| Project Title | Thromboembolic Events After Immunoglobulin Administration |
| Date Posted | Thursday, July 13, 2017 |
| Status | Complete |
| Deliverables | |
| Related Links | |
| 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). |
| Medical Product | intravenous immunoglobulin (IVIg) |
| Health Outcome | acute myocardial infarction (AMI) ischemic stroke thromboembolic events (TEE) venous thromboembolism (VTE) |
| Population / Cohort | All individuals who are immunoglobulin users |
| Time Period | 2006 - 2012 |
| Assessment Type | Safety Analyses |
| Study Type | Protocol/Surveillance Plan |
| 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 |
| Data Sources | Sentinel Distributed Database (SDD) |
| FDA Center | CBER |
