S M Belknap
Affiliation: Northwestern University
- Clinical features and correlates of gemcitabine-associated lung injury: findings from the RADAR projectSteven M Belknap
Division of General Internal Medicine, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois 60611, USA
Cancer 106:2051-7. 2006....
- Quality of methods for assessing and reporting serious adverse events in clinical trials of cancer drugsS M Belknap
Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA
Clin Pharmacol Ther 88:231-6. 2010..The use of a validated tool to describe and assess event type, severity, and causality may lead to more timely, accurate identification of safety signals in cancer treatment...
- Application of software design principles and debugging methods to an analgesia prescription reduces risk of severe injury from medical use of opioidsS M Belknap
Division of General Internal Medicine, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA
Clin Pharmacol Ther 84:385-92. 2008..2.7%, number needed to treat (NNT) = 35, P < 0.015). The widespread diffusion of POPA was associated with a substantial hospitalwide decline in opioid-associated severe/fatal ADEs...
- Reporting of serious adverse events during cancer clinical trials to the institutional review board: an evaluation by the research on adverse drug events and reports (RADAR) projectS M Belknap
Department of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA
J Clin Pharmacol 53:1334-40. 2013..SCA provided more useful information as to whether an SAE was caused by a cancer drug exposure. Our results suggest that SCA may improve SAE detection and the accuracy of attribution of causality during cancer drug clinical trials. ..
- Rituximab-associated hepatitis B virus (HBV) reactivation in lymphoproliferative diseases: meta-analysis and examination of FDA safety reportsA M Evens
Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA
Ann Oncol 22:1170-80. 2011..Rituximab has been associated with hepatitis B virus reactivation (HBV-R). However, the characteristics and scope of this association remain largely undefined...
- The Research on Adverse Drug Events and Reports (RADAR) projectCharles L Bennett
Jesse Brown VA Medical Center Mid West Center for Health Services and Policy Research, Chicago, Ill 60611, USA
JAMA 293:2131-40. 2005....
- Long-term outcome of individuals with pure red cell aplasia and antierythropoietin antibodies in patients treated with recombinant epoetin: a follow-up report from the Research on Adverse Drug Events and Reports (RADAR) ProjectCharles L Bennett
MidWest Center for Health Services Research and Policy Studies, VA Chicago Healthcare System, Chicago, IL, USA
Blood 106:3343-7. 2005..Reinitiation of epoetin therapy among individuals could be considered if antierythropoietin antibodies are undetectable...
- Pure red-cell aplasia and epoetin therapyCharles L Bennett
MidWest Center for Health Services Research and Policy Studies, Jesse Brown Veterans Affairs Medical Center, Chicago, IL 60611, USA
N Engl J Med 351:1403-8. 2004....
- Evaluation of serious adverse drug reactions: a proactive pharmacovigilance program (RADAR) vs safety activities conducted by the Food and Drug Administration and pharmaceutical manufacturersCharles L Bennett
Northwestern University Feinberg School of Medicine, Chicago, IL 60611, USA
Arch Intern Med 167:1041-9. 2007..We compare safety efforts for evaluating serious ADRs conducted by the FDA and pharmaceutical manufacturers vs the RADAR project...
- Dissemination of information on potentially fatal adverse drug reactions for cancer drugs from 2000 to 2002: first results from the research on adverse drug events and reports projectLisa A Ladewski
Veterans Affairs Midwest Center for Health and Policy Research, Lakeside Division, Northwestern University Medical Center, Chicago, IL 60611, USA
J Clin Oncol 21:3859-66. 2003..To describe the clinical findings, occurrence rates, causality evidence, and dissemination media for serious cancer drug-associated adverse drug reactions (ADRs) reported in the postmarketing setting...
- Serious adverse cutaneous and hepatic toxicities associated with nevirapine use by non-HIV-infected individualsShilpa M Patel
Veterans Affairs Chicago Healthcare System Lakeside Division, Chicago, IL, USA
J Acquir Immune Defic Syndr 35:120-5. 2004..Because of its favorable pharmacokinetic profile, non-HIV-infected individuals have received nevirapine-containing postexposure prophylaxis (PEP)...
- Adverse drug events in emergency department patientsJohn W Hafner
Department of Emergency Medicine, OSF Saint Francis Medical Center, Peoria, IL 61637, USA
Ann Emerg Med 39:258-67. 2002..Less is known about this common type of injury in emergency department patients. This study seeks to measure the risks, incidence, severity, and costs of ADEs in an ED population...