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Adherence to Absolute Neutrophil Count (ANC) Monitoring Recommendations Following Clozapine Use: First Descriptive Analysis

Basic Details
Date Posted
Status
Complete
Medical Product
clozapine
Health Outcome(s)
adherence to absolute neutrophil count (ANC) monitoring
Description

This analysis examined adherence to FDA's Risk Evaluation and Mitigation Strategy (REMS) absolute neutrophil count (ANC) monitoring recommendations among clozapine users in the Sentinel Distributed Database (SDD).

The study period includes data from January 1, 2005 to December 31, 2020. We distributed this request to seven Sentinel Data Partners on June 7, 2021.

Deliverables (1)
Sentinel Modular Program Report: Adherence to Absolute Neutrophil Count (ANC) Monitoring Recommendations Following Clozapine Use: First Descriptive Analysis
Additional Details
FDA Center
CDER
Time Period
January 1, 2005 – December 31, 2020
Analysis Type
Descriptive
Population / Cohort
Individuals 12 years of age and older
Data Sources
Sentinel Distributed Database (SDD)
Related Links
Sentinel Drug Study: Clozapine & Adherence to Absolute Neutrophil Count (ANC) Monitoring and Neutropenia