Table 4.
Summary of treatment emergent adverse events (TEAE) reported for CDI and CIP in phase 3 clinical studies in BE patients [11–13, 57, 58]
| CDI (28-d) (N = 389) N (%) | CDI Placebo (N = 193) N (%) | CIP (14-d) (N = 310) N (%) | CIP (28-d) (N = 312) N (%) | CIP Placebo (N = 311) N (%) | |
|---|---|---|---|---|---|
| Adverse events (AE) | 343 (88.2) | 182 (94.3) | 239 (77.1) | 204 (65.4) | 230 (74.0) |
| Drug-related AEs | 136 (35.0) | 66 (34.2) | 61 (19.7) | 54 (17.3) | 60 (19.3) |
| Cough | 42 (10.8) | 26 (13.5) | 4 (1.3) | 6 (1.9) | 11 (3.5) |
| Dyspnea | 25 (6.4) | 13 (6.7) | 7 (2.3) | 6 (1.9) | 5 (1.6) |
| Wheezing | 20 (5.1) | 10 (5.2) | NR | NR | NR |
| Serious AEs (SAE) | 91 (23.4) | 52 (26.9) | 68 (21.9) | 56 (18.0) | 73 (23.5) |
| Drug-related SAE | 7 (1.8) | 2 (1.0) | 2 (0.6) | 4 (1.3) | 1 (0.3) |
| Severe AEs | 85 (21.9) | 47 (24.4) | 48 (15.5) | 38 (12.2) | 51 (16.4) |
| AEs Leading to discontinuation | 34 (8.7) | 16 (8.3) | 32 (10.3) | 26 (8.3) | 19 (2.0) |
| AEs Leading to death | 6 (1.5) | 5 (2.6) | 4 (1.3) | 6 (1.9) | 5 (1.6) |
NR not reported (less than 2% threshold)