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NCT02609828 · OUTCOME

Average Number of Doses of Rescue Opioid Consumption 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
MEAN
Unit
Doses
Interval / dispersion
Standard Deviation
Time frame
Weeks 1, 2, 4, 6, 8, 12, 16 and 24

What was measured

In this outcome measure average number of doses of rescue opioid consumption at specified time points were reported.

Analysis population: The mITT analysis set: participants randomized to tanezumab 20 mg or placebo SC, received at least 1dose of SC study medication. LOCF data 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 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

GroupSource count
Placebo73
Tanezumab 10 mg9
Tanezumab 10/20 mg1
Tanezumab 20 mg72

Reported measurements

Week 1

Analysis denominator · Participants

GroupSource count
Placebo52
Tanezumab 10 mg8
Tanezumab 10/20 mg1
Tanezumab 20 mg42
Values in Doses · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo1.150.76Not reportedNot reportedNot reported
Tanezumab 10 mgNANANot reportedNot reportedData for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values were 1, 1, 1, 1, 0.14, 1,1 and 1.
Tanezumab 10/20 mgNANANot reportedNot reportedData for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values was 1.
Tanezumab 20 mg0.960.48Not reportedNot reportedNot reported
Week 2

Analysis denominator · Participants

GroupSource count
Placebo54
Tanezumab 10 mg8
Tanezumab 10/20 mg1
Tanezumab 20 mg44
Values in Doses · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo1.110.69Not reportedNot reportedNot reported
Tanezumab 10 mgNANANot reportedNot reportedData for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values were 1, 1, 1, 1, 0.14, 1,1 and 1.
Tanezumab 10/20 mgNANANot reportedNot reportedData for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values was 1.
Tanezumab 20 mg0.890.52Not reportedNot reportedNot reported
Week 4

Analysis denominator · Participants

GroupSource count
Placebo56
Tanezumab 10 mg9
Tanezumab 10/20 mg1
Tanezumab 20 mg46
Values in Doses · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo1.080.69Not reportedNot reportedNot reported
Tanezumab 10 mgNANANot reportedNot reportedData for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values were 1, 1, 1, 1, 0.14, 0.14, 0.85,1 and 1.
Tanezumab 10/20 mgNANANot reportedNot reportedData for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values was 0.43.
Tanezumab 20 mg0.800.57Not reportedNot reportedNot reported
Week 6

Analysis denominator · Participants

GroupSource count
Placebo61
Tanezumab 10 mg9
Tanezumab 10/20 mg1
Tanezumab 20 mg48
Values in Doses · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo0.950.70Not reportedNot reportedNot reported
Tanezumab 10 mgNANANot reportedNot reportedData for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values were 1, 1, 1, 0.85, 0.14, 0.14, 1, 1 and 1.
Tanezumab 10/20 mgNANANot reportedNot reportedData for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values was 1.
Tanezumab 20 mg0.800.65Not reportedNot reportedNot reported
Week 8

Analysis denominator · Participants

GroupSource count
Placebo61
Tanezumab 10 mg9
Tanezumab 10/20 mg1
Tanezumab 20 mg48
Values in Doses · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo0.990.72Not reportedNot reportedNot reported
Tanezumab 10 mgNANANot reportedNot reportedData for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values were 1, 1, 1, 1, 0.28, 0.14, 0.71, 1 and 1.
Tanezumab 10/20 mgNANANot reportedNot reportedData for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values was 1.
Tanezumab 20 mg0.810.61Not reportedNot reportedNot reported
Week 12

Analysis denominator · Participants

GroupSource count
Placebo61
Tanezumab 10 mg9
Tanezumab 10/20 mg1
Tanezumab 20 mg48
Values in Doses · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo0.920.94Not reportedNot reportedNot reported
Tanezumab 10 mgNANANot reportedNot reportedData for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values were 1, 1, 1, 1, 1, 0.14, 0.14, 1 and 1.
Tanezumab 10/20 mgNANANot reportedNot reportedData for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values was 1.
Tanezumab 20 mg0.730.57Not reportedNot reportedNot reported
Week 16

Analysis denominator · Participants

GroupSource count
Placebo62
Tanezumab 10 mg9
Tanezumab 10/20 mg1
Tanezumab 20 mg48
Values in Doses · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo0.860.93Not reportedNot reportedNot reported
Tanezumab 10 mgNANANot reportedNot reportedData for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values were 1, 1, 1, 1, 0.85, 0.14, 0.14, 1 and 1.
Tanezumab 10/20 mgNANANot reportedNot reportedData for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values was 1.
Tanezumab 20 mg0.750.57Not reportedNot reportedNot reported
Week 24

