{"groups":[{"description":"Participants received placebo matched to tanezumab subcutaneous (SC) once every 8 weeks for 24 weeks.","id":"FG000","title":"Placebo"},{"description":"Participants in this discontinued treatment arm, received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and completed their treatment before the amendment.","id":"FG001","title":"Tanezumab 10 mg"},{"description":"Participants in this treatment group had received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and after the amendment they continued remaining treatment with tanezumab 20 mg SC once every 8 weeks.","id":"FG002","title":"Tanezumab 10/20 mg"},{"description":"Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks.","id":"FG003","title":"Tanezumab 20 mg"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"6"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"19"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Insufficient clinical response"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"10"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"6"}],"type":"Other"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Randomized but not treated"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"74"},{"comment":"A total of 10 participants were initially randomized to this arm. This arm was discontinued per protocol amendment 3. At time of amendment, out of 10 participants, 1 participant was still in treatment with tanezumab 10 mg. Post-amendment, this participant continued treatment with tanezumab 20 mg and was included in tanezumab 10/20 mg arm.","groupId":"FG001","numSubjects":"9"},{"comment":"The participant switched to this arm from tanezumab 10 mg post protocol amendment 3 implementation for remaining doses.","groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"72"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"73"},{"groupId":"FG001","numSubjects":"9"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"72"}],"type":"Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"31"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"29"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"43"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"43"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Total 325 participants signed the inform consent form (ICF). Out of which 158 participants were screen failures, and 11 participants were screened but not enrolled and randomized into the study. Total of 156 participants were enrolled and randomized into the study and assigned to study treatments.","recruitmentDetails":"Participants with cancer pain predominantly due to bone metastasis and receiving background opioid therapy, were randomized into 3 treatment arms: tanezumab 20 milligrams (mg), tanezumab 10 mg and placebo. After study start, tanezumab 10 mg arm was discontinued in protocol amendment 3: no new participants were enrolled into the arm. Existing participants in the arm received tanezumab 20 mg for any remaining doses and were included in tanezumab 10/20 mg arm."}