Thromboembolic Events After Immunoglobulin Administration

Basic Details
Date Posted
Thursday, July 13, 2017
Status
Complete
Medical Product
intravenous immunoglobulin (IVIg)
Health Outcome(s)
acute myocardial infarction (AMI)
ischemic stroke
thromboembolic events (TEE)
venous thromboembolism (VTE)
Description

Project to assess the risk of thromboembolic events after immunoglobulin administration using a self-controlled risk interval design. Potential post intravenous immunoglobulin and thromboembolic event cases were identified in the Sentinel Distributed Database (SDD) and underwent medical record review. Protocol-based assessments use study designs and analysis plans customized for the product-outcome pairs being assessed.

The Mini-Sentinel Operations Center posted this protocol for public comment from September 20, 2013 through October 4, 2013. Revised versions were approved for implementation by FDA on April 22, 2014 and September 28, 2015. A log of changes is included in the revised protocol (v3.0).

Deliverables (2)
Sentinel Evaluation of the Risk of Thromboembolic Events After Immunoglobulin Administration Report Mini-Sentinel Thromboembolic Events After Immunoglobulin Administration Protocol
Additional Details
FDA Center
CBER
Time Period
2006 - 2012
Study Type
Protocol/Surveillance Plan
Assessment Type
Safety Analyses
HOI Study Type
Validations Supported by Traditional Medical Chart Review
Population / Cohort
All individuals who are immunoglobulin users
Data Sources
Sentinel Distributed Database (SDD)
Related Links
Chart Validation of Inpatient ICD-9-CM Administrative Diagnosis Codes for Ischemic Stroke Among IGIV Users in the Sentinel Distributed Database
Chart Validation of Inpatient ICD-9-CM Administrative Diagnosis Codes for Acute Myocardial Infarction (AMI) Among Intravenous Immune Globulin (IGIV) Users in the Sentinel Distributed Database
Chart Validation of Inpatient ICD-9-CM Administrative Diagnosis Codes for Venous Thromboembolism among Intravenous Immune Globulin Users in the Sentinel Distributed Database
Retrieving Medical Records Within FDA’s Sentinel Distributed Network: Lessons Learned During a Protocol-Based Assessment Involving 13 Data Partners
2017 ICPE Presentation: Protocol-Based Assessment of Thromboembolic Events (TEEs) after Intravenous Immune Globulin (IVIg) in the Sentinel Distributed Database (2006-2012)
2017 ICPE Presentation: Practical Lessons Learned for Identification of Thromboembolic Events and Intravenous Immunoglobulin Exposure in the Sentinel Distributed Database
Workgroup Leader(s)

Elizabeth A. Chrischilles, PhD, MS; Ryan M. Carnahan, PharmD, MS, BCPP; University of Iowa, College of Public Health, Iowa City, IA

Scott K. Winiecki, MD; Center for Biologics Evaluation and Research, FDA, Silver Spring, MD

Workgroup Members

Eric Ammann, MS; Jayasheel Eshcol, MD; Saket Girotra, MD, MS; Rami Kafa, MD; Enrique C. Leira, MD, MS; Usha Perepu, MBBS, MRCP; Jennifer G. Robinson, MD, MPH; Nicholas Rudzianski, BS; Marin L. Schweizer, PhD; James C. Torner, PhD; University of Iowa, College of Public Health, Iowa City, IA

Meghan A. Baker, MD, ScD; Carly A. Comins, BS; Casey Covarrubias, BA; Candace Fuller, PhD; Crystal Garcia, MPH; Madelyn Pimentel, BA; Darren Toh, ScD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Adam Cuker, MD, MS; Charles E. Leonard, PharmD, MSCE; Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA

Sudeepta Dandapat, MD; Nandakumar Nagaraja, MD, MS; Erin Rindels, MSN, RN, CNRN, SCRN, NVRN-BC; Department of Neurology, University of Iowa Carver College of Medicine, Iowa City, IA

Bruce Fireman, MA; Kaiser Permanente Northern California, Oakland, CA 

Joshua J. Gagne, PharmD, ScD; Brigham and Women's Hospital, Division of Pharmacoepidemiology, Boston, MA

Sherry Grund, RN; Adela Niedermann, RN; Lois Pedelty, RN; Victoria Polich, RN; Kim Price, RN, CCM; Telligen, West Des Moines, IA

Cole Haskins, BS; University of Iowa Medical Scientist Training Program, Iowa City, IA

David Martin, MD, MPH; Michael Nguyen, MD; Center for Biologics Evaluation and Research, FDA, Silver Spring, MD

Cynthia Nakasato, MD; Vinutha Vijayadeva, PhD, MBBS, MPH; Kaiser Permanente Hawaii, Honolulu, HI

Angela M. Overton, MSN, RN, CNRN, SCRN; University of Iowa Hospitals and Clinics, Iowa City, IA

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