Grade 3 to 5 treatment-related AEs throughout the entire study period
| . | IR, % (n = 352) . | FCR, % (n = 158) . | P value . |
|---|---|---|---|
| Anemia | 4.3 | 15.8 | <.001 |
| Arthralgia | 5.4 | 0.6 | .011 |
| Diarrhea | 2.6 | 0.6 | .185 |
| Fatigue | 2.0 | 2.5 | .745 |
| Hemolysis | 0 | 2.5 | .009 |
| Hypertension | 11.4 | 1.9 | <.001 |
| Leukocytosis | 9.7 | 0.6 | <.001 |
| Lymphocyte count decreased | 6.8 | 65.2 | <.001 |
| Lymphocyte count increased | 28.1 | 13.9 | <.001 |
| Neutrophil count decreased | 28.4 | 45.6 | <.001 |
| Platelet count decreased | 3.4 | 16.5 | <.001 |
| Rash maculo-papular | 2.6 | 1.9 | .762 |
| White blood cell decreased | 6.5 | 40.5 | <.001 |
| Infection | 11.4 | 19.6 | .018 |
| Lung infection | 4.5 | 2.5 | .333 |
| Febrile neutropenia | 2.3 | 15.8 | <.001 |
| Sepsis | 1.1 | 3.2 | .144 |
| Other infection | 9.7 | 6.3 | .237 |
| Cardiac | 7.7 | 0 | <.001 |
| Atrial fibrillation | 4.5 | 0 | .004 |
| Other Cardiac* | 4.3 | 0 | .008 |
| Any grade 3-5 treatment related AEs | 73.0 | 83.5 | .010 |
| . | IR, % (n = 352) . | FCR, % (n = 158) . | P value . |
|---|---|---|---|
| Anemia | 4.3 | 15.8 | <.001 |
| Arthralgia | 5.4 | 0.6 | .011 |
| Diarrhea | 2.6 | 0.6 | .185 |
| Fatigue | 2.0 | 2.5 | .745 |
| Hemolysis | 0 | 2.5 | .009 |
| Hypertension | 11.4 | 1.9 | <.001 |
| Leukocytosis | 9.7 | 0.6 | <.001 |
| Lymphocyte count decreased | 6.8 | 65.2 | <.001 |
| Lymphocyte count increased | 28.1 | 13.9 | <.001 |
| Neutrophil count decreased | 28.4 | 45.6 | <.001 |
| Platelet count decreased | 3.4 | 16.5 | <.001 |
| Rash maculo-papular | 2.6 | 1.9 | .762 |
| White blood cell decreased | 6.5 | 40.5 | <.001 |
| Infection | 11.4 | 19.6 | .018 |
| Lung infection | 4.5 | 2.5 | .333 |
| Febrile neutropenia | 2.3 | 15.8 | <.001 |
| Sepsis | 1.1 | 3.2 | .144 |
| Other infection | 9.7 | 6.3 | .237 |
| Cardiac | 7.7 | 0 | <.001 |
| Atrial fibrillation | 4.5 | 0 | .004 |
| Other Cardiac* | 4.3 | 0 | .008 |
| Any grade 3-5 treatment related AEs | 73.0 | 83.5 | .010 |
Includes grade 3 to 5 treatment-related AEs that occurred in ≥2% of the treated patients in either arm. The worst grade is based on all grade 3 to 5 treatment-related AEs.
Pericardial effusion, heart failure, chest pain-cardiac, sinus tachycardia, supraventricular tachycardia, atrial flutter, ventricular tachycardia, cardiac arrest.