{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"305"},{"groupId":"OG001","value":"270"}]}],"title":"Participants With Adverse Events (AEs)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"52"}]}],"title":"Participants With Serious Adverse Events (SAEs)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"189"},{"groupId":"OG001","value":"61"}]}],"title":"Participants With Grade 3 or 4 AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"5"}]}],"title":"Participants With Grade 5 AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"86"},{"groupId":"OG001","value":"16"}]}],"title":"Participants Discontinued Due to AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"106"},{"groupId":"OG001","value":"6"}]}],"title":"Participants With Dose Reduced Due to AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"141"},{"groupId":"OG001","value":"40"}]}],"title":"Temporary Discontinuation Due to AEs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"306"},{"groupId":"OG001","value":"304"}],"units":"Participants"}],"description":"TEAEs are all AEs (serious and non-serious) occurred, for the first time, on or after the first day of study treatment. AEs started before the first dose of study treatment but increased in severity (CTC grade) over the baseline will also be considered TEAEs.\n\nParticipants were followed for AEs from the first day of study treatment until at least 28 days after the last on-study treatment administration, or until all serious or study medication-related toxicities had resolved or were determined to be \"chronic\" or \"stable,\" whichever was later. The treatment was administered to the participants from cycle1/day 1 up to 9 cycles or until relapse, secondary malignancy, death or withdraw for other reasons such as toxicity or withdraw of consent.","groups":[{"description":"Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.","id":"OG000","title":"Sunitinib"},{"description":"Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.","id":"OG001","title":"Placebo"}],"paramType":"NUMBER","populationDescription":"The As-Treated (AT) population included all participants who received at least 1 dose of study drug with treatment assignments designated according to actual study treatment received. This population was the primary population for evaluating treatment administration/ compliance and safety.","reportingStatus":"POSTED","timeFrame":"Cycle 1(Day 1 & Day 28); subsequent cycles (Day 1); end of treatment/withdrawal and 28 days post treatment, or until all serious or study medication-related toxicities had resolved or were determined to be \"chronic\" or \"stable,\" whichever was later","title":"Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity","type":"SECONDARY","unitOfMeasure":"Number of participants"}