| Description of Adverse Event | Start Date | Stop Date | Severity Grade | Relationship to Study Drug | Action Taken | Outcome | Expected? | Serious*? | PI Initial and Date |
| Severity Grade | Relationship to Study Drug: | Action Taken | Outcome | Expected | Serious |
| 1=Mild 2=Moderate 3=Severe 4=Life-threatening/urgent intervention indicated/ disabling 5=Death related to AE | 1=Not Related 2=Unlikely Related 3=Possibly Related 4=Probably Related 5=Definitely Related | 1 = No change (continued same dose) 2 = Dose Decreased 3 = Drug held 4 = Drug discontinued 5 = Other | 1 = Recovered/resolved, no sequelea 2 = Recovered/resolved with sequelea 3 = Recovering/resolving 4 = Not recovered/resolved 5 = Unknown 6 = Death/Fatal | 1 = Yes 2 = No | 1 = Yes 2 = No Complete SAE CRF |
*Serious = death, life-threatening, requires hospitalization (initial or prolonged), results in disability or permanent damage, results in congenital abnormality or birth defect, or other serious important medical event (based on medical judgment)