TABLE 3.
Participant withdrawal and AEs reported by ≥ 5% of participants in any group
| EMP16‐120/40 (n = 52) | EMP16‐150/50 (n = 52) | Placebo (n = 52) | |
|---|---|---|---|
| Overall withdrawal rate | 8 (15%) | 7 (14%) | 6 (12%) |
| Any AE | 32 (62%) | 39 (75%) | 30 (58%) |
| Any AE leading to withdrawal | 4 (8%) | 6 (12%) | 0 |
| Most frequent AEs by MedDRA PT | |||
| Nasopharyngitis | 4 (8%); 4 | 10 (19%); 10 | 13(25%); 15 |
| Diarrhea | 8 (15%); 9 | 8 (15%); 9 | 0 |
| Headache | 4 (8%); 5 | 2 (4%); 2 | 3 (6%); 4 |
| Flatulence | 4 (8%); 4 | 3 (6%); 4 | 1 (2%); 1 |
| COVID‐19 | 0 | 6 (12%); 6 | 2 (4%); 2 |
| Abdominal distension | 4 (8%); 4 | 1 (2%); 1 | 0 |
| Causality | |||
| Unlikely | 22 (42%) | 28 (54%) | 27 (52%) |
| Possibly | 7 (13%) | 9 (17%) | 6 (12%) |
| Probably | 13 (25%) | 12 (23%) | 2 (4%) |
| Severity | |||
| Mild | 21 (40%) | 24 (46%) | 22 (42%) |
| Moderate | 11 (21%) | 13 (25%) | 11 (21%) |
| Severe | 14 (27%) | 12 (23%) | 3 (6%) |
Note: Data are shown as number of participants (percentage of treatment arm); number of events. Data are from the safety population (all participants who were randomized and exposed to at least one treatment dose). Full list in online Supporting Information.
Abbreviations: AE, adverse event; MedDRA, medical dictionary for regulatory activities; PT, preferred term.