Table 2.
Selected treatment-emergent adverse events
| Adverse Event | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Total n = 31 |
|---|---|---|---|---|---|
| General | |||||
| Fatigue | 9 (29%) | 5 (16%) | 14 (45%) | ||
| Gastrointestinal disorders | |||||
| Nausea | 13 (42%) | 5 (16%) | 18 (58%) | ||
| Diarrhea | 8 (6%) | 4 (13%) | 2 (6%) | 14 (45%) | |
| Vomiting | 8 (26%) | 3 (10%) | 11 (35%) | ||
| Constipation | 6 (19%) | 2 6%) | 8 (26%) | ||
| Dyspepsia | 3 (10%) | 1 (3%) | 4 (13%) | ||
| Flatulence | 3 (10%) | 1 (3%) | 4 (13%) | ||
| Gastrointestinal hemorrhage | 3 (10%) | 3 (10%) | |||
| Diarrhea | 1 (3%) | 1 (3%) | |||
| Respiratory | |||||
| Dyspnea | 5 (16%) | 1 (3%) | 6 (19%) | ||
| Dysphonia | 5 (16%) | 5 (16%) | |||
| Cough | 4 (13%) | 4 (13%) | |||
| Hypoxia | 1 (3%) | 1 (3%) | |||
| Infections | |||||
| Urinary tract infection | 2 (16%) | 3 (10%) | 5 (16%) | ||
| Cholangitis | 1 (3%) | 1 (3%) | |||
| Lung infection | 1 (3%) | 1 (3%) | |||
| Metabolism and nutrition | |||||
| Anorexia | 3 (10%) | 4 (13%) | 7 (23%) | ||
| Dehydration | 1 (3%) | 1 (3%) | |||
| Neurologic | |||||
| Headache | 3 (10%) | 7 (23%) | 11 (35%) | 11 (35%) | |
| Vasovagal syncope | 1 (3%) | 1 (3%) | |||
| Vascular | |||||
| Hypertension | 5 (16%) | 1 (3%) | 6 (19%) | ||
| Flushing | 4 (13%) | 4 (13%) | |||
| Deep vein thrombosis | 1 (3%) | 1 (3%) | |||
| Cutaneous | |||||
| Rash | 4 (13%) | 4 (13%) | |||
| Psychiatric | |||||
| Insomnia | 2 (6%) | 1 (3%) | 1 (3%) | 4 (13%) | |
| Suicidal ideation | 1 (3%) | 1 (3%) | |||
| Hematologic | 1 (3%) | ||||
| Anemia | 1 (3%) | 1 (3%) |
The number of patients experiencing selected events is shown. Events experienced by >10% of patients or events classified as grade 3 or 4 are listed