Serious adverse events
| Patient age, y . | Preferred term . | Days from dosing to onset . | Relationship to trial drug* . | Outcome . |
|---|---|---|---|---|
| 7 | Ab test positive | 15 | Probable | Recovered |
| 14 | Small intestinal obstruction | 4 | Unlikely | Recovered |
| Ab test positive | 17 | Possible | Recovered | |
| 16 | Ab test positive | 17 | Possible | Recovered |
| 19 | Road traffic accident | 28 | Unlikely | Recovered |
| 55 | Noncardiac chest pain | 23 | Unlikely | Recovered |
| Headache | 24 | Unlikely | Recovered | |
| 57 | Diverticulitis | 3 | Unlikely | Recovered |
| Patient age, y . | Preferred term . | Days from dosing to onset . | Relationship to trial drug* . | Outcome . |
|---|---|---|---|---|
| 7 | Ab test positive | 15 | Probable | Recovered |
| 14 | Small intestinal obstruction | 4 | Unlikely | Recovered |
| Ab test positive | 17 | Possible | Recovered | |
| 16 | Ab test positive | 17 | Possible | Recovered |
| 19 | Road traffic accident | 28 | Unlikely | Recovered |
| 55 | Noncardiac chest pain | 23 | Unlikely | Recovered |
| Headache | 24 | Unlikely | Recovered | |
| 57 | Diverticulitis | 3 | Unlikely | Recovered |
Relationship to trial drug assessment definitions: probable, good reasons and sufficient documentation to assume a causal relationship; possible, a causal relationship is conceivable and cannot be dismissed; and unlikely, the event is most likely related to an etiology other than the trial product.