{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"184"},{"groupId":"OG001","value":"115"}]}],"title":"Any adverse event (AE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"70"},{"groupId":"OG001","value":"29"}]}],"title":"AE with worst grade of 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"5"}]}],"title":"AE with worst grade of 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"15"}]}],"title":"AE with worst grade of 5"},{"categories":[{"measurements":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"37"}]}],"title":"Serious adverse event (SAE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"20"},{"comment":"Not applicable for BSC Alone arm","groupId":"OG001","value":"NA"}]}],"title":"AE leading to discontinuation of panitumumab"},{"categories":[{"measurements":[{"groupId":"OG000","value":"166"},{"groupId":"OG001","value":"7"}]}],"title":"Treatment-related adverse event (TRAE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"1"}]}],"title":"Treatment-related AE with worst grade of 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"1"}]}],"title":"Treatment-related AE with worst grade of 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}],"title":"Treatment-related AE with worst grade of 5"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"}]}],"title":"Serious treatment-related AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"comment":"Not applicable for BSC Alone arm","groupId":"OG001","value":"NA"}]}],"title":"TRAE leading to discontinuation of panitumumab"}],"denoms":[{"counts":[{"groupId":"OG000","value":"189"},{"groupId":"OG001","value":"188"}],"units":"Participants"}],"description":"The severity of each AE was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (Grade 1 = Mild; 2 = Moderate (discomfort enough to cause interference with usual activity); 3 = Severe (incapacitating with inability to work or do usual activity); 4 = Life-threatening and 5 = Fatal), with the exception of the skin-or nail-related AEs which were graded using a CTCAE version 3.0 with modifications. A serious AE was defined as an AE that met at least 1 of the following criteria: • fatal, • life-threatening, • required in-patient hospitalization or prolongation of existing hospitalization, • resulted in persistent or significant disability/incapacity, • congenital anomaly/birth defect, and/or • other medically important serious event. Treatment-related AEs (TRAEs) are those the investigator considered there was reasonable possibility that the event might have been caused by study drug.","groups":[{"description":"Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.","id":"OG000","title":"Panitumumab + BSC"},{"description":"Participants received best supportive care until disease progression, withdrawal of consent, or death.","id":"OG001","title":"BSC Alone"}],"paramType":"NUMBER","populationDescription":"Safety Analysis Set (all randomized participants)","reportingStatus":"POSTED","timeFrame":"From first dose until 30 days after last dose; median safety reporting periods were 4.2 months and 2.2 months for panitumumab plus BSC arm and BSC alone arm, respectively.","title":"Number of Participants With Adverse Events (AEs)","type":"SECONDARY","unitOfMeasure":"participants"}