{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.8"},{"groupId":"OG001","value":"0.0"},{"groupId":"OG002","value":"2.3"}]}],"title":"Pyrexia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0.8"},{"groupId":"OG001","value":"1.7"},{"groupId":"OG002","value":"0.0"}]}],"title":"Weight Decreased"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1.6"},{"groupId":"OG001","value":"1.7"},{"groupId":"OG002","value":"7.0"}]}],"title":"Hypertension"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1.6"},{"groupId":"OG001","value":"1.7"},{"groupId":"OG002","value":"2.3"}]}],"title":"Hypotension"}],"denoms":[{"counts":[{"groupId":"OG000","value":"123"},{"groupId":"OG001","value":"59"},{"groupId":"OG002","value":"43"}],"units":"Participants"}],"description":"Clinically significant vital signs were recorded as adverse events; there were some vital signs reported as Grade 3 or higher adverse events. Grading categories were determined by NCI CTCAE, version 4.03.","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"},{"description":"Participants who experienced disease progression and received placebo were allowed to cross over to receive AG-120 500 mg, tablet, orally, QD in each 28-day treatment cycle for up to approximately 32 months.","id":"OG002","title":"After Crossover to AG-120"}],"paramType":"NUMBER","populationDescription":"SAS included all participants who received at least one dose of study drug (AG-120 or Placebo).","reportingStatus":"POSTED","timeFrame":"From first dose of the study drug up to end of treatment visit for each intervention (Up to approximately 4 Years)","title":"Percentage of Participants With Clinically Significant Grade 3 or Higher Vital Signs AEs","type":"SECONDARY","unitOfMeasure":"percentage of participants"}