An Observational Post-Authorization Safety Study of Temodar® (Temozolomide) and Severe Acute Liver Injury in the HealthCore Integrated Research Environment (MK-7365-295)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/22860
• EU PAS number:
  EUPAS7622
• Study ID:
  22860
• Official title and acronym:
  An Observational Post-Authorization Safety Study of Temodar® (Temozolomide) and Severe Acute Liver Injury in the HealthCore Integrated Research Environment (MK-7365-295)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This is a is a retrospective case-control study nested within a cohort of patients (age 18-99 years) with malignant brain cancer using a healthcare claims database, augmented with information obtained from medical records, to assess the relation, if any, between temozolomide exposure and severe acute liver injury (SALI).
• Study status:
  Finalised

Research institutions and networks

Institutions

Merck & Co.

Study timelines

Date when funding contract was signed

Actual: 22/05/2014

Study start date

Actual: 24/09/2014

Data analysis start date

Planned: 02/11/2015

Actual: 26/10/2015

Date of final study report

Planned: 16/12/2015

Actual: 07/12/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme Corp.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)