Estimating Event Rates Using the Medication Cohort Module: Hypertension and Negative Control Outcomes in New Users of Onabotulinumtoxin A and Monoclonal Antibodies Targeting the Calcitonin-Gene-Related Pathway in the Marketscan EarlyView Claims Database (20200218)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/40208
• EU PAS number:
  EUPAS34832
• Study ID:
  40208
• Official title and acronym:
  Estimating Event Rates Using the Medication Cohort Module: Hypertension and Negative Control Outcomes in New Users of Onabotulinumtoxin A and Monoclonal Antibodies Targeting the Calcitonin-Gene-Related Pathway in the Marketscan EarlyView Claims Database (20200218)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This retrospective observational study will estimate event rates in migraine patients in four medication cohorts in an administrative claims database: new users of erenumab-aooe, new users of fremanezumab-vfrm, new users of galcanezumab-gnlm, and new users of onabotulinumtoxin A. The outcomes of interest include any hypertension, serious hypertension, hypertensive crisis, road traffic accidents, falls, and influenza vaccination.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned: 17/04/2020

Actual: 17/04/2020

Study start date

Planned: 24/04/2020

Actual: 24/04/2020

Data analysis start date

Planned: 24/04/2020

Actual: 24/04/2020

Date of final study report

Planned: 24/04/2021

Actual: 19/03/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

01.02.06 Public Redacted Protocol Ver 1.0 2020-04-15 English

Regulatory

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