Overview of safety and AEs reported at grade 3/4 severity in ≥5 patients (2%) with venetoclax plus R-CHOP (safety-evaluable population)
| . | CAVALLI phase 2 (N = 206) . | GOYA IPI 2 to 5 (N = 564) . | ||
|---|---|---|---|---|
| Safety overview | ||||
| Any AE | 204 (99) | 528 (94) | ||
| Total number of AEs, n | 3345 | 4926 | ||
| AE with fatal outcome (grade 5) | 5 (2) | 30 (5) | ||
| SAE | 116 (56) | 230 (41) | ||
| Grade 3/4 AE | 178 (86) | 373 (66) | ||
| AE leading to withdrawal from any treatment | 50 (24) | 56 (10) | ||
| AE (MedDRA preferred term), n (%) | All grades | Grade 3/4 | All grades | Grade 3/4 |
| Neutropenia | 141 (68) | 141 (68) | 232 (41) | 219 (39) |
| Infections and infestations* | 130 (63) | 47 (23) | 260 (46) | 90 (16) |
| Nausea | 107 (52) | 7 (3) | 155 (27) | 2 (< 1) |
| Fatigue | 83 (40) | 6 (3) | 100 (18) | 11 (2) |
| Diarrhea | 80 (39) | 9 (4) | 79 (14) | 9 (2) |
| Anemia | 76 (37) | 50 (24) | 91 (16) | 50 (9) |
| Vomiting | 68 (33) | 7 (3) | 64 (11) | 2 (< 1) |
| Febrile neutropenia | 63 (31) | 63 (31) | 93 (16) | 92 (16) |
| Thrombocytopenia | 53 (26) | 45 (22) | 17 (3) | 9 (2) |
| Hypokalemia | 35 (17) | 8 (4) | 44 (8) | 14 (2) |
| Asthenia | 33 (16) | 5 (2) | 61 (11) | 7 (1) |
| Leucopenia | 24 (12) | 21 (10) | 65 (12) | 54 (10) |
| Pneumonia | 13 (6) | 9 (4) | 52 (9) | 28 (5) |
| Hyperglycemia | 8 (4) | 6 (3) | 20 (4) | 7 (1) |
| Sepsis | 6 (3) | 5 (2) | 10 (2) | 6 (1) |
| Hyponatremia | 5 (2) | 5 (2) | 10 (2) | 9 (2) |
| . | CAVALLI phase 2 (N = 206) . | GOYA IPI 2 to 5 (N = 564) . | ||
|---|---|---|---|---|
| Safety overview | ||||
| Any AE | 204 (99) | 528 (94) | ||
| Total number of AEs, n | 3345 | 4926 | ||
| AE with fatal outcome (grade 5) | 5 (2) | 30 (5) | ||
| SAE | 116 (56) | 230 (41) | ||
| Grade 3/4 AE | 178 (86) | 373 (66) | ||
| AE leading to withdrawal from any treatment | 50 (24) | 56 (10) | ||
| AE (MedDRA preferred term), n (%) | All grades | Grade 3/4 | All grades | Grade 3/4 |
| Neutropenia | 141 (68) | 141 (68) | 232 (41) | 219 (39) |
| Infections and infestations* | 130 (63) | 47 (23) | 260 (46) | 90 (16) |
| Nausea | 107 (52) | 7 (3) | 155 (27) | 2 (< 1) |
| Fatigue | 83 (40) | 6 (3) | 100 (18) | 11 (2) |
| Diarrhea | 80 (39) | 9 (4) | 79 (14) | 9 (2) |
| Anemia | 76 (37) | 50 (24) | 91 (16) | 50 (9) |
| Vomiting | 68 (33) | 7 (3) | 64 (11) | 2 (< 1) |
| Febrile neutropenia | 63 (31) | 63 (31) | 93 (16) | 92 (16) |
| Thrombocytopenia | 53 (26) | 45 (22) | 17 (3) | 9 (2) |
| Hypokalemia | 35 (17) | 8 (4) | 44 (8) | 14 (2) |
| Asthenia | 33 (16) | 5 (2) | 61 (11) | 7 (1) |
| Leucopenia | 24 (12) | 21 (10) | 65 (12) | 54 (10) |
| Pneumonia | 13 (6) | 9 (4) | 52 (9) | 28 (5) |
| Hyperglycemia | 8 (4) | 6 (3) | 20 (4) | 7 (1) |
| Sepsis | 6 (3) | 5 (2) | 10 (2) | 6 (1) |
| Hyponatremia | 5 (2) | 5 (2) | 10 (2) | 9 (2) |
Unless otherwise indicated, data are n (%).
MedDRA, Medical Dictionary for Regulatory Activities.
System organ class (all others are preferred terms).