Grade ≥ 3 adverse events in ≥ 2 patients
Preferred term . | N = 299 (%) . |
---|---|
Any AE of grade ≥ 3 severity, n (%) | 83 (28) |
Thrombocytopenia | 7 (2) |
ALT increased | 6 (2) |
Fatigue | 6 (2) |
Pain in extremity | 5 (2) |
Anemia | 4 (1) |
Aspartate aminotransferase increased | 4 (1) |
Back pain | 4 (1) |
Hypertension | 4 (1) |
Myocardial infarction | 4 (1) |
Abdominal pain | 3 (1) |
Blood bilirubin increased | 3 (1) |
Cataract | 3 (1) |
Dyspnea | 3 (1) |
Menorrhagia | 3 (1) |
Pneumonia | 3 (1) |
Arthritis | 2 (< 1) |
Chest pain | 2 (< 1) |
Deep vein thrombosis | 2 (< 1) |
Diarrhea | 2 (< 1) |
Dizziness | 2 (< 1) |
Gastrointestinal hemorrhage | 2 (< 1) |
Headache | 2 (< 1) |
Insomnia | 2 (< 1) |
Migraine | 2 (< 1) |
Renal failure | 2 (< 1) |
Preferred term . | N = 299 (%) . |
---|---|
Any AE of grade ≥ 3 severity, n (%) | 83 (28) |
Thrombocytopenia | 7 (2) |
ALT increased | 6 (2) |
Fatigue | 6 (2) |
Pain in extremity | 5 (2) |
Anemia | 4 (1) |
Aspartate aminotransferase increased | 4 (1) |
Back pain | 4 (1) |
Hypertension | 4 (1) |
Myocardial infarction | 4 (1) |
Abdominal pain | 3 (1) |
Blood bilirubin increased | 3 (1) |
Cataract | 3 (1) |
Dyspnea | 3 (1) |
Menorrhagia | 3 (1) |
Pneumonia | 3 (1) |
Arthritis | 2 (< 1) |
Chest pain | 2 (< 1) |
Deep vein thrombosis | 2 (< 1) |
Diarrhea | 2 (< 1) |
Dizziness | 2 (< 1) |
Gastrointestinal hemorrhage | 2 (< 1) |
Headache | 2 (< 1) |
Insomnia | 2 (< 1) |
Migraine | 2 (< 1) |
Renal failure | 2 (< 1) |
AE indicates adverse event; ALT, alanine aminotransferase; and AST, aspartate aminotransferase.