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NCT02609828 · OUTCOME

Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in 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

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: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24

What was measured

Daily worst pain intensity in the index bone metastasis cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores = more severity of pain. The participants recorded 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. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 pain intensity value = mean of the daily worst pain intensity NRS scores for the 7 days prior to the each week. Number of participants with cumulative reduction of \>= 30, 50, 70, and 90 % in daily worst pain intensity NRS score in the index bone metastasis cancer pain site from Baseline to Weeks 1, 2, 4, 6, 8, 12, 16 and 24 were reported. Participants might be reported more than once in the specified rows for a time point. Rows with only non-zero data for cumulative reduction at specified time points, for at least 1 reporting arm, are reported below.

Analysis population: The mITT analysis set was analyzed. Multiple imputation method was applied. 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 10 mg

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 10 mg	9
Tanezumab 10/20 mg	1
Tanezumab 20 mg	71

Reported measurements

Week 1: Reduction of >=30%

Analysis denominator · Participants

Group	Source count
Placebo	73
Tanezumab 10 mg	9
Tanezumab 10/20 mg	1
Tanezumab 20 mg	71

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	7	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	2	Not reported	Not reported	Not reported	Not reported
Tanezumab 10/20 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	9	Not reported	Not reported	Not reported	Not reported

Week 1: Reduction of >=50%

Analysis denominator · Participants

Group	Source count
Placebo	73
Tanezumab 10 mg	9
Tanezumab 10/20 mg	1
Tanezumab 20 mg	71

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	1	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 10/20 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	3	Not reported	Not reported	Not reported	Not reported

Week 1: Reduction of >=70%

Analysis denominator · Participants

Group	Source count
Placebo	73
Tanezumab 10 mg	9
Tanezumab 10/20 mg	1
Tanezumab 20 mg	71

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 10/20 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	2	Not reported	Not reported	Not reported	Not reported

Week 1: Reduction of >=90%

Analysis denominator · Participants

Group	Source count
Placebo	73
Tanezumab 10 mg	9
Tanezumab 10/20 mg	1
Tanezumab 20 mg	71

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 10/20 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	0	Not reported	Not reported	Not reported	Not reported

Week 2: Reduction of >=30%

Analysis denominator · Participants

Group	Source count
Placebo	73
Tanezumab 10 mg	9
Tanezumab 10/20 mg	1
Tanezumab 20 mg	71

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	9	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	2	Not reported	Not reported	Not reported	Not reported
Tanezumab 10/20 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	17	Not reported	Not reported	Not reported	Not reported

Week 2: Reduction of >=50%

Analysis denominator · Participants

Group	Source count
Placebo	73
Tanezumab 10 mg	9
Tanezumab 10/20 mg	1
Tanezumab 20 mg	71

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	2	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	1	Not reported	Not reported	Not reported	Not reported
Tanezumab 10/20 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	8	Not reported	Not reported	Not reported	Not reported

Week 2: Reduction of >=70%

Analysis denominator · Participants

Group	Source count
Placebo	73
Tanezumab 10 mg	9
Tanezumab 10/20 mg	1
Tanezumab 20 mg	71

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 10/20 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	5	Not reported	Not reported	Not reported	Not reported

Week 2: Reduction of >=90%

Analysis denominator · Participants

Group	Source count
Placebo	73
Tanezumab 10 mg	9
Tanezumab 10/20 mg	1
Tanezumab 20 mg	71

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 10/20 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	2	Not reported	Not reported	Not reported	Not reported

Week 4: Reduction of >=30%

Analysis denominator · Participants

Group	Source count
Placebo	73
Tanezumab 10 mg	9
Tanezumab 10/20 mg	1
Tanezumab 20 mg	71

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	12	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	1	Not reported	Not reported	Not reported	Not reported
Tanezumab 10/20 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	21	Not reported	Not reported	Not reported	Not reported

Week 4: Reduction of >=50%

Analysis denominator · Participants

Group	Source count
Placebo	73
Tanezumab 10 mg	9
Tanezumab 10/20 mg	1
Tanezumab 20 mg	71

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	5	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	1	Not reported	Not reported	Not reported	Not reported
Tanezumab 10/20 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	14	Not reported	Not reported	Not reported	Not reported

Week 4: Reduction of >=70%

Analysis denominator · Participants

Group	Source count
Placebo	73
Tanezumab 10 mg	9
Tanezumab 10/20 mg	1
Tanezumab 20 mg	71

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	1	Not reported	Not reported	Not reported	Not reported
Tanezumab 10/20 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	6	Not reported	Not reported	Not reported	Not reported

