Summary of safety (safety population)
| . | Arm A: VEN + R (n = 52) . | Arm B: VEN + BR (n = 49) . | Arm C: BR (n = 50) . |
|---|---|---|---|
| Total number of AEs | 425 | 936 | 502 |
| Patients with ≥1 event, n (%) | |||
| Any grade AE | 51 (98.1) | 49 (100.0) | 50 (100.0) |
| Grade 3/4 AE | 26 (50.0) | 45 (91.9) | 29 (58.0) |
| AE with fatal outcome (grade 5) | 3 (5.8) | 1 (2.0) | 1 (2.0) |
| SAE | 16 (30.8) | 26 (53.1) | 10 (20.0) |
| AE leading to dose modification/interruption from any treatment | 30 (57.7) | 44 (89.8) | 21 (42.0) |
| AE leading to VEN dose modification/interruption | 20 (38.5) | 43 (87.8) | NA |
| AE leading to withdrawal from any treatment | 3 (5.8) | 20 (40.8) | 2 (4.0) |
| AE leading to withdrawal of VEN | 2 (3.8) | 17 (34.7) | NA |
| All AEs occurring in ≥20% of patients in any treatment arm, n (%) | |||
| Nausea | 14 (26.9) | 32 (65.3) | 22 (44.0) |
| Neutropenia | 14 (26.9) | 30 (61.2) | 17 (34.0) |
| Thrombocytopenia | 7 (13.5) | 28 (57.1) | 8 (16.0) |
| Diarrhea | 21 (40.4) | 24 (49.0) | 11 (22.0) |
| Vomiting | 7 (13.5) | 24 (49.0) | 13 (26.0) |
| Fatigue | 13 (25.0) | 21 (42.9) | 15 (30.0) |
| Anemia | 3 (5.8) | 19 (38.8) | 7 (14.0) |
| Infusion-related reaction | 18 (34.6) | 10 (20.4) | 7 (14.0) |
| Constipation | 5 (9.6) | 10 (20.4) | 17 (34.0) |
| Cough | 6 (11.5) | 12 (24.5) | 12 (24.0) |
| Pyrexia | 5 (9.6) | 10 (20.4) | 9 (18.0) |
| Hypokalemia | 6 (11.5) | 13 (26.5) | 4 (8.0) |
| Decreased appetite | 5 (9.6) | 10 (20.4) | 6 (12.0) |
| Grade 3/4 AEs occurring in ≥10% ofpatients in any treatment arm, n (%) | |||
| Neutropenia | 13 (25.0) | 29 (59.2) | 14 (28.0) |
| Thrombocytopenia | 4 (7.7) | 22 (44.9) | 3 (6.0) |
| Anemia | 3 (5.8) | 7 (14.3) | 1 (2.0) |
| Leukopenia | 2 (3.8) | 5 (10.2) | 2 (4.0) |
| Febrile neutropenia | 0 | 6 (12.2) | 3 (6.0) |
| Vomiting | 0 | 5 (10.2) | 0 |
| Hypokalemia | 1 (1.9) | 6 (12.2) | 1 (2.0) |
| SAEs occurring in ≥3% of patients in anytreatment arm, n (%) | |||
| Febrile neutropenia | 0 | 6 (12.2) | 3 (6.0) |
| Pneumonia | 2 (3.8) | 3 (6.1) | 0 |
| Pneumocystis jirovecii pneumonia | 0 | 3 (6.1) | 0 |
| Myelodysplastic syndrome | 0 | 3 (6.1) | 0 |
| Lung infection | 0 | 2 (4.1) | 1 (2.0) |
| Cellulitis | 0 | 0 | 2 (4.0) |
| Increased blood lactate dehydrogenase | 2 (3.8) | 0 | 0 |
| . | Arm A: VEN + R (n = 52) . | Arm B: VEN + BR (n = 49) . | Arm C: BR (n = 50) . |
|---|---|---|---|
| Total number of AEs | 425 | 936 | 502 |
| Patients with ≥1 event, n (%) | |||
| Any grade AE | 51 (98.1) | 49 (100.0) | 50 (100.0) |
| Grade 3/4 AE | 26 (50.0) | 45 (91.9) | 29 (58.0) |
| AE with fatal outcome (grade 5) | 3 (5.8) | 1 (2.0) | 1 (2.0) |
| SAE | 16 (30.8) | 26 (53.1) | 10 (20.0) |
| AE leading to dose modification/interruption from any treatment | 30 (57.7) | 44 (89.8) | 21 (42.0) |
| AE leading to VEN dose modification/interruption | 20 (38.5) | 43 (87.8) | NA |
| AE leading to withdrawal from any treatment | 3 (5.8) | 20 (40.8) | 2 (4.0) |
| AE leading to withdrawal of VEN | 2 (3.8) | 17 (34.7) | NA |
| All AEs occurring in ≥20% of patients in any treatment arm, n (%) | |||
| Nausea | 14 (26.9) | 32 (65.3) | 22 (44.0) |
| Neutropenia | 14 (26.9) | 30 (61.2) | 17 (34.0) |
| Thrombocytopenia | 7 (13.5) | 28 (57.1) | 8 (16.0) |
| Diarrhea | 21 (40.4) | 24 (49.0) | 11 (22.0) |
| Vomiting | 7 (13.5) | 24 (49.0) | 13 (26.0) |
| Fatigue | 13 (25.0) | 21 (42.9) | 15 (30.0) |
| Anemia | 3 (5.8) | 19 (38.8) | 7 (14.0) |
| Infusion-related reaction | 18 (34.6) | 10 (20.4) | 7 (14.0) |
| Constipation | 5 (9.6) | 10 (20.4) | 17 (34.0) |
| Cough | 6 (11.5) | 12 (24.5) | 12 (24.0) |
| Pyrexia | 5 (9.6) | 10 (20.4) | 9 (18.0) |
| Hypokalemia | 6 (11.5) | 13 (26.5) | 4 (8.0) |
| Decreased appetite | 5 (9.6) | 10 (20.4) | 6 (12.0) |
| Grade 3/4 AEs occurring in ≥10% ofpatients in any treatment arm, n (%) | |||
| Neutropenia | 13 (25.0) | 29 (59.2) | 14 (28.0) |
| Thrombocytopenia | 4 (7.7) | 22 (44.9) | 3 (6.0) |
| Anemia | 3 (5.8) | 7 (14.3) | 1 (2.0) |
| Leukopenia | 2 (3.8) | 5 (10.2) | 2 (4.0) |
| Febrile neutropenia | 0 | 6 (12.2) | 3 (6.0) |
| Vomiting | 0 | 5 (10.2) | 0 |
| Hypokalemia | 1 (1.9) | 6 (12.2) | 1 (2.0) |
| SAEs occurring in ≥3% of patients in anytreatment arm, n (%) | |||
| Febrile neutropenia | 0 | 6 (12.2) | 3 (6.0) |
| Pneumonia | 2 (3.8) | 3 (6.1) | 0 |
| Pneumocystis jirovecii pneumonia | 0 | 3 (6.1) | 0 |
| Myelodysplastic syndrome | 0 | 3 (6.1) | 0 |
| Lung infection | 0 | 2 (4.1) | 1 (2.0) |
| Cellulitis | 0 | 0 | 2 (4.0) |
| Increased blood lactate dehydrogenase | 2 (3.8) | 0 | 0 |
SAE, serious AE.