Antipsychotics and Stroke (PSM)

Project Title Antipsychotics and Stroke (PSM)
Date Posted
Thursday, November 2, 2017
Project ID
cder_mpl2p_wp004
Status
Complete
Deliverables
Related Links
Description

This request investigated the association between new typical antipsychotic use and stroke, with new atypical antipsychotic use as the comparison exposure. Data from January 1, 2001 to September 30, 2015 from 13 Data Partners contributing to the Sentinel Distributed Database (SSD) were included in this report. This request was distributed to Data Partners on March 10, 2017.

  • Report 1 (primary analysis): New typical antipsychotic use and stroke, with new atypical antipsychotic use as the comparison exposure
  • Report 2: New typical antipsychotic use and stroke, with new atypical antipsychotic use as the comparison exposure, using a risk window of 1 day to 15 days following exposure initiation
  • Report 3: New typical antipsychotic use and stroke, with new atypical antipsychotic use as the comparison exposure, using a risk window of 16 to 90 days following exposure initiation
  • Report 4: New haloperidol use and stroke, with new atypical antipsychotic use as the comparison exposure
Medical Product
antipsychotic
Health Outcome
stroke
Population / Cohort
All individuals 18 to 64 years of age
Time Period
January 1, 2001 - September 30, 2015
Assessment Type
Exploratory Analyses
Study Type
Modular Program
Data Sources
Sentinel Distributed Database (SSD)
FDA Center
CDER