Table 3 TEAEsa of grade 3 or 4 occurring in ≥2% of patients in any treatment group (all cycles)
TEAE, n (%) | Schedule 1 (n = 20) | Schedule 2 (n = 38) | All patients (n = 58) | |||
|---|---|---|---|---|---|---|
Grade 3 | Grade 4 | Grade 3 | Grade 4 | Grade 3 | Grade 4 | |
Any | 9 (45.0) | 3 (15.0) | 9 (23.7) | 7 (18.4) | 18 (31.0) | 10 (17.2) |
Blood and lymphatic system disorders | ||||||
Febrile neutropenia | 0 | 1 (5.0) | 1 (2.6) | 1 (2.6) | 1 (1.7) | 2 (3.4) |
Neutropenia | 2 (10.0) | 0 | 3 (7.9) | 5 (13.2) | 5 (8.6) | 5 (8.6) |
Gastrointestinal disorders | ||||||
Ascites | 1 (5.0) | 0 | 0 | 0 | 1 (1.7) | 0 |
Nausea | 0 (0) | 0 (0) | 1 (2.6) | 0 | 1 (1.7) | 0 |
Stomatitis | 0 (0) | 0 (0) | 2 (5.3) | 0 | 2 (3.4) | 0 |
General disorders and administration-site conditions | ||||||
Device occlusion | 1 (5.0) | 0 | 0 | 0 | 1 (1.7) | 0 |
Pyrexia | 2 (10) | 0 (0) | 0 | 0 | 2 (3.4) | 0 |
Infections and infestations | ||||||
Neutropenic sepsis | 1 (5.0) | 0 | 1 (2.6) | 0 | 2 (3.4) | 0 |
Sepsis | 0 | 0 | 0 | 1 (2.6) | 0 | 1 (1.7) |
Upper respiratory tract infection | 0 | 0 | 2 (5.3) | 0 | 2 (3.4) | 0 |
Urinary tract infection | 0 | 0 | 2 (5.3) | 0 | 2 (3.4) | 0 |
Wound infection | 0 | 0 | 1 (2.6) | 0 | 1 (1.7) | 0 |
Metabolism and nutrition disorders | ||||||
Hypernatremia | 0 | 0 | 1 (2.6) | 0 | 1 (1.7) | 0 |
Hypomagnesemia | 0 | 0 | 1 (2.6) | 0 | 1 (1.7) | 0 |
Hypophosphatemia | 0 | 1 (5.0) | 3 (7.9) | 0 | 3 (5.2) | 1 (1.7) |
Musculoskeletal and connective tissue disorders | ||||||
Musculoskeletal chest pain | 2 (10.0) | 0 (0) | 1 (2.6) | 0 | 3 (5.2) | 0 |
Investigations | ||||||
Alanine aminotransferase level increased | 0 | 0 | 1 (2.6) | 0 | 1 (1.7) | 0 |
Respiratory, thoracic, and mediastinal disorders | ||||||
Pleuritic pain | 1 (5.0) | 0 | 0 | 0 | 1 (1.7) | 0 |
Pulmonary embolism | 1 (5.0) | 0 | 0 | 0 | 1 (1.7) | 0 |
