Summary of common TEAEs (≥10% total)
| System organ class/preferred term . | FL (n = 147) . | MZL (n = 82) . | DLBCL/MCL (n = 74) . | CLL/SLL (n = 43) . | Other (n = 25) . | Total (N = 371) . |
|---|---|---|---|---|---|---|
| Any TEAE | 144 (98.0) | 82 (100.0) | 72 (97.3) | 43 (100.0) | 25 (100.0) | 366 (98.7) |
| Gastrointestinal disorders | ||||||
| Diarrhea | 83 (56.5) | 50 (61.0) | 27 (36.5) | 24 (55.8) | 10 (40.0) | 194 (52.3) |
| Nausea | 62 (42.2) | 28 (34.1) | 33 (44.6) | 23 (53.5) | 8 (32.0) | 154 (41.5) |
| Vomiting | 35 (23.8) | 16 (19.5) | 19 (25.7) | 15 (34.9) | 1 (4.0) | 86 (23.2) |
| Constipation | 14 (9.5) | 7 (8.5) | 10 (13.5) | 6 (14.0) | 2 (8.0) | 39 (10.5) |
| Abdominal pain | 16 (10.9) | 8 (9.8) | 7 (9.5) | 6 (14.0) | 1 (4.0) | 38 (10.2) |
| General disorders and administration site conditions | ||||||
| Fatigue | 47 (32.0) | 26 (31.7) | 22 (29.7) | 16 (37.2) | 7 (28.0) | 118 (31.8) |
| Pyrexia | 14 (9.5) | 10 (12.2) | 10 (13.5) | 8 (18.6) | 5 (20.0) | 47 (12.7) |
| Edema peripheral | 14 (9.5) | 13 (15.9) | 7 (9.5) | 3 (7.0) | 2 (8.0) | 39 (10.5) |
| Nervous system disorders | ||||||
| Dizziness | 27 (18.4) | 13 (15.9) | 9 (12.2) | 12 (27.9) | 4 (16.0) | 65 (17.5) |
| Headache | 21 (14.3) | 19 (23.2) | 8 (10.8) | 8 (18.6) | 4 (16.0) | 60 (16.2) |
| Infections and infestations | ||||||
| Upper respiratory tract infection | 21 (14.3) | 11 (13.4) | 5 (6.8) | 8 (18.6) | 1 (4.0) | 46 (12.4) |
| Metabolism and nutrition disorders | ||||||
| Decreased appetite | 25 (17.0) | 18 (22.0) | 9 (12.2) | 7 (16.3) | 6 (24.0) | 65 (17.5) |
| Hypokalemia | 18 (12.2) | 7 (8.5) | 8 (10.8) | 2 (4.7) | 4 (16.0) | 39 (10.5) |
| Respiratory, thoracic, and mediastinal disorders | ||||||
| Cough | 25 (17.0) | 18 (22.0) | 7 (9.5) | 13 (30.2) | 9 (36.0) | 72 (19.4) |
| Investigations | ||||||
| ALT increased | 23 (15.6) | 20 (24.4) | 5 (6.8) | 5 (11.6) | 3 (12.0) | 56 (15.1) |
| AST increased | 18 (12.2) | 23 (28.0) | 6 (8.1) | 5 (11.6) | 3 (12.0) | 55 (14.8) |
| Blood creatinine increased | 17 (11.6) | 10 (12.2) | 7 (9.5) | 3 (7.0) | 2 (8.0) | 39 (10.5) |
| Blood and lymphatic system disorders | ||||||
| Neutropenia | 19 (12.9) | 11 (13.4) | 8 (10.8) | 12 (27.9) | 3 (12.0) | 53 (14.3) |
| Anemia | 13 (8.8) | 7 (8.5) | 10 (13.5) | 7 (16.3) | 4 (16.0) | 41 (11.1) |
| Psychiatric disorders | ||||||
| Insomnia | 21 (14.3) | 11 (13.4) | 5 (6.8) | 8 (18.6) | 2 (8.0) | 47 (12.7) |
