Table 2.
All-grade AEs occurring in ≥20% of patients overall in either arm
| Arm A: VEN + R-CHOP, n (%) | VEN 200 mg, | VEN 400 mg, | VEN 600 mg, | VEN 800 mg, | Total (N = 24) |
|---|---|---|---|---|---|
| Cohort 1 (n = 7) | Cohort 2 (n = 3) | Cohort 3 (n = 8) | Cohort 4 (n = 6) | ||
| Neutropenia | 4 (57.1) | 2 (66.7) | 5 (62.5) | 2 (33.3) | 13 (54.2) |
| Nausea | 3 (42.9) | 2 (66.7) | 1 (12.5) | 5 (83.3) | 11 (45.8) |
| Diarrhea | 3 (42.9) | 2 (66.7) | 2 (25.0) | 3 (50.0) | 10 (41.7) |
| Fatigue | 5 (71.4) | 0 | 3 (37.5) | 2 (33.3) | 10 (41.7) |
| Neuropathy peripheral | 2 (28.6) | 1 (33.3) | 3 (37.5) | 3 (50.0) | 9 (37.5) |
| Constipation | 1 (14.3) | 2 (66.7) | 3 (37.5) | 2 (33.3) | 8 (33.3) |
| Peripheral sensory neuropathy | 3 (42.9) | 1 (33.3) | 2 (25.0) | 2 (33.3) | 8 (33.3) |
| Anemia | 4 (57.1) | 1 (33.3) | 1 (12.5) | 2 (33.3) | 8 (33.3) |
| Febrile neutropenia | 3 (42.9) | 0 | 2 (25.0) | 3 (50.0) | 8 (33.3) |
| Thrombocytopenia | 4 (57.1) | 1 (33.3) | 2 (25.0) | 0 | 7 (29.2) |
| Cough | 2 (28.6) | 0 | 3 (37.5) | 1 (16.7) | 6 (25.0) |
| Infusion-related reaction | 1 (14.3) | 2 (66.7) | 1 (12.5) | 2 (33.3) | 6 (25.0) |
| Stomatitis | 2 (28.6) | 1 (33.3) | 1 (12.5) | 2 (33.3) | 6 (25.0) |
| Asthenia | 2 (28.6) | 1 (33.3) | 3 (37.5) | 0 | 6 (25.0) |
| Hypokalemia | 3 (42.9) | 1 (33.3) | 2 (25.0) | 0 | 6 (25.0) |
| Dyspnea | 3 (42.9) | 1 (33.3) | 0 | 1 (16.7) | 5 (20.8) |
| Headache | 1 (14.3) | 0 | 3 (37.5) | 1 (16.7) | 5 (20.8) |
| Vomiting | 0 | 2 (66.7) | 1 (12.5) | 2 (33.3) | 5 (20.8) |
| 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 (57.7) | 5 (83.3) | 6 (100.0) | 2 (33.3) | 19 (59.4) |
| Nausea | 3 (42.9) | 4 (57.1) | 3 (50.0) | 5 (83.3) | 4 (66.7) | 19 (59.4) |
| Constipation | 6 (85.7) | 3 (42.9) | 2 (33.3) | 2 (33.3) | 1 (16.7) | 14 (43.8) |
| Vomiting | 5 (71.4) | 4 (57.1) | 0 | 4 (66.7) | 1 (16.7) | 14 (43.8) |
| Diarrhea | 5 (71.4) | 3 (42.9) | 2 (33.3) | 2 (33.3) | 1 (16.7) | 13 (40.6) |
| Fatigue | 5 (71.4) | 2 (28.6) | 2 (33.3) | 3 (50.0) | 1 (16.7) | 13 (40.6) |
| Thrombocytopenia | 2 (28.6) | 3 (42.9) | 2 (33.3) | 4 (66.7) | 2 (33.3) | 13 (40.6) |
| Infusion-related reaction | 4 (57.1) | 1 (14.3) | 2 (33.3) | 2 (33.3) | 3 (50.0) | 12 (37.5) |
| Anemia | 1 (14.3) | 1 (14.3) | 1 (16.7) | 5 (83.3) | 4 (66.7) | 12 (37.5) |
| Cough | 3 (42.9) | 3 (42.9) | 0 | 3 (50.0) | 2 (33.3) | 11 (34.4) |
| Pyrexia | 1 (14.3) | 5 (71.4) | 2 (33.3) | 1 (16.7) | 2 (33.3) | 11 (34.4) |
| Dysgeusia | 1 (14.3) | 3 (42.9) | 1 (16.7) | 2 (33.3) | 4 (66.7) | 11 (34.4) |
| Febrile neutropenia | 2 (28.6) | 4 (57.1) | 0 | 1 (16.7) | 1 (16.7) | 8 (25.0) |
| Decreased appetite | 2 (28.6) | 2 (28.6) | 1 (16.7) | 2 (33.3) | 1 (16.7) | 8 (25.0) |
| Headache | 3 (42.9) | 3 (42.9) | 1 (16.7) | 0 | 0 | 7 (21.9) |
| Peripheral sensory neuropathy | 0 | 1 (14.3) | 1 (16.7) | 1 (16.7) | 1 (16.7) | 4 (12.5) |
| Dyspnea | 0 | 1 (14.3) | 0 | 1 (16.7) | 1 (16.7) | 3 (9.4) |
| Stomatitis | 0 | 0 | 1 (16.7) | 0 | 1 (16.7) | 2 (6.3) |
Percentages represent the incidence of that specific AE per cohort in each arm.
AEs were coded using the most recent version of the Medical Dictionary for Regulatory Activities and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0). The protocol-specified safety reporting window was 30 d after the last dose of VEN or CHOP, or 90 d after the last dose of rituximab or obinutuzumab. After this period, only serious AEs, AEs of special interest, and AEs that were deemed by the investigator to be related to study drug were reported.