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Safety Outcomes in Meta-analyses of Phase 2 vs...
Journal article

Safety Outcomes in Meta-analyses of Phase 2 vs Phase 3 Randomized Trials: Intracranial Hemorrhage in Trials of Bolus Thrombolytic Therapy

Abstract

CONTEXT: Recent studies have reported disagreement between meta-analysis of small trials and subsequent large trials addressing the same question. However, disagreement for uncommon but serious adverse safety outcomes has not been examined. OBJECTIVE: To explore disagreement for serious adverse safety (intracranial hemorrhage [ICH]) and efficacy outcomes between meta-analysis of phase 2 (small) vs meta-analysis of phase 3 (large) randomized …

Authors

Eikelboom JW; Mehta SR; Pogue J; Yusuf S

Journal

JAMA: The Journal of the American Medical Association, Vol. 285, No. 4, pp. 444–450

Publisher

American Medical Association (AMA)

Publication Date

January 24, 2001

DOI

10.1001/jama.285.4.444

ISSN

0098-7484