{"groups":[{"description":"Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Note: Safety Data of participants in the arm presented here are reported in Reporting Groups (RG) RG1 and RG3 in the Safety section.","id":"FG000","title":"A1) Sorafenib (Nexavar, BAY43-9006) - no Open Label Phase"},{"description":"Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study Note: Safety Data of participants in the arm presented here are reported in Reporting Groups (RG) RG1 and RG3 in the Safety section.","id":"FG001","title":"A2) Sorafenib (Nexavar, BAY43-9006) - With Open Label Phase"},{"description":"Sorafenib-matching placebo tablets were orally administered twice daily (bid).\n\nNote: Safety Data of participants in the arm presented here are reported in Reporting Groups (RG) RG2 and RG4 in the Safety section.","id":"FG002","title":"B1) Placebo - no Open Label Phase"},{"description":"Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.\n\nNote: Safety Data of participants in the arm presented here are reported in Reporting Groups (RG) RG2, RG4, and RG5 in the Safety section.","id":"FG003","title":"B2) Placebo First - Then Open Label Sorafenib Treatment Phase"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"7"},{"groupId":"FG003","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"0"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}],"type":"Radiological and symptomatic progression"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"242"},{"groupId":"FG001","numSubjects":"57"},{"groupId":"FG002","numSubjects":"256"},{"groupId":"FG003","numSubjects":"47"}],"type":"STARTED"},{"achievements":[{"comment":"Subjects at Risk/Safety Population - partly in RG1 and RG3 (RG = Reporting Group for Safety Data)","groupId":"FG000","numSubjects":"240"},{"comment":"Subjects at Risk/Safety Population - partly in RG1 and RG3","groupId":"FG001","numSubjects":"57"},{"comment":"Subjects at Risk/Safety Population - partly in RG2 and RG4","groupId":"FG002","numSubjects":"255"},{"comment":"Subjects at Risk/Safety Population - partly in RG2 and RG4 as well as RG5","groupId":"FG003","numSubjects":"47"}],"type":"Received Treatment"},{"achievements":[{"comment":"228 participants directly switched to the Follow-up (FU) phase only","groupId":"FG000","numSubjects":"228"},{"comment":"47 participants continued with Sorafenib Open Label (OL); 10 first to FU prior to also switch to OL","groupId":"FG001","numSubjects":"57"},{"comment":"245 participants directly switched to the Follow-up (FU) phase","groupId":"FG002","numSubjects":"245"},{"comment":"36 participants switched to Sorafenib Open Label (OL); 11 first to FU prior to also switch to OL","groupId":"FG003","numSubjects":"47"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"11"},{"groupId":"FG003","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Double-Blind Treatment"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"180"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"219"},{"groupId":"FG003","numSubjects":"4"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"10"},{"groupId":"FG003","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"24"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"13"},{"groupId":"FG003","numSubjects":"4"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"14"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"16"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"5"}],"type":"Progression by clinical judgment"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"3"}],"type":"Progression, measurement proven"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}],"type":"Disease progression, recurrence, relapse"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"2"}],"type":"Endpoint record not completed"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Planned switch to OL; record incomplete"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}],"type":"Non-compliant with study medication"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}],"type":"Reached ECOG 4"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"23"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"11"}],"type":"Switch to commercial drug"}],"milestones":[{"achievements":[{"comment":"At start of period, 228 participants directly switched to Follow-up (FU)","groupId":"FG000","numSubjects":"228"},{"comment":"At start of period, 47 participants directly switched to Open Label (OL) Sorafenib treatment","groupId":"FG001","numSubjects":"57"},{"comment":"At start of period, 245 participants directly switched to Follow-up (FU)","groupId":"FG002","numSubjects":"245"},{"comment":"At start of period, 36 participants directly switched to Open Label (OL) Sorafenib treatment","groupId":"FG003","numSubjects":"47"}],"type":"STARTED"},{"achievements":[{"comment":"In parallel to \"Open Label treatment only\" phase","groupId":"FG000","numSubjects":"228"},{"groupId":"FG001","numSubjects":"0"},{"comment":"In parallel to \"Open Label treatment only\" phase","groupId":"FG002","numSubjects":"245"},{"groupId":"FG003","numSubjects":"0"}],"type":"Follow-up Only (no Open Label Treatment)"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"comment":"In parallel to \"Follow-up only\" phase; participants received Sorafenib 400 mg bid","groupId":"FG001","numSubjects":"47"},{"groupId":"FG002","numSubjects":"0"},{"comment":"In parallel to \"Follow-up only\" phase; participants received Sorafenib 400 mg bid","groupId":"FG003","numSubjects":"36"}],"type":"Open Label Treatment Only (no Follow-up)"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"11"}],"type":"Follow-up First, Then Open Label"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"comment":"57 participants in total (47 + 10) received Open Label Sorafenib treatment (Subjects at Risk)","groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"comment":"47 participants in total (36 + 11) received Open Label Sorafenib treatment (Subjects at Risk)","groupId":"FG003","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"228"},{"groupId":"FG001","numSubjects":"57"},{"groupId":"FG002","numSubjects":"245"},{"groupId":"FG003","numSubjects":"47"}],"type":"NOT COMPLETED"}],"title":"Follow-up and/or Open Label Nexavar"}],"preAssignmentDetails":"After a 28 day screening period (902 subjects), 602 were randomized to Sorafenib (400 mg) twice daily (bid), or matching placebo. Majority of screen failures did not meet inclusion criteria. Efficacy population (intent-to-treat, ITT) was all randomized subjects (602), safety population was all subjects receiving at least 1 dose of study drug (599).","recruitmentDetails":"Subjects with advanced hepatocellular carcinoma (HCC) were enrolled from Mar 10, 2005 to Apr 11, 2006 at 121 study centers in 21 countries around the Globe."}