{"analyses":[{"groupDescription":"The ORR was compared against a null benchmark value of 5%. If the observed ORR were ≥5 of 31 (16%), it would then be concluded that the agent is promising and worthy of further investigation. When the number of analyzable cases (who were eligible and treated, and with outside assay results confirmed by the central MATCH assay) was \\<31, the one-sided exact binomial test would be used for significance test with one-side type I error rate of 5%.","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0341","statisticalMethod":"one-sided exact binomial test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6","upperLimit":"33","value":"16"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"25"}],"units":"Participants"}],"description":"ORR is defined as the percentage of patients whose tumors have a complete or partial response to treatment among analyzable (ie, eligible, treated and PIK3CA mutation status confirmed) 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 copanlisib IV over 1 hour on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity","id":"OG000","title":"Treatment (Copanlisib)"}],"paramType":"NUMBER","populationDescription":"Eligible, treated and PIK3CA 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 30 months post registration","title":"Overall Response Rate (ORR)","type":"PRIMARY","unitOfMeasure":"percentage of participants"}