{"analyses":[{"ciLowerLimit":"-0.49","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.38","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.22","groupDescription":"Week 2 Frequency Composite Score: Mixed model for repeated measurements (MMRM) model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\\*time interaction, baseline OR-SDS frequency scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.","groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.8069","paramType":"Difference in LS mean","paramValue":"-0.05","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-0.28","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.41","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.17","groupDescription":"Week 4 Frequency Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\\*time interaction, baseline OR-SDS frequency scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.","groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.7127","paramType":"Difference in LS mean","paramValue":"0.06","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-0.57","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.23","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.20","groupDescription":"Week 8 Frequency Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\\*time interaction, baseline OR-SDS frequency scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.","groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.3933","paramType":"Difference in LS mean","paramValue":"-0.17","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-0.71","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.41","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.28","groupDescription":"Week 16 Frequency Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\\*time interaction, baseline OR-SDS frequency scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.","groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.5869","paramType":"Difference in LS mean","paramValue":"-0.15","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-1.05","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.21","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.30","groupDescription":"Week 24 Frequency Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\\*time interaction, baseline OR-SDS frequency scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.","groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.1814","paramType":"Difference in LS mean","paramValue":"-0.42","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-0.14","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.46","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.15","groupDescription":"Week 2 Severity Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\\*time interaction, baseline OR-SDS severity scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.","groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.2822","paramType":"Difference in LS mean","paramValue":"0.16","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-0.23","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.41","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.16","groupDescription":"Week 4 Severity Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\\*time interaction, baseline OR-SDS severity scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.","groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.5795","paramType":"Difference in LS mean","paramValue":"0.09","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-0.42","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.22","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.16","groupDescription":"Week 8 Severity Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\\*time interaction, baseline OR-SDS severity scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.","groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.5486","paramType":"Difference in LS mean","paramValue":"-0.10","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-0.24","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.63","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.22","groupDescription":"Week 16 Severity Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\\*time interaction, baseline OR-SDS severity scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.","groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.3692","paramType":"Difference in LS mean","paramValue":"0.20","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-0.30","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.63","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.23","groupDescription":"Week 24 Severity Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\\*time interaction, baseline OR-SDS severity scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.","groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.4724","paramType":"Difference in LS mean","paramValue":"0.17","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-0.30","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.64","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.23","groupDescription":"Week 2 Distress Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\\*time interaction, baseline OR-SDS distress scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.","groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.4770","paramType":"Difference in LS mean","paramValue":"0.17","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-0.38","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.37","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.18","groupDescription":"Week 4 Distress Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\\*time interaction, baseline OR-SDS distress scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.","groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.9791","paramType":"Difference in LS mean","paramValue":"-0.00","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-0.27","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.74","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.25","groupDescription":"Week 8 Distress Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\\*time interaction, baseline OR-SDS distress scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.","groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.3574","paramType":"Difference in LS mean","paramValue":"0.23","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-0.77","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.42","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.29","groupDescription":"Week 16 Distress Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\\*time interaction, baseline OR-SDS distress scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.","groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.5607","paramType":"Difference in LS mean","paramValue":"0.17","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-0.68","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.47","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.28","groupDescription":"Week 24 Distress Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\\*time interaction, baseline OR-SDS distress scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.","groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.7143","paramType":"Difference in LS mean","paramValue":"-0.10","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-0.28","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.45","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.18","groupDescription":"Week 2 MDA Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\\*time interaction, baseline OR-SDS MDA scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.","groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.6381","paramType":"Difference in LS mean","paramValue":"0.09","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-0.25","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.37","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.15","groupDescription":"Week 4 MDA Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\\*time interaction, baseline OR-SDS MDA scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.","groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.7181","paramType":"Difference in LS mean","paramValue":"0.06","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-0.38","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.31","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.17","groupDescription":"Week 8 MDA Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\\*time interaction, baseline OR-SDS MDA scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.","groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.8378","paramType":"Difference in least square (LS) mean","paramValue":"-0.04","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-0.52","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.40","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.23","groupDescription":"Week 16 MDA Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\\*time interaction, baseline OR-SDS MDA scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.","groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.7950","paramType":"Difference in LS mean","paramValue":"-0.06","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-0.62","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.40","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.25","groupDescription":"Week 24 MDA Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\\*time interaction, baseline OR-SDS MDA scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.","groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.6719","paramType":"Difference in LS mean","paramValue":"-0.11","statisticalMethod":"Mixed Models Analysis"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.16","value":"-0.06"},{"comment":"Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.