Table 3.
Adverse events: randomized population
| Event, n (%) | Varlitinib + capecitabine (n = 64) | Placebo + capecitabine (n = 63) |
|---|---|---|
| Any TEAE | 64 (100) | 59 (93.7) |
| Grade ≥3 TEAE | 42 (65.6) | 37 (58.7) |
| Serious TEAE | 25 (39.1) | 27 (42.9) |
| Treatment-related TEAE leading to treatment discontinuation | 3 (4.7) | 0 (0) |
| Treatment-related TEAE leading to death | 1 (1.6) | 0 (0) |
| TEAEs in ≥20 patients | ||
| Nausea | 33 (51.6) | 14 (22.2) |
| Blood bilirubin increased | 28 (43.8) | 14 (22.2) |
| Diarrhea | 26 (40.6) | 16 (25.4) |
| Decreased appetite | 25 (39.1) | 11 (17.5) |
| Vomiting | 22 (34.4) | 11 (17.5) |
| Palmar-plantar erythrodysesthesia syndrome | 20 (31.3) | 19 (30.2) |
| Abdominal pain | 16 (25.0) | 12 (19.0) |
| Fatigue | 16 (25.0) | 12 (19.0) |
| Pyrexia | 15 (23.4) | 11 (17.5) |
| Grade ≥3 TEAEs in ≥5 patients | ||
| Blood bilirubin increased | 9 (14.1) | 7 (11.1) |
| Anemia | 7 (10.9) | 6 (9.5) |
| Hyperbilirubinemia | 6 (9.4) | 1 (1.6) |
| Abdominal pain | 5 (7.8) | 5 (7.9) |
| Vomiting | 5 (7.8) | 2 (3.2) |
| Alanine transaminase increased | 5 (7.8) | 1 (1.6) |
| Cholangiolitis | 4 (6.3) | 4 (6.3) |
| Asthenia | 4 (6.3) | 1 (1.6) |
| Palmar-plantar erythrodysesthesia syndrome | 2 (3.1) | 3 (4.8) |
| Serious TEAEs in >2 patients receiving varlitinib | ||
| Blood bilirubin increased | 5 (7.8) | 5 (7.9) |
| Cholangiolitis | 4 (6.3) | 4 (6.3) |
| Vomiting | 4 (6.3) | 2 (3.2) |
| Hyperbilirubinemia | 4 (6.3) | 0 (0) |
| Pyrexia | 3 (4.7) | 0 (0) |
TEAE, treatment-emergent adverse event.