{"analyses":[{"ciLowerLimit":"-0.73","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.07","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.20","groupDescription":"Change at Week 1: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.","groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.1103","paramType":"Difference in LS mean","paramValue":"-0.33","statisticalMethod":"ANCOVA"},{"ciLowerLimit":"-1.26","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-0.19","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.27","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 average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.","groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0084","paramType":"Difference in LS mean","paramValue":"-0.73","statisticalMethod":"ANCOVA"},{"ciLowerLimit":"-1.39","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-0.10","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.33","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 average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.","groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0236","paramType":"Difference in LS mean","paramValue":"-0.75","statisticalMethod":"ANCOVA"},{"ciLowerLimit":"-1.59","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-0.17","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.36","groupDescription":"Change at Week 6: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.","groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0155","paramType":"Difference in LS mean","paramValue":"-0.88","statisticalMethod":"ANCOVA"},{"ciLowerLimit":"-1.52","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.00","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.38","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 average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.","groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0505","paramType":"Difference in LS mean","paramValue":"-0.76","statisticalMethod":"ANCOVA"},{"ciLowerLimit":"-1.52","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.08","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.40","groupDescription":"Change at Week 12: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.","groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0761","paramType":"Difference in LS mean","paramValue":"-0.72","statisticalMethod":"ANCOVA"},{"ciLowerLimit":"-1.70","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.21","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.48","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 average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.","groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.1263","paramType":"Difference in LS mean","paramValue":"-0.74","statisticalMethod":"ANCOVA"},{"ciLowerLimit":"-1.76","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.17","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.49","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 average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.","groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.1051","paramType":"Difference in LS mean","paramValue":"-0.79","statisticalMethod":"ANCOVA"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.18","value":"-0.52"},{"comment":"Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE. Individual values were 0.4, 0.2, -2.85, -0.4, -1.8, -0.4, 0, 0.45 and 0.","groupId":"OG001","spread":"NA","value":"NA"},{"comment":"Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE. Individual value was -1.42.","groupId":"OG002","spread":"NA","value":"NA"},{"groupId":"OG003","spread":"0.19","value":"-0.84"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"72"}],"units":"Participants"}],"title":"Change at Week 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.25","value":"-0.74"},{"comment":"Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE. Individual values were 0.4, -0.08, -4, -0.25, -2.37, -0.4, 0, 0.6 and 0.","groupId":"OG001","spread":"NA","value":"NA"},{"comment":"Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE. Individual value was -1.57","groupId":"OG002","spread":"NA","value":"NA"},{"groupId":"OG003","spread":"0.25","value":"-1.47"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"72"}],"units":"Participants"}],"title":"Change at Week 2"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.30","value":"-1.14"},{"comment":"Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE. Individual values were -0.02, -0.51, -1.85, -0.4, -4.08, -1.4, 0, 0.02 and -1.14.","groupId":"OG001","spread":"NA","value":"NA"},{"comment":"Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE. Individual value was -1.42.","groupId":"OG002","spread":"NA","value":"NA"},{"groupId":"OG003","spread":"0.31","value":"-1.88"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"72"}],"units":"Participants"}],"title":"Change at Week 4"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.33","value":"-1.20"},{"comment":"Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE. Individual values were -2.74, -0.94, -0.54, -2.94, -1.97, -3, -0.4 and -2.","groupId":"OG001","spread":"NA","value":"NA"},{"comment":"Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE. Individual value was -1.14.","groupId":"OG002","spread":"NA","value":"NA"},{"groupId":"OG003","spread":"0.34","value":"-2.08"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"72"}],"units":"Participants"}],"title":"Change at Week 6"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.36","value":"-1.38"},{"comment":"Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE. Individual values were -4.6, -1.51, -0.4, -3.65, -2.4, -3, -0.25 and -2.","groupId":"OG001","spread":"NA","value":"NA"},{"comment":"Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE. Individual value was -0.85.","groupId":"OG002","spread":"NA","value":"NA"},{"groupId":"OG003","spread":"0.37","value":"-2.14"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"72"}],"units":"Participants"}],"title":"Change at Week 8"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.36","value":"-1.53"},{"comment":"Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE. Individual values were -4.63, -1.8, -3.5, 0.6, -2.22, -2.4, -1.75, 0.1 and -2.75.","groupId":"OG001","spread":"NA","value":"NA"},{"comment":"Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE. Individual value was -2.","groupId":"OG002","spread":"NA","value":"NA"},{"groupId":"OG003","spread":"0.38","value":"-2.25"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"72"}],"units":"Participants"}],"title":"Change at Week 12"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.44","value":"-1.32"},{"comment":"Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE. Individual values were -4.6, -2.3, -1.3, -1.9, -1, -0.73 and -3.","groupId":"OG001","spread":"NA","value":"NA"},{"groupId":"OG003","spread":"0.43","value":"-2.06"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"72"}],"units":"Participants"}],"title":"Change at Week 16"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.44","value":"-1.10"},{"comment":"Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE. Individual values were -4.93, -1.8, -2.55, -1.15, -5.4 and -3.","groupId":"OG001","spread":"NA","value":"NA"},{"groupId":"OG003","spread":"0.45","value":"-1.90"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"72"}],"units":"Participants"}],"title":"Change at Week 24"}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"72"}],"units":"Participants"}],"description":"Daily worst pain intensity in the index bone metastasis cancer pain site is assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), higher scores signified more severity of pain. The participants describe their daily worst pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline daily worst pain intensity was mean of daily worst pain intensity NRS score during the baseline assessment period prior to randomization. Baseline assessment period was up to 5 days prior to dosing. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 daily worst pain intensity value was the mean of the daily worst pain intensity NRS scores recorded for each of the 7 days prior to the each specified week.","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 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":"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, ''number analyzed'' signifies participants evaluable at specified time points.","reportingStatus":"POSTED","timeFrame":"Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24","title":"Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24","type":"SECONDARY","unitOfMeasure":"Units on a scale"}