Table 4:
Treatment-emergent adverse events in the safety population
| Treatment-emergent adverse event of any grade in ≥20% of patients* | Treatment-emergent adverse event of grades 3 or 4 | |||
|---|---|---|---|---|
| Elotuzumab 10 mg/kg (n=36) | Elotuzumab 20 mg/kg (n=37) | Total (N=73) | Total (N=73) | |
| Any grade 3 or 4 | 32 (89%) | 25 (68%) | 57 (78%) | 57 (78%) |
| Blood and lymphatic system disorders | ||||
| Anaemia | 17 (47%) | 12 (32%) | 29 (40%) | 11 (15%) |
| Lymphopenia | 13 (36%) | 8 (22%) | 21 (29%) | 15 (21%) |
| Thrombocytopenia | 13 (36%) | 7 (19%) | 20 (27%) | 13 (18%) |
| Neutropenia | 11 (31%) | 8 (22%) | 19 (26%) | 14 (19%) |
| Leucopenia | 8 (22%) | 5 (14%) | 13 (18%) | 7 (10%) |
| Eye disorders | ||||
| Vision blurred | 9 (25%) | 3 (8%) | 12 (16%) | 0 |
| Gastrointestinal disorders | ||||
| Diarrhoea | 24 (67%) | 24 (65%) | 48 (66%) | 7 (10%) |
| Constipation | 18 (50%) | 19 (51%) | 37 (51%) | 0 |
| Nausea | 18 (50%) | 17 (46%) | 35 (48%) | 1 (1%) |
| Vomiting | 10 (28%) | 6 (16%) | 16 (22%) | 1 (1%) |
| Dyspepsia | 8 (22%) | 2 (5%) | 10 (14%) | 0 |
| General disorders and administration-site conditions | ||||
| Fatigue | 24 (67%) | 17 (46%) | 41 (56%) | 5 (7%) |
| Pyrexia | 14 (39%) | 17 (46%) | 31 (42%) | 2 (3%) |
| Peripheral oedema | 12 (33%) | 8 (22%) | 20 (27%) | 1 (1%) |
| Asthenia | 7 (19%) | 12 (32%) | 19 (26%) | 2 (3%) |
| Infections and infestations | ||||
| Upper respiratory tract infections | 19 (53%) | 15 (41%) | 34 (47%) | 2 (3%) |
| Nasopharyngitis | 10 (28%) | 9 (24%) | 19 (26%) | 0 |
| Bronchitis | 8 (22%) | 9 (24%) | 17 (23%) | 2 (3%) |
| Rhinitis | 5 (14%) | 8 (22%) | 13 (18%) | 0 |
| Influenza | 8 (22%) | 2 (5%) | 10 (14%) | 1 (%) |
| Metabolism and nutritional disorders | ||||
| Hyperglycaemia | 9 (25%) | 12 (32%) | 21 (29%) | 7 (10%) |
| Decreased appetite | 10 (28%) | 8 (22%) | 18 (25%) | 1 (1%) |
| Musculoskeletal and connective tissue disorders | ||||
| Muscle spasms | 22 (61%) | 23 (62%) | 45 (62%) | 2 (3%) |
| Back pain | 17 (47%) | 13 (35%) | 30 (41%) | 4 (5%) |
| Pain in extremity | 9 (25%) | 12 (32%) | 21 (29%) | 0 |
| Arthralgia | 10 (28%) | 8 (22%) | 18 (25%) | 1 (1%) |
| Bone pain | 4 (11%) | 8 (22%) | 12 (16%) | 2 (3%) |
| Nervous system disorders | ||||
| Dizziness | 11 (31%) | 7 (19%) | 18 (25%) | 0 |
| Headache | 13 (36%) | 5 (14%) | 18 (25%) | 1 (1%) |
| Dysgeusia | 9 (25%) | 6 (16%) | 15 (21%) | 0 |
| Peripheral neuropathy | 8 (22%) | 6 (16%) | 14 (19%) | 0 |
| Psychiatric disorders | ||||
| Insomnia | 10 (28%) | 15 (41%) | 25 (34%) | 2 (3%) |
| Respiratory and mediastinal disorders | ||||
| Cough | 12 (33%) | 12 (32%) | 24 (33%) | 0 |
| Dyspnoea | 10 (28%) | 10 (27%) | 20 (27%) | 4 (5%) |
| Dyspnoea, exertional | 9 (25%) | 5 (14%) | 14 (19%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Night sweats | 8 (22%) | 10 (27%) | 18 (25%) | 0 |
| Rash | 8 (22%) | 9 (24%) | 17 (23%) | 2 (3%) |
Data are n (%). Adverse events listed by preferred terms as defined in the Medical Dictionary for Regulatory Activities, version 16.1. 20% or more patients from either group experienced the adverse events listed in this table (this was not necessarily the case for both groups or overall).