Adverse events occurring in ≥ 15% of patients, by preferred term, n (%) | Dovitinib + fulvestrant (n = 47) | Placebo + fulvestrant (n = 50) | ||
---|---|---|---|---|
Any grade | Grade 3a | Any grade | Grade 3a | |
Any adverse event | 47 (100) | 32 (68.1) | 47 (94.0) | 19 (38.0) |
Diarrhea | 37 (78.7) | 7 (14.9) | 16 (32.0) | 2 (4.0) |
Nausea | 34 (72.3) | 4 (8.5) | 11 (22.0) | 1 (2.0) |
Vomiting | 27 (57.4) | 3 (6.4) | 4 (8.0) | 0 |
Asthenia | 18 (38.8) | 4 (8.5) | 11 (22.0) | 1 (2.0) |
Headache | 17 (36.2) | 2 (4.3) | 3 (6.0) | 0 |
Fatigue | 16 (34.0) | 6 (12.8) | 13 (26.0) | 1 (2.0) |
Rash | 16 (34.0) | 1 (2.1) | 3 (6.0) | 0 |
Alanine aminotransferase increase | 15 (31.9) | 7 (14.9) | 5 (10.0) | 1 (2.0) |
Dysgeusia | 15 (31.9) | 0 | 1 (2.0) | 0 |
Decreased appetite | 13 (27.7) | 2 (4.3) | 8 (16.0) | 0 |
Hypertension | 13 (27.7) | 10 (21.3) | 4 (8.0) | 3 (6.0) |
Dyspepsia | 12 (25.5) | 0 | 0 | 0 |
Blood alkaline phosphatase increase | 11 (23.4) | 6 (12.8) | 1 (2.0) | 0 |
Aspartate aminotransferase increase | 10 (21.3) | 3 (6.4) | 4 (8.0) | 1 (2.0) |
Abdominal pain upper | 10 (21.3) | 0 | 3 (6.0) | 0 |
Stomatitis | 10 (21.3) | 0 | 2 (4.0) | 0 |
Anemia | 9 (19.1) | 2 (4.3) | 4 (8.0) | 1 (2.0) |
γ-Glutamyltransferase increase | 9 (19.1) | 5 (10.6)b | 4 (8.0) | 3 (6.0)b |
Pain in extremity | 9 (19.1) | 0 | 3 (6.0) | 0 |
Dry skin | 9 (19.1) | 0 | 2 (4.0) | 0 |
Dyspnea | 8 (17.0) | 1 (2.1) | 6 (12.0) | 0 |
Abdominal pain | 8 (17.0) | 0 | 5 (10.0) | 0 |
Constipation | 8 (17.0) | 0 | 5 (10.0) | 0 |
Hypertriglyceridemia | 8 (17.0) | 4 (8.5) | 1 (2.0) | 0 |