{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.7413","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"70.8","upperLimit":"81.9","value":"76.3"},{"groupId":"OG001","lowerLimit":"69.0","upperLimit":"80.3","value":"74.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"224"},{"groupId":"OG001","value":"225"}],"units":"Participants"}],"description":"ORR was defined as the percentage of randomized participants achieving a best overall response of partial response (PR) or complete response (CR) assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as the disappearance of all lesions, pathological lymph node reduction in short axis to \\<10 mm, and normalization of tumor marker levels of non-target lesions. PR was at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression.","dispersionType":"95% Confidence Interval","groups":[{"description":"Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally.\n\nParticipants may continue to receive treatment until discontinuation criteria are met.","id":"OG000","title":"Part B: Ramucirumab+ Erlotinib"},{"description":"Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally.\n\nParticipants may continue to receive treatment until discontinuation criteria are met.","id":"OG001","title":"Part B: Placebo+ Erlotinib"}],"paramType":"NUMBER","populationDescription":"Part B: All randomized participants grouped according to their assigned treatment at randomization. Per protocol, Part A did not evaluate efficacy.","reportingStatus":"POSTED","timeFrame":"Randomization to Progressive Disease (Up To 37 Months)","title":"Part B: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])","type":"SECONDARY","unitOfMeasure":"percentage of participants"}