{"analyses":[{"ciLowerLimit":"-0.28","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.19","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.12","groupDescription":"Change at Week 2: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.","groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.7045","paramType":"Difference in LS mean","paramValue":"-0.04","statisticalMethod":"ANCOVA"},{"ciLowerLimit":"-0.59","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-0.01","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.14","groupDescription":"Change at Week 4: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.","groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0402","paramType":"Difference in LS mean","paramValue":"-0.30","statisticalMethod":"ANCOVA"},{"ciLowerLimit":"-0.67","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.02","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.17","groupDescription":"Change at Week 8: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.","groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0637","paramType":"Difference in LS mean","paramValue":"-0.33","statisticalMethod":"ANCOVA"},{"ciLowerLimit":"-0.53","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.20","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.18","groupDescription":"Change at Week 16: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.","groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.3804","paramType":"Difference in LS mean","paramValue":"-0.16","statisticalMethod":"ANCOVA"},{"ciLowerLimit":"-0.47","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.27","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.18","groupDescription":"Change at Week 24: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.","groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.5894","paramType":"Difference in LS mean","paramValue":"-0.10","statisticalMethod":"ANCOVA"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.11","value":"-0.39"},{"comment":"Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.\n\nIndividual values were 0, 0, -3, 0, -2, 1, 0, -1 and -1.","groupId":"OG001","spread":"NA","value":"NA"},{"comment":"Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.\n\nIndividual values was 1.","groupId":"OG002","spread":"NA","value":"NA"},{"groupId":"OG003","spread":"0.12","value":"-0.43"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"71"}],"units":"Participants"}],"title":"Change at Week 2"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.14","value":"-0.36"},{"comment":"Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.\n\nIndividual values were 0, 1, 0, 0, -3, 1, 0, 0 and -1.","groupId":"OG001","spread":"NA","value":"NA"},{"comment":"Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.\n\nIndividual values was 0.","groupId":"OG002","spread":"NA","value":"NA"},{"groupId":"OG003","spread":"0.14","value":"-0.66"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"71"}],"units":"Participants"}],"title":"Change at Week 4"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.16","value":"-0.23"},{"comment":"Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.\n\nIndividual values were -1, 0, -1, 0, -3, 1, 0, -1 and -1.","groupId":"OG001","spread":"NA","value":"NA"},{"comment":"Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.\n\nIndividual values was 1.","groupId":"OG002","spread":"NA","value":"NA"},{"groupId":"OG003","spread":"0.17","value":"-0.56"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"71"}],"units":"Participants"}],"title":"Change at Week 8"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.16","value":"-0.16"},{"comment":"Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.\n\nIndividual values were -2, 0, -3, 1, 0 and -1.","groupId":"OG001","spread":"NA","value":"NA"},{"groupId":"OG003","spread":"0.17","value":"-0.32"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"71"}],"units":"Participants"}],"title":"Change at Week 16"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.18","value":"-0.19"},{"comment":"Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.\n\nIndividual values were -1, 0, -3, 1, 2 and -1.","groupId":"OG001","spread":"NA","value":"NA"},{"groupId":"OG003","spread":"0.17","value":"-0.29"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"71"}],"units":"Participants"}],"title":"Change at Week 24"}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"71"}],"units":"Participants"}],"description":"Participants at specified time points, answered to the following question, \"Considering all the ways your cancer pain affects you, how are you doing today?\" on a Likert scale ranging from 1 to 5, on IRT diaries. Scores: 1= very good (asymptomatic and no limitation of normal activities); 2= good (mild symptoms and no limitation of normal activities); 3= fair (moderate symptoms and limitation of some normal activities); 4= poor (severe symptoms and inability to carry out most normal activities); and 5= very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores signified worsening of condition.","dispersionType":"Standard Error","groups":[{"description":"Participants received placebo matched to tanezumab SC once every 8 weeks for 24 weeks.","id":"OG000","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":"OG001","title":"Tanezumab 10mg"},{"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":"OG002","title":"Tanezumab 10/20 mg"},{"description":"Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks.","id":"OG003","title":"Tanezumab 20 mg"}],"paramType":"LEAST_SQUARES_MEAN","populationDescription":"The mITT analysis set: participants randomized to tanezumab 20 mg or placebo SC, received at least 1dose of SC study medication. Multiple imputation method was applied. As planned summarized efficacy data for tanezumab 10 mg and 10/20 mg arms not reported; for these 2 arms individual values are reported. Here, \"Overall Number of Participants Analyzed\" signifies participants evaluable for this outcome measure and ''number analyzed'' signifies participants evaluable at specified time points.","reportingStatus":"POSTED","timeFrame":"Baseline, Weeks 2, 4, 8, 16 and 24","title":"Change From Baseline in Participant's Global Assessment of Cancer Pain (PGA-CP) at Weeks 2, 4, 8, 16 and 24","type":"SECONDARY","unitOfMeasure":"Units on a scale"}