A Post-marketing Safety Study to Investigate the Risk of Serious CV Events among Galcanezumab (Emgality®) Users Using the Japan Medical Data Center Claim Database (I5Q-JE-B007)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/104467
• EU PAS number:
  EUPAS104412
• Study ID:
  104467
• Official title and acronym:
  A Post-marketing Safety Study to Investigate the Risk of Serious CV Events among Galcanezumab (Emgality®) Users Using the Japan Medical Data Center Claim Database (I5Q-JE-B007)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  The primary objective of this study is to describe the incidence rate of serious CV events among migraine patients treated with galcanezumab. This objective is descriptive and aims to describe the incidence and distribution of time to first serious CV events in adult patients treated with galcanezumab, overall, by age, gender, and treatment duration of galcanezumab.
• Study status:
  Planned

Research institution and networks

Institutions

Eli Lilly and Company

Study timelines

Date when funding contract was signed

Planned: 25/04/2023

Study start date

Planned: 01/04/2020

Date of final study report

Planned: 30/09/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly Japan K.K

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only