{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}],"title":"Gastrointestinal Monotherapy"},{"categories":[{"measurements":[{"groupId":"OG000","value":"13"}]}],"title":"Gastrointestinal Combination Therapy"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Hepatic Monotherapy"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}],"title":"Hepatic Combination Therapy"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Pulmonary Monotherapy"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}],"title":"Pulmonary Combination Therapy"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Renal Monotherapy"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Renal Combination Therapy"},{"categories":[{"measurements":[{"groupId":"OG000","value":"17"}]}],"title":"Skin Monotherapy"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9"}]}],"title":"Skin Combination Therapy"},{"categories":[{"measurements":[{"groupId":"OG000","value":"16"}]}],"title":"Hypersensitivity/Infusion Reactions Monotherapy"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}],"title":"Hypersensitivity/Infusion Reactions Combination"}],"denoms":[{"counts":[{"groupId":"OG000","value":"51"}],"units":"Participants"}],"description":"An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Select AEs have been categorized into seven areas: pulmonary toxicity, gastrointestinal toxicity, hepatotoxicity, endocrinopathy, skin toxicity, neurological toxicity and renal toxicity. Select AEs, in particular pneumonitis, are considered clinically meaningful as they require greater vigilance and for early recognition and prompt intervention.","groups":[{"description":"Four doses of nivolumab flat dose 240 mg IV were administered every 2 weeks (monotherapy phase), followed by 12 doses of the combination of AVD (adriamycin/ doxorubicin 25 mg/m2, vinblastine 6 mg/m2, dacarbazine 375 mg/m2) chemotherapy and nivolumab flat dose 240 mg IV for 6 cycles (combination phase).","id":"OG000","title":"Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All treated participants in Cohort D","reportingStatus":"POSTED","timeFrame":"From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months)","title":"Number of Participants With Select AEs in Cohort D","type":"SECONDARY","unitOfMeasure":"Participants"}