There is no contraindication for the use of fezolinetant in women with a clinical history of deep vein thrombosis (DVT), pulmonary embolism (PE) or stroke/cerebrovascular accident (CVA), although the numbers of such individuals in the Phase 3 trial program were small (≤1%) and no subgroup analyses were performed
Table 1: Medical history of DVT / PE / CVA in SKYLIGHT 2 (52-week study period) in the safety analysis set (all participants who were randomized and received at least one dose of fezolinetant during either the 12-week double-blind or the 40-week active treatment extension periods)1
Preferred term | Fezolinetant 30 mg (n = 166) | Fezolinetant 45 mg (n = 167) | Placebo / Fezolinetant 30 mg (n = 76) | Placebo / Fezolinetant 45 mg (n = 75) |
---|---|---|---|---|
DVT | 0 | 1 (0.6%) | 0 | 0 |
Post procedural PE | 0 | 0 | 1 (1.3%) | 0 |
CVA | 0 | 0 | 1 (1.3%) | 1 (1.3%) |
Table 2: Medical history of DVT / PE / CVA in SKYLIGHT 4 in the safety analysis set (all randomized participants who took at least one dose of study intervention)1
Preferred term | Placebo (n = 610) | Fezolinetant 30 mg (n = 611) | Fezolinetant 45 mg (n = 609) |
---|---|---|---|
DVT | 3 (0.5%) | 2 (0.3%) | 3 (0.5%) |
DVT post operative | 0 | 0 | 1 (0.2%) |
PE | 1 (0.2%) | 1 (0.2%) | 4 (0.7%) |
CVA | 0 | 1 (0.2%) | 2 (0.3%) |
Data on file.
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