Analysis denominator · Participants

GroupSource count
Placebo65
Tanezumab 10 mg9
Tanezumab 10/20 mg1
Tanezumab 20 mg49
Values in Doses · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo0.790.93Not reportedNot reportedNot reported
Tanezumab 10 mgNANANot reportedNot reportedData for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values were 1, 1, 1, 1, 1, 0.14, 0.14, 0.42 and 1.
Tanezumab 10/20 mgNANANot reportedNot reportedData for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values was 1.
Tanezumab 20 mg0.690.57Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.76
        value
        1.15
      2. comment
        Data for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values were 1, 1, 1, 1, 0.14, 1,1 and 1.
        group Id
        OG001
        spread
        NA
        value
        NA
      3. comment
        Data for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values was 1.
        group Id
        OG002
        spread
        NA
        value
        NA
      4. group Id
        OG003
        spread
        0.48
        value
        0.96
    denoms
    1. counts
      1. group Id
        OG000
        value
        52
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        42
      units
      Participants
    title
    Week 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.69
        value
        1.11
      2. comment
        Data for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values were 1, 1, 1, 1, 0.14, 1,1 and 1.
        group Id
        OG001
        spread
        NA
        value
        NA
      3. comment
        Data for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values was 1.
        group Id
        OG002
        spread
        NA
        value
        NA
      4. group Id
        OG003
        spread
        0.52
        value
        0.89
    denoms
    1. counts
      1. group Id
        OG000
        value
        54
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        44
      units
      Participants
    title
    Week 2
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.69
        value
        1.08
      2. comment
        Data for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values were 1, 1, 1, 1, 0.14, 0.14, 0.85,1 and 1.
        group Id
        OG001
        spread
        NA
        value
        NA
      3. comment
        Data for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values was 0.43.
        group Id
        OG002
        spread
        NA
        value
        NA
      4. group Id
        OG003
        spread
        0.57
        value
        0.80
    denoms
    1. counts
      1. group Id
        OG000
        value
        56
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        46
      units
      Participants
    title
    Week 4
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.70
        value
        0.95
      2. comment
        Data for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values were 1, 1, 1, 0.85, 0.14, 0.14, 1, 1 and 1.
        group Id
        OG001
        spread
        NA
        value
        NA
      3. comment
        Data for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values was 1.
        group Id
        OG002
        spread
        NA
        value
        NA
      4. group Id
        OG003
        spread
        0.65
        value
        0.80
    denoms
    1. counts
      1. group Id
        OG000
        value
        61
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        48
      units
      Participants
    title
    Week 6
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.72
        value
        0.99
      2. comment
        Data for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values were 1, 1, 1, 1, 0.28, 0.14, 0.71, 1 and 1.
        group Id
        OG001
        spread
        NA
        value
        NA
      3. comment
        Data for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values was 1.
        group Id
        OG002
        spread
        NA
        value
        NA
      4. group Id
        OG003
        spread
        0.61
        value
        0.81
    denoms
    1. counts
      1. group Id
        OG000
        value
        61
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        48
      units
      Participants
    title
    Week 8
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.94
        value
        0.92
      2. comment
        Data for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values were 1, 1, 1, 1, 1, 0.14, 0.14, 1 and 1.
        group Id
        OG001
        spread
        NA
        value
        NA
      3. comment
        Data for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values was 1.
        group Id
        OG002
        spread
        NA
        value
        NA
      4. group Id
        OG003
        spread
        0.57
        value
        0.73
    denoms
    1. counts
      1. group Id
        OG000
        value
        61
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        48
      units
      Participants
    title
    Week 12
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.93
        value
        0.86
      2. comment
        Data for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values were 1, 1, 1, 1, 0.85, 0.14, 0.14, 1 and 1.
        group Id
        OG001
        spread
        NA
        value
        NA
      3. comment
        Data for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values was 1.
        group Id
        OG002
        spread
        NA
        value
        NA
      4. group Id
        OG003
        spread
        0.57
        value
        0.75
    denoms
    1. counts
      1. group Id
        OG000
        value
        62
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        48
      units
      Participants
    title
    Week 16
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.93
        value
        0.79
      2. comment
        Data for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values were 1, 1, 1, 1, 1, 0.14, 0.14, 0.42 and 1.
        group Id
        OG001
        spread
        NA
        value
        NA
      3. comment
        Data for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values was 1.
        group Id
        OG002
        spread
        NA
        value
        NA
      4. group Id
        OG003
        spread
        0.57
        value
        0.69
    denoms
    1. counts
      1. group Id
        OG000
        value
        65
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        49
      units
      Participants
    title
    Week 24
denoms
  1. counts
    1. group Id
      OG000
      value
      73
    2. group Id
      OG001
      value
      9
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      72
    units
    Participants
description
In this outcome measure average number of doses of rescue opioid consumption at specified time points were reported.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received placebo matched to tanezumab SC once every 8 weeks for 24 weeks.
    id
    OG000
    title
    Placebo
  2. 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
  3. 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
  4. description
    Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks.
    id
    OG003
    title
    Tanezumab 20 mg
param Type
MEAN
population Description
The mITT analysis set: participants randomized to tanezumab 20 mg or placebo SC, received at least 1dose of SC study medication. LOCF data 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
Weeks 1, 2, 4, 6, 8, 12, 16 and 24
title
Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24
type
SECONDARY
unit Of Measure
Doses

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

Preserved source evidence · Not medical advice