{"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":"FG000","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":"FG001","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":"FG002","title":"Physician's Choice Paclitaxel"},{"description":"Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.","id":"FG003","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":"FG004","title":"Exploratory: Naïve HER2 IHC 1+, DS-8201a"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"85"},{"groupId":"FG001","numSubjects":"44"},{"groupId":"FG002","numSubjects":"6"},{"groupId":"FG003","numSubjects":"16"},{"groupId":"FG004","numSubjects":"20"}],"type":"Progressive disease per RECIST"},{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"1"}],"type":"Clinical progression"},{"reasons":[{"groupId":"FG000","numSubjects":"22"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"2"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}],"type":"Miscellaneous"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"0"}],"type":"Did not receive treatment"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"126"},{"groupId":"FG001","numSubjects":"55"},{"groupId":"FG002","numSubjects":"7"},{"groupId":"FG003","numSubjects":"21"},{"groupId":"FG004","numSubjects":"24"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"125"},{"groupId":"FG001","numSubjects":"55"},{"groupId":"FG002","numSubjects":"7"},{"groupId":"FG003","numSubjects":"20"},{"groupId":"FG004","numSubjects":"24"}],"type":"Received Treatment"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"126"},{"groupId":"FG001","numSubjects":"55"},{"groupId":"FG002","numSubjects":"7"},{"groupId":"FG003","numSubjects":"21"},{"groupId":"FG004","numSubjects":"24"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"In the Primary Cohort, participants with HER2 overexpressing gastric of GEJ adenocarcinoma were randomized (2:1) to either DS-8201a or physician's choice (irinotecan or paclitaxel). In the Exploratory Cohorts, participants with HER2 IHC 2+/ISH negative advanced gastric or GEJ adenocarcinoma who were naïve to HER2 treatment received DS-8201a.","recruitmentDetails":"In the Primary Cohort, a total of 188 participants who met all inclusion criteria and no exclusion criteria were enrolled and randomized to treatment. In the Exploratory Cohorts, a total of 45 non-randomized participants were enrolled and 44 patients received treatment. Study participants for all cohorts were enrolled at clinic sites in South Korea and Japan. Participants took part of the study from November 2, 2017 to Data Cut-Off (DCO) date of December 11, 2020."}