Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24
Phase 3 Study on the Efficacy and Safety of Tanezumab in Patients With Cancer Pain Due to Bone Metastasis Who Are Taking Background Opioid Therapy · Source last updated 2023-02-16
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
LEAST_SQUARES_MEAN
Unit
Units on a scale
Interval / dispersion
Standard Error
Time frame
Baseline, Weeks 2, 4, 8, 16, and 24
What was measured
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.
Analysis population: 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.
Groups in this outcome
Placebo
Participants received placebo matched to tanezumab SC once every 8 weeks for 24 weeks.
Tanezumab 10mg
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.
Tanezumab 10/20 mg
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.
Tanezumab 20 mg
Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Placebo
73
Tanezumab 10mg
2
Tanezumab 10/20 mg
1
Tanezumab 20 mg
72
Reported measurements
Change at Week 2: Frequency Composite Score
Analysis denominator · Participants
Group
Source count
Placebo
73
Tanezumab 10mg
2
Tanezumab 10/20 mg
1
Tanezumab 20 mg
72
Values in Units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Placebo
-0.06
0.16
Not reported
Not reported
Not reported
Tanezumab 10mg
NA
NA
Not reported
Not reported
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values were -1 and -0.6.
Tanezumab 10/20 mg
NA
NA
Not reported
Not reported
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values was -1.33.
Tanezumab 20 mg
-0.11
0.17
Not reported
Not reported
Not reported
Change at Week 2: Severity Composite Score
Analysis denominator · Participants
Group
Source count
Placebo
73
Tanezumab 10mg
2
Tanezumab 10/20 mg
1
Tanezumab 20 mg
72
Values in Units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Placebo
-0.18
0.11
Not reported
Not reported
Not reported
Tanezumab 10mg
NA
NA
Not reported
Not reported
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values were 0 and 0.2.
Tanezumab 10/20 mg
NA
NA
Not reported
Not reported
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values was -0.83.
Tanezumab 20 mg
-0.02
0.12
Not reported
Not reported
Not reported
Change at Week 2: Distress Composite Score
Analysis denominator · Participants
Group
Source count
Placebo
73
Tanezumab 10mg
2
Tanezumab 10/20 mg
1
Tanezumab 20 mg
72
Values in Units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Placebo
-0.08
0.18
Not reported
Not reported
Not reported
Tanezumab 10mg
NA
NA
Not reported
Not reported
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values were -1 and -0.25.
Tanezumab 10/20 mg
NA
NA
Not reported
Not reported
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values was 0.17.
Tanezumab 20 mg
0.09
0.19
Not reported
Not reported
Not reported
Change at Week 2: MDA Composite Score
Analysis denominator · Participants
Group
Source count
Placebo
73
Tanezumab 10mg
2
Tanezumab 10/20 mg
1
Tanezumab 20 mg
72
Values in Units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Placebo
-0.10
0.14
Not reported
Not reported
Not reported
Tanezumab 10mg
NA
NA
Not reported
Not reported
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values were -0.67 and -0.22.
Tanezumab 10/20 mg
NA
NA
Not reported
Not reported
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values was -0.67.
Tanezumab 20 mg
-0.02
0.15
Not reported
Not reported
Not reported
Change at Week 4: Frequency Composite Score
Analysis denominator · Participants
Group
Source count
Placebo
73
Tanezumab 10mg
1
Tanezumab 10/20 mg
1
Tanezumab 20 mg
72
Values in Units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Placebo
-0.19
0.14
Not reported
Not reported
Not reported
Tanezumab 10mg
NA
NA
Not reported
Not reported
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values were -0.8.
Tanezumab 10/20 mg
NA
NA
Not reported
Not reported
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values was -1.5.
