2022
Vibration of effect in more than 16 000 pooled analyses of individual participant data from 12 randomised controlled trials comparing canagliflozin and placebo for type 2 diabetes mellitus: multiverse analysis
Gouraud H, Wallach J, Boussageon R, Ross J, Naudet F. Vibration of effect in more than 16 000 pooled analyses of individual participant data from 12 randomised controlled trials comparing canagliflozin and placebo for type 2 diabetes mellitus: multiverse analysis. BMJ Medicine 2022, 1: e000154. PMID: 36936564, PMCID: PMC9978683, DOI: 10.1136/bmjmed-2022-000154.Peer-Reviewed Original ResearchMajor adverse cardiovascular eventsType 2 diabetes mellitusIndividual participant dataAdverse cardiovascular eventsSerious adverse eventsPooled analysisCanagliflozin treatmentFirst centileCardiovascular eventsHazard ratioAdverse eventsDiabetes mellitusParticipant dataEffect estimatesFavour of placeboSerum glycated hemoglobinIndividual patient dataVibration of effectsWeek 12Glycated hemoglobinPlaceboCentileCanagliflozinPatient dataTrials
2009
Pooled Analysis of Rofecoxib Placebo-Controlled Clinical Trial Data: Lessons for Postmarket Pharmaceutical Safety Surveillance
Ross JS, Madigan D, Hill KP, Egilman DS, Wang Y, Krumholz HM. Pooled Analysis of Rofecoxib Placebo-Controlled Clinical Trial Data: Lessons for Postmarket Pharmaceutical Safety Surveillance. JAMA Internal Medicine 2009, 169: 1976-1985. PMID: 19933959, PMCID: PMC2830805, DOI: 10.1001/archinternmed.2009.394.Peer-Reviewed Original ResearchMeSH KeywordsAdverse Drug Reaction Reporting SystemsCardiovascular SystemCyclooxygenase 2 InhibitorsDrug IndustryHumansIncidenceLactonesMyocardial InfarctionRandomized Controlled Trials as TopicRisk AssessmentSafety-Based Drug WithdrawalsSulfonesTime FactorsUnited StatesUnited States Food and Drug AdministrationConceptsPlacebo-controlled trialVoluntary market withdrawalAdverse eventsCardiovascular riskThromboembolic adverse eventsMain outcome measurementsClinical trial dataRofecoxib groupOutcome measurementsTrial dataPlaceboTrial durationSafety surveillanceTrialsMarket withdrawalDeathRiskP-valueSurveillance effortsSubjectsWithdrawalRofecoxibYearsIncidenceDose