Table 2 TRAEs (in ≥30% of patients), select TRAEs, and TRAEs leading to discontinuation in ≥2 patients
TRAE, preferred term, n (%)a | Treatment arm | |||
|---|---|---|---|---|
N + S (N = 33) | N + P (N = 20) | |||
All grades | Grade 3 or 4 | All grades | Grade 3 or 4 | |
Total patients with an event | 33 (100.0) | 27 (81.8) | 20 (100.0) | 14 (70.0) |
 Fatigue | 28 (84.8) | 3 (9.1) | 12 (60.0) | 3 (15.0) |
 Diarrhea | 21 (63.6) | 3 (9.1) | 12 (60.0) | 4 (20.0) |
 Dysgeusia | 21 (63.6) | 0 | 10 (50.0) | 0 |
 Nausea | 19 (57.6) | 1 (3.0) | 15 (75.0) | 0 |
 Hypertension | 16 (48.5) | 6 (18.2) | 5 (25.0) | 2 (10.0) |
 Decreased appetite | 16 (48.5) | 1 (3.0) | 8 (40.0) | 0 |
 Increased ALT | 13 (39.4) | 6 (18.2) | 5 (25.0) | 4 (20.0) |
 Palmar-plantar erythrodysesthesia syndrome | 13 (39.4) | 0 | 0 | 0 |
 Increased AST | 12 (36.4) | 3 (9.1) | 6 (30.0) | 4 (20.0) |
 Blood creatinine increased | 11 (33.3) | 2 (6.1) | 1 (5.0) | 0 |
 Hypothyroidism | 11 (33.3) | 0 | 4 (20.0) | 1 (5.0) |
 Dyspepsia | 11 (33.3) | 0 | 4 (20.0) | 0 |
 Dry skin | 11 (33.3) | 0 | 2 (10.0) | 0 |
 Mucosal inflammation | 10 (30.3) | 0 | 5 (25.0) | 0 |
 Dry mouth | 10 (30.3) | 0 | 1 (5.0) | 0 |
 Arthralgia | 8 (24.2) | 0 | 7 (35.0) | 1 (5.0) |
 Pruritus | 8 (24.2) | 0 | 7 (35.0) | 0 |
 Vomiting | 7 (21.2) | 1 (3.0) | 6 (30.0) | 0 |
Select TRAE, organ class, n (%)b | ||||
 Skin | 26 (78.8) | 2 (6.1) | 11 (55.0) | 0 |
 Endocrine | 12 (36.4) | 0 | 5 (25.0) | 2 (10.0) |
 Gastrointestinal | 21 (63.6) | 3 (9.1) | 12 (60.0) | 4 (20.0) |
 Hepatic | 15 (45.5) | 8 (24.2) | 7 (35.0) | 4 (20.0) |
 Renal | 13 (39.4) | 4 (12.1) | 1 (5.0) | 0 |
 Pulmonary | 1 (3.0) | 1 (3.0) | 1 (5.0) | 0 |
TRAE leading to discontinuation, preferred term, n (%)a | ||||
 Total patients with an event | 13 (39.4) | 11 (33.3) | 5 (25.0) | 4 (20.0) |
  Increased ALT | 3 (9.1) | 2 (6.1) | 3 (15.0) | 3 (15.0) |
  Acute kidney injury | 3 (9.1) | 1 (3.0) | 0 | 0 |
  Increased AST | 1 (3.0) | 1 (3.0) | 3 (15.0) | 3 (15.0) |