Tanezumab 20 mg
-0.12
0.14
Not reported
Not reported
Not reported
Change at Week 4: Severity Composite Score
Analysis denominator · Participants
Group
Source count
Placebo
73
Tanezumab 10mg
1
Tanezumab 10/20 mg
1
Tanezumab 20 mg
72
Values in Units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Placebo
-0.10
0.12
Not reported
Not reported
Not reported
Tanezumab 10mg
NA
NA
Not reported
Not reported
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values were 0.
Tanezumab 10/20 mg
NA
NA
Not reported
Not reported
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values was -0.5.
Tanezumab 20 mg
-0.01
0.13
Not reported
Not reported
Not reported
Change at Week 4: Distress Composite Score
Analysis denominator · Participants
Group
Source count
Placebo
73
Tanezumab 10mg
1
Tanezumab 10/20 mg
1
Tanezumab 20 mg
72
Values in Units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Placebo
0.12
0.15
Not reported
Not reported
Not reported
Tanezumab 10mg
NA
NA
Not reported
Not reported
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values were -0.25.
Tanezumab 10/20 mg
NA
NA
Not reported
Not reported
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values was 0.
Tanezumab 20 mg
0.11
0.15
Not reported
Not reported
Not reported
Change at Week 4: MDA Composite Score
Analysis denominator · Participants
Group
Source count
Placebo
73
Tanezumab 10mg
1
Tanezumab 10/20 mg
1
Tanezumab 20 mg
72
Values in Units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Placebo
-0.06
0.12
Not reported
Not reported
Not reported
Tanezumab 10mg
NA
NA
Not reported
Not reported
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values were -0.35.
Tanezumab 10/20 mg
NA
NA
Not reported
Not reported
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values was -0.67.
Tanezumab 20 mg
-0.00
0.13
Not reported
Not reported
Not reported
Change at Week 8: Frequency Composite Score
Analysis denominator · Participants
Group
Source count
Placebo
73
Tanezumab 10mg
2
Tanezumab 10/20 mg
1
Tanezumab 20 mg
72
Values in Units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Placebo
0.07
0.15
Not reported
Not reported
Not reported
Tanezumab 10mg
NA
NA
Not reported
Not reported
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values were -1 and 0.
Tanezumab 10/20 mg
NA
NA
Not reported
Not reported
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values was -1.
Tanezumab 20 mg
-0.10
0.16
Not reported
Not reported
Not reported
Change at Week 8: Severity Composite Score
Analysis denominator · Participants
Group
Source count
Placebo
73
Tanezumab 10mg
2
Tanezumab 10/20 mg
1
Tanezumab 20 mg
72
Values in Units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Placebo
-0.07
0.12
Not reported
Not reported
Not reported
Tanezumab 10mg
NA
NA
Not reported
Not reported
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values were 0 and 0.
Tanezumab 10/20 mg
NA
NA
Not reported
Not reported
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values was -0.75.
Tanezumab 20 mg
-0.17
0.13
Not reported
Not reported
Not reported
Change at Week 8: Distress Composite Score
Analysis denominator · Participants
Group
Source count
Placebo
73
Tanezumab 10mg
2
Tanezumab 10/20 mg
1
Tanezumab 20 mg
72
Values in Units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Placebo
0.03
0.19
Not reported
Not reported
Not reported
Tanezumab 10mg
NA
NA
Not reported
Not reported
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values were -1 and -0.25.
Tanezumab 10/20 mg
NA
NA
Not reported
Not reported
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values was 0.25.
Tanezumab 20 mg
0.26
0.20
Not reported
Not reported
Not reported
Change at Week 8: MDA Composite Score
Analysis denominator · Participants
Group
Source count
Placebo
73
Tanezumab 10mg
2
Tanezumab 10/20 mg
1
Tanezumab 20 mg
72
Values in Units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Placebo
0.02
0.13
Not reported
Not reported
Not reported
Tanezumab 10mg
NA
NA
Not reported
Not reported
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values were -0.67 and -0.08.
Tanezumab 10/20 mg
NA
NA
Not reported
Not reported
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values was -0.5.
