{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"7"}]}],"title":"Any AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}],"title":"Any SAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}],"title":"AE leading to discontinuation of Durvalumab"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}],"title":"AE leading to discontinuation of Tremelimumab"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"2"}]}],"title":"AESIs or AEPIs related to Durvalumab"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}],"title":"AESIs or AEPIs related to Tremelimumab"}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"8"}],"units":"Participants"}],"description":"An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. Some AEs and higher-level terms were considered AESI or AEPIs and this list of categories were provided by the patient safety team.","groups":[{"description":"Participants who weighed \\>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.","id":"OG000","title":"Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg"},{"description":"Participants who weighed \\>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.","id":"OG001","title":"Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg"},{"description":"Participants who weighed \\< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.","id":"OG002","title":"Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg"},{"description":"Participants who weighed \\< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.","id":"OG003","title":"Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The Safety analysis set included all participants who received any amount of study treatment.","reportingStatus":"POSTED","timeFrame":"From Day 1 up to 15 months","title":"Dose-Finding Phase: Number of Participants With Adverse Events (AE), Serious AE (SAE), AE Leading to Discontinuation of Durvalumab and Tremelimumab, AE of Special Interest (AESI) or AE of Possible Interest (AEPI) Related to Durvalumab and Tremelimumab","type":"PRIMARY","unitOfMeasure":"Participants"}