Table 3.
Treatment-emergent AEs reported in ≥20% of patients in any arm in the overall population (safety population)
| Overall |
GCB |
Non-GCB |
||||
|---|---|---|---|---|---|---|
| TEAEa | Len n = 54 n (%) | IC n = 55 n (%) | Len n = 24 n (%) | IC n = 25 n (%) | Len n = 28 n (%) | IC n = 28 n (%) |
| Patients with ≥1 AE | 54 (100) | 55 (100) | 24 (100) | 25 (100) | 28 (100) | 28 (100) |
| General disorders and administration-site conditions | 40 (74.1) | 34 (61.8) | 20 (83.3) | 14 (56.0) | 18 (64.3) | 18 (64.3) |
| Fatigue | 18 (33.3) | 15 (27.3) | 10 (41.7) | 6 (24.0) | 7 (25.0) | 8 (28.6) |
| Pyrexia | 16 (29.6) | 16 (29.1) | 7 (29.2) | 6 (24.0) | 9 (32.1) | 9 (32.1) |
| Gastrointestinal disorders | 39 (72.2) | 37 (67.3) | 20 (83.3) | 14 (56.0) | 18 (64.3) | 21 (75.0) |
| Constipation | 16 (29.6) | 12 (21.8) | 9 (37.5) | 4 (16.0) | 7 (25.0) | 8 (28.6) |
| Diarrhea | 15 (27.8) | 12 (21.8) | 8 (33.3) | 5 (20.0) | 7 (25.0) | 6 (21.4) |
| Nausea | 10 (18.5) | 20 (36.4) | 5 (20.8) | 7 (28.0) | 4 (14.3) | 11 (39.3) |
| Blood and lymphatic system disorders | 34 (63.0) | 41 (74.5) | 14 (58.3) | 18 (72.0) | 19 (67.9) | 21 (75.0) |
| Neutropenia | 23 (42.6) | 20 (36.4) | 11 (45.8) | 10 (40.0) | 11 (39.3) | 10 (35.7) |
| Anemia | 18 (33.3) | 26 (47.3) | 6 (25.0) | 13 (52.0) | 12 (42.9) | 11 (39.3) |
| Thrombocytopenia | 13 (24.1) | 24 (43.6) | 4 (16.7) | 15 (60.0) | 9 (32.1) | 8 (28.6) |
| Respiratory, thoracic, and mediastinal disorders | 29 (53.7) | 22 (40.0) | 12 (50.0) | 10 (40.0) | 16 (57.1) | 10 (35.7) |
| Cough | 13 (24.1) | 6 (10.9) | 5 (20.8) | 5 (20.0) | 8 (28.6) | 0 (0.0) |
| Musculoskeletal and connective tissue disorders | 26 (48.1) | 20 (36.4) | 12 (50.0) | 10 (40.0) | 14 (50.0) | 10 (35.7) |
| Infections and infestations | 25 (46.3) | 32 (58.2) | 11 (45.8) | 12 (48.0) | 14 (50.0) | 18 (64.3) |
a
Safety population, defined as all randomized patients who received ≥1 dose of study treatment.