Table IV.
Safety in cytogenetic subgroups.
| High‐risk | Standard‐risk | |||
|---|---|---|---|---|
| Isa‐Pd (n = 23) | Pd (n = 34) | Isa‐Pd (n = 103) | Pd (n = 76) | |
| Median duration of treatment exposure, wk (range) | 32·0 (1·3–60·1) | 18·0 (1·0–56·0) | 42·0 (4·0–76·7) | 31·3 (2·0–69·0) |
| Any TEAE | 23 (100) | 32 (94·1) | 102 (99·0) | 75 (98·7) |
| Grade ≥3 TEAE | 22 (95·7) | 23 (67·6) | 88 (85·4) | 58 (76·3) |
| Serious TEAE | 17 (73·9) | 17 (50·0) | 60 (58·3) | 47 (61·8) |
| TEAE leading to definitive discontinuation | 2 (8·7) | 8 (23·5) | 7 (6·8) | 6 (7·9) |
| Death due to adverse event | 1 (4·3) | 3 (8·8) | 1 (1·0) | 1 (1·3) |
| Treatment‐related | – | 1 (2·9) | – | 1 (1·3) |
| Grade ≥3 events in >5% of patients with Isa‐Pd in either subgroup, n (%) | ||||
| Laboratory abnormalities | ||||
| Neutropenia | 19 (82·6) | 25 (75·8)* | 88 (85·4) | 53 (69·7) |
| Thrombocytopenia | 11 (47·8) | 9 (27·3)* | 27 (26·2) | 19 (25·0) |
| TEAEs | ||||
| Febrile neutropenia | 3 (13·0) | 0 | 12 (11·7) | 2 (2·6) |
| Pneumonia | 5 (21·7) | 6 (17·6) | 16 (15·5) | 14 (18·4) |
| Influenzal pneumonia | 2 (8·7) | 0 | 0 | 2 (2·6) |
| Urinary tract infection | 2 (8·7) | 1 (2·9) | 4 (3·9) | 1 (1·3) |
| Lower respiratory tract infection | 2 (8·7) | 0 | 3 (2·9) | 4 (5·3) |
| Asthenia | 2 (8·7) | 1 (2·9) | 2 (1·9) | 3 (3·9) |
| Fatigue | 2 (8·7) | 0 | 3 (2·9) | 0 |
| Infusion reaction | 2 (8·7) | 0 | 1 (1·0) | 0 |
| Pulmonary embolism | 2 (8·7) | 0 | 1 (1·0) | 3 (3·9) |
| Vomiting | 2 (8·7) | 0 | 0 | 0 |
d, dexamethasone; Isa, isatuximab; P, pomalidomide; TEAE, treatment‐emergent adverse event.
*
n = 33.