Tanezumab 20 mg
-0.02
0.14
Not reported
Not reported
Not reported
Change at Week 16: Frequency Composite Score
Analysis denominator · Participants
Group
Source count
Placebo
73
Tanezumab 10mg
1
Tanezumab 10/20 mg
0
Tanezumab 20 mg
72
Values in Units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Placebo
0.08
0.19
Not reported
Not reported
Not reported
Tanezumab 10mg
NA
NA
Not reported
Not reported
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values were -1.
Tanezumab 20 mg
-0.07
0.22
Not reported
Not reported
Not reported
Change at Week 16: Severity Composite Score
Analysis denominator · Participants
Group
Source count
Placebo
73
Tanezumab 10mg
1
Tanezumab 10/20 mg
0
Tanezumab 20 mg
72
Values in Units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Placebo
-0.12
0.15
Not reported
Not reported
Not reported
Tanezumab 10mg
NA
NA
Not reported
Not reported
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values were 0.
Tanezumab 20 mg
0.08
0.17
Not reported
Not reported
Not reported
Change at Week 16: Distress Composite Score
Analysis denominator · Participants
Group
Source count
Placebo
73
Tanezumab 10mg
1
Tanezumab 10/20 mg
0
Tanezumab 20 mg
72
Values in Units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Placebo
0.10
0.20
Not reported
Not reported
Not reported
Tanezumab 10mg
NA
NA
Not reported
Not reported
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values were -0.75.
Tanezumab 20 mg
-0.07
0.24
Not reported
Not reported
Not reported
Change at Week 16: MDA Composite Score
Analysis denominator · Participants
Group
Source count
Placebo
73
Tanezumab 10mg
1
Tanezumab 10/20 mg
0
Tanezumab 20 mg
72
Values in Units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Placebo
0.02
0.16
Not reported
Not reported
Not reported
Tanezumab 10mg
NA
NA
Not reported
Not reported
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values were -0.58.
Tanezumab 20 mg
-0.04
0.19
Not reported
Not reported
Not reported
Change at Week 24: Frequency Composite Score
Analysis denominator · Participants
Group
Source count
Placebo
73
Tanezumab 10mg
0
Tanezumab 10/20 mg
0
Tanezumab 20 mg
72
Values in Units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Placebo
0.29
0.21
Not reported
Not reported
Not reported
Tanezumab 20 mg
-0.13
0.24
Not reported
Not reported
Not reported
Change at Week 24: Severity Composite Score
Analysis denominator · Participants
Group
Source count
Placebo
73
Tanezumab 10mg
0
Tanezumab 10/20 mg
0
Tanezumab 20 mg
72
Values in Units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Placebo
-0.01
0.17
Not reported
Not reported
Not reported
Tanezumab 20 mg
0.16
0.18
Not reported
Not reported
Not reported
Change at Week 24: Distress Composite Score
Analysis denominator · Participants
Group
Source count
Placebo
73
Tanezumab 10mg
0
Tanezumab 10/20 mg
0
Tanezumab 20 mg
72
Values in Units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Placebo
0.33
0.21
Not reported
Not reported
Not reported
Tanezumab 20 mg
0.22
0.23
Not reported
Not reported
Not reported
Change at Week 24: MDA Composite Score
Analysis denominator · Participants
Group
Source count
Placebo
73
Tanezumab 10mg
0
Tanezumab 10/20 mg
0
Tanezumab 20 mg
72
Values in Units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Placebo
0.17
0.18
Not reported
Not reported
Not reported
Tanezumab 20 mg
0.07
0.20
Not reported
Not reported
Not reported
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
ci Lower Limit
-0.49
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.38
dispersion Type
STANDARD_ERROR_OF_MEAN
dispersion Value
0.22
group Description
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.
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.8069
param Type
Difference in LS mean
param Value
-0.05
statistical Method
Mixed Models Analysis
ci Lower Limit
-0.28
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.41
dispersion Type
STANDARD_ERROR_OF_MEAN
dispersion Value
0.17
group Description
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.
