Mavacamten Pregnancy Surveillance Program
Bristol-Myers Squibb
Summary
The purpose of this observational pregnancy safety study is to assess maternal, fetal, and infant outcomes after exposure to mavacamten at any time during pregnancy and/or breastfeeding.
Eligibility
- Age range
- 15+ years
- Sex
- Female
- Healthy volunteers
- Not specified
Inclusion Criteria: * Exposure to at least 1 dose of mavacamten at any time during pregnancy (from 4 months prior to conception to pregnancy outcome) and/or at any time during breastfeeding (up to 12 months of infant age or weaning, whichever comes first) * At least 15 years of age or older at the time of enrollment * Informed consent or institutional review board/ethics committee-approved waiver of informed consent Exclusion Criteria: \- None
Interventions
- DrugMavacamten
Observational study of individuals exposed to at least 1 dose of mavacamten at any time during pregnancy and/or breastfeeding
Location
- The Mavacamten Pregnancy Surveillance Program, PPD IncWilmington, North Carolina