Week 4: Reduction of >=90%

Analysis denominator · Participants

Group	Source count
Placebo	73
Tanezumab 10 mg	9
Tanezumab 10/20 mg	1
Tanezumab 20 mg	71

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 10/20 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	2	Not reported	Not reported	Not reported	Not reported

Week 6: Reduction of >=30%

Analysis denominator · Participants

Group	Source count
Placebo	73
Tanezumab 10 mg	8
Tanezumab 10/20 mg	1
Tanezumab 20 mg	71

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	13	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	4	Not reported	Not reported	Not reported	Not reported
Tanezumab 10/20 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	26	Not reported	Not reported	Not reported	Not reported

Week 6: Reduction of >=50%

Analysis denominator · Participants

Group	Source count
Placebo	73
Tanezumab 10 mg	8
Tanezumab 10/20 mg	1
Tanezumab 20 mg	71

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	4	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	1	Not reported	Not reported	Not reported	Not reported
Tanezumab 10/20 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	14	Not reported	Not reported	Not reported	Not reported

Week 6: Reduction of >=70%

Analysis denominator · Participants

Group	Source count
Placebo	73
Tanezumab 10 mg	8
Tanezumab 10/20 mg	1
Tanezumab 20 mg	71

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	2	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 10/20 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	7	Not reported	Not reported	Not reported	Not reported

Week 6: Reduction of >=90%

Analysis denominator · Participants

Group	Source count
Placebo	73
Tanezumab 10 mg	8
Tanezumab 10/20 mg	1
Tanezumab 20 mg	71

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 10/20 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	2	Not reported	Not reported	Not reported	Not reported

Week 8: Reduction of >=30%

Analysis denominator · Participants

Group	Source count
Placebo	73
Tanezumab 10 mg	8
Tanezumab 10/20 mg	1
Tanezumab 20 mg	71

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	14	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	5	Not reported	Not reported	Not reported	Not reported
Tanezumab 10/20 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	24	Not reported	Not reported	Not reported	Not reported

Week 8: Reduction of >=50%

Analysis denominator · Participants

Group	Source count
Placebo	73
Tanezumab 10 mg	8
Tanezumab 10/20 mg	1
Tanezumab 20 mg	71

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	7	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	2	Not reported	Not reported	Not reported	Not reported
Tanezumab 10/20 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	16	Not reported	Not reported	Not reported	Not reported

Week 8: Reduction of >=70%

Analysis denominator · Participants

Group	Source count
Placebo	73
Tanezumab 10 mg	8
Tanezumab 10/20 mg	1
Tanezumab 20 mg	71

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	2	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 10/20 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	8	Not reported	Not reported	Not reported	Not reported

Week 8: Reduction of >=90%

Analysis denominator · Participants

Group	Source count
Placebo	73
Tanezumab 10 mg	8
Tanezumab 10/20 mg	1
Tanezumab 20 mg	71

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	2	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 10/20 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	2	Not reported	Not reported	Not reported	Not reported

Week 12: Reduction of >=30%

Analysis denominator · Participants

Group	Source count
Placebo	73
Tanezumab 10 mg	9
Tanezumab 10/20 mg	1
Tanezumab 20 mg	71

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	16	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	5	Not reported	Not reported	Not reported	Not reported
Tanezumab 10/20 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	24	Not reported	Not reported	Not reported	Not reported

Week 12: Reduction of >=50%

Analysis denominator · Participants

Group	Source count
Placebo	73
Tanezumab 10 mg	9
Tanezumab 10/20 mg	1
Tanezumab 20 mg	71

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	8	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	2	Not reported	Not reported	Not reported	Not reported
Tanezumab 10/20 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	16	Not reported	Not reported	Not reported	Not reported

Week 12: Reduction of >=70%

Analysis denominator · Participants

Group	Source count
Placebo	73
Tanezumab 10 mg	9
Tanezumab 10/20 mg	1
Tanezumab 20 mg	71

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	5	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	1	Not reported	Not reported	Not reported	Not reported
Tanezumab 10/20 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	7	Not reported	Not reported	Not reported	Not reported

Week 12: Reduction of >=90%

Analysis denominator · Participants

Group	Source count
Placebo	73
Tanezumab 10 mg	9
Tanezumab 10/20 mg	1
Tanezumab 20 mg	71

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	2	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 10/20 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	4	Not reported	Not reported	Not reported	Not reported

Week 16: Reduction of >=30%

Analysis denominator · Participants

Group	Source count
Placebo	73
Tanezumab 10 mg	7
Tanezumab 10/20 mg	0
Tanezumab 20 mg	71

