Table 4.
Most common adverse drug reactions occurring in ≥ 1 participant in any subgroup according to frailty score in individuals treated with isatuximab plus pomalidomide and dexamethasone
| n (%) | Frail (n = 40) | Fit/intermediate (n = 29) | Missing frailty score (n = 51) |
|---|---|---|---|
| Any-grade ADR | 31 (77.5) | 19 (65.5) | 19 (37.3) |
| Neutrophil count decreased | 16 (40.0) | 6 (20.7) | 9 (17.7) |
| Neutropenia | 7 (17.5) | 1 (3.5) | 1 (2.0) |
| Anemia | 6 (15.0) | 4 (13.8) | 2 (3.9) |
| Platelet count decreased | 6 (15.0) | 4 (13.8) | 5 (9.8) |
| White blood cell count decreased | 4 (10.0) | 4 (13.8) | 1 (2.0) |
| Infusion-related reaction | 3 (7.5) | 1 (3.5) | 4 (7.8) |
| Febrile neutropenia | 2 (5.0) | 3 (10.3) | 1 (2.0) |
| Fever | 2 (5.0) | 0 | 0 |
| Pneumonia | 1 (2.5) | 1 (3.5) | 2 (3.9) |
| Hypertension | 0 | 0 | 2 (3.9) |
| Hypotension | 0 | 2 (6.9) | 0 |
| Hypoxia | 0 | 2 (6.9) | 0 |
| Oropharyngeal discomfort | 0 | 2 (6.9) | 1 (2.0) |
ADRs were coded according to the systems order class and preferred terms of the MedDRA-J
ADR, adverse drugs reaction; MedDRA-J, Medical Dictionary for Regulatory Activities, Japanese version