TABLE 3.
Treatment-related TEAE observed in more than 5% of subjects in any treatment group (ITT population)a
| Adverse event | No. (%) with indicated TEAE who received: |
|
|---|---|---|
| Rifalazil, 25 mg (n = 40) | Azithromycin, 1 g (n = 42) | |
| At least 1 TEAE | 22 (55.0) | 26 (61.9) |
| Gastrointestinal disorders | 10 (25.0) | 22 (52.4) |
| Abdominal pain | 2 (5.0) | 4 (9.5) |
| Upper abdominal pain | 0 | 3 (7.1) |
| Diarrhea | 0 | 9 (21.4) |
| Nausea | 3 (7.5) | 14 (33.3) |
| Vomiting | 4 (10.0) | 3 (7.1) |
| General disorders and administration site conditions | 11 (27.5) | 1 (2.4) |
| Asthenia | 3 (7.5) | 0 |
| Influenza-like illness | 5 (12.5) | 0 |
| Pyrexia | 3 (7.5) | 0 |
| Infections and infestations | 9 (22.5) | 8 (19.0) |
| Bacterial vaginitis | 2 (5.0) | 5 (11.9) |
| Nervous system disorders | 4 (10.0) | 7 (16.7) |
| Headache | 3 (7.5) | 7 (16.7) |
a
Treatment-related treatment-emergent adverse events (TEAE) were coded using MedDRA version 15. Boldface indicates the system organ class (SOC) and the overall TEAE rates.