Table 2.
Treatment-emergent adverse events
| All-grade TEAEs (≥20% total patients), n (%) | Arm A (3/28-day VEN [+BR]) n = 8 | Arm B (7/28-day VEN [+BR]) n = 13 | Arm C (28-day VEN [+BR]) n = 39 | Total N = 60 |
|---|---|---|---|---|
| Any TEAE | 8 (100) | 12 (92) | 39 (100) | 59 (98) |
| Nausea | 7 (88) | 8 (61) | 27 (69) | 42 (70) |
| Neutropenia | 5 (63) | 10 (77) | 26 (67) | 41 (68) |
| Diarrhea | 4 (50) | 7 (54) | 22 (56) | 33 (55) |
| Thrombocytopenia | 2 (25) | 6 (46) | 23 (59) | 31 (52) |
| Vomiting | 5 (63) | 4 (31) | 19 (49) | 28 (47) |
| Lymphocyte count decrease | 0 | 6 (46) | 17 (44) | 23 (38) |
| Fatigue | 4 (50) | 4 (31) | 20 (51) | 28 (47) |
| Constipation | 0 | 6 (46) | 18 (46) | 24 (40) |
| Anemia | 3 (38) | 7 (54) | 13 (33) | 23 (38) |
| Hyperglycemia | 0 | 6 (46) | 14 (36) | 20 (33) |
| Hypokalemia | 1 (13) | 4 (31) | 13 (33) | 18 (30) |
| Cough | 3 (38) | 5 (39) | 9 (23) | 17 (28) |
| Hypocalcemia | 0 | 6 (46) | 10 (26) | 16 (27) |
| Leukopenia | 2 (25) | 4 (31) | 9 (23) | 15 (25) |
| White blood cell count decrease | 0 | 3 (23) | 12 (31) | 15 (25) |
| Headache | 2 (25) | 4 (31) | 9 (23) | 15 (25) |
| Pyrexia | 1 (13) | 3 (23) | 10 (26) | 14 (23) |
| Upper respiratory tract infection | 2 (25) | 3 (23) | 9 (23) | 14 (23) |
| Appetite decrease | 3 (38) | 1 (7) | 8 (21) | 12 (20) |
| Grade 3/4 TEAEs (≥5% total patients), n (%) | ||||
| Any grade 3/4 TEAE | 4 (50) | 12 (92) | 34 (87) | 50 (83) |
| Neutropenia | 3 (38) | 10 (77) | 23 (59) | 36 (60) |
| Lymphocyte count decrease | 0 | 6 (46) | 17 (44) | 23 (38) |
| White blood cell count decrease | 0 | 3 (23) | 10 (26) | 13 (22) |
| Leukopenia | 1 (13) | 4 (31) | 7 (18) | 12 (20) |
| Thrombocytopenia | 2 (25) | 1 (8) | 14 (36) | 17 (28) |
| Anemia | 2 (25) | 2 (15) | 6 (15) | 10 (17) |
| Febrile neutropenia | 1 (13) | 1 (8) | 3 (8) | 5 (8) |
| CD4 lymphocytes decrease | 0 | 0 | 4 (10) | 4 (7) |
| Dyspnea | 0 | 2 (15) | 1 (3) | 3 (5) |
| Fatigue | 0 | 1 (8) | 2 (5) | 3 (5) |
| Hypokalemia | 0 | 1 (8) | 2 (5) | 3 (5) |
| Hypophosphatemia | 0 | 1 (8) | 2 (5) | 3 (5) |
| Lymphopenia | 0 | 1 (8) | 2 (5) | 3 (5) |
| Nausea | 0 | 0 | 3 (8) | 3 (5) |
| Serious TEAEs (>2% total patients), n (%) | ||||
| Any serious TEAE | 3 (38) | 7 (54) | 14 (36) | 24 (40) |
| Febrile neutropenia | 1 (13) | 1 (8) | 3 (8) | 5 (8) |
| Malignant neoplasm progression | 0 | 0 | 5 (13) | 5 (8) |
| Diarrhea | 0 | 1 (8) | 1 (3) | 2 (3) |
| Dyspnea | 0 | 1 (8) | 1 (3) | 2 (3) |
| Malignant melanoma | 0 | 1 (8) | 1 (3) | 2 (3) |
| Nausea | 0 | 0 | 2 (5) | 2 (3) |
| Respiratory failure | 0 | 0 | 2 (5) | 2 (3) |
| Syncope | 0 | 2 (15) | 0 | 2 (3) |
| Vomiting | 0 | 0 | 2 (5) | 2 (3) |