15 | mg | 3 | BASELINE | 1 | 0 | 2014-01-02 00:00:00+00:00 | None | H | 2014-01-16 00:00:00+00:00 | None | H | 1 | 15 | 0 | 0 | DURD | 15 | None | INDIVIDUAL | Study drug duration during constant dosing interval (days) | 1 | None |
| 1 | CDISCPILOT01 | 01-701-1015 | 1015 | 701 | USA | EX | 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 | 2 | 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 | PLACEBO | 0 | PATCH | QD | TRANSDERMAL | None | 2014-01-02 | 2014-01-16 | 1 | 15 | 1 | 2014-01-02 | 2014-01-16 | 15 | mg | 3 | BASELINE | 1 | 0 | 2014-01-02 00:00:00+00:00 | None | H | 2014-01-16 00:00:00+00:00 | None | H | 1 | 15 | 0 | 0 | DOSE | 0 | None | INDIVIDUAL | Dose administered during constant dosing interval (mg) | 2 | None |
| 2 | CDISCPILOT01 | 01-701-1015 | 1015 | 701 | USA | EX | 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 | 3 | 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 | PLACEBO | 0 | PATCH | QD | TRANSDERMAL | None | 2014-01-02 | 2014-01-16 | 1 | 15 | 1 | 2014-01-02 | 2014-01-16 | 15 | mg | 3 | BASELINE | 1 | 0 | 2014-01-02 00:00:00+00:00 | None | H | 2014-01-16 00:00:00+00:00 | None | H | 1 | 15 | 0 | 0 | PLDOSE | 0 | None | INDIVIDUAL | Planned dose during constant dosing interval (mg) | 3 | None |
| 3 | CDISCPILOT01 | 01-701-1015 | 1015 | 701 | USA | EX | 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 | 4 | 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 | PLACEBO | 0 | PATCH | QD | TRANSDERMAL | None | 2014-01-02 | 2014-01-16 | 1 | 15 | 1 | 2014-01-02 | 2014-01-16 | 15 | mg | 3 | BASELINE | 1 | 0 | 2014-01-02 00:00:00+00:00 | None | H | 2014-01-16 00:00:00+00:00 | None | H | 1 | 15 | 0 | 0 | ADJ | None | None | INDIVIDUAL | Dose adjusted during constant dosing interval | 4 | None |
| 4 | CDISCPILOT01 | 01-701-1015 | 1015 | 701 | USA | EX | 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 | 5 | 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 | PLACEBO | 0 | PATCH | QD | TRANSDERMAL | None | 2014-01-02 | 2014-01-16 | 1 | 15 | 1 | 2014-01-02 | 2014-01-16 | 15 | mg | 3 | BASELINE | 1 | 0 | 2014-01-02 00:00:00+00:00 | None | H | 2014-01-16 00:00:00+00:00 | None | H | 1 | 15 | 0 | 0 | ADJAE | None | None | INDIVIDUAL | Dose adjusted due to AE during constant dosing interval | 5 | None |
| 5 | CDISCPILOT01 | 01-701-1015 | 1015 | 701 | USA | EX | 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 | 6 | 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 | PLACEBO | 0 | PATCH | QD | TRANSDERMAL | None | 2014-01-17 | 2014-06-18 | 16 | 168 | 2 | 2014-01-17 | 2014-06-18 | 153 | mg | 4 | WEEK 2 | 14 | 0 | 2014-01-17 00:00:00+00:00 | None | H | 2014-06-18 00:00:00+00:00 | None | H | 16 | 168 | 0 | 0 | DURD | 153 | None | INDIVIDUAL | Study drug duration during constant dosing interval (days) | 1 | None |
| 6 | CDISCPILOT01 | 01-701-1015 | 1015 | 701 | USA | EX | 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 | 7 | 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 | PLACEBO | 0 | PATCH | QD | TRANSDERMAL | None | 2014-01-17 | 2014-06-18 | 16 | 168 | 2 | 2014-01-17 | 2014-06-18 | 153 | mg | 4 | WEEK 2 | 14 | 0 | 2014-01-17 00:00:00+00:00 | None | H | 2014-06-18 00:00:00+00:00 | None | H | 16 | 168 | 0 | 0 | DOSE | 0 | None | INDIVIDUAL | Dose administered during constant dosing interval (mg) | 2 | None |
| 7 | CDISCPILOT01 | 01-701-1015 | 1015 | 701 | USA | EX | 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 | 8 | 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 | PLACEBO | 0 | PATCH | QD | TRANSDERMAL | None | 2014-01-17 | 2014-06-18 | 16 | 168 | 2 | 2014-01-17 | 2014-06-18 | 153 | mg | 4 | WEEK 2 | 14 | 0 | 2014-01-17 00:00:00+00:00 | None | H | 2014-06-18 00:00:00+00:00 | None | H | 16 | 168 | 0 | 0 | PLDOSE | 0 | None | INDIVIDUAL | Planned dose during constant dosing interval (mg) | 3 | None |
| 8 | CDISCPILOT01 | 01-701-1015 | 1015 | 701 | USA | EX | 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 | 9 | 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 | PLACEBO | 0 | PATCH | QD | TRANSDERMAL | None | 2014-01-17 | 2014-06-18 | 16 | 168 | 2 | 2014-01-17 | 2014-06-18 | 153 | mg | 4 | WEEK 2 | 14 | 0 | 2014-01-17 00:00:00+00:00 | None | H | 2014-06-18 00:00:00+00:00 | None | H | 16 | 168 | 0 | 0 | ADJ | None | None | INDIVIDUAL | Dose adjusted during constant dosing interval | 4 | None |
| 9 | CDISCPILOT01 | 01-701-1015 | 1015 | 701 | USA | EX | 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 | 10 | 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 | PLACEBO | 0 | PATCH | QD | TRANSDERMAL | None | 2014-01-17 | 2014-06-18 | 16 | 168 | 2 | 2014-01-17 | 2014-06-18 | 153 | mg | 4 | WEEK 2 | 14 | 0 | 2014-01-17 00:00:00+00:00 | None | H | 2014-06-18 00:00:00+00:00 | None | H | 16 | 168 | 0 | 0 | ADJAE | None | None | INDIVIDUAL | Dose adjusted due to AE during constant dosing interval | 5 | None |