{"analyses":[{"ciLowerLimit":"0.545","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.171","estimateComment":"Stratified analysis","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.2382","paramType":"Hazard Ratio (HR)","paramValue":"0.799","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.79","upperLimit":"4.40","value":"3.71"},{"groupId":"OG001","lowerLimit":"1.64","upperLimit":"2.89","value":"2.79"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"197"},{"groupId":"OG001","value":"95"}],"units":"Participants"}],"description":"The FACT Hepatobiliary Symptom Index (FHSI-8) is a instrument with specific focus regarding the most frequent and concerning symptoms experienced by participants with hepatobiliary malignancies, including lack of energy, nausea, pain, weight loss, pain in back, fatigue, jaundice, stomach pain or discomfort. The (FHSI-8) questionnaire was used to assess the time to deterioration of FSHI-8 total score issued from the date of randomization to the first date observing deterioration, with the deterioration threshold defined as a decrease ≥ 3-points from baseline. In case of no deterioration, the participants were censored at the time of the last FSHI-8 item recording. FHSI-8 total score ranges from 0 to 32 where \"0\" is a severely symptomatic participant and the highest score indicates an asymptomatic participant. Kaplan-Meier method Hazard ratio was used to estimate (Ramucirumab versus Placebo) and 95% Confidence Interval (CI) (Wald) were estimated from un-stratified/stratified Cox model.","dispersionType":"95% Confidence Interval","groups":[{"description":"8 mg/kg ramucirumab administered as an IV injection on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.","id":"OG000","title":"Ramucirumab + BSC"},{"description":"Placebo administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.\n\nParticipants still on treatment at the time of study completion may have the option to crossover to the ramucirumab arm.","id":"OG001","title":"Placebo + BSC"}],"paramType":"MEDIAN","populationDescription":"All randomized participants who had evaluable FHSI-8 data.","reportingStatus":"POSTED","timeFrame":"From Randomization to the First Date of Deterioration Observation (≥ 3-point decrease) (Up to 28 Months)","title":"Time to Deterioration of Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index-8 (FHSI-8)","type":"SECONDARY","unitOfMeasure":"Months"}