Crizanlizumab Pregnancy Outcomes Intensive Monitoring

Adakveo® (Crizanlizumab) PRegnancy Outcomes Intensive Monitoring (PRIM)

This was a non-interventional study to evaluate pre-specified pregnancy and infant outcomes in women treated with crizanlizumab during pregnancy or within 105 days before the last menstrual period (LMP).

Inclusion Criteria:

All prospective and retrospective pregnancy cases exposed to crizanlizumab during pregnancy or 105 days before LMP reported to the Novartis global safety database were eligible for the PRIM program.

Exclusion Criteria:

Cases with the following exclusion criteria were excluded from the crizanlizumab PRIM study:

• Patients who upon initial case report refuse to be contacted to obtain any FU information. In such cases necessary information using PRIM follow-up checklists cannot be obtained.
• Indirect cases (reported by someone other than the patient or the healthcare provider (HCP)) for which the reporter refuses to provide FU information and the patient or HCP cannot be identified based on the information provided.
• Pregnancies of female partners of male patients taking crizanlizumab. Such cases were to be processed as per Manual for Argus Processing (MAP).
• Cases lacking reporter contact details (e.g., cases from social media) or incomplete cases in which data was missing to allow classification of pregnancy or infant outcomes.