| 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 |
