Risk factors for cardiac events in carfilzomib-treated patients in the Marketscan database (20160186)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/19462
• EU PAS number:
  EUPAS13518
• Study ID:
  19462
• Official title and acronym:
  Risk factors for cardiac events in carfilzomib-treated patients in the Marketscan database (20160186)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Descriptive analysis comparing the characteristics of carfilzomib-treated patients who do and do not have claims for a defined cardiac event in the Marketscan administrative claims database. Exploratory objectives will compare incidence of defined cardiac events in carfilzomib-treated patients to multiple myeloma patients not treated with carfilzomib
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned: 31/05/2016

Actual: 31/05/2016

Study start date

Planned: 31/05/2016

Actual: 31/05/2016

Data analysis start date

Planned: 31/05/2016

Actual: 15/06/2016

Date of final study report

Planned: 15/06/2017

Actual: 08/06/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

Protocol for Marketscan CVD Events MM _05022016_final

Regulatory

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