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.7127
param Type
Difference in LS mean
param Value
0.06
statistical Method
Mixed Models Analysis
ci Lower Limit
-0.57
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.23
dispersion Type
STANDARD_ERROR_OF_MEAN
dispersion Value
0.20
group Description
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.
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.3933
param Type
Difference in LS mean
param Value
-0.17
statistical Method
Mixed Models Analysis
ci Lower Limit
-0.71
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.41
dispersion Type
STANDARD_ERROR_OF_MEAN
dispersion Value
0.28
group Description
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.
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.5869
param Type
Difference in LS mean
param Value
-0.15
statistical Method
Mixed Models Analysis
ci Lower Limit
-1.05
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.21
dispersion Type
STANDARD_ERROR_OF_MEAN
dispersion Value
0.30
group Description
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.
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.1814
param Type
Difference in LS mean
param Value
-0.42
statistical Method
Mixed Models Analysis
ci Lower Limit
-0.14
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.46
dispersion Type
STANDARD_ERROR_OF_MEAN
dispersion Value
0.15
group Description
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.
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.2822
param Type
Difference in LS mean
param Value
0.16
statistical Method
Mixed Models Analysis
ci Lower Limit
-0.23
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.41
dispersion Type
STANDARD_ERROR_OF_MEAN
dispersion Value
0.16
group Description
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.
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.5795
param Type
Difference in LS mean
param Value
0.09
statistical Method
Mixed Models Analysis
ci Lower Limit
-0.42
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.22
dispersion Type
STANDARD_ERROR_OF_MEAN
dispersion Value
0.16
group Description
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.
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.5486
param Type
Difference in LS mean
param Value
-0.10
statistical Method
Mixed Models Analysis
ci Lower Limit
-0.24
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.63
dispersion Type
STANDARD_ERROR_OF_MEAN
dispersion Value
0.22
group Description
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.
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.3692
param Type
Difference in LS mean
param Value
0.20
statistical Method
Mixed Models Analysis
ci Lower Limit
-0.30
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.63
dispersion Type
STANDARD_ERROR_OF_MEAN
dispersion Value
0.23
group Description
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.
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.4724
param Type
Difference in LS mean
param Value
0.17
statistical Method
Mixed Models Analysis
ci Lower Limit
-0.30
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.64
dispersion Type
STANDARD_ERROR_OF_MEAN
dispersion Value
0.23
group Description
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.
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.4770
param Type
Difference in LS mean
param Value
0.17
statistical Method
Mixed Models Analysis
ci Lower Limit
-0.38
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.37
dispersion Type
STANDARD_ERROR_OF_MEAN
dispersion Value
0.18
group Description
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.
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.9791
param Type
Difference in LS mean
param Value
-0.00
statistical Method
Mixed Models Analysis
Complete source fields
analyses
ci Lower Limit
-0.49
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.38
dispersion Type
STANDARD_ERROR_OF_MEAN
dispersion Value
0.22
group Description
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.
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.8069
param Type
Difference in LS mean
param Value
-0.05
statistical Method
Mixed Models Analysis
ci Lower Limit
-0.28
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.41
dispersion Type
STANDARD_ERROR_OF_MEAN
dispersion Value
0.17
group Description
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.
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.7127
param Type
Difference in LS mean
param Value
0.06
statistical Method
Mixed Models Analysis
ci Lower Limit
-0.57
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.23
dispersion Type
STANDARD_ERROR_OF_MEAN
dispersion Value
0.20
group Description
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.
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.3933
param Type
Difference in LS mean
param Value
-0.17
statistical Method
Mixed Models Analysis
ci Lower Limit
-0.71
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.41
dispersion Type
STANDARD_ERROR_OF_MEAN
dispersion Value
0.28
group Description
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.
