Table 1 Adverse events for patients enrolled on the phase 1 trial
Event term | Number of patients (%) N = 11ǂ | |||
|---|---|---|---|---|
Grade 3–5 AEs* regardless of attribution | 11 (100%) | |||
AEs leading to treatment discontinuation | 1 (9%) | |||
TRAEs** leading to death | 1 (9%) | |||
TRAEs at a frequency > 20% or any grade 3–5 | All | Grade 3 | Grade 4 | Grade 5 |
Respiratory disorder, infection | 1 (9%) | 0 | 0 | 1 (9%) |
Anemia | 10 (91%) | 10 (91%) | 0 | 0 |
Decreased platelet count | 8 (73%) | 3 (27%) | 2 (18%) | 0 |
Nausea | 8 (73%) | 1 (9%) | 0 | 0 |
Constipation | 7 (64%) | 0 | 0 | 0 |
Fatigue | 7 (64%) | 0 | 0 | 0 |
Decreased neutrophil count | 6 (55%) | 2 (18%) | 3 (27%) | 0 |
Decreased lymphocyte count | 6 (55%) | 0 | 5 (45%) | 0 |
Fever | 6 (55%) | 0 | 0 | 0 |
Hypoalbuminemia | 6 (55%) | 0 | 0 | 0 |
Hypertension | 5 (45%) | 3 (27%) | 0 | 0 |
Anorexia | 5 (45%) | 2 (18%) | 0 | 0 |
Dyspnea | 5 (45%) | 1 (9%) | 0 | 0 |
Decreased white cell count | 5 (45%) | 0 | 5 (45%) | 0 |
Cytokine release syndrome | 5 (45%) | 0 | 0 | 0 |
Diarrhea | 5 (45%) | 0 | 0 | 0 |
Vomiting | 5 (45%) | 0 | 0 | 0 |
Dysphagia | 4 (36%) | 2 (18%) | 0 | 0 |
Hypothyroidism | 4 (36%) | 0 | 0 | 0 |
Elevated alkaline phosphatase | 4 (36%) | 0 | 0 | 0 |
Elevated aspartate aminotransferase | 4 (36%) | 0 | 0 | 0 |
Hyperglycemia | 4 (36%) | 0 | 0 | 0 |
Hypophosphatemia | 4 (36%) | 0 | 0 | 0 |
Hypotension | 4 (36%) | 0 | 0 | 0 |
Febrile neutropenia | 3 (27%) | 3 (27%) | 0 | 0 |
Hypoxemia | 3 (27%) | 3 (27%) | 0 | 0 |
Dry mouth | 3 (27%) | 0 | 0 | 0 |
Hyponatremia | 3 (27%) | 0 | 0 | 0 |
Generalized pain | 3 (27%) | 0 | 0 | 0 |
Sinus tachycardia | 3 (27%) | 0 | 0 | 0 |
Cough | 3 (27%) | 0 | 0 | 0 |
Acute kidney injury | 2 (18%) | 1 (9%) | 0 | 0 |
Back pain | 1 (9%) | 1 (9%) | 0 | 0 |
Facial edema | 1 (9%) | 1 (9%) | 0 | 0 |
Oral mucositis | 1 (9%) | 1 (9%) | 0 | 0 |
Tumor bleeding | 1 (9%) | 1 (9%) | 0 | 0 |