\n\nIndividual values were -1 and -0.6.","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 -1.33.","groupId":"OG002","spread":"NA","value":"NA"},{"groupId":"OG003","spread":"0.17","value":"-0.11"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"72"}],"units":"Participants"}],"title":"Change at Week 2: Frequency Composite Score"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.11","value":"-0.18"},{"comment":"Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.\n\nIndividual values were 0 and 0.2.","groupId":"OG001","spread":"NA","value":"NA"},{"comment":"Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.\n\nIndividual values was -0.83.","groupId":"OG002","spread":"NA","value":"NA"},{"groupId":"OG003","spread":"0.12","value":"-0.02"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"72"}],"units":"Participants"}],"title":"Change at Week 2: Severity Composite Score"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.18","value":"-0.08"},{"comment":"Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.\n\nIndividual values were -1 and -0.25.","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 0.17.","groupId":"OG002","spread":"NA","value":"NA"},{"groupId":"OG003","spread":"0.19","value":"0.09"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"72"}],"units":"Participants"}],"title":"Change at Week 2: Distress Composite Score"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.14","value":"-0.10"},{"comment":"Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.\n\nIndividual values were -0.67 and -0.22.","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 -0.67.","groupId":"OG002","spread":"NA","value":"NA"},{"groupId":"OG003","spread":"0.15","value":"-0.02"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"72"}],"units":"Participants"}],"title":"Change at Week 2: MDA Composite Score"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.14","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 -0.8.","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 -1.5.","groupId":"OG002","spread":"NA","value":"NA"},{"groupId":"OG003","spread":"0.14","value":"-0.12"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"72"}],"units":"Participants"}],"title":"Change at Week 4: Frequency Composite Score"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.12","value":"-0.10"},{"comment":"Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.\n\nIndividual values were 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.\n\nIndividual values was -0.5.","groupId":"OG002","spread":"NA","value":"NA"},{"groupId":"OG003","spread":"0.13","value":"-0.01"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"72"}],"units":"Participants"}],"title":"Change at Week 4: Severity Composite Score"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.15","value":"0.12"},{"comment":"Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.\n\nIndividual values were -0.25.","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":"0.15","value":"0.11"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"72"}],"units":"Participants"}],"title":"Change at Week 4: Distress Composite Score"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.12","value":"-0.06"},{"comment":"Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.\n\nIndividual values were -0.35.","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 -0.67.","groupId":"OG002","spread":"NA","value":"NA"},{"groupId":"OG003","spread":"0.13","value":"-0.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"72"}],"units":"Participants"}],"title":"Change at Week 4: MDA Composite Score"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.15","value":"0.07"},{"comment":"Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.\n\nIndividual values were -1 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.\n\nIndividual values was -1.","groupId":"OG002","spread":"NA","value":"NA"},{"groupId":"OG003","spread":"0.16","value":"-0.10"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"72"}],"units":"Participants"}],"title":"Change at Week 8: Frequency Composite Score"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.12","value":"-0.07"},{"comment":"Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.\n\nIndividual values were 0 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.\n\nIndividual values was -0.75.","groupId":"OG002","spread":"NA","value":"NA"},{"groupId":"OG003","spread":"0.13","value":"-0.17"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"72"}],"units":"Participants"}],"title":"Change at Week 8: Severity Composite Score"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.19","value":"0.03"},{"comment":"Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.\n\nIndividual values were -1 and -0.25.","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 0.25.","groupId":"OG002","spread":"NA","value":"NA"},{"groupId":"OG003","spread":"0.20","value":"0.26"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"72"}],"units":"Participants"}],"title":"Change at Week 8: Distress Composite Score"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.13","value":"0.02"},{"comment":"Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.\n\nIndividual values were -0.67 and -0.08.","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 -0.5.","groupId":"OG002","spread":"NA","value":"NA"},{"groupId":"OG003","spread":"0.14","value":"-0.02"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"72"}],"units":"Participants"}],"title":"Change at Week 8: MDA Composite Score"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.19","value":"0.08"},{"comment":"Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.\n\nIndividual values were -1.","groupId":"OG001","spread":"NA","value":"NA"},{"groupId":"OG003","spread":"0.22","value":"-0.07"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"72"}],"units":"Participants"}],"title":"Change at Week 16: Frequency Composite Score"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.15","value":"-0.12"},{"comment":"Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.\n\nIndividual values were 0.","groupId":"OG001","spread":"NA","value":"NA"},{"groupId":"OG003","spread":"0.17","value":"0.08"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"72"}],"units":"Participants"}],"title":"Change at Week 16: Severity Composite Score"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.20","value":"0.10"},{"comment":"Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.\n\nIndividual values were -0.75.","groupId":"OG001","spread":"NA","value":"NA"},{"groupId":"OG003","spread":"0.24","value":"-0.07"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"72"}],"units":"Participants"}],"title":"Change at Week 16: Distress Composite Score"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.16","value":"0.02"},{"comment":"Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.\n\nIndividual values were -0.58.","groupId":"OG001","spread":"NA","value":"NA"},{"groupId":"OG003","spread":"0.19","value":"-0.04"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"72"}],"units":"Participants"}],"title":"Change at Week 16: MDA Composite Score"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.21","value":"0.29"},{"groupId":"OG003","spread":"0.24","value":"-0.13"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"72"}],"units":"Participants"}],"title":"Change at Week 24: Frequency Composite Score"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.17","value":"-0.01"},{"groupId":"OG003","spread":"0.18","value":"0.16"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"72"}],"units":"Participants"}],"title":"Change at Week 24: Severity Composite Score"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.21","value":"0.33"},{"groupId":"OG003","spread":"0.23","value":"0.22"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"72"}],"units":"Participants"}],"title":"Change at Week 24: Distress Composite Score"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.18","value":"0.17"},{"groupId":"OG003","spread":"0.20","value":"0.07"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"72"}],"units":"Participants"}],"title":"Change at Week 24: MDA Composite Score"}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"72"}],"units":"Participants"}],"description":"OR-SDS: questionnaire evaluated opioid-related 12 symptoms. For each symptom, participants assigned integer scores to assess severity (none =0 to very severe =4), distress (none =0 to very much =5), and frequency (none =0 to almost constantly =4; participants reported number of retching/vomiting episodes (none =0, 1-2 episodes =1, 3-4 episodes =2, 5-6 episodes =3, \\>6 episodes =4). Frequency composite score: mean of frequency scores from all symptoms, ranged from 0 (none) to 4 (almost constantly); higher scores = worse condition. Severity composite score: mean of severity scores from all 12 symptoms, ranged from 0 (none) to 4 (maximum severity); higher scores = worse condition. Distress composite score: mean of distress scores from all 12 symptoms, ranged from 0 (none) to 5 (maximum distress); higher scores = worse condition. Multi domain average (MDA): average of each symptom for frequency, severity, and distress; ranged from 0 (none) to 4.34 (worse); higher scores = worse 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 the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24","type":"SECONDARY","unitOfMeasure":"Units on a scale"}