Incidence of adverse events related to treatment over the entire study period for all evaluable patients (n = 24)
| . | Maximum grade per patient per event (at least possibly related), n (%) . | ||||
|---|---|---|---|---|---|
| Grade 1 . | Grade 2 . | Grade 3 . | Grade 4 . | Grade 5 . | |
| Hematologic adverse events | |||||
| Anemia | 10 (42) | 8 (33) | 2 (8) | 0 | 0 |
| Lymphopenia | 0 | 4 (17) | 1 (4) | 1 (4) | 0 |
| Neutropenia | 3 (13) | 12 (50) | 3 (13) | 2 (8) | 0 |
| Thrombocytopenia | 8 (33) | 1 (4) | 1 (4) | 1 (4) | 0 |
| Leukopenia | 5 (21) | 5 (21) | 3 (13) | 2 (8) | 0 |
| Nonhematologic adverse events | |||||
| Endocrine disorders | |||||
| Hypothyroidism | 0 | 1 (4) | 0 | 0 | 0 |
| Eye disorders | |||||
| Eyelid function disorder | 0 | 1 (4) | 0 | 0 | 0 |
| Gastrointestinal disorders | |||||
| Constipation | 0 | 1 (4) | 0 | 0 | 0 |
| Diarrhea | 2 (8) | 0 | 0 | 0 | 0 |
| Dyspepsia | 0 | 1 (4) | 0 | 0 | 0 |
| Mucositis oral | 0 | 1 (4) | 0 | 0 | 0 |
| Nausea | 1 (4) | 0 | 0 | 0 | 0 |
| General and administration site disorders | |||||
| Fatigue | 1 (4) | 7 (29) | 2 (8) | 0 | 0 |
| Infections and infestations | |||||
| Bronchial infection | 0 | 2 (8) | 0 | 0 | 0 |
| Infections and infestations | 0 | 1 (4) | 0 | 0 | 0 |
| Lung infection | 0 | 2 (8) | 2 (8) | 1 (4) | 0 |
| Mucosal infection | 0 | 1 (4) | 0 | 0 | 0 |
| Sepsis | 0 | 0 | 0 | 1 (4) | 0 |
| Upper respiratory infection | 0 | 1 (4) | 0 | 0 | 0 |
| Investigations | |||||
| AST increased | 0 | 1 (4) | 0 | 0 | 0 |
| Blood bilirubin increased | 0 | 1 (4) | 0 | 0 | 0 |
| Metabolism and nutrition disorders | |||||
| Anorexia | 0 | 1 (4) | 0 | 0 | 0 |
| Hyperglycemia | 0 | 1 (4) | 0 | 0 | 0 |
| Hypocalcemia | 0 | 1 (4) | 0 | 0 | 0 |
| Hypophosphatemia | 0 | 1 (4) | 0 | 0 | 0 |
| Nervous system disorders | |||||
| Peripheral sensory neuropathy | 1 (4) | 1 (4) | 0 | 0 | 0 |
| Syncope | 0 | 0 | 1 (4) | 0 | 0 |
| Psychiatric disorders | |||||
| Delirium | 0 | 1 (4) | 0 | 0 | 0 |
| Respiratory, thoracic, mediastinal disorders | |||||
| Dyspnea | 0 | 0 | 1 (4) | 0 | 0 |
| Hypoxia | 0 | 0 | 1 (4) | 0 | 0 |
| Respiratory failure | 0 | 0 | 0 | 2 (8) | 0 |
| Skin and subcutaneous tissue disorders | |||||
| Photosensitivity | 0 | 1 (4) | 0 | 0 | 0 |
| Rash, maculopapular | 0 | 1 (4) | 1 (4) | 0 | 0 |
| Vascular disorders | |||||
| Thromboembolic event | 0 | 2 (8) | 0 | 0 | 0 |
| . | Maximum grade per patient per event (at least possibly related), n (%) . | ||||
|---|---|---|---|---|---|
| Grade 1 . | Grade 2 . | Grade 3 . | Grade 4 . | Grade 5 . | |
| Hematologic adverse events | |||||
| Anemia | 10 (42) | 8 (33) | 2 (8) | 0 | 0 |
| Lymphopenia | 0 | 4 (17) | 1 (4) | 1 (4) | 0 |
| Neutropenia | 3 (13) | 12 (50) | 3 (13) | 2 (8) | 0 |
| Thrombocytopenia | 8 (33) | 1 (4) | 1 (4) | 1 (4) | 0 |
| Leukopenia | 5 (21) | 5 (21) | 3 (13) | 2 (8) | 0 |
| Nonhematologic adverse events | |||||
| Endocrine disorders | |||||
| Hypothyroidism | 0 | 1 (4) | 0 | 0 | 0 |
| Eye disorders | |||||
| Eyelid function disorder | 0 | 1 (4) | 0 | 0 | 0 |
| Gastrointestinal disorders | |||||
| Constipation | 0 | 1 (4) | 0 | 0 | 0 |
| Diarrhea | 2 (8) | 0 | 0 | 0 | 0 |
| Dyspepsia | 0 | 1 (4) | 0 | 0 | 0 |
| Mucositis oral | 0 | 1 (4) | 0 | 0 | 0 |
| Nausea | 1 (4) | 0 | 0 | 0 | 0 |
| General and administration site disorders | |||||
| Fatigue | 1 (4) | 7 (29) | 2 (8) | 0 | 0 |
| Infections and infestations | |||||
| Bronchial infection | 0 | 2 (8) | 0 | 0 | 0 |
| Infections and infestations | 0 | 1 (4) | 0 | 0 | 0 |
| Lung infection | 0 | 2 (8) | 2 (8) | 1 (4) | 0 |
| Mucosal infection | 0 | 1 (4) | 0 | 0 | 0 |
| Sepsis | 0 | 0 | 0 | 1 (4) | 0 |
| Upper respiratory infection | 0 | 1 (4) | 0 | 0 | 0 |
| Investigations | |||||
| AST increased | 0 | 1 (4) | 0 | 0 | 0 |
| Blood bilirubin increased | 0 | 1 (4) | 0 | 0 | 0 |
| Metabolism and nutrition disorders | |||||
| Anorexia | 0 | 1 (4) | 0 | 0 | 0 |
| Hyperglycemia | 0 | 1 (4) | 0 | 0 | 0 |
| Hypocalcemia | 0 | 1 (4) | 0 | 0 | 0 |
| Hypophosphatemia | 0 | 1 (4) | 0 | 0 | 0 |
| Nervous system disorders | |||||
| Peripheral sensory neuropathy | 1 (4) | 1 (4) | 0 | 0 | 0 |
| Syncope | 0 | 0 | 1 (4) | 0 | 0 |
| Psychiatric disorders | |||||
| Delirium | 0 | 1 (4) | 0 | 0 | 0 |
| Respiratory, thoracic, mediastinal disorders | |||||
| Dyspnea | 0 | 0 | 1 (4) | 0 | 0 |
| Hypoxia | 0 | 0 | 1 (4) | 0 | 0 |
| Respiratory failure | 0 | 0 | 0 | 2 (8) | 0 |
| Skin and subcutaneous tissue disorders | |||||
| Photosensitivity | 0 | 1 (4) | 0 | 0 | 0 |
| Rash, maculopapular | 0 | 1 (4) | 1 (4) | 0 | 0 |
| Vascular disorders | |||||
| Thromboembolic event | 0 | 2 (8) | 0 | 0 | 0 |
One patient was lost to follow-up.