Table 3.
Adverse events (occurring in ≥5% of patients) by Common Terminology Criteria for Adverse Events (CTCAE) grade
| Adverse events, n (%) | Any grade | Grade 1/2 | Grade 3 | Grade 4 | Grade 5 | Grade ≥3 |
|---|---|---|---|---|---|---|
| Any TEAE | 164 (87.7) | 155 (82.9) | 45 (24.1) | 3 (1.6) | – | 48 (25.7) |
| By MedDRA PT | ||||||
| Diarrhea | 147 (78.6) | 127 (67.9) | 36 (19.3) | 2 (1.1) | – | 38 (20.3) |
| Nausea | 38 (20.3) | 38 (20.3) | – | – | – | – |
| Fatigue | 32 (17.1) | 30 (16.0) | 2 (1.1) | – | – | 2 (1.1) |
| Abdominal pain upper | 18 (9.6) | 18 (9.6) | – | – | – | – |
| Headache | 14 (7.5) | 14 (7.5) | – | – | – | – |
| Rash | 14 (7.5) | 14 (7.5) | – | – | – | – |
| Muscle spasms | 13 (7.0) | 13 (7.0) | – | – | – | – |
| Vomiting | 13 (7.0) | 13 (7.0) | 1 (0.5) | – | – | 1 (0.5) |
| Constipation | 12 (6.4) | 12 (6.4) | – | – | – | – |
| Dry skin | 12 (6.4) | 12 (6.4) | – | – | – | – |
| Abdominal pain | 10 (5.3) | 10 (5.3) | – | – | – | – |
| Dry mouth | 10 (5.3) | 10 (5.3) | – | – | – | – |
| Epistaxis | 10 (5.3) | 10 (5.3) | – | – | – | – |
MedDRA PT, Medical Dictionary for Regulatory Activities Terminology Preferred Term; TEAE, treatment-emergent adverse event.