All-grade TEAEs reported in ≥10% of patients with B-NHL who received loncastuximab tesirine in order of incidence by system order class (safety analysis set)
| TEAE . | n (%) . | ||||
|---|---|---|---|---|---|
| ≤90 µg/kg (n = 17) . | 120 µg/kg (n = 42) . | 150 µg/kg (n = 88) . | 200 µg/kg (n = 36) . | Total (N = 183) . | |
| Any | 16 (94.1) | 42 (100) | 87 (98.9) | 36 (100) | 181 (98.9) |
| Hematologic | |||||
| Platelet count decreased* | 11 (64.7) | 28 (68.3) | 62 (71.3) | 27 (77.1) | 128 (71.1) |
| Neutrophil count decreased* | 10 (58.8) | 21 (51.2) | 50 (58.1) | 25 (71.4) | 106 (59.2) |
| Anemia | 4 (23.5) | 10 (23.8) | 32 (36.4) | 14 (38.9) | 60 (32.8) |
| WBC count decreased | 0 | 7 (16.7) | 6 (6.8) | 9 (25.0) | 22 (12.0) |
| Nonhematologic | |||||
| General disorders and administration site conditions | |||||
| Fatigue | 7 (41.2) | 22 (52.4) | 33 (37.5) | 16 (44.4) | 78 (42.6) |
| Edema peripheral | 1 (5.9) | 12 (28.6) | 31 (35.2) | 14 (38.9) | 58 (31.7) |
| Pyrexia | 2 (11.8) | 7 (16.7) | 13 (14.8) | 11 (30.6) | 33 (18.0) |
| Gastrointestinal disorders | |||||
| Nausea | 3 (17.6) | 12 (28.6) | 28 (31.8) | 16 (44.4) | 59 (32.2) |
| Constipation | 2 (11.8) | 12 (28.6) | 20 (22.7) | 6 (16.7) | 40 (21.9) |
| Vomiting | 1 (5.9) | 7 (16.7) | 17 (19.3) | 7 (19.4) | 32 (17.5) |
| Abdominal pain | 1 (5.9) | 9 (21.4) | 12 (13.6) | 7 (19.4) | 29 (15.8) |
| Diarrhea | 2 (11.8) | 5 (11.9) | 16 (18.2) | 5 (13.9) | 28 (15.3) |
| Investigations | |||||
| GGT increased | 5 (29.4) | 13 (31.0) | 22 (25.0) | 17 (47.2) | 57 (31.1) |
| Blood ALP increased | 4 (23.5) | 6 (14.3) | 18 (20.5) | 9 (25.0) | 37 (20.2) |
| AST increased | 3 (17.6) | 5 (11.9) | 15 (17.0) | 11 (30.6) | 34 (18.6) |
| ALT increased | 3 (17.6) | 6 (14.3) | 14 (15.9) | 9 (25.0) | 32 (17.5) |
| Skin and subcutaneous tissue disorders | |||||
| Rash | 2 (11.8) | 7 (16.7) | 27 (30.7) | 9 (25.0) | 45 (24.6) |
| Erythema | 1 (5.9) | 5 (11.9) | 11 (12.5) | 4 (11.1) | 21 (11.5) |
| Pruritus | 2 (11.8) | 4 (9.5) | 7 (8.0) | 7 (19.4) | 20 (10.9) |
| Rash maculopapular | 3 (17.6) | 4 (9.5) | 7 (8.0) | 5 (13.9) | 19 (10.4) |
| Metabolism and nutrition disorders | |||||
| Decreased appetite | 2 (11.8) | 7 (16.7) | 13 (14.8) | 12 (33.3) | 34 (18.6) |
| Hypokalemia | 1 (5.9) | 3 (7.1) | 15 (17.0) | 4 (11.1) | 23 (12.6) |
| Hyperglycemia | 1 (5.9) | 3 (7.1) | 10 (11.4) | 5 (13.9) | 19 (10.4) |
| Respiratory, thoracic, and mediastinal disorders | |||||
| Dyspnea | 1 (5.9) | 11 (26.2) | 21 (23.9) | 8 (22.2) | 41 (22.4) |
| Pleural effusion | 2 (11.8) | 10 (23.8) | 19 (21.6) | 8 (22.2) | 39 (21.3) |
| Cough | 0 | 10 (23.8) | 16 (18.2) | 8 (22.2) | 34 (18.6) |
| Nervous system disorders | |||||
| Dizziness | 1 (5.9) | 6 (14.3) | 9 (10.2) | 4 (11.1) | 20 (10.9) |
| TEAE . | n (%) . | ||||
|---|---|---|---|---|---|
| ≤90 µg/kg (n = 17) . | 120 µg/kg (n = 42) . | 150 µg/kg (n = 88) . | 200 µg/kg (n = 36) . | Total (N = 183) . | |
