Assessment of risk factors for Myocarditis in the United States (US) using Electronic Health Records and Claims data

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/104404
• EU PAS number:
  EUPAS104403
• Study ID:
  104404
• Official title and acronym:
  Assessment of risk factors for Myocarditis in the United States (US) using Electronic Health Records and Claims data
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study status:
  Ongoing

Research institutions and networks

Institutions

Pfizer

Optum

Germany

Study timelines

Date when funding contract was signed

Planned: 29/11/2022

Actual: 29/11/2022

Study start date

Planned: 26/05/2023

Actual: 19/01/2023

Date of final study report

Planned: 30/11/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

C4591055 NI study protocol_v1.0_11 May 2023_final

Updated protocol

C4591055 NI study protocol_v2.0_11 Jan 2025_clean.pdf

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable