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. Author manuscript; available in PMC: 2019 Nov 21.
Published in final edited form as: Lancet Haematol. 2015 Nov 16;2(12):e516–e527. doi: 10.1016/S2352-3026(15)00197-0

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.