Table 5:
Grade 3 or 4 treatment-emergent adverse events reported before and after 24 months of study drug in the safety population
≤24 months of elotuzumab* | >24 months of elotuzumab* | |||||
---|---|---|---|---|---|---|
10 mg/kg (n=36) | 20 mg/kg (n=37) | All (N=73) | 10 mg/kg (n=17) | 20 mg/kg (n=13) | All (N=30) | |
≥one grade 3 or 4 event | 31 (86%) | 25 (68%) | 56 (77%) | 14 (82%) | 4 (31%) | 18 (60%) |
Lymphopenia | 9 (25%) | 5 (14%) | 14 (19%) | 1 (6%) | 0 | 1 (3%) |
Neutropenia | 6 (17%) | 7 (19%) | 13 (18%) | 2 (12%) | 0 | 2 (7%) |
Thrombocytopenia | 6 (17%) | 6 (16%) | 12 (16%) | 1 (6%) | 0 | 1 (3%) |
Anaemia | 4 (11%) | 5 (14%) | 9 (12%) | 2 (12%) | 0 | 2 (7%) |
Hyperglycaemia | 2 (6%) | 5 (14%) | 7 (10%) | 0 | 0 | 0 |
Leucopenia | 3 (8%) | 4 (11%) | 7 (10%) | 1 (6%) | 0 | 1 (3%) |
Diarrhoea | 3 (8%) | 2 (5%) | 5 (7%) | 3 (18%) | 0 | 3 (10%) |
Fatigue | 3 (8%) | 2 (5%) | 5 (7%) | 1 (6%) | 0 | 1 (3%) |
Pneumonia | 3 (8%) | 2 (5%) | 5 (7%) | 0 | 2 (15%) | 2 (7%) |
Hypokalaemia | 3 (8%) | 1 (3%) | 4 (5%) | 1 (6%) | 0 | 1 (3%) |
Back pain | 2 (6%) | 1 (3%) | 3 (4%) | 1 (6%) | 0 | 1 (3%) |
Syncope | 2 (7%) | 0 | 2 (3%) | 2 (12%) | 0 | 2 (7%) |
Dyspnoea | 1 (3%) | 1 (3%) | 2 (3%) | 2 (12%) | 0 | 2 (7%) |
Data are number (%). Adverse events listed by preferred terms as defined in the Medical Dictionary for Regulatory Activities, version 16.1.
Sample sizes used as denominator for percentages.