Table 2.
Summary of adverse events of any grade and of grade ≥ 3 adverse events irrespective of the relationship to study treatment
| Adverse event | No. of patients having an adverse event (%) | |||||||
|---|---|---|---|---|---|---|---|---|
| Cohort 1 N = 2 |
Cohort 2 N = 20 |
Cohort 3 N = 13 |
All patients N = 35 |
|||||
| All grades | Grade ≥ 3 | All grades | Grade ≥ 3 | All grades | Grade ≥ 3 | All grades | Grade ≥ 3 | |
| Diarrhea | 2 (100) | 2 (100) | 20 (100) | 10 (50.0) | 13 (100) | 4 (30.8) | 35 (100) | 16 (45.7) |
| Nausea | 1 (50.0) | 0 | 16 (80.0) | 0 | 7 (53.8) | 0 | 24 (68.6) | 0 |
| Hypokalemia | 2 (100) | 1 (50.0) | 13 (65.0) | 11 (55.0) | 5 (38.5) | 2 (15.4) | 20 (57.1) | 14 (40.0) |
| Weight loss | 1 (50.0) | 0 | 13 (65.0) | 4 (20.0) | 4 (30.8) | 0 | 18 (51.4) | 4 (11.4) |
| Alopecia | 0 | 0 | 8 (40.0) | 0 | 9 (69.2) | 0 | 17 (48.6) | 0 |
| Decreased appetite | 1 (50.0) | 0 | 12 (60.0) | 1 (5.0) | 2 (15.4) | 1 (7.7) | 15 (42.9) | 2 (5.7) |
| Rash | 0 | 0 | 9 (45.0) | 1 (5.0) | 4 (30.8) | 0 | 13 (37.1) | 1 (2.9) |
| Asthenia | 2 (100) | 1 (50.0) | 7 (35.0) | 1 (5.0) | 3 (23.1) | 1 (7.7) | 12 (34.3) | 3 (8.6) |
| Hypomagnesemia | 1 (50.0) | 1 (50.0) | 8 (40.0) | 0 | 3 (23.1) | 0 | 12 (34.3) | 1 (2.9) |
| Vomiting | 0 | 0 | 6 (30.0) | 0 | 6 (46.2) | 0 | 12 (34.3) | 0 |
| Urinary tract infection | 0 | 0 | 6 (30.0) | 0 | 4 (30.8) | 1 (7.7) | 10 (28.6) | 1 (2.9) |
| Mucosal inflammation | 1 (50.0) | 0 | 4 (20.0) | 0 | 5 (38.5) | 0 | 10 (28.6) | 0 |
| Dygeusia | 0 | 0 | 7 (35.0) | 0 | 3 (23.1) | 0 | 10 (28.6) | 0 |
| Fatigue | 0 | 0 | 4 (20.0) | 0 | 5 (38.5) | 0 | 9 (25.7) | 0 |
| Pyrexia | 1 (50.0) | 0 | 6 (30.0) | 0 | 2 (15.4) | 0 | 9 (25.7) | 0 |
| Nasopharyngitis | 0 | 0 | 3 (15.0) | 0 | 6 (46.2) | 0 | 9 (25.7) | 0 |
| ALT increased | 0 | 0 | 7 (35.0) | 4 (20.0) | 1 (7.7) | 0 | 8 (22.9) | 4 (11.4) |
| Infusion-related reaction | 0 | 0 | 5 (25.0) | 0 | 3 (23.1) | 0 | 8 (22.9) | 0 |
| Neurotoxicity | 0 | 0 | 4 (20.0) | 3 (15.0) | 3 (23.1) | 1 (7.7) | 7 (20.0) | 4 (11.4) |
| AST increased | 0 | 0 | 6 (30.0) | 2 (10.0) | 1 (7.7) | 0 | 7 (20.0) | 2 (5.7) |
| Abdominal pain | 1 (50.0) | 0 | 5 (25.0) | 0 | 1 (7.7) | 0 | 7 (20.0) | 0 |
| Anemia | 1 (50.0) | 0 | 3 (15.0) | 0 | 3 (23.1) | 0 | 7 (20.0) | 0 |
| Hypophosphatemia | 1 (50.0) | 1 (50.0) | 2 (10.0) | 1 (5.0) | 3 (23.1) | 3 (23.1) | 6 (17.1) | 5 (14.3) |
| Epistaxis | 0 | 0 | 2 (10.0) | 0 | 4 (30.8) | 0 | 6 (17.1) | 0 |
| Headache | 0 | 0 | 3 (15.0) | 0 | 3 (23.1) | 0 | 6 (17.1) | 0 |
| Polyneuropathy | 0 | 0 | 5 (25.0) | 0 | 1 (7.7) | 0 | 6 (17.1) | 0 |
| Flatulence | 0 | 0 | 3 (15.0) | 0 | 3 (23.1) | 0 | 6 (17.1) | 0 |
| Lymphopenia | 0 | 0 | 1 (5.0) | 0 | 3 (23.1) | 2 (15.4) | 4 (11.4) | 2 (5.7) |
| Constipation | 0 | 0 | 2 (10.0) | 1 (5.0) | 3 (23.1) | 0 | 5 (14.3) | 1 (2.9) |
| Edema peripheral | 0 | 0 | 2 (10.0) | 0 | 3 (23.1) | 0 | 5 (14.3) | 0 |
| Hypocalcemia | 1 (50.0) | 0 | 2 (10.0) | 0 | 2 (15.4) | 0 | 5 (14.3) | 0 |
| Dry mouth | 0 | 0 | 4 (20.0) | 0 | 0 | 0 | 4 (11.4) | 0 |
| Stomatitis | 0 | 0 | 2 (10.0) | 0 | 2 (15.4) | 0 | 4 (11.4) | 0 |
| Neuropathy peripheral | 0 | 0 | 2 (10.0) | 0 | 2 (15.4) | 0 | 4 (11.4) | 0 |
| Acne | 0 | 0 | 2 (10.0) | 0 | 2 (15.4) | 0 | 4 (11.4) | 0 |
| Erythema | 0 | 0 | 3 (15.0) | 0 | 1 (7.7) | 0 | 4 (11.4) | 0 |
| Onycholysis | 0 | 0 | 2 (10.0) | 0 | 2 (15.4) | 0 | 4 (11.4) | 0 |
| Pruritus | 0 | 0 | 3 (15.0) | 0 | 1 (7.7) | 0 | 4 (11.4) | 0 |
| Back pain | 0 | 0 | 2 (10.0) | 0 | 2 (15.4) | 0 | 4 (11.4) | 0 |
| Pain in extremity | 0 | 0 | 3 (15.0) | 0 | 1 (7.7) | 0 | 4 (11.4) | 0 |
Only adverse events reported by >10% of the patients overall are shown. Adverse events are ordered by decreasing frequency for all grade events in the overall population
N = number of patients