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2020)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"28"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"29"},{"groupId":"OG004","value":"9"},{"groupId":"OG005","value":"10"}]}],"title":"Confirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"28"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"29"},{"groupId":"OG004","value":"9"},{"groupId":"OG005","value":"10"}]}],"title":"Confirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"18"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"8"}]}],"title":"Confirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"18"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"8"}]}],"title":"Confirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}],"title":"Confirmed Not evaluable (NE), 25 months (DCO: Nov 8, 2019)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}],"title":"Confirmed Not evaluable (NE), 36 months (DCO: Dec 11, 2020)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"119"},{"groupId":"OG001","value":"51"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"56"},{"groupId":"OG004","value":"19"},{"groupId":"OG005","value":"21"}],"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 Investigator based on RECIST version 1.1. The best overall response is the best overall response (BOR) recorded from the start of the study treatment until the end of treatment and includes CR, PR, stable disease (SD), progressive disease (PD) and not evaluable (NE) as assessed by Investigator based on RECIST version 1.1. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (at least a 20% increase in the sum of diameters of target lesions). Unconfirmed ORR and BOR (not confirmed by Investigator) and confirmed ORR and BOR (confirmed by Investigator) 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"},{"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":"COUNT_OF_PARTICIPANTS","populationDescription":"Objective response rate (ORR) and best overall response (BOR) were assessed in the Response Evaluable Set.","reportingStatus":"POSTED","timeFrame":"From randomization to first documented objective response, up to 36 months postdose","title":"Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set)","type":"SECONDARY","unitOfMeasure":"Participants"}