Table 2.
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 |
One patient was lost to follow-up.