Table 4.
Adverse event profile for all fidaxomicin-treated patients.
| AE, n (%) | Number of AEs | Number of patients, N=296 |
|---|---|---|
| All AEs | 175 | 121 (40.9) |
| Severe AEs | 89 | 69 (23.3) |
| Serious AEs | 110 | 82 (27.7) |
| Severe serious AEs | 86 | 66 (22.3) |
| AEs leading to death | 52 | 48 (16.2) |
| AEs related to fidaxomicin | 18 | 16 (5.4) |
| Serious AEs related to fidaxomicin | 4 | 3 (1.0) |
| AEs related to underlying medical condition | 93 | 72 (24.3) |
| AEs related to concomitant medication | 17 | 16 (5.4) |
| AEs related to other condition | 47 | 40 (13.5) |
AE, adverse event; n, number of patients with the stated AE; N, number of fidaxomicin-treated patients.