{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"134"},{"groupId":"OG001","value":"92"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"307"},{"groupId":"OG001","value":"309"}],"units":"Participants"}],"description":"AEs associated with pembrolizumab exposure may be a result of an immune response. These irAEs may occur shortly after the first dose or several months after the last dose of pembrolizumab treatment and may affect more than one body system simultaneously. For this study irAEs included, but were not limited to: -Pneumonitis;\n\n* Diarrhea/Colitis;\n* Aspartate transaminase (AST)/Alanine transaminase (ALT) elevation or Increased bilirubin;\n* Type 1 diabetes mellitus or Hyperglycemia;\n* Hypophysitis;\n* Hyperthyroidism;\n* Hypothyroidism;\n* Nephritis and Renal dysfunction; and\n* Myocarditis. The number of participants who experienced an irAE is presented.","groups":[{"description":"On Day 1 of each 21-day cycle, participants received an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\\^2 PLUS cisplatin 50 mg/m\\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\\^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.","id":"OG000","title":"Pembrolizumab+Chemotherapy"},{"description":"On Day 1 of each 21-day cycle, participants received an IV infusion of placebo (Normal Saline or Dextrose solution) for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\\^2 PLUS cisplatin 50 mg/m\\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\\^2 PLUS carboplatin AUC 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity.","id":"OG001","title":"Placebo+Chemotherapy"}],"paramType":"NUMBER","populationDescription":"All randomized participants who received at least one dose of study treatment.","reportingStatus":"POSTED","timeFrame":"Up to approximately 66 months","title":"Number of Participants Who Experienced an Immune-related AE (irAE)","type":"SECONDARY","unitOfMeasure":"Number of Participants"}