{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"123"}]}],"title":"Any AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"35"}]}],"title":"AE leading to drug discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"72"}]}],"title":"Serious AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Vital signs abnormal - clinically meaningful"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"ECG abnormal - clinically meaningful"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Grade 3 or 4 hemoglobin"},{"categories":[{"measurements":[{"groupId":"OG000","value":"35"}]}],"title":"Grade 3 or 4 neutrophils"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9"}]}],"title":"Grade 3 or 4 platelets"},{"categories":[{"measurements":[{"groupId":"OG000","value":"16"}]}],"title":"Grade 3 or 4 alanine aminotransferase"},{"categories":[{"measurements":[{"groupId":"OG000","value":"11"}]}],"title":"Grade 3 or 4 aspartate aminotransferase"}],"denoms":[{"counts":[{"groupId":"OG000","value":"125"}],"units":"Participants"}],"description":"This composite endpoint measured the safety and tolerability profile of idelalisib. \"Clinically meaningful\" abnormalities in vital signs and electrocardiograms (ECG) were as determined by the investigator.","groups":[{"description":"Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.","id":"OG000","title":"Idelalisib"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Participants in the ITT Analysis Set were analyzed.","reportingStatus":"POSTED","timeFrame":"Start of Treatment to End of Treatment (up to 81 months) plus 30 days","title":"Safety and Tolerability of Idelalisib Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms","type":"SECONDARY","unitOfMeasure":"Participants"}