TABLE 2.
Occurrence of common adverse events (with an incidence of ≥20%) a overall and by study cohort
| Phase 1 | Phase 2 (N = 35) | Total (N = 47) | ||
|---|---|---|---|---|
| Cohort 1 (N = 6) | Cohort 2 (N = 6) | |||
| Number of evaluable cases | 6 | 6 | 35 | 47 |
| Number of cases with AE | 6 (100.0) | 6 (100.0) | 35 (100.0) | 47 (100.0) |
| Occurrence of AE, SOC (PT) | ||||
| Blood and lymphatic system disorders | ||||
| Febrile neutropenia | 0 | 0 | 8 (22.9) | 8 (17.0) |
| Gastrointestinal disorders | ||||
| Nausea | 0 | ─ | ─ | ─ |
| Stomatitis | 2 (33.3) | 0 | 4 (11.4) | 6 (12.8) |
| General disorders and administration site conditions | ||||
| Injection‐site reaction | 6 (100.0) | 6 (100.0) | 31 (88.6) | 43 (91.5) |
| Pyrexia | 1 (16.7) | 1 (16.7) | 12 (34.3) | 14 (29.8) |
| Edema | 0 | 2 (33.3) | 1 (2.9) | 3 (6.4) |
| Infections and infestations | ||||
| Pharyngitis | 2 (33.3) | 0 | 1 (2.9) | 3 (6.4) |
| Sepsis | 0 | 2 (33.3) | 0 | 2 (4.3) |
| Injury, poisoning, and procedural complications | ||||
| Contusion | 0 | 2 (33.3) | 1 (2.9) | 3 (6.4) |
| Metabolism and nutrition disorders | ||||
| Iron overload | 1 (16.7) | 3 (50.0) | 6 (17.1) | 10 (21.3) |
| Nervous system disorders | ||||
| Dysgeusia | 2 (33.3) | 1 (16.7) | 1 (2.9) | 4 (8.5) |
| Skin and subcutaneous tissue disorders | ||||
| Rash | 2 (33.3) | 1 (16.7) | 1 (2.9) | 4 (8.5) |
| Asteatosis | 0 | 2 (33.3) | 2 (5.7) | 4 (8.5) |
Data are presented as n (%).
AE, adverse event; PT, preferred term; SAE, serious adverse event; SOC, system organ class.
a
Rows that contain any event with a frequency of ≥20% are presented.