Table 4.
Treatment-related events occurring in at least 15% of patients, all grade 3 or 4 toxicities and immune-related adverse events.
| Toxicity description CTCAE v4.0 | Grade 1 or 2 | Grade 3 | Grade 4 | |
|---|---|---|---|---|
| N (%) | N (%) | N (%) | ||
| Gastrointestinal disorders | Abdominal pain or discomfort | 4 (22%) | – | – |
| Constipation | 4 (22%) | – | – | |
| Diarrhea | 3 (17%) | 1 (6%) | – | |
| Nausea | 6 (33%) | – | – | |
| Vomiting | 5 (28%) | – | – | |
| Constitutional | Fatigue | 7 (39%) | – | – |
| Fever | 6 (33%) | – | – | |
| Weight loss | 4 (22%) | – | – | |
| Anorexia | 6 (33%) | – | – | |
| Hepatobiliary disorders infections | Hepatitis | – | 1 (6%) | – |
| Alanine aminotransferase increaseda | 3 (17%) | 2 (11%) | – | |
| Aspartate aminotransferase increaseda | 4 (22%) | 2 (11%) | – | |
| Alkaline phosphatase increaseda | 2 (11%) | – | – | |
| Amylase increased | – | 1 (6%) | – | |
| Lipase increased | – | – | 1 (6%) | |
| Aspiration pneumonia | – | 1 (6%) | – | |
| Sepsis | – | 1 (6%) | – | |
| Renal | Acute kidney injury | – | 1 (6%) | – |
| Hypokalemia | – | 1 (6%) | – | |
| Musculoskeletal | Back pain | 4 (22%) | – | – |
| Nervous system | Encephalopathy | – | 1 (6%) | – |
| Headache | 4 (22%) | – | – | |
| Skin disorders | Pruritus | 4 (22%) | – | – |
| Rash | 6 (33%) | – | – | |
| Vascular disorders | Hypotension | – | 1 (6%) | – |
aImmune-related adverse events.