Frequency of adverse events (all grades, and grades 3 or 4) during the first 3 months and during the 5-year treatment period, by PK category
| Adverse events . | Quartile 1, n=87, % all (% grade 3/4) . | Quartiles 2 and 3, n=178, % all (% grade 3/4) . | Quartile 4, n=86, % all (% grade 3/4) . |
|---|---|---|---|
| AEs within 3 mo | |||
| Fluid retention; superficial edemas | 31.0 (0); 28.7 (0) | 43.8 (0); 43.3 (0) | 52.3 (0); 50.0 (0) |
| Abdominal pain | 28.7 (1.1) | 11.2 (0) | 14.0 (1.2) |
| Nausea | 28.7 (0) | 27.0 (0) | 41.9 (0) |
| Fatigue | 26.4 (0) | 16.9 (0) | 17.4 (1.2) |
| Diarrhea | 24.1 (0) | 26.4 (0) | 16.3 (0) |
| Headache | 21.8 (0) | 20.8 (0) | 17.4 (0) |
| Muscle cramps | 20.7 (0) | 24.2 (0.6) | 17.4 (1.2) |
| Musculoskeletal pain | 20.7 (1.1) | 22.5 (1.7) | 25.6 (2.3) |
| Joint pain | 18.4 (1.1) | 14.6 (1.1) | 19.8 (0) |
| Hemorrhage | 16.1 (1.1) | 9.6 (0.6) | 11.6 (0) |
| Rash and related | 13.8 (1.1) | 20.8 (1.7) | 19.8 (0) |
| Myalgia | 12.6 (0) | 14.6 (1.7) | 24.4 (1.2) |
| Neutropenia | 10.3 (9.2) | 6.7 (5.6) | 7.0 (5.8) |
| Thrombocytopenia | 8.0 (4.6) | 6.2 (2.8) | 9.3 (3.5) |
| Anemia | 2.3 (0) | 4.5 (1.1) | 5.8 (0) |
| AEs within 5 y | |||
| Fluid retention; superficial edema | 52.9 (2.3); 51.7 (1.1) | 61.8 (3.4); 61.2 (1.7) | 75.6 (3.5); 69.8 (1.2) |
| Fatigue | 51.7 (0) | 34.3 (1.1) | 30.2 (2.3) |
| Nausea | 50.6 (1.1) | 43.8 (2.2) | 52.3 (0) |
| Muscle cramps | 49.4 (2.3) | 50.0 (2.2) | 41.9 (1.2) |
| Musculoskeletal pain | 48.3 (3.4) | 47.8 (7.3) | 53.5 (3.5) |
| Diarrhea | 46.0 (3.4) | 57.3 (4.5) | 38.4 (2.3) |
| Abdominal pain | 43.7 (6.9) | 35.4 (4.5) | 31.4 (3.5) |
| Joint pain | 40.2 (2.3) | 27.0 (3.4) | 32.6 (0) |
| Headache | 39.1 (1.1) | 40.4 (0.6) | 32.6 (0) |
| Rash and related | 32.2 (3.4) | 38.8 (2.2) | 51.2 (1.2) |
| Hemorrhage | 31.0 (1.1) | 32.0 (2.2) | 24.4 (1.2) |
| Myalgia | 19.5 (0) | 24.7 (2.2) | 30.2 (1.2) |
| Neutropenia | 14.9 (12.6) | 9.6 (5.6) | 9.3 (8.1) |
| Thrombocytopenia | 13.8 (9.2) | 10.1 (5.1) | 15.1 (4.7) |
| Anemia | 8.0 (0) | 11.8 (3.4) | 19.8 (7.0) |
| Adverse events . | Quartile 1, n=87, % all (% grade 3/4) . | Quartiles 2 and 3, n=178, % all (% grade 3/4) . | Quartile 4, n=86, % all (% grade 3/4) . |
|---|---|---|---|
| AEs within 3 mo | |||
| Fluid retention; superficial edemas | 31.0 (0); 28.7 (0) | 43.8 (0); 43.3 (0) | 52.3 (0); 50.0 (0) |
| Abdominal pain | 28.7 (1.1) | 11.2 (0) | 14.0 (1.2) |
| Nausea | 28.7 (0) | 27.0 (0) | 41.9 (0) |
| Fatigue | 26.4 (0) | 16.9 (0) | 17.4 (1.2) |
| Diarrhea | 24.1 (0) | 26.4 (0) | 16.3 (0) |
| Headache | 21.8 (0) | 20.8 (0) | 17.4 (0) |
| Muscle cramps | 20.7 (0) | 24.2 (0.6) | 17.4 (1.2) |
| Musculoskeletal pain | 20.7 (1.1) | 22.5 (1.7) | 25.6 (2.3) |
| Joint pain | 18.4 (1.1) | 14.6 (1.1) | 19.8 (0) |
| Hemorrhage | 16.1 (1.1) | 9.6 (0.6) | 11.6 (0) |
| Rash and related | 13.8 (1.1) | 20.8 (1.7) | 19.8 (0) |
| Myalgia | 12.6 (0) | 14.6 (1.7) | 24.4 (1.2) |
| Neutropenia | 10.3 (9.2) | 6.7 (5.6) | 7.0 (5.8) |
| Thrombocytopenia | 8.0 (4.6) | 6.2 (2.8) | 9.3 (3.5) |
| Anemia | 2.3 (0) | 4.5 (1.1) | 5.8 (0) |
| AEs within 5 y | |||
| Fluid retention; superficial edema | 52.9 (2.3); 51.7 (1.1) | 61.8 (3.4); 61.2 (1.7) | 75.6 (3.5); 69.8 (1.2) |
| Fatigue | 51.7 (0) | 34.3 (1.1) | 30.2 (2.3) |
| Nausea | 50.6 (1.1) | 43.8 (2.2) | 52.3 (0) |
| Muscle cramps | 49.4 (2.3) | 50.0 (2.2) | 41.9 (1.2) |
| Musculoskeletal pain | 48.3 (3.4) | 47.8 (7.3) | 53.5 (3.5) |
| Diarrhea | 46.0 (3.4) | 57.3 (4.5) | 38.4 (2.3) |
| Abdominal pain | 43.7 (6.9) | 35.4 (4.5) | 31.4 (3.5) |
| Joint pain | 40.2 (2.3) | 27.0 (3.4) | 32.6 (0) |
| Headache | 39.1 (1.1) | 40.4 (0.6) | 32.6 (0) |
| Rash and related | 32.2 (3.4) | 38.8 (2.2) | 51.2 (1.2) |
| Hemorrhage | 31.0 (1.1) | 32.0 (2.2) | 24.4 (1.2) |
| Myalgia | 19.5 (0) | 24.7 (2.2) | 30.2 (1.2) |
| Neutropenia | 14.9 (12.6) | 9.6 (5.6) | 9.3 (8.1) |
| Thrombocytopenia | 13.8 (9.2) | 10.1 (5.1) | 15.1 (4.7) |
| Anemia | 8.0 (0) | 11.8 (3.4) | 19.8 (7.0) |