{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.3","upperLimit":"6.9","value":"5.6"},{"groupId":"OG001","lowerLimit":"2.0","upperLimit":"4.3","value":"2.8"},{"comment":"Missing upper limit was not calculable due to right censored data; last timepoint censored and estimate is infinity.","groupId":"OG002","lowerLimit":"2.0","upperLimit":"NA","value":"4.9"},{"groupId":"OG003","lowerLimit":"2.0","upperLimit":"4.3","value":"3.5"},{"groupId":"OG004","lowerLimit":"2.7","upperLimit":"7.1","value":"4.4"},{"groupId":"OG005","lowerLimit":"1.5","upperLimit":"4.3","value":"2.8"}]}],"title":"PFS, 25 months (DCO: Nov 8, 2019)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.3","upperLimit":"6.9","value":"5.6"},{"groupId":"OG001","lowerLimit":"2.0","upperLimit":"4.3","value":"2.8"},{"comment":"Missing upper limit was not calculable due to right censored data; last timepoint censored and estimate is infinity.","groupId":"OG002","lowerLimit":"2.0","upperLimit":"NA","value":"4.9"},{"groupId":"OG003","lowerLimit":"2.0","upperLimit":"4.3","value":"3.5"},{"groupId":"OG004","lowerLimit":"2.7","upperLimit":"7.1","value":"4.4"},{"groupId":"OG005","lowerLimit":"1.5","upperLimit":"4.3","value":"2.8"}]}],"title":"PFS, 36 months (DCO: Dec 11, 2020)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"126"},{"groupId":"OG001","value":"55"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"62"},{"groupId":"OG004","value":"21"},{"groupId":"OG005","value":"22"}],"units":"Participants"}],"description":"Progression-free survival (PFS) was defined as the time from the date of randomization (the date of the registration for the Exploratory Cohorts) to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause. PD was defined as at least a 20% increase in the sum of diameters of target lesions.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.","id":"OG000","title":"DS-8201a"},{"description":"Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.","id":"OG001","title":"Physician's Choice Irinotecan"},{"description":"Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.","id":"OG002","title":"Physician's Choice Paclitaxel"},{"description":"Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.","id":"OG003","title":"Physician's Choice Overall"},{"description":"Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.","id":"OG004","title":"Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a"},{"description":"Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.","id":"OG005","title":"Exploratory: Naïve HER2 IHC 1+, DS-8201a"}],"paramType":"MEDIAN","populationDescription":"Progression-free survival (PFS) was assessed in the Intent-to-Treat Analysis Set.","reportingStatus":"POSTED","timeFrame":"From the date of randomization to the first documented disease progression or date of death (whichever occurs first), up to 36 months postdose","title":"Progression-Free Survival Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)","type":"SECONDARY","unitOfMeasure":"months"}