2023
Multicenter, Real-World Study in Patients with R/R Large B-Cell Lymphoma (LBCL) Who Received Lisocabtagene Maraleucel (liso-cel) in the United States (US)
Crombie J, Nastoupil L, Andreadis C, Isufi I, Hunter B, Winter A, Hess B, Barta S, Frigault M, Palomba M, Grover N, Jain M, Moyo T, Patel S, Pophali P, Bernasconi D, Parrilla C, Kitali A, Liu F, Gharibo M, Pasquini M. Multicenter, Real-World Study in Patients with R/R Large B-Cell Lymphoma (LBCL) Who Received Lisocabtagene Maraleucel (liso-cel) in the United States (US). Blood 2023, 142: 104. DOI: 10.1182/blood-2023-180242.Peer-Reviewed Original ResearchImmune effector cell-associated neurotoxicity syndromeR LBCLLarge B-cell lymphomaCytokine release syndromeProgression-free survivalDuration of responseReal-world clinical effectivenessHigh-grade B-cell lymphomaLiso-celInternational Prognostic IndexB-cell lymphomaOverall survivalSystemic therapyReal-world studyData cutoffPostmarketing studyMedian timeClinical effectivenessClinical studiesFavorable benefit/risk profileReal-world settingMedian DORMedian progression-free survivalBenefit/risk profileCAR T-cell products
2021
Reporting of Study Participant Demographic Characteristics and Demographic Representation in Premarketing and Postmarketing Studies of Novel Cancer Therapeutics
Varma T, Wallach JD, Miller JE, Schnabel D, Skydel JJ, Zhang AD, Dinan MA, Ross JS, Gross CP. Reporting of Study Participant Demographic Characteristics and Demographic Representation in Premarketing and Postmarketing Studies of Novel Cancer Therapeutics. JAMA Network Open 2021, 4: e217063. PMID: 33877309, PMCID: PMC8058642, DOI: 10.1001/jamanetworkopen.2021.7063.Peer-Reviewed Original ResearchConceptsNovel cancer therapeuticsPostmarketing studyBlack patientsCancer therapeuticsDemographic dataOlder adultsUS cancer populationUS Cancer StatisticsCross-sectional studyRace/ethnicityParticipants' demographic characteristicsPercentage of trialsPatient sexCancer populationClinical studiesCancer statisticsMAIN OUTCOMEDrug AdministrationFDA approvalStudy participantsCancer typesDemographic characteristicsDemographic informationStudy samplePatientsCharacteristics of Postmarketing Studies for Vaccines Approved by the US Food and Drug Administration, 2006-2020
Moneer O, Lee CC, Avorn J, Kesselheim AS. Characteristics of Postmarketing Studies for Vaccines Approved by the US Food and Drug Administration, 2006-2020. JAMA Network Open 2021, 4: e218530. PMID: 33929526, PMCID: PMC8087952, DOI: 10.1001/jamanetworkopen.2021.8530.Peer-Reviewed Original ResearchConceptsUS FoodCross-sectional studyPostmarketing studyPostmarketing requirementsNew vaccinesDrug AdministrationVaccine
2006
Detecting Rare Adverse Events in Postmarketing Studies: Sample Size Considerations
Wu Y, Makuch R. Detecting Rare Adverse Events in Postmarketing Studies: Sample Size Considerations. Therapeutic Innovation & Regulatory Science 2006, 40: 89-98. DOI: 10.1177/009286150604000111.Peer-Reviewed Original Research
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