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	11	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	2	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	24	Not reported	Not reported	Not reported	Not reported

Week 16: Reduction of >=50%

Analysis denominator · Participants

Group	Source count
Placebo	73
Tanezumab 10 mg	7
Tanezumab 10/20 mg	0
Tanezumab 20 mg	71

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	9	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	2	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	18	Not reported	Not reported	Not reported	Not reported

Week 16: Reduction of >=70%

Analysis denominator · Participants

Group	Source count
Placebo	73
Tanezumab 10 mg	7
Tanezumab 10/20 mg	0
Tanezumab 20 mg	71

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	7	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	11	Not reported	Not reported	Not reported	Not reported

Week 16: Reduction of >=90%

Analysis denominator · Participants

Group	Source count
Placebo	73
Tanezumab 10 mg	7
Tanezumab 10/20 mg	0
Tanezumab 20 mg	71

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	3	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	3	Not reported	Not reported	Not reported	Not reported

Week 24: Reduction of >=30%

Analysis denominator · Participants

Group	Source count
Placebo	73
Tanezumab 10 mg	6
Tanezumab 10/20 mg	0
Tanezumab 20 mg	71

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	11	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	4	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	25	Not reported	Not reported	Not reported	Not reported

Week 24: Reduction of >=50%

Analysis denominator · Participants

Group	Source count
Placebo	73
Tanezumab 10 mg	6
Tanezumab 10/20 mg	0
Tanezumab 20 mg	71

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	9	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	3	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	18	Not reported	Not reported	Not reported	Not reported

Week 24: Reduction of >=70%

Analysis denominator · Participants

Group	Source count
Placebo	73
Tanezumab 10 mg	6
Tanezumab 10/20 mg	0
Tanezumab 20 mg	71

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	4	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	2	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	9	Not reported	Not reported	Not reported	Not reported

Week 24: Reduction of >=90%

Analysis denominator · Participants

Group	Source count
Placebo	73
Tanezumab 10 mg	6
Tanezumab 10/20 mg	0
Tanezumab 20 mg	71

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	2	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	3	Not reported	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
0.43
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
3.70
group Description
Week 1 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.6658
param Type
Odds Ratio (OR)
param Value
1.27
statistical Method
Regression, Logistic
ci Lower Limit
0.30
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
31.35
group Description
Week 1 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.3443
param Type
Odds Ratio (OR)
param Value
3.07
statistical Method
Regression, Logistic
group Description
Week 1 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.9527
statistical Method
Regression, Logistic
ci Lower Limit
0.92
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
5.50
group Description
Week 2 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.0757
param Type
Odds Ratio (OR)
param Value
2.25
statistical Method
Regression, Logistic
ci Lower Limit
0.91
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
22.42
group Description
Week 2 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.0659
param Type
Odds Ratio (OR)
param Value
4.51
statistical Method
Regression, Logistic
group Description
Week 2 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.9380
statistical Method
Regression, Logistic
group Description
Week 2 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.9493
statistical Method
Regression, Logistic
ci Lower Limit
0.89
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
4.59
group Description
Week 4 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.0914
param Type
Odds Ratio (OR)
param Value
2.02
statistical Method
Regression, Logistic
ci Lower Limit
1.08
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
9.61
group Description
Week 4 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.0359
param Type
Odds Ratio (OR)
param Value
3.22
statistical Method
Regression, Logistic
group Description
Week 4 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.9538
statistical Method
Regression, Logistic
group Description
Week 4 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.9493
statistical Method
Regression, Logistic
ci Lower Limit
1.22
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
5.80
group Description
Week 6 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.0143
param Type
Odds Ratio (OR)
param Value
2.66
statistical Method
Regression, Logistic

Complete source fields

analyses

ci Lower Limit
0.43
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
3.70
group Description
Week 1 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.6658
param Type
Odds Ratio (OR)
param Value
1.27
statistical Method
Regression, Logistic
ci Lower Limit
0.30
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
31.35
group Description
Week 1 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.3443
param Type
Odds Ratio (OR)
param Value
3.07
statistical Method
Regression, Logistic
group Description
Week 1 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.9527
statistical Method
Regression, Logistic
ci Lower Limit
0.92
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
5.50
group Description
Week 2 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.0757
param Type
Odds Ratio (OR)
param Value
2.25
statistical Method
Regression, Logistic
ci Lower Limit
0.91
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
22.42
group Description
Week 2 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.0659
param Type
Odds Ratio (OR)
param Value
4.51
statistical Method
Regression, Logistic
group Description
Week 2 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.9380
statistical Method
Regression, Logistic
group Description
Week 2 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.9493
statistical Method
Regression, Logistic
ci Lower Limit
0.89
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
4.59
group Description
Week 4 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.0914
param Type
Odds Ratio (OR)
param Value
2.02
statistical Method
Regression, Logistic
ci Lower Limit
1.08
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
9.61
group Description
Week 4 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.0359
param Type
Odds Ratio (OR)
param Value
3.22
statistical Method
Regression, Logistic
group Description
Week 4 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.9538
statistical Method
Regression, Logistic
group Description
Week 4 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.9493
statistical Method
Regression, Logistic
ci Lower Limit
1.22
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
5.80
group Description
Week 6 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.0143
param Type
Odds Ratio (OR)
param Value
2.66
statistical Method
Regression, Logistic

