2023
Novel Approaches for Dynamic Visualization of Adverse Event Data in Oncology Clinical Trials: A Case Study Using Immunotherapy Trial S1400-I (SWOG)
Lee S, Fan W, Wang A, Vaidya R, Redman M, Gettinger S, Bazhenova L, Herbst R, Hershman D, Unger J. Novel Approaches for Dynamic Visualization of Adverse Event Data in Oncology Clinical Trials: A Case Study Using Immunotherapy Trial S1400-I (SWOG). JCO Clinical Cancer Informatics 2023, 7: e2200165. PMID: 37084329, PMCID: PMC10281446, DOI: 10.1200/cci.22.00165.Peer-Reviewed Original ResearchConceptsSystem organ classAdverse event dataRandomized phase III trialPhase III trialsCell lung cancerOncology clinical trialsOverall toxicity profileIII trialsNeurologic toxicityTreatment armsCardiac toxicityLung cancerClinical trialsGrade 3High prevalenceOrgan classToxicity profileNivolumabTreatment groupsStage IVEndocrine toxicityType of AEToxicity typesAE termsIpilimumab
2012
A phase I study of BMS-936558 in combination with gemcitabine/cisplatin, pemetrexed/cisplatin, or carboplatin/paclitaxel in patients with treatment-naive, stage IIIB/IV non-small-cell lung cancer.
Gettinger S, Rizvi N, Shepherd F, Chow L, Laurie S, Spigel D, Sbar E, Shen Y, Brahmer J. A phase I study of BMS-936558 in combination with gemcitabine/cisplatin, pemetrexed/cisplatin, or carboplatin/paclitaxel in patients with treatment-naive, stage IIIB/IV non-small-cell lung cancer. Journal Of Clinical Oncology 2012, 30: tps2615-tps2615. DOI: 10.1200/jco.2012.30.15_suppl.tps2615.Peer-Reviewed Original ResearchBMS-936558Cell lung cancerAdverse eventsTreatment armsLung cancerDisease progressionAnti-PD-1 monoclonal antibodyStage IIIB/IV NSCLCPlatinum-based doublet chemotherapyStage IIIB/IVImpressive tumor responsesCarboplatin/paclitaxelDisease control rateIIIB/IVFirst-line standardPD-1 expressionSerious adverse eventsDose-limiting toxicityGemcitabine/cisplatinPhase 1 studyPlatinum-based chemotherapyPhase 1 trialCancer-related mortalityOverall response rateWithdrawal of consent