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.