classes

categories
measurements
group Id
OG000
value
7
group Id
OG001
value
2
group Id
OG002
value
0
group Id
OG003
value
9
denoms
counts
group Id
OG000
value
73
group Id
OG001
value
9
group Id
OG002
value
1
group Id
OG003
value
71
units
Participants
title
Week 1: Reduction of >=30%
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
3
denoms
counts
group Id
OG000
value
73
group Id
OG001
value
9
group Id
OG002
value
1
group Id
OG003
value
71
units
Participants
title
Week 1: Reduction of >=50%
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
2
denoms
counts
group Id
OG000
value
73
group Id
OG001
value
9
group Id
OG002
value
1
group Id
OG003
value
71
units
Participants
title
Week 1: Reduction of >=70%
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
denoms
counts
group Id
OG000
value
73
group Id
OG001
value
9
group Id
OG002
value
1
group Id
OG003
value
71
units
Participants
title
Week 1: Reduction of >=90%
categories
measurements
group Id
OG000
value
9
group Id
OG001
value
2
group Id
OG002
value
0
group Id
OG003
value
17
denoms
counts
group Id
OG000
value
73
group Id
OG001
value
9
group Id
OG002
value
1
group Id
OG003
value
71
units
Participants
title
Week 2: Reduction of >=30%
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
8
denoms
counts
group Id
OG000
value
73
group Id
OG001
value
9
group Id
OG002
value
1
group Id
OG003
value
71
units
Participants
title
Week 2: Reduction of >=50%
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
5
denoms
counts
group Id
OG000
value
73
group Id
OG001
value
9
group Id
OG002
value
1
group Id
OG003
value
71
units
Participants
title
Week 2: Reduction of >=70%
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
2
denoms
counts
group Id
OG000
value
73
group Id
OG001
value
9
group Id
OG002
value
1
group Id
OG003
value
71
units
Participants
title
Week 2: Reduction of >=90%
categories
measurements
group Id
OG000
value
12
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
21
denoms
counts
group Id
OG000
value
73
group Id
OG001
value
9
group Id
OG002
value
1
group Id
OG003
value
71
units
Participants
title
Week 4: Reduction of >=30%
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
14
denoms
counts
group Id
OG000
value
73
group Id
OG001
value
9
group Id
OG002
value
1
group Id
OG003
value
71
units
Participants
title
Week 4: Reduction of >=50%
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
6
denoms
counts
group Id
OG000
value
73
group Id
OG001
value
9
group Id
OG002
value
1
group Id
OG003
value
71
units
Participants
title
Week 4: Reduction of >=70%
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
2
denoms
counts
group Id
OG000
value
73
group Id
OG001
value
9
group Id
OG002
value
1
group Id
OG003
value
71
units
Participants
title
Week 4: Reduction of >=90%

denoms

counts
group Id
OG000
value
73
group Id
OG001
value
9
group Id
OG002
value
1
group Id
OG003
value
71
units
Participants

description

Daily worst pain intensity in the index bone metastasis cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores = more severity of pain. The participants recorded 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. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 pain intensity value = mean of the daily worst pain intensity NRS scores for the 7 days prior to the each week. Number of participants with cumulative reduction of \>= 30, 50, 70, and 90 % in daily worst pain intensity NRS score in the index bone metastasis cancer pain site from Baseline to Weeks 1, 2, 4, 6, 8, 12, 16 and 24 were reported. Participants might be reported more than once in the specified rows for a time point. Rows with only non-zero data for cumulative reduction at specified time points, for at least 1 reporting arm, are reported below.

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

param Type

COUNT_OF_PARTICIPANTS

population Description

The mITT analysis set was analyzed. Multiple imputation method was applied. 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 1, 2, 4, 6, 8, 12, 16 and 24

title

Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in 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

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice