Most common TEAEs (any grade, at least 10% incidence; grade 3 or higher, at least 3% incidence) by system organ class and severity in the all-treated population
| Any grade TEAE,∗ n (%) . | N = 117 . | ||
|---|---|---|---|
| Any grade . | Grade 2 . | Grade ≥3 . | |
| Skin and subcutaneous tissue disorders | 92 (78.6) | 29 (24.8) | 26 (22.2) |
| Maculopapular rash | 38 (32.5) | 12 (10.3) | 8 (6.8) |
| Rash | 31 (26.5) | 11 (9.4) | 3 (2.6) |
| Pruritus | 28 (23.9) | 6 (5.1) | 4 (3.4) |
| Erythema | 14 (12.0) | 1 (0.9) | 6 (5.1) |
| General disorders and administration site conditions | 84 (71.8) | 33 (28.2) | 9 (7.7) |
| Fatigue | 45 (38.5) | 19 (16.2) | 5 (4.3) |
| Pyrexia | 35 (29.9) | 7 (6.0) | 1 (0.9) |
| Peripheral edema | 14 (12.0) | 2 (1.7) | 1 (0.9) |
| Chills | 12 (10.3) | 2 (1.7) | 0 |
| Gastrointestinal disorders | 64 (54.7) | 24 (20.5) | 9 (7.7) |
| Nausea | 32 (27.4) | 8 (6.8) | 1 (0.9) |
| Constipation | 20 (17.1) | 5 (4.3) | 0 |
| Diarrhea | 19 (16.2) | 3 (2.6) | 3 (2.6) |
| Vomiting | 13 (11.1) | 6 (5.1) | 0 |
| Abdominal pain | 12 (10.3) | 8 (6.8) | 1 (0.9) |
| Investigations | 56 (47.9) | 18 (15.4) | 19 (16.2) |
| Increased GGT | 20 (17.1) | 9 (7.7) | 6 (5.1) |
| Increased ALT | 15 (12.8) | 2 (1.7) | 3 (2.6) |
| Increased AST | 14 (12.0) | 2 (1.7) | 1 (0.9) |
| Increased lipase | 9 (7.7) | 3 (2.6) | 5 (4.3) |
| Increased amylase | 9 (7.7) | 1 (0.9) | 4 (3.4) |
| Metabolism and nutrition disorders | 56 (47.9) | 8 (6.8) | 17 (14.5) |
| Hypophosphatemia | 21 (17.9) | 2 (1.7) | 9 (7.7) |
| Hyperglycemia | 14 (12.0) | 4 (3.4) | 4 (3.4) |
| Hypokalemia | 14 (12.0) | 4 (3.4) | 3 (2.6) |
| Decreased appetite | 12 (10.3) | 2 (1.7) | 0 |
| Nervous system disorders | 54 (46.2) | 11 (9.4) | 8 (6.8) |
| Headache | 19 (16.2) | 4 (3.4) | 0 |
| Dizziness | 12 (10.3) | 2 (1.7) | 0 |
| GBS | 4 (3.4) | 0 | 4 (3.4) |
| Blood and lymphatic system disorders | 51 (43.6) | 14 (12.0) | 32 (27.4) |
| Anemia | 29 (24.8) | 14 (12.0) | 10 (8.5) |
| Thrombocytopenia | 24 (20.5) | 3 (2.6) | 11 (9.4) |
| Neutropenia | 19 (16.2) | 8 (6.8) | 9 (7.7) |
| Lymphopenia | 18 (15.4) | 2 (1.7) | 12 (10.3) |
| Respiratory, thoracic, and mediastinal disorders | 39 (33.3) | 16 (13.7) | 5 (4.3) |
| Dyspnea | 16 (13.7) | 5 (4.3) | 3 (2.6) |
| Cough | 12 (10.3) | 3 (2.6) | 0 |
| Musculoskeletal and connective tissue disorders | 38 (32.5) | 12 (10.3) | 3 (2.6) |
| Arthralgia | 19 (16.2) | 8 (6.8) | 0 |
| Psychiatric disorders | 23 (19.7) | 11 (9.4) | 1 (0.9) |
| Insomnia | 16 (13.7) | 5 (4.3) | 1 (0.9) |
| Endocrine disorders | 22 (18.8) | 15 (12.8) | 0 |
| Hypothyroidism | 12 (10.3) | 7 (6.0) | 0 |
| Any grade TEAE,∗ n (%) . | N = 117 . | ||
|---|---|---|---|
| Any grade . | Grade 2 . | Grade ≥3 . | |
| Skin and subcutaneous tissue disorders | 92 (78.6) | 29 (24.8) | 26 (22.2) |
| Maculopapular rash | 38 (32.5) | 12 (10.3) | 8 (6.8) |
| Rash | 31 (26.5) | 11 (9.4) | 3 (2.6) |
| Pruritus | 28 (23.9) | 6 (5.1) | 4 (3.4) |
| Erythema | 14 (12.0) | 1 (0.9) | 6 (5.1) |
| General disorders and administration site conditions | 84 (71.8) | 33 (28.2) | 9 (7.7) |
| Fatigue | 45 (38.5) | 19 (16.2) | 5 (4.3) |
| Pyrexia | 35 (29.9) | 7 (6.0) | 1 (0.9) |
| Peripheral edema | 14 (12.0) | 2 (1.7) | 1 (0.9) |
| Chills | 12 (10.3) | 2 (1.7) | 0 |
| Gastrointestinal disorders | 64 (54.7) | 24 (20.5) | 9 (7.7) |
| Nausea | 32 (27.4) | 8 (6.8) | 1 (0.9) |
| Constipation | 20 (17.1) | 5 (4.3) | 0 |
| Diarrhea | 19 (16.2) | 3 (2.6) | 3 (2.6) |
| Vomiting | 13 (11.1) | 6 (5.1) | 0 |
| Abdominal pain | 12 (10.3) | 8 (6.8) | 1 (0.9) |
| Investigations | 56 (47.9) | 18 (15.4) | 19 (16.2) |
| Increased GGT | 20 (17.1) | 9 (7.7) | 6 (5.1) |
| Increased ALT | 15 (12.8) | 2 (1.7) | 3 (2.6) |
| Increased AST | 14 (12.0) | 2 (1.7) | 1 (0.9) |
| Increased lipase | 9 (7.7) | 3 (2.6) | 5 (4.3) |
| Increased amylase | 9 (7.7) | 1 (0.9) | 4 (3.4) |
| Metabolism and nutrition disorders | 56 (47.9) | 8 (6.8) | 17 (14.5) |
| Hypophosphatemia | 21 (17.9) | 2 (1.7) | 9 (7.7) |
| Hyperglycemia | 14 (12.0) | 4 (3.4) | 4 (3.4) |
| Hypokalemia | 14 (12.0) | 4 (3.4) | 3 (2.6) |
| Decreased appetite | 12 (10.3) | 2 (1.7) | 0 |
| Nervous system disorders | 54 (46.2) | 11 (9.4) | 8 (6.8) |
| Headache | 19 (16.2) | 4 (3.4) | 0 |
| Dizziness | 12 (10.3) | 2 (1.7) | 0 |
| GBS | 4 (3.4) | 0 | 4 (3.4) |
| Blood and lymphatic system disorders | 51 (43.6) | 14 (12.0) | 32 (27.4) |
| Anemia | 29 (24.8) | 14 (12.0) | 10 (8.5) |
| Thrombocytopenia | 24 (20.5) | 3 (2.6) | 11 (9.4) |
| Neutropenia | 19 (16.2) | 8 (6.8) | 9 (7.7) |
| Lymphopenia | 18 (15.4) | 2 (1.7) | 12 (10.3) |
| Respiratory, thoracic, and mediastinal disorders | 39 (33.3) | 16 (13.7) | 5 (4.3) |
| Dyspnea | 16 (13.7) | 5 (4.3) | 3 (2.6) |
| Cough | 12 (10.3) | 3 (2.6) | 0 |
| Musculoskeletal and connective tissue disorders | 38 (32.5) | 12 (10.3) | 3 (2.6) |
| Arthralgia | 19 (16.2) | 8 (6.8) | 0 |
| Psychiatric disorders | 23 (19.7) | 11 (9.4) | 1 (0.9) |
| Insomnia | 16 (13.7) | 5 (4.3) | 1 (0.9) |
| Endocrine disorders | 22 (18.8) | 15 (12.8) | 0 |
| Hypothyroidism | 12 (10.3) | 7 (6.0) | 0 |
AE, adverse event; ALT, alanine aminotransferase; AST aspartate aminotransferase; GBS, Guillain-Barré syndrome; GGT, gamma-glutamyl transferase; MedDRA, Medical Dictionary for Regulatory Activities; TEAE, treatment-emergent adverse event.
AEs coded using MedDRA version 22.0.