| Question | Response |
|---|---|
| Adverse Event Verbatim |
AETERM, FA.FAOBJ |
| Event Category |
AECAT General Adverse Event Event of Interest |
| Did the event start before administering first dose of study medication? |
PRFDOS in SUPPAE Yes No |
| Date Started |
AESTDTC |
| Event ongoing? |
AEENRTPT=ONGOING |
| Date Ended |
AEENDTC |
| Severity of the Event |
AESEV Mild Moderate Severe |
| Event Related to Study Drug |
AEREL Yes No |
| Toxicity Grade of the Event (CTCAE) |
AETOXGR 1 2 3 4 5 |
| Action Taken with Study Drug because of Adverse Event |
AEACN No action taken Dose increased Dose reduced Drug interrupted Drug withdrawn |
| Other action taken? |
AEACNOTH |
| Serious Event? |
AESER Yes No |
| Resulted in Death? |
AESDTH Yes No |
| Immediately Life Threatening? |
AESLIFE Yes No |
| Required Hospitalization or Prolonged Hospitalization? |
AESHOSP Yes No |
| If hospitalized,? | |
| date of hospitalization |
HOSTDTC |
| Time of hospitalization |
HOSTDTC |
| If hospitalized,? | |
| date of discharge |
HOENDTC |
| Time of discharge |
HOENDTC |
| Persistent or Significant Disability? |
AESDISAB Yes No |
| Congenital Anomaly/Birth Defect? |
AESCONG Yes No |
| Other Medically Important Serious Event? |
AESMIE Yes No |
| Outcome of the Event? |
AEOUT Recovered/Resolved Not Recovered/Not Resolved Fatal Unknown |
| Was the event adjudicated |
FAORRES when FATESTCD=ADJUD Yes No |
| Adjudication Result |
FAORRES when FATESTCD=ADJRES Positive Negative |
| Relationship to Non-Study Treatment |
ARELNST Adjunct Therapy Study Disease Other Medical Condition Study Procedure None |