Table 3.
Adverse Events.*
| Event | All Patients (N = 126) | ||||
|---|---|---|---|---|---|
| Any Grade | Grade 1 or 2 | Grade 3 | Grade 4 | Fatal | |
| number of patients (percent) | |||||
| Adverse event | 125 (99.2) | 48 (38.1) | 53 (42.1) | 4 (3.2) | 20 (15.9) |
| Treatment-related adverse event | 88 (69.8) | 62 (49.2) | 25 (19.8) | 1 (0.8) | 0 |
| Treatment-related adverse event leading to dose modification | 28 (22.2) | 8 (6.3) | 20 (15.9) | 0 | 0 |
| Treatment-related adverse event leading to discontinuation of therapy | 9 (7.1) | 4 (3.2) | 4 (3.2) | 1 (0.8) | 0 |
| Treatment-related adverse event of any grade occurring in >5% of the patients or that was grade ≥3 |
|||||
| Diarrhea | 40 (31.7) | 35 (27.8) | 5 (4.0) | 0 | 0 |
| Nausea | 24 (19.0) | 24 (19.0) | 0 | 0 | 0 |
| Alanine aminotransferase increase | 19 (15.1) | 11 (8.7) | 8 (6.3) | 0 | 0 |
| Aspartate aminotransferase increase | 19 (15.1) | 12 (9.5) | 7 (5.6) | 0 | 0 |
| Fatigue | 14 (11.1) | 14 (11.1) | 0 | 0 | 0 |
| Vomiting | 10 (7.9) | 10 (7.9) | 0 | 0 | 0 |
| Blood alkaline phosphatase increase | 9 (7.1) | 8 (6.3) | 1 (0.8) | 0 | 0 |
| Maculopapular rash | 7 (5.6) | 7 (5.6) | 0 | 0 | 0 |
| Hypokalemia | 5 (4.0) | 4 (3.2) | 1 (0.8) | 0 | 0 |
| Drug-induced liver injury | 3 (2.4) | 1 (0.8) | 2 (1.6) | 0 | 0 |
| γ-Glutamyltransferase increase | 3 (2.4) | 0 | 3 (2.4) | 0 | 0 |
| Lymphocyte count decrease | 3 (2.4) | 2 (1.6) | 1 (0.8) | 0 | 0 |
| Dyspnea | 2 (1.6) | 1 (0.8) | 0 | 1 (0.8) | 0 |
| Pneumonitis | 2 (1.6) | 0 | 1 (0.8) | 1 (0.8) | 0 |
| Abnormal hepatic function | 2 (1.6) | 1 (0.8) | 1 (0.8) | 0 | 0 |
| Lymphopenia | 1 (0.8) | 0 | 1 (0.8) | 0 | 0 |
| Neutropenia | 1 (0.8) | 0 | 1 (0.8) | 0 | 0 |
| Hepatotoxic event | 1 (0.8) | 0 | 1 (0.8) | 0 | 0 |
| Drug hypersensitivity | 1 (0.8) | 0 | 1 (0.8) | 0 | 0 |
| Cellulitis | 1 (0.8) | 0 | 1 (0.8) | 0 | 0 |
| Lipase increased | 1 (0.8) | 0 | 1 (0.8) | 0 | 0 |
| Increase in liver-function level† | 1 (0.8) | 0 | 1 (0.8) | 0 | 0 |
| Neutrophil count decrease | 1 (0.8) | 0 | 1 (0.8) | 0 | 0 |
| Abnormal aminotransferase level‡ | 1 (0.8) | 0 | 1 (0.8) | 0 | 0 |
*
For patients who had an adverse event of multiple grades, the worst grade is reported. Adverse events were graded with the use of the Common Terminology Criteria for Adverse Events, version 5.0, which incorporates certain elements of Medical Dictionary for Regulatory Activities (MedDRA) terminology.
†
The MedDRA preferred term “increased liver-function test” was used for this event.
‡
The MedDRA preferred term “transaminases abnormal” was used for this event.