{"analyses":[{"ciLowerLimit":"-3.8","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"21.4","estimateComment":"95% CI was approximated with Hauck-Anderson continuity correction.","groupDescription":"Comparison of responders at baseline versus Week 8/9","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.1859","paramType":"Difference in Response Rates","paramValue":"8.8","statisticalMethod":"Fisher Exact"},{"ciLowerLimit":"-14","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"20.9","estimateComment":"95% CI was approximated with Hauck-Anderson continuity correction.","groupDescription":"Comparison of responders at baseline versus at Week 16/18","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.8309","paramType":"Difference in Response Rates","paramValue":"3.5","statisticalMethod":"Fisher Exact"},{"ciLowerLimit":"-15","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"34.1","estimateComment":"95% CI was approximated with Hauck-Anderson continuity correction.","groupDescription":"Comparison of responders at baseline versus at Week 24","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.5790","paramType":"Difference in Response Rates","paramValue":"9.3","statisticalMethod":"Fisher Exact"},{"ciLowerLimit":"-40","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"30.6","estimateComment":"95% CI was approximated with Hauck-Anderson continuity correction.","groupDescription":"Comparison of responders at baseline versus at Week 30","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.7339","paramType":"Difference in Response Rates","paramValue":"-4.8","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11.3","upperLimit":"29.1","value":"19.0"},{"groupId":"OG001","lowerLimit":"20.1","upperLimit":"36.7","value":"27.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"84"},{"groupId":"OG001","value":"122"}],"units":"Participants"}],"title":"Weeks 8/9"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11.8","upperLimit":"38.6","value":"23.3"},{"groupId":"OG001","lowerLimit":"17.8","upperLimit":"37.4","value":"26.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"86"}],"units":"Participants"}],"title":"Weeks 16/18"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.8","upperLimit":"45.4","value":"22.7"},{"groupId":"OG001","lowerLimit":"19.9","upperLimit":"46.3","value":"32.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"53"}],"units":"Participants"}],"title":"Week 24"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"9.9","upperLimit":"65.1","value":"33.3"},{"groupId":"OG001","lowerLimit":"15.7","upperLimit":"44.6","value":"28.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"42"}],"units":"Participants"}],"title":"Week 30"}],"denoms":[{"counts":[{"groupId":"OG000","value":"84"},{"groupId":"OG001","value":"122"}],"units":"Participants"}],"description":"The EORTC OV-28 module is a questionnaire that focuses on issues specific to ovarian cancer. It assesses AB/GI symptoms, among others. Participants were asked to indicate the extent to which they experienced AB/GI symptoms in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following: Did you have abdominal pain? Did you have a bloated feeling in your abdomen/stomach? Did you have problems with your clothes feeling too tight? Did you experience any change in bowel habit as a result of your disease or treatment? Were you troubled by passing wind/gas/flatulence? Have you felt full too quickly after beginning to eat? Have you had indigestion/heartburn? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms). Participants were considered a responder if they had a 10 point or more reduction in EORTC QLQ-OV28 AB/GI symptom scale score from baseline.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m\\^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m\\^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m\\^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m\\^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.","id":"OG000","title":"Chemotherapy"},{"description":"Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m\\^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m\\^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m\\^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m\\^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m\\^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.","id":"OG001","title":"Chemotherapy + Bevacizumab"}],"paramType":"NUMBER","populationDescription":"ITT population; n (number) = (equals) number of participants that completed the questionnaire at baseline and at the specified visit.","reportingStatus":"POSTED","timeFrame":"Baseline and Weeks 8, 9, 16, 18, 24 and 30 (Data Cutoff 14 November 2011)","title":"European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Ovarian (OV) 28 Abdominal/Gastrointestinal (AB/GI) Symptom Scale - Percentage of Responders (Data Cutoff 14 November 2011)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}