{"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalComment":"CMH test with region as a stratification factor","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"8"}]}],"title":"Unconfirmed ORR, 25 months (DCO: Nov 8, 2019)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"8"}]}],"title":"Unconfirmed ORR, 36 months (DCO: Dec 11, 2020)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"7"}]}],"title":"Confirmed ORR, 25 months (DCO: Nov 8, 2019)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"7"}]}],"title":"Confirmed ORR, 36 months (DCO: Dec 11, 2020)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"126"},{"groupId":"OG001","value":"55"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"62"}],"units":"Participants"}],"description":"The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR), assessed by independent central imaging review (ICR) based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Unconfirmed ORR (not confirmed by ICR) and confirmed ORR (confirmed by ICR) are reported.","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"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Objective response rate was assessed in the Primary Cohort in the Intent-to-Treat Analysis Set.","reportingStatus":"POSTED","timeFrame":"Baseline to date of first documented objective response (CR or PR), up to 36 months postdose","title":"Percentage of Participants With Objective Response Rate 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":"PRIMARY","unitOfMeasure":"Participants"}