TABLE 4.
Safety analysis of treatment-related AEsa
| Regimen (no. of patients) | No. (%) of patients:
|
||||
|---|---|---|---|---|---|
| With at least one treatment-related AE | Who discontinued treatment because of AE | With indicated most frequent AE (>5% of subjects)
|
|||
| Diarrhea | Nausea | Flatulence | |||
| AZM-3 (312) | 97 (31.1) | 7 (2.2) | 53 (17.0) | 23 (7.4) | 17 (5.4) |
| AZM-6 (311) | 117 (37.6) | 11 (3.5) | 66 (21.2) | 27 (8.7) | 11 (3.5) |
| AMC (313) | 160 (51.1) | 28 (8.9) | 101 (32.3) | 38 (12.1) | 6 (1.9) |
a
Subjects were counted once and included through 35 days from the last dose of active therapy.