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.5869
param Type
Difference in LS mean
param Value
-0.15
statistical Method
Mixed Models Analysis
ci Lower Limit
-1.05
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.21
dispersion Type
STANDARD_ERROR_OF_MEAN
dispersion Value
0.30
group Description
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.
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.1814
param Type
Difference in LS mean
param Value
-0.42
statistical Method
Mixed Models Analysis
ci Lower Limit
-0.14
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.46
dispersion Type
STANDARD_ERROR_OF_MEAN
dispersion Value
0.15
group Description
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.
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.2822
param Type
Difference in LS mean
param Value
0.16
statistical Method
Mixed Models Analysis
ci Lower Limit
-0.23
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.41
dispersion Type
STANDARD_ERROR_OF_MEAN
dispersion Value
0.16
group Description
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.
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.5795
param Type
Difference in LS mean
param Value
0.09
statistical Method
Mixed Models Analysis
ci Lower Limit
-0.42
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.22
dispersion Type
STANDARD_ERROR_OF_MEAN
dispersion Value
0.16
group Description
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.
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.5486
param Type
Difference in LS mean
param Value
-0.10
statistical Method
Mixed Models Analysis
ci Lower Limit
-0.24
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.63
dispersion Type
STANDARD_ERROR_OF_MEAN
dispersion Value
0.22
group Description
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.
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.3692
param Type
Difference in LS mean
param Value
0.20
statistical Method
Mixed Models Analysis
ci Lower Limit
-0.30
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.63
dispersion Type
STANDARD_ERROR_OF_MEAN
dispersion Value
0.23
group Description
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.
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.4724
param Type
Difference in LS mean
param Value
0.17
statistical Method
Mixed Models Analysis
ci Lower Limit
-0.30
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.64
dispersion Type
STANDARD_ERROR_OF_MEAN
dispersion Value
0.23
group Description
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.
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.4770
param Type
Difference in LS mean
param Value
0.17
statistical Method
Mixed Models Analysis
ci Lower Limit
-0.38
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.37
dispersion Type
STANDARD_ERROR_OF_MEAN
dispersion Value
0.18
group Description
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.
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.9791
param Type
Difference in LS mean
param Value
-0.00
statistical Method
Mixed Models Analysis
classes
categories
measurements
group Id
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.
Individual values were -1 and -0.6.
group Id
OG001
spread
NA
value
NA
comment
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values was -1.33.
group Id
OG002
spread
NA
value
NA
group Id
OG003
spread
0.17
value
-0.11
denoms
counts
group Id
OG000
value
73
group Id
OG001
value
2
group Id
OG002
value
1
group Id
OG003
value
72
units
Participants
title
Change at Week 2: Frequency Composite Score
categories
measurements
group Id
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.
Individual values were 0 and 0.2.
group Id
OG001
spread
NA
value
NA
comment
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values was -0.83.
group Id
OG002
spread
NA
value
NA
group Id
OG003
spread
0.12
value
-0.02
denoms
counts
group Id
OG000
value
73
group Id
OG001
value
2
group Id
OG002
value
1
group Id
OG003
value
72
units
Participants
title
Change at Week 2: Severity Composite Score
categories
measurements
group Id
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.
Individual values were -1 and -0.25.
group Id
OG001
spread
NA
value
NA
comment
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values was 0.17.
group Id
OG002
spread
NA
value
NA
group Id
OG003
spread
0.19
value
0.09
denoms
counts
group Id
OG000
value
73
group Id
OG001
value
2
group Id
OG002
value
1
group Id
OG003
value
72
units
Participants
title
Change at Week 2: Distress Composite Score
categories
measurements
group Id
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.
Individual values were -0.67 and -0.22.
group Id
OG001
spread
NA
value
NA
comment
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values was -0.67.
group Id
OG002
spread
NA
value
NA
group Id
OG003
spread
0.15
value
-0.02
denoms
counts
group Id
OG000
value
73
group Id
OG001
value
2
group Id
OG002
value
1
group Id
OG003
value
72
units
Participants
title
Change at Week 2: MDA Composite Score
categories
measurements
group Id
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.
