Evaluation of pregnancy and infant outcomes in Mayzent patients using PRegnancy outcomes Intensive Monitoring (PRIM) data – The Mayzent-PRIM study

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49696
• EU PAS number:
  EUPAS45875
• Study ID:
  49696
• Official title and acronym:
  Evaluation of pregnancy and infant outcomes in Mayzent patients using PRegnancy outcomes Intensive Monitoring (PRIM) data – The Mayzent-PRIM study
• DARWIN EU® study:
  No
• Study countries:
  Switzerland
• Study description:
  The Mayzent PRIM study is a secondary use of data, non-interventional study (NIS) based on Novartis’ pharmacovigilance (PV) system leveraging data collected via PRIM using a set of targeted checklists with structured follow-up on pregnancies spontaneously reported to the Novartis global safety database (Argus). Although pharmacovigilance data may be collected from any country in the world where the product is approved, the anonymized patient level data will be analyzed at a global level in Switzerland.
• Study status:
  Ongoing

Research institution and networks

Institutions

Novartis Pharmaceuticals

Study timelines

Date when funding contract was signed

Planned: 15/02/2019

Actual: 15/02/2019

Study start date

Planned: 25/03/2022

Actual: 25/03/2022

Data analysis start date

Planned: 25/03/2031

Date of interim report, if expected

Planned: 03/06/2023

Date of final study report

Planned: 03/06/2031

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis Pharmaceuticals

Study protocol

Initial protocol

BAF312A2411 protocol V1.0_Redacted

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

CBAF312A2411