{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.1","upperLimit":"32.6","value":"11.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"17"}],"units":"Participants"}],"description":"ORR is defined as the percentage of patients whose tumors have a complete or partial response to treatment among analyzable patients. Objective response is defined consistent with Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Details about how to define complete response and partial response can be found in the master protocol. 90% two-sided binomial exact confidence interval is calculated for ORR.","dispersionType":"90% Confidence Interval","groups":[{"description":"Patients receive afatinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients may also undergo ECHO or nuclear study throughout the trial as clinically necessary. Patients undergo biopsies and blood sample collection on study.","id":"OG000","title":"Treatment (Afatinib)"}],"paramType":"NUMBER","populationDescription":"Eligible, treated and mutation status confirmed","reportingStatus":"POSTED","timeFrame":"Tumor assessments occurred at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration","title":"Objective Response Rate (ORR)","type":"PRIMARY","unitOfMeasure":"percentage of participants"}