{"groups":[{"description":"Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m\\^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m\\^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest","id":"FG000","title":"Albumin-bound Paclitaxel (ABI-007)/Gemcitabine (Gem)"},{"description":"Gemcitabine 1000 mg/m\\^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)","id":"FG001","title":"Gemcitabine (Gem)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"196"},{"groupId":"FG001","numSubjects":"245"}],"type":"Progressive Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"128"},{"groupId":"FG001","numSubjects":"73"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"25"},{"groupId":"FG001","numSubjects":"18"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"6"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"28"},{"groupId":"FG001","numSubjects":"39"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"10"}],"type":"Other"},{"reasons":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"27"}],"type":"Withdrew prior to starting treatment"}],"milestones":[{"achievements":[{"comment":"Started = Intent to Treat Population and includes all randomized participants","groupId":"FG000","numSubjects":"431"},{"comment":"Started = Intent to Treat Population and includes all randomized participants","groupId":"FG001","numSubjects":"430"}],"type":"STARTED"},{"achievements":[{"comment":"Treated population = all randomized patients who received at least one dose of study drug","groupId":"FG000","numSubjects":"421"},{"comment":"Treated population = all randomized patients who received at least one dose of study drug","groupId":"FG001","numSubjects":"402"}],"type":"Treated Population"},{"achievements":[{"comment":"Completed = participants remaining on treatment at the time of the data cut off 17 Sept 2012","groupId":"FG000","numSubjects":"26"},{"comment":"Completed = participants remaining on treatment at the time of the data cut off 17 Sept 2012","groupId":"FG001","numSubjects":"12"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"405"},{"groupId":"FG001","numSubjects":"418"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"38 participants were randomized but not treated due to the participants request to withdraw after the randomization results became known. 1 participant was randomized to Gemcitabine and was treated with Albumin-bound paclitaxel ABI-007/Gemcitabine in error and analyzed as treated and included in the intent to treat population (ITT)","recruitmentDetails":"Participants were randomized in a 1:1 ratio and the randomization was stratified by geographic region (Australia versus Eastern Europe versus Western Europe versus North America), Karnofsky performance status (70 to 80 versus 90 to 100), and by the presence of liver metastases (yes versus no)"}