{"analyses":[{"ciLowerLimit":"7.47","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"123.77","estimateComment":"The odds ratio is defined as the odds of having an objective response in the panitumumab plus BSC arm relative to the odds in BSC alone arm.","groupDescription":"ORR was not formally tested and the p-values are descriptive only. An exact test was used to test the hypothesis that the common odds ratio for panitumumab plus BSC relative to BSC alone for the objective response is equal to 1.0 stratified by the randomization factors.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","paramType":"Odds Ratio (OR)","paramValue":"24.89","statisticalComment":"Stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).","statisticalMethod":"Stratified exact test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"20.80","upperLimit":"33.91","value":"26.98"},{"groupId":"OG001","lowerLimit":"0.33","upperLimit":"4.59","value":"1.60"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"189"},{"groupId":"OG001","value":"188"}],"units":"Participants"}],"description":"Objective response rate (ORR) is defined as the percentage of participants with either a complete response (CR) or partial response (PR) per RECIST version 1.1. Radiographic tumor assessments and investigator's assessment of response were performed at Week 4, Week 8, and then every 8 weeks until disease progression (radiographic or clinical progression). CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm. PR: At least a 30% decrease in the size of target lesions with no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions with persistence of one or more non-target lesions not qualifying for either CR or PD and no new lesions.","dispersionType":"95% Confidence Interval","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":"ITT analysis set","reportingStatus":"POSTED","timeFrame":"Response was assessed at Week 4, Week 8, and then every 8 weeks until the data cut-off date of 10 June 2014. The median follow-up time was 34.9 weeks (panitumumab plus BSC: 41.0 weeks; BSC alone: 25.5 weeks).","title":"Objective Response Rate","type":"SECONDARY","unitOfMeasure":"percentage of participants"}