{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.299","pValueComment":"P-value was calculated from 1-sided Fisher exact test.","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.5","upperLimit":"6.9","value":"2.4"},{"groupId":"OG001","lowerLimit":"0.0","upperLimit":"5.9","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"124"},{"groupId":"OG001","value":"61"}],"units":"Participants"}],"description":"ORR as assessed by the IRC was defined as the percentage of participants with a best overall response (BOR) defined as complete response (CR) or partial response (PR) per RECIST v1.1. CR: disappearance of all target and non-target lesions (TLs) and all pathological lymph nodes (LNs) (target and non target), with short axis \\<10mm. PR: ≥30% decrease in sum of diameters (SOD) from Baseline.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received AG-120 500 mg, tablet, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up, or the sponsor ended the study for up to approximately 45 months.","id":"OG000","title":"AG-120"},{"description":"Participants received AG-120 matched placebo, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up or the sponsor ended the study for up to approximately 7 months. Participants who experienced disease progression and received placebo were allowed to cross over and receive AG-120.","id":"OG001","title":"Placebo"}],"paramType":"NUMBER","populationDescription":"ITT population included all participants who were randomized, with the treatment group designated according to the randomization. Number analyzed is the number of participants with data available for analyses at the specified time point. Two participants were excluded from the analysis as they were randomized in the study after the data cutoff date (31 January 2019) for the analysis of tumor response.","reportingStatus":"POSTED","timeFrame":"From the date of randomization up to confirmed CR or PR (Up to approximately 2 years)","title":"ORR as Assessed by the IRC Per RECIST v1.1","type":"SECONDARY","unitOfMeasure":"percentage of participants"}