| System organ class/preferred term . | FL (n = 147) . | MZL (n = 82) . | DLBCL/MCL (n = 74) . | CLL/SLL (n = 43) . | Other (n = 25) . | Total (N = 371) . |
|---|---|---|---|---|---|---|
| Any TEAE | 144 (98.0) | 82 (100.0) | 72 (97.3) | 43 (100.0) | 25 (100.0) | 366 (98.7) |
| Gastrointestinal disorders | ||||||
| Diarrhea | 83 (56.5) | 50 (61.0) | 27 (36.5) | 24 (55.8) | 10 (40.0) | 194 (52.3) |
| Nausea | 62 (42.2) | 28 (34.1) | 33 (44.6) | 23 (53.5) | 8 (32.0) | 154 (41.5) |
| Vomiting | 35 (23.8) | 16 (19.5) | 19 (25.7) | 15 (34.9) | 1 (4.0) | 86 (23.2) |
| Constipation | 14 (9.5) | 7 (8.5) | 10 (13.5) | 6 (14.0) | 2 (8.0) | 39 (10.5) |
| Abdominal pain | 16 (10.9) | 8 (9.8) | 7 (9.5) | 6 (14.0) | 1 (4.0) | 38 (10.2) |
| General disorders and administration site conditions | ||||||
| Fatigue | 47 (32.0) | 26 (31.7) | 22 (29.7) | 16 (37.2) | 7 (28.0) | 118 (31.8) |
| Pyrexia | 14 (9.5) | 10 (12.2) | 10 (13.5) | 8 (18.6) | 5 (20.0) | 47 (12.7) |
| Edema peripheral | 14 (9.5) | 13 (15.9) | 7 (9.5) | 3 (7.0) | 2 (8.0) | 39 (10.5) |
| Nervous system disorders | ||||||
| Dizziness | 27 (18.4) | 13 (15.9) | 9 (12.2) | 12 (27.9) | 4 (16.0) | 65 (17.5) |
| Headache | 21 (14.3) | 19 (23.2) | 8 (10.8) | 8 (18.6) | 4 (16.0) | 60 (16.2) |
| Infections and infestations | ||||||
| Upper respiratory tract infection | 21 (14.3) | 11 (13.4) | 5 (6.8) | 8 (18.6) | 1 (4.0) | 46 (12.4) |
| Metabolism and nutrition disorders | ||||||
| Decreased appetite | 25 (17.0) | 18 (22.0) | 9 (12.2) | 7 (16.3) | 6 (24.0) | 65 (17.5) |
| Hypokalemia | 18 (12.2) | 7 (8.5) | 8 (10.8) | 2 (4.7) | 4 (16.0) | 39 (10.5) |
| Respiratory, thoracic, and mediastinal disorders | ||||||
| Cough | 25 (17.0) | 18 (22.0) | 7 (9.5) | 13 (30.2) | 9 (36.0) | 72 (19.4) |
| Investigations | ||||||
| ALT increased | 23 (15.6) | 20 (24.4) | 5 (6.8) | 5 (11.6) | 3 (12.0) | 56 (15.1) |
| AST increased | 18 (12.2) | 23 (28.0) | 6 (8.1) | 5 (11.6) | 3 (12.0) | 55 (14.8) |
| Blood creatinine increased | 17 (11.6) | 10 (12.2) | 7 (9.5) | 3 (7.0) | 2 (8.0) | 39 (10.5) |
| Blood and lymphatic system disorders | ||||||
| Neutropenia | 19 (12.9) | 11 (13.4) | 8 (10.8) | 12 (27.9) | 3 (12.0) | 53 (14.3) |
| Anemia | 13 (8.8) | 7 (8.5) | 10 (13.5) | 7 (16.3) | 4 (16.0) | 41 (11.1) |
| Psychiatric disorders | ||||||
| Insomnia | 21 (14.3) | 11 (13.4) | 5 (6.8) | 8 (18.6) | 2 (8.0) | 47 (12.7) |
Data are expressed as n (%). TEAE sorting is done by decreasing frequency of system organ class and preferred term based on the total column. MCL, mantle cell lymphoma.