{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"584"},{"groupId":"OG001","value":"573"}]}],"title":"Any adverse event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"232"},{"groupId":"OG001","value":"175"}]}],"title":"Serious adverse event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"123"},{"groupId":"OG001","value":"64"}]}],"title":"Leading to discontinuation of any study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"577"},{"groupId":"OG001","value":"542"}]}],"title":"Treatment-related adverse event (TRAE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"124"},{"groupId":"OG001","value":"90"}]}],"title":"Serious treatment-related adverse event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"97"},{"groupId":"OG001","value":"34"}]}],"title":"TRAE leading to discontinuation of any study drug"}],"denoms":[{"counts":[{"groupId":"OG000","value":"587"},{"groupId":"OG001","value":"594"}],"units":"Participants"}],"description":"A serious adverse event (SAE) is defined by regulatory authorities as one that • is fatal • is life threatening (places the subject at immediate risk of death) • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard. The relationship of the adverse event to the study treatment was assessed by the Investigator by means of the question: \"Is there a reasonable possibility that the event may have been caused by the study treatment?\"","groups":[{"description":"Participants received 6 mg/kg panitumumab IV plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.","id":"OG000","title":"Panitumumab Plus FOLFIRI"},{"description":"Participants received FOLFIRI chemotherapy regimen administered in cycles every two weeks.","id":"OG001","title":"FOLFIRI Alone"}],"paramType":"NUMBER","populationDescription":"Safety analysis set: all participants who received at least 1 dose of panitumumab or chemotherapy. One participant was randomized to Panitumumab Plus FOLFIRI, but received FOLFIRI Alone and is included in the FOLFIRI Alone group for safety analyses.","reportingStatus":"POSTED","timeFrame":"From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months.","title":"Number of Participants With Adverse Events (AEs)","type":"SECONDARY","unitOfMeasure":"participants"}