| Any | 16 (94.1) | 42 (100) | 87 (98.9) | 36 (100) | 181 (98.9) |
| Hematologic | |||||
| Platelet count decreased* | 11 (64.7) | 28 (68.3) | 62 (71.3) | 27 (77.1) | 128 (71.1) |
| Neutrophil count decreased* | 10 (58.8) | 21 (51.2) | 50 (58.1) | 25 (71.4) | 106 (59.2) |
| Anemia | 4 (23.5) | 10 (23.8) | 32 (36.4) | 14 (38.9) | 60 (32.8) |
| WBC count decreased | 0 | 7 (16.7) | 6 (6.8) | 9 (25.0) | 22 (12.0) |
| Nonhematologic | |||||
| General disorders and administration site conditions | |||||
| Fatigue | 7 (41.2) | 22 (52.4) | 33 (37.5) | 16 (44.4) | 78 (42.6) |
| Edema peripheral | 1 (5.9) | 12 (28.6) | 31 (35.2) | 14 (38.9) | 58 (31.7) |
| Pyrexia | 2 (11.8) | 7 (16.7) | 13 (14.8) | 11 (30.6) | 33 (18.0) |
| Gastrointestinal disorders | |||||
| Nausea | 3 (17.6) | 12 (28.6) | 28 (31.8) | 16 (44.4) | 59 (32.2) |
| Constipation | 2 (11.8) | 12 (28.6) | 20 (22.7) | 6 (16.7) | 40 (21.9) |
| Vomiting | 1 (5.9) | 7 (16.7) | 17 (19.3) | 7 (19.4) | 32 (17.5) |
| Abdominal pain | 1 (5.9) | 9 (21.4) | 12 (13.6) | 7 (19.4) | 29 (15.8) |
| Diarrhea | 2 (11.8) | 5 (11.9) | 16 (18.2) | 5 (13.9) | 28 (15.3) |
| Investigations | |||||
| GGT increased | 5 (29.4) | 13 (31.0) | 22 (25.0) | 17 (47.2) | 57 (31.1) |
| Blood ALP increased | 4 (23.5) | 6 (14.3) | 18 (20.5) | 9 (25.0) | 37 (20.2) |
| AST increased | 3 (17.6) | 5 (11.9) | 15 (17.0) | 11 (30.6) | 34 (18.6) |
| ALT increased | 3 (17.6) | 6 (14.3) | 14 (15.9) | 9 (25.0) | 32 (17.5) |
| Skin and subcutaneous tissue disorders | |||||
| Rash | 2 (11.8) | 7 (16.7) | 27 (30.7) | 9 (25.0) | 45 (24.6) |
| Erythema | 1 (5.9) | 5 (11.9) | 11 (12.5) | 4 (11.1) | 21 (11.5) |
| Pruritus | 2 (11.8) | 4 (9.5) | 7 (8.0) | 7 (19.4) | 20 (10.9) |
| Rash maculopapular | 3 (17.6) | 4 (9.5) | 7 (8.0) | 5 (13.9) | 19 (10.4) |
| Metabolism and nutrition disorders | |||||
| Decreased appetite | 2 (11.8) | 7 (16.7) | 13 (14.8) | 12 (33.3) | 34 (18.6) |
| Hypokalemia | 1 (5.9) | 3 (7.1) | 15 (17.0) | 4 (11.1) | 23 (12.6) |
| Hyperglycemia | 1 (5.9) | 3 (7.1) | 10 (11.4) | 5 (13.9) | 19 (10.4) |
| Respiratory, thoracic, and mediastinal disorders | |||||
| Dyspnea | 1 (5.9) | 11 (26.2) | 21 (23.9) | 8 (22.2) | 41 (22.4) |
| Pleural effusion | 2 (11.8) | 10 (23.8) | 19 (21.6) | 8 (22.2) | 39 (21.3) |
| Cough | 0 | 10 (23.8) | 16 (18.2) | 8 (22.2) | 34 (18.6) |
| Nervous system disorders | |||||
| Dizziness | 1 (5.9) | 6 (14.3) | 9 (10.2) | 4 (11.1) | 20 (10.9) |
ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; GGT, γ-glutamyltransferase.
Platelet count decreased and neutrophil count decreased are based on laboratory abnormality reporting and are reported out of number of patients with postbaseline test values; data for 4 patients (1 at 120 µg/kg, 2 at 150 µg/kg, and 1 at 200 µg/kg) were missing for neutrophil count decreased, and data for 3 patients (1 each at 120, 150, and 200 µg/kg) were missing for platelet count decreased.