Table 4.
Unsolicited adverse events - summary table
| Subjects with at least one or more AE | Ad26/MVA | Ad26/Ad26 + gp140 | Placebo |
|---|---|---|---|
| Analysis set: full analysis set | 10 | 9 | 6 |
| Post-any dose | 10 | 9 | 6 |
| Unsolicited AE | 5 (50.0%) | 6(66.7%) | 2 (33.3%) |
| Unsolicited AE with severity grade 1 as worst grade | 2 (20.0%) | 2 (22.2%) | 2 (33.3%) |
| Unsolicited AE with severity grade 2 as worst grade | 1 (10.0%) | 3 (33.3%) | 0 |
| Unsolicited AE with severity grade 3 as worst grade | 2 (20.0%) | 1 (11.1%) | 0 |
| Unsolicited AE with severity grade 4 as worst grade | 0 | 0 | 0 |
| Unsolicited AE that is thought to be relateda to vaccine | 2 (20.0%) | 2 (22.2%) | 1 (16.7%) |
| Unsolicited AE with worst grade 3 or 4 thought to be relateda to vaccine | 1 (10.0%) | 0 | 0 |
| AE leading to study discontinuation | 0 | 0 | 0 |
| AE leading to permanent stop of the vaccine | 0 | 0 | 0 |
| SAE | 0 | 0 | 0 |
| SAE that is thought to be relateda to vaccine | 0 | 0 | 0 |
| SAE that is leading to study discontinuation | 0 | 0 | 0 |
| AEs with fatalb outcome | 0 | 0 | 0 |
Subjects are counted only once for any given event, regardless of the number of times they actually experienced the event. Only unsolicited AEs collected during the 28-day post-vaccination phase are included.
AE adverse event, SAE serious adverse event.
aAn AE is categorized as related if assessed by the investigator as possibly, probably, or very likely related to study vaccination.
bAEs leading to death are based on AE outcome of Fatal.