| Question | Response |
|---|---|
| Adverse Event Verbatim | |
| Event Category | General Adverse Event Event of Interest |
| Did the event start before administering first dose of study medication? | Yes No |
| Date Started | |
| Event ongoing? | No Yes |
| Date Ended | |
| Severity of the Event | Mild Moderate Severe |
| Event Related to Study Drug | Yes No |
| Toxicity Grade of the Event (CTCAE) | 1 2 3 4 5 |
| Action Taken with Study Drug because of Adverse Event | No action taken Dose increased Dose reduced Drug interrupted Drug withdrawn |
| Other action taken? | |
| Serious Event? | Yes No |
| Resulted in Death? | Yes No |
| Immediately Life Threatening? | Yes No |
| Required Hospitalization or Prolonged Hospitalization? | Yes No |
| If hospitalized,? | |
| date of hospitalization | |
| Time of hospitalization | |
| If hospitalized,? | |
| date of discharge | |
| Time of discharge | |
| Persistent or Significant Disability? | Yes No |
| Congenital Anomaly/Birth Defect? | Yes No |
| Other Medically Important Serious Event? | Yes No |
| Outcome of the Event? | Recovered/Resolved Not Recovered/Not Resolved Fatal Unknown |
| Was the event adjudicated | Yes No |
| Adjudication Result | Positive Negative |
| Relationship to Non-Study Treatment | Adjunct Therapy Study Disease Other Medical Condition Study Procedure None |