{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"133"},{"groupId":"OG002","value":"184"}]}],"title":"All Deaths"},{"categories":[{"measurements":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"26"}]}],"title":"Deaths on-study or within 30 days post dose"},{"categories":[{"measurements":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"259"},{"groupId":"OG002","value":"334"}]}],"title":"SAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"153"},{"groupId":"OG002","value":"196"}]}],"title":"AEs Leading to Discontinuation of Treatment"}],"denoms":[{"counts":[{"groupId":"OG000","value":"165"},{"groupId":"OG001","value":"497"},{"groupId":"OG002","value":"662"}],"units":"Participants"}],"description":"AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Baseline=closest to, but no later than, the first day of study drug for treated participants. After the 2-year analysis and Protocol Amendment 02, those on a BID dosing schedule were allowed to switch to a QD dosing schedule. Due to the large number of participants switching from BID dosing to QD dosing, the abbreviated dosing data collection method incorporated in Amendment 03, the overall safety data are presented for the 100 mg QD group and combined for the other treatment groups.","groups":[{"description":"Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.","id":"OG000","title":"100 mg QD"},{"description":"Participants participated in all other treatment arms until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.","id":"OG001","title":"Other Treatment Groups"},{"description":"Participants received study drug in any schedule or total daily dose until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.","id":"OG002","title":"Total"}],"paramType":"NUMBER","populationDescription":"All randomized participants who received at least one dose of study drug were summarized.","reportingStatus":"POSTED","timeFrame":"Baseline to 30 days post last dose, up to 7 years (study closure July 2014)","title":"Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) That Led toTreatment Discontinuation After 7 Year Follow-up","type":"SECONDARY","unitOfMeasure":"participants"}