Grade 3/4 AEs occurring in 2 or more patients in either study arm
| Arm A: VEN + R-CHOP, n (%) . | VEN 200 mg, . | VEN 400 mg, . | VEN 600 mg, . | VEN 800 mg, . | Total . | |
|---|---|---|---|---|---|---|
| Cohort 1 (n = 7) . | Cohort 2 (n = 3) . | Cohort 3 (n = 8) . | Cohort 4 (n = 6) . | (N = 24) . | ||
| Neutropenia | 4 (57.1) | 2 (66.6) | 5 (62.5) | 2 (33.3) | 13 (54.2) | |
| Febrile neutropenia | 3 (42.9) | 0 | 2 (25.0) | 3 (50.0) | 8 (33.3) | |
| Thrombocytopenia | 3 (42.9) | 0 | 1 (12.5) | 0 | 4 (16.7) | |
| Anemia | 2 (28.6) | 0 | 0 | 1 (16.7) | 3 (12.5) | |
| Pneumonia | 0 | 0 | 0 | 0 | 1 (4.2) | |
| Diarrhea | 1 (14.3) | 1 (33.3) | 0 | 0 | 2 (8.3) | |
| TLS | 0 | 0 | 1 (12.5) | 0 | 1 (4.2) | |
| Arm A: VEN + R-CHOP, n (%) . | VEN 200 mg, . | VEN 400 mg, . | VEN 600 mg, . | VEN 800 mg, . | Total . | |
|---|---|---|---|---|---|---|
| Cohort 1 (n = 7) . | Cohort 2 (n = 3) . | Cohort 3 (n = 8) . | Cohort 4 (n = 6) . | (N = 24) . | ||
| Neutropenia | 4 (57.1) | 2 (66.6) | 5 (62.5) | 2 (33.3) | 13 (54.2) | |
| Febrile neutropenia | 3 (42.9) | 0 | 2 (25.0) | 3 (50.0) | 8 (33.3) | |
| Thrombocytopenia | 3 (42.9) | 0 | 1 (12.5) | 0 | 4 (16.7) | |
| Anemia | 2 (28.6) | 0 | 0 | 1 (16.7) | 3 (12.5) | |
| Pneumonia | 0 | 0 | 0 | 0 | 1 (4.2) | |
| Diarrhea | 1 (14.3) | 1 (33.3) | 0 | 0 | 2 (8.3) | |
| TLS | 0 | 0 | 1 (12.5) | 0 | 1 (4.2) | |
| Arm B: VEN + G-CHOP, n (%) . | VEN 200 mg, . | VEN 400 mg, . | VEN 600 mg, . | VEN 800 mg, . | VEN 800 mg, . | Total (N = 32) . |
|---|---|---|---|---|---|---|
| Cohort 1 (n = 7) . | Cohort 2 (n = 7) . | Cohort 3 (n = 6) . | Cohort 4A (n = 6) . | Cohort 4B (n = 6) . | ||
| Neutropenia | 2 (28.6) | 4 (57.1) | 5 (83.3) | 6 (100) | 2 (33.3) | 19 (59.4) |
| Febrile neutropenia | 2 (28.6) | 4 (57.1) | 0 | 1 (16.7) | 1 (16.7) | 8 (25.0) |
| Thrombocytopenia | 2 (28.6) | 2 (28.6) | 2 (33.3) | 4 (66.7) | 2 (33.3) | 12 (37.5) |
| Anemia | 1 (14.3) | 1 (14.3) | 1 (16.7) | 4 (66.7) | 3 (50.0) | 10 (31.3) |
| Pneumonia | 1 (14.3) | 1 (14.3) | 0 | 0 | 0 | 2 (6.3) |
| Diarrhea | 0 | 0 | 0 | 0 | 0 | 0 |
| TLS | 0 | 0 | 1 (16.7) | 1 (16.7) | 0 | 2 (6.3) |
| Lung infection | 0 | 1 (14.3) | 0 | 1 (16.7) | 0 | 2 (6.3) |
| Arm B: VEN + G-CHOP, n (%) . | VEN 200 mg, . | VEN 400 mg, . | VEN 600 mg, . | VEN 800 mg, . | VEN 800 mg, . | Total (N = 32) . |
|---|---|---|---|---|---|---|
| Cohort 1 (n = 7) . | Cohort 2 (n = 7) . | Cohort 3 (n = 6) . | Cohort 4A (n = 6) . | Cohort 4B (n = 6) . | ||
| Neutropenia | 2 (28.6) | 4 (57.1) | 5 (83.3) | 6 (100) | 2 (33.3) | 19 (59.4) |
| Febrile neutropenia | 2 (28.6) | 4 (57.1) | 0 | 1 (16.7) | 1 (16.7) | 8 (25.0) |
| Thrombocytopenia | 2 (28.6) | 2 (28.6) | 2 (33.3) | 4 (66.7) | 2 (33.3) | 12 (37.5) |
| Anemia | 1 (14.3) | 1 (14.3) | 1 (16.7) | 4 (66.7) | 3 (50.0) | 10 (31.3) |
| Pneumonia | 1 (14.3) | 1 (14.3) | 0 | 0 | 0 | 2 (6.3) |
| Diarrhea | 0 | 0 | 0 | 0 | 0 | 0 |
| TLS | 0 | 0 | 1 (16.7) | 1 (16.7) | 0 | 2 (6.3) |
| Lung infection | 0 | 1 (14.3) | 0 | 1 (16.7) | 0 | 2 (6.3) |
Percentages represent the incidence of that specific AE per cohort in each arm.