{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"592"},{"groupId":"OG001","value":"606"}]}],"title":"Treatment-Emergent Adverse Event (TEAE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"198"},{"groupId":"OG001","value":"294"}]}],"title":"Serious TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"37"}]}],"title":"TEAE leading to Death"},{"categories":[{"measurements":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"164"}]}],"title":"TEAE causing permanent treatment discontinuation"}],"denoms":[{"counts":[{"groupId":"OG000","value":"605"},{"groupId":"OG001","value":"611"}],"units":"Participants"}],"description":"All AEs regardless of seriousness or relationship to study treatment, spanning from the first administration of study treatment until 30 days after the last administration of study treatment, were recorded, and followed until resolution or stabilization.\n\nThe number of participants with all treatment emergent adverse events (TEAE), serious adverse events (SAE), TEAE leading to death, and TEAE leading to permanent treatment discontinuation are reported.","groups":[{"description":"Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks","id":"OG000","title":"Placebo/FOLFIRI"},{"description":"Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks","id":"OG001","title":"Aflibercept/FOLFIRI"}],"paramType":"NUMBER","populationDescription":"The safety population was the subset of the ITT population that took at least one dose of study treatment. Analyses was based on the treatment actually received (any participant who received at least one dose of aflibercept, even when receiving the rest of study treatment with placebo, was counted in the aflibercept treatment arm).","reportingStatus":"POSTED","timeFrame":"From the date of the first randomization up to 30 days after the treatment discontinuation or until TEAE was resolved or stabilized","title":"Number of Participants With Adverse Events (AE)","type":"SECONDARY","unitOfMeasure":"participants"}