TABLE 3.
Occurrence of common adverse drug reactions (with an incidence of ≥5%) 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 cases with ADR | 6 (100.0) | 6 (100.0) | 31 (88.6) | 43 (91.5) |
| Number of related SAE | 1 (16.7) | 2 (33.3) | 6 (17.1) | 9 (19.1) |
| Number of deaths related to study drug | 0 | 0 | 0 | 0 |
| Number of discontinuations due to ADR | 1 (16.7) | 0 | 1 (2.9) | 2 (4.3) |
| Number of dose reductions due to ADR | 2 (33.3) | 4 (66.7) | 11 (31.4) | 17 (36.2) |
| Number of dose interruptions due to ADR | 2 (33.3) | 1 (16.7) | 4 (11.4) | 7 (14.9) |
| Occurrence of ADR, SOC (PT) | ||||
| Blood and lymphatic system disorders | ||||
| Febrile neutropenia | 0 | 0 | 4 (11.4) | 4 (8.5) |
| Cardiac disorders | ||||
| Myocarditis | 1 (16.7) | 0 | 0 | 1 (2.1) |
| Supraventricular tachycardia | 0 | 1 (16.7) | 0 | 1 (2.1) |
| 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) | 0 | 4 (11.4) | 5 (10.6) |
| Musculoskeletal and connective tissue conditions | ||||
| Myalgia | 1 (16.7) | 0 | 0 | 1 (2.1) |
| Nervous system disorders | ||||
| Dysgeusia | 2 (33.3) | 0 | 0 | 2 (4.3) |
Data are presented as n (%).
ADR, adverse drug reaction; PT, preferred term; SOC, system organ class.
a
Rows that contain any event with a frequency of ≥5% are presented.