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NCT02609828 · OUTCOME

Average Daily Total 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
mg of MED
Interval / dispersion
Standard Deviation
Time frame
Weeks 1, 2, 4, 6, 8, 12, 16 and 24

What was measured

In this outcome measure average daily opioid consumption was reported in milligram of morphine equivalent dose (mg of MED).

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
Placebo72
Tanezumab 10 mg9
Tanezumab 10/20 mg1
Tanezumab 20 mg69
Values in mg of MED · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo183.94275.05Not 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 0.3, 30, 181.54, 1082.74, 122.03, 10, 120, 22.5 and 30.
Tanezumab 10/20 mgNANANot reportedNot reportedData for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values was 510.
Tanezumab 20 mg186.86351.83Not reportedNot reportedNot reported
Week 2

Analysis denominator · Participants

GroupSource count
Placebo73
Tanezumab 10 mg9
Tanezumab 10/20 mg1
Tanezumab 20 mg69
Values in mg of MED · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo177.98270.67Not 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 0.3, 30, 182.4, 1082.22, 120.96, 10, 120, 22.5 and 30.
Tanezumab 10/20 mgNANANot reportedNot reportedData for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values was 510.
Tanezumab 20 mg188.41356.15Not reportedNot reportedNot reported
Week 4

Analysis denominator · Participants

GroupSource count
Placebo73
Tanezumab 10 mg9
Tanezumab 10/20 mg1
Tanezumab 20 mg69
Values in mg of MED · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo177.87266.93Not 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 0.3, 34.28, 182.4, 1082.22, 120.96, 52.85, 120, 22.5 and 30.
Tanezumab 10/20 mgNANANot reportedNot reportedData for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values was 480.
Tanezumab 20 mg181.32349.82Not reportedNot reportedNot reported
Week 6

Analysis denominator · Participants

GroupSource count
Placebo73
Tanezumab 10 mg9
Tanezumab 10/20 mg1
Tanezumab 20 mg70
Values in mg of MED · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo186.20280.44Not 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 0.3, 95, 182.4, 1081.54, 120.96, 10, 137.14, 22.5 and 30.
Tanezumab 10/20 mgNANANot reportedNot reportedData for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values was 510.
Tanezumab 20 mg173.45346.27Not reportedNot reportedNot reported
Week 8

Analysis denominator · Participants

GroupSource count
Placebo73
Tanezumab 10 mg9
Tanezumab 10/20 mg1
Tanezumab 20 mg70
Values in mg of MED · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo188.10281.01Not 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 0.3, 122.14, 2.4, 1081.71, 120.96, 10, 120, 22.5 and 30.
Tanezumab 10/20 mgNANANot reportedNot reportedData for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values was 510.
Tanezumab 20 mg170.31327.19Not reportedNot reportedNot reported
Week 12

Analysis denominator · Participants

GroupSource count
Placebo73
Tanezumab 10 mg9
Tanezumab 10/20 mg1
Tanezumab 20 mg70
Values in mg of MED · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo187.43336.74Not 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 0.3, 258.57, 2.4, 1.2, 88.45, 10, 120, 22.5 and 30.
Tanezumab 10/20 mgNANANot reportedNot reportedData for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values was 480.
Tanezumab 20 mg177.06332.39Not reportedNot reportedNot reported
Week 16

Analysis denominator · Participants

GroupSource count
Placebo73
Tanezumab 10 mg9
Tanezumab 10/20 mg1
Tanezumab 20 mg70
Values in mg of MED · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo189.62333.77Not 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 0.3, 170, 2.4, 1.2, 86.31, 10, 120, 22.5 and 30.
Tanezumab 10/20 mgNANANot reportedNot reportedData for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values was 480.
Tanezumab 20 mg173.48329.17Not reportedNot reportedNot reported
Week 24

Analysis denominator · Participants

GroupSource count
Placebo73
Tanezumab 10 mg9
Tanezumab 10/20 mg1
Tanezumab 20 mg70
Values in mg of MED · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo189.78353.10Not 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 0.3, 170, 2.4, 1.2, 88.45, 74.28, 120, 18.21 and 30.
Tanezumab 10/20 mgNANANot reportedNot reportedData for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values was 480.
Tanezumab 20 mg346.951537.00Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        275.05
        value
        183.94
      2. comment
        Data for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values were 0.3, 30, 181.54, 1082.74, 122.03, 10, 120, 22.5 and 30.
        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 510.
        group Id
        OG002
        spread
        NA
        value
        NA
      4. group Id
        OG003
        spread
        351.83
        value
        186.86
    denoms
    1. counts
      1. group Id
        OG000
        value
        72
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        69
      units
      Participants
    title
    Week 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        270.67
        value
        177.98
      2. comment
        Data for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values were 0.3, 30, 182.4, 1082.22, 120.96, 10, 120, 22.5 and 30.
        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 510.
        group Id
        OG002
        spread
        NA
        value
        NA
      4. group Id
        OG003
        spread
        356.15
        value
        188.41
    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
        69
      units
      Participants
    title
    Week 2
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        266.93
        value
        177.87
      2. comment
        Data for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values were 0.3, 34.28, 182.4, 1082.22, 120.96, 52.85, 120, 22.5 and 30.
        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 480.
        group Id
        OG002
        spread
        NA
        value
        NA
      4. group Id
        OG003
        spread
        349.82
        value
        181.32
    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
        69
      units
      Participants
    title
    Week 4
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        280.44
        value
        186.20
      2. comment
        Data for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values were 0.3, 95, 182.4, 1081.54, 120.96, 10, 137.14, 22.5 and 30.
        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 510.
        group Id
        OG002
        spread
        NA
        value
        NA
      4. group Id
        OG003
        spread
        346.27
        value
        173.45
    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
        70
      units
      Participants
    title
    Week 6
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        281.01
        value
        188.10
      2. comment
        Data for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values were 0.3, 122.14, 2.4, 1081.71, 120.96, 10, 120, 22.5 and 30.
        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 510.
        group Id
        OG002
        spread
        NA
        value
        NA
      4. group Id
        OG003
        spread
        327.19
        value
        170.31
    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
        70
      units
      Participants
    title
    Week 8
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        336.74
        value
        187.43
      2. comment
        Data for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values were 0.3, 258.57, 2.4, 1.2, 88.45, 10, 120, 22.5 and 30.
        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 480.
        group Id
        OG002
        spread
        NA
        value
        NA
      4. group Id
        OG003
        spread
        332.39
        value
        177.06
    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
        70
      units
      Participants
    title
    Week 12
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        333.77
        value
        189.62
      2. comment
        Data for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values were 0.3, 170, 2.4, 1.2, 86.31, 10, 120, 22.5 and 30.
        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 480.
        group Id
        OG002
        spread
        NA
        value
        NA
      4. group Id
        OG003
        spread
        329.17
        value
        173.48
    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
        70
      units
      Participants
    title
    Week 16
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        353.10
        value
        189.78
      2. comment
        Data for this arm was not summarized per plan. Hence, not reported as Mean and SD. Individual values were 0.3, 170, 2.4, 1.2, 88.45, 74.28, 120, 18.21 and 30.
        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 480.
        group Id
        OG002
        spread
        NA
        value
        NA
      4. group Id
        OG003
        spread
        1537.00
        value
        346.95
    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
        70
      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 daily opioid consumption was reported in milligram of morphine equivalent dose (mg of MED).
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 Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24
type
SECONDARY
unit Of Measure
mg of MED

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

Preserved source evidence · Not medical advice