{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5.6"},{"groupId":"OG001","value":"5.5"}]}],"title":"Immunogenicity Any Time During Study (n=516, 512)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3.1"},{"groupId":"OG001","value":"3.8"}]}],"title":"Immunogenicity Post-Treatment (n=477, 473)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"516"},{"groupId":"OG001","value":"512"}],"units":"Participants"}],"description":"Blood samples were tested to determine if a participant reacted to ramucirumab by producing anti-ramucirumab antibodies. Samples were identified as treatment emergent anti-drug antibody (TE ADA) if the post-treatment sample had an increase of at least 4 fold in titer from pre-treatment values. If the pre-treatment value was not detected or was not present, a 1:20 post-treatment titer was required to indicate treatment emergence. The percentage of participants with TE ADA was calculated as: (the number of participants with TE ADA / total number of participants with at least 1 post-treatment immunogenicity sample analyzed)\\*100.","groups":[{"description":"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.\n\nRamucirumab: 8 mg/kg administered intravenously.\n\nIrinotecan: 180 mg/m\\^2 administered intravenously.\n\nFolinic Acid: 400 mg/m\\^2 administered intravenously.\n\n5-Fluorouracil: 400 mg/m\\^2 bolus immediately followed by 2400 mg/m\\^2 continuous infusion.","id":"OG000","title":"Ramucirumab + FOLFIRI"},{"description":"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.\n\nPlacebo: Administered intravenously.\n\nIrinotecan: 180 mg/m\\^2 administered intravenously.\n\nFolinic Acid: 400 mg/m\\^2 administered intravenously.\n\n5-Fluorouracil: 400 mg/m\\^2 bolus immediately followed by 2400 mg/m\\^2 continuous infusion.","id":"OG001","title":"Placebo + FOLFIRI"}],"paramType":"NUMBER","populationDescription":"All participants who received study treatment and who had immunogenicity samples analyzed at the specified time points.","reportingStatus":"POSTED","timeFrame":"Cycles 1, 3, 5, and 30-Day FU","title":"Percentage of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies","type":"SECONDARY","unitOfMeasure":"percentage of participants"}