Table 3. Adverse events of special interest (FAS, n = 4005).
| Preferred term | Relationship to trial vaccine determined by investigator | Outcome | |
|---|---|---|---|
| Group 1 (Lot 1) | |||
| Troponin I increase ≥ 2 x ULN | Unlikely | Resolved | |
| Wolff-Parkinson-White Syndrome | Unrelated | Resolved | |
| Group 2 (Lot 2) | |||
| Troponin I increase ≥ 2 x ULN | Unlikely | Resolved | |
| Supraventricular extrasystoles | Unrelated | Resolved | |
| Bundle branch block right | Possible | Not Resolved | |
| Tachycardia | Unrelated | Resolved | |
| ECG ST Segment abnormal | Unrelated | Unknown | |
| Group 3 (Lot 3) | |||
| Pericarditis | Possible | Resolved | |
| Group 4 (Placebo) | |||
| Bundle branch block right | Unrelated | Resolved | |