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NCT02609828 · OUTCOME

Number of Participants With Individual Adjudicated Joint Safety Outcome/Event

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
During the study, maximum up to Week 48

What was measured

Joint-related safety events resulting in total joint replacement and/or discontinuation from the study as well as adverse events were reviewed by the External Adjudication Committee to confirm the potential events as adjudicated join safety event. In this outcome measure, number of participants with any of the joint safety adjudication outcomes of primary osteonecrosis, rapidly progressive osteoarthritis (OA) (type 1 and type 2), subchondral insufficiency fracture (or SPONK), or pathological fracture were reported. Other adjudication outcomes included normal progression of OA and other joint outcome.

Analysis population: The safety analysis set was analyzed. Here, "Overall Number of Participants Analyzed" signifies participants who were analyzed by the Adjudication Committee. In reporting arm, "Tanezumab10/20 mg" the participant did not have potential joint related safety event for analysis by Adjudication Committee.

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
Placebo1
Tanezumab 10 mg1
Tanezumab 10/20 mg0
Tanezumab 20 mg3

Reported measurements

Rapidly Progressive OA
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo0Not reportedNot reportedNot reportedNot reported
Tanezumab 10 mg0Not reportedNot reportedNot reportedNot reported
Tanezumab 20 mg0Not reportedNot reportedNot reportedNot reported
Rapidly Progressive OA type 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo0Not reportedNot reportedNot reportedNot reported
Tanezumab 10 mg0Not reportedNot reportedNot reportedNot reported
Tanezumab 20 mg0Not reportedNot reportedNot reportedNot reported
Rapidly Progressive OA type 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo0Not reportedNot reportedNot reportedNot reported
Tanezumab 10 mg0Not reportedNot reportedNot reportedNot reported
Tanezumab 20 mg0Not reportedNot reportedNot reportedNot reported
Primary Osteonecrosis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo0Not reportedNot reportedNot reportedNot reported
Tanezumab 10 mg0Not reportedNot reportedNot reportedNot reported
Tanezumab 20 mg0Not reportedNot reportedNot reportedNot reported
Pathological Fracture
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo0Not reportedNot reportedNot reportedNot reported
Tanezumab 10 mg0Not reportedNot reportedNot reportedNot reported
Tanezumab 20 mg2Not reportedNot reportedNot reportedNot reported
Subchondral Insufficiency Fracture
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo0Not reportedNot reportedNot reportedNot reported
Tanezumab 10 mg0Not reportedNot reportedNot reportedNot reported
Tanezumab 20 mg0Not reportedNot reportedNot reportedNot reported
Normal Progression of OA
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo0Not reportedNot reportedNot reportedNot reported
Tanezumab 10 mg0Not reportedNot reportedNot reportedNot reported
Tanezumab 20 mg0Not reportedNot reportedNot reportedNot reported
Other Joint Outcome
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo1Not reportedNot reportedNot reportedNot reported
Tanezumab 10 mg1Not reportedNot reportedNot reportedNot reported
Tanezumab 20 mg1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG003
        value
        0
    title
    Rapidly Progressive OA
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG003
        value
        0
    title
    Rapidly Progressive OA type 1
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG003
        value
        0
    title
    Rapidly Progressive OA type 2
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG003
        value
        0
    title
    Primary Osteonecrosis
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG003
        value
        2
    title
    Pathological Fracture
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG003
        value
        0
    title
    Subchondral Insufficiency Fracture
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG003
        value
        0
    title
    Normal Progression of OA
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG003
        value
        1
    title
    Other Joint Outcome
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      3
    units
    Participants
description
Joint-related safety events resulting in total joint replacement and/or discontinuation from the study as well as adverse events were reviewed by the External Adjudication Committee to confirm the potential events as adjudicated join safety event. In this outcome measure, number of participants with any of the joint safety adjudication outcomes of primary osteonecrosis, rapidly progressive osteoarthritis (OA) (type 1 and type 2), subchondral insufficiency fracture (or SPONK), or pathological fracture were reported. Other adjudication outcomes included normal progression of OA and other joint outcome.
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
COUNT_OF_PARTICIPANTS
population Description
The safety analysis set was analyzed. Here, "Overall Number of Participants Analyzed" signifies participants who were analyzed by the Adjudication Committee. In reporting arm, "Tanezumab10/20 mg" the participant did not have potential joint related safety event for analysis by Adjudication Committee.
reporting Status
POSTED
time Frame
During the study, maximum up to Week 48
title
Number of Participants With Individual Adjudicated Joint Safety Outcome/Event
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice