Table 3.
Summary of Treatment-Related Treatment-Emergent Adverse Events (TEAEs) Reported in >2% of Patients
| Ibrexafungerp (n = 247) | Placebo (n = 124) | |
|---|---|---|
| Patients with ≥1 TEAE | 98 (39.7) | 21 (16.9) |
| Mild | 78 (31.6) | 17 (13.7) |
| Moderate | 24 (9.7) | 4 (3.2) |
| Severe | 1 (0.4) | 0 |
| Diarrhea | 55 (22.3) | 5 (4.0) |
| Mild | 38 (15.4) | 4 (3.2) |
| Moderate | 17 (6.9) | 1 (0.8) |
| Nausea | 27 (10.9) | 5 (4.0) |
| Mild | 24 (9.7) | 5 (4.0) |
| Moderate | 2 (0.8) | 0 |
| Severe | 1 (0.4) | 0 |
| Abdominal pain | 13 (5.3) | 0 |
| Mild | 12 (4.9) | 0 |
| Moderate | 1 (0.4) | 0 |
| Abdominal discomfort | 11 (4.5) | 2 (1.6) |
| Mild | 6 (2.4) | 2 (1.6) |
| Moderate | 5 (2.0) | 0 |
| Dizziness | 9 (3.6) | 2 (1.6) |
| Mild | 7 (2.8) | 2 (1.6) |
| Moderate | 2 (0.8) | 0 |
| Abdominal pain upper | 7 (2.8) | 1 (0.8) |
| Mild | 6 (2.4) | 1 (0.8) |
| Moderate | 1 (0.4) | 0 |
| Flatulence | 6 (2.4) | 1 (0.8) |
| Mild | 5 (2.0) | 1 (0.8) |
| Moderate | 1 (0.4) | 0 |
| Headache | 6 (2.4) | 3 (2.4) |
| Mild | 5 (2.0) | 3 (2.4) |
| Moderate | 1 (0.4) | 0 |
Mild was defined as awareness of sign or symptom, but easily tolerated and not requiring medical attention. Moderate was defined as discomfort enough to cause some interference with daily activity and may require medical attention. Severe was defined as intense enough to disrupt daily activities and likely required medical attention.