Table 3.
Overview of subjects who presented adverse events during the study.
| Total (N = 243) | INM005 (N = 119) | Placebo (N = 124) | |
|---|---|---|---|
| Subjects with any AE | 107 (44•0%) | 52 (43•7%) | 55 (44•3%) |
| Subjects with any SAE | 41 (16•9%) | 16 (13•4%) | 25 (20•1%) |
| Subjects with any related treatment-emergent SAE | 3 (1•2%) | 2 (0•8%) | 1 (0•8%) |
| Subjects with any treatment-emergent AESI | 11 (4•5%) | 9 (7•6%) | 2 (1•6%) |
| Subjects with a related TEAE | 33 (13•6%) | 21 (17•6%) | 12 (9•7%) |
| Subjects with any AE with fatal outcome* | 27 (11•1%) | 11 (9•2%) | 16 (12•9%) |
| Subjects with any related TEAE with fatal outcome | 0 (0•0%) | 0 (0•0%) | 0 (0•0%) |
| Subjects with any TEAE that required permanent treatment discontinuation | 0 (0•0%) | 0 (0•0%) | 0 (0•0%) |
Data are in n (%): amount and percentage of subjects with at least one TEAE. AE: Adverse event, TEAE: Treatment-emergent adverse event, SAE: Serious adverse event, AESI: Adverse event of special interest.
⁎
Data include deaths after day 28.