{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"583"},{"groupId":"OG001","value":"579"}]}],"title":"Any adverse event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"262"},{"groupId":"OG001","value":"198"}]}],"title":"Serious adverse event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"136"},{"groupId":"OG001","value":"84"}]}],"title":"Leading to discontinuation of any study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"581"},{"groupId":"OG001","value":"565"}]}],"title":"Treatment-related adverse event (TRAE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"162"},{"groupId":"OG001","value":"89"}]}],"title":"Serious treatment-related adverse event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"117"},{"groupId":"OG001","value":"63"}]}],"title":"TRAE leading to discontinuation of any study drug"}],"denoms":[{"counts":[{"groupId":"OG000","value":"585"},{"groupId":"OG001","value":"584"}],"units":"Participants"}],"description":"A serious adverse event (SAE) is defined as an AE that • is fatal • is life threatening • 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 were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.","id":"OG000","title":"FOLFOX + Panitumumab"},{"description":"Participants were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.","id":"OG001","title":"FOLFOX Alone"}],"paramType":"NUMBER","populationDescription":"Safety analysis set; One participant was randomized to 'Panitumumab Plus FOLFOX', but received 'FOLFOX Alone' so is counted in that group.","reportingStatus":"POSTED","timeFrame":"From randomization until the data cut-off date of 28 August 2009; Maximum time on follow-up was 153 weeks.","title":"Number of Participants With Adverse Events (AEs)","type":"SECONDARY","unitOfMeasure":"participants"}