Table 6.
Summary of Adverse Events (All Participants as Treated)
| Bezlotoxumab (n = 107) | Placebo (n = 36) | Difference Estimate | |||
|---|---|---|---|---|---|
| Participants With: | n | (%) | n | (%) | % (95% CI) |
| One or more adverse events | 95 | (88.8) | 34 | (94.4) | −5.7 (−14.5, 7.7) |
| Drug-relateda adverse events | 17 | (15.9) | 3 | (8.3) | 7.6 (−7.1, 17.8) |
| Serious adverse events | 57 | (53.3) | 29 | (80.6) | −27.3 (−41.4, −9.3) |
| Serious drug-relateda adverse events | 2 | (1.9) | 0 | (0.0) | 1.9 (−7.9, 6.6) |
| Deathsb | 5 | (4.7) | 1 | (2.8) | 1.9 (−9.8, 8.4) |
| Discontinued due to an adverse event | 0 | (0.0) | 0 | (0.0) | 0.0 (−9.7, 3.5) |
| Most common adverse eventsc | |||||
| Anemia | 8 | (7.5) | 6 | (16.7) | −9.2 (−25.1, 1.8) |
| Febrile neutropenia | 23 | (21.5) | 11 | (30.6) | −9.1 (−27.0, 6.4) |
| Abdominal pain | 15 | (14.0) | 6 | (16.7) | −2.6 (−19.0, 9.4) |
| Diarrhea | 8 | (7.5) | 5 | (13.9) | −6.4 (−21.8, 3.9) |
| Nausea | 8 | (7.5) | 4 | (11.1) | −3.6 (−18.5, 5.9) |
| Vomiting | 14 | (13.1) | 8 | (22.2) | − 9.1 (−26.0, 4.0) |
| Pyrexia | 19 | (17.8) | 11 | (30.6) | −12.8 (−30.5, 2.4) |
| Hypokalemia | 9 | (8.4) | 6 | (16.7) | −8.3 (−24.2, 2.9) |
| Headache | 15 | (14.0) | 8 | (22.2) | −8.2 (−25.2, 5.0) |
aDetermined by the investigator to be related to the study treatment.
bThree participants died after completing the 12-week follow-up period.
cEvents occurring in ≥12 participants in the bezlotoxumab group or ≥2 participants in the placebo group.