Individual values were -0.8.
group Id
OG001
spread
NA
value
NA
comment
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values was -1.5.
group Id
OG002
spread
NA
value
NA
group Id
OG003
spread
0.14
value
-0.12
denoms
counts
group Id
OG000
value
73
group Id
OG001
value
1
group Id
OG002
value
1
group Id
OG003
value
72
units
Participants
title
Change at Week 4: Frequency Composite Score
categories
measurements
group Id
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.
Individual values were 0.
group Id
OG001
spread
NA
value
NA
comment
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values was -0.5.
group Id
OG002
spread
NA
value
NA
group Id
OG003
spread
0.13
value
-0.01
denoms
counts
group Id
OG000
value
73
group Id
OG001
value
1
group Id
OG002
value
1
group Id
OG003
value
72
units
Participants
title
Change at Week 4: Severity Composite Score
categories
measurements
group Id
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.
Individual values were -0.25.
group Id
OG001
spread
NA
value
NA
comment
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values was 0.
group Id
OG002
spread
NA
value
NA
group Id
OG003
spread
0.15
value
0.11
denoms
counts
group Id
OG000
value
73
group Id
OG001
value
1
group Id
OG002
value
1
group Id
OG003
value
72
units
Participants
title
Change at Week 4: Distress Composite Score
categories
measurements
group Id
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.
Individual values were -0.35.
group Id
OG001
spread
NA
value
NA
comment
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values was -0.67.
group Id
OG002
spread
NA
value
NA
group Id
OG003
spread
0.13
value
-0.00
denoms
counts
group Id
OG000
value
73
group Id
OG001
value
1
group Id
OG002
value
1
group Id
OG003
value
72
units
Participants
title
Change at Week 4: MDA Composite Score
categories
measurements
group Id
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.
Individual values were -1 and 0.
group Id
OG001
spread
NA
value
NA
comment
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values was -1.
group Id
OG002
spread
NA
value
NA
group Id
OG003
spread
0.16
value
-0.10
denoms
counts
group Id
OG000
value
73
group Id
OG001
value
2
group Id
OG002
value
1
group Id
OG003
value
72
units
Participants
title
Change at Week 8: Frequency Composite Score
categories
measurements
group Id
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.
Individual values were 0 and 0.
group Id
OG001
spread
NA
value
NA
comment
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values was -0.75.
group Id
OG002
spread
NA
value
NA
group Id
OG003
spread
0.13
value
-0.17
denoms
counts
group Id
OG000
value
73
group Id
OG001
value
2
group Id
OG002
value
1
group Id
OG003
value
72
units
Participants
title
Change at Week 8: Severity Composite Score
categories
measurements
group Id
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.
Individual values were -1 and -0.25.
group Id
OG001
spread
NA
value
NA
comment
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values was 0.25.
group Id
OG002
spread
NA
value
NA
group Id
OG003
spread
0.20
value
0.26
denoms
counts
group Id
OG000
value
73
group Id
OG001
value
2
group Id
OG002
value
1
group Id
OG003
value
72
units
Participants
title
Change at Week 8: Distress Composite Score
categories
measurements
group Id
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.
Individual values were -0.67 and -0.08.
group Id
OG001
spread
NA
value
NA
comment
Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE.
Individual values was -0.5.
group Id
OG002
spread
NA
value
NA
group Id
OG003
spread
0.14
value
-0.02
denoms
counts
group Id
OG000
value
73
group Id
OG001
value
2
group Id
OG002
value
1
group Id
OG003
value
72
units
Participants
title
Change at Week 8: MDA Composite Score
denoms
counts
group Id
OG000
value
73
group Id
OG001
value
2
group Id
OG002
value
1
group Id
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.
dispersion Type
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
param Type
LEAST_SQUARES_MEAN
population Description
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.
reporting Status
POSTED
time Frame
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
Triangle