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NCT02609828 · OUTCOME

Number of Participants With Categorical Summary of Electrocardiogram (ECG) (QTC) Data

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 (Day 1, before dosing) up to Week 24

What was measured

Electrocardiogram assessment included QT interval corrected using Fridericia's formula (QTcF), QT interval corrected using Bazett's formula (QTcB), both had following categories: 450\<=Value\<480 millisecond (msec), 480\<=Value\<500 msec and Value\>=500 msec.

Analysis population: The safety analysis set was analyzed. Here, "Overall Number of Participants Analyzed" signifies number of participants with post-baseline results evaluated against criteria. In reporting arm "Tanezumab10/20 mg", the participant did not have post-baseline results evaluated against ECG (QTC) criteria, hence was not evaluable for this outcome measure.

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
Placebo40
Tanezumab 10 mg8
Tanezumab 10/20 mg0
Tanezumab 20 mg44

Reported measurements

QTCB Interval 450<=Value<480
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo2Not reportedNot reportedNot reportedNot reported
Tanezumab 10 mg1Not reportedNot reportedNot reportedNot reported
Tanezumab 20 mg6Not reportedNot reportedNot reportedNot reported
QTCB Interval 480<=Value<500
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo0Not reportedNot reportedNot reportedNot reported
Tanezumab 10 mg0Not reportedNot reportedNot reportedNot reported
Tanezumab 20 mg1Not reportedNot reportedNot reportedNot reported
QTCF Interval 450<=Value<480
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo1Not reportedNot reportedNot reportedNot reported
Tanezumab 10 mg0Not reportedNot reportedNot reportedNot reported
Tanezumab 20 mg5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      3. group Id
        OG003
        value
        6
    title
    QTCB Interval 450<=Value<480
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG003
        value
        1
    title
    QTCB Interval 480<=Value<500
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG003
        value
        5
    title
    QTCF Interval 450<=Value<480
denoms
  1. counts
    1. group Id
      OG000
      value
      40
    2. group Id
      OG001
      value
      8
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      44
    units
    Participants
description
Electrocardiogram assessment included QT interval corrected using Fridericia's formula (QTcF), QT interval corrected using Bazett's formula (QTcB), both had following categories: 450\<=Value\<480 millisecond (msec), 480\<=Value\<500 msec and Value\>=500 msec.
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 number of participants with post-baseline results evaluated against criteria. In reporting arm "Tanezumab10/20 mg", the participant did not have post-baseline results evaluated against ECG (QTC) criteria, hence was not evaluable for this outcome measure.
reporting Status
POSTED
time Frame
Baseline (Day 1, before dosing) up to Week 24
title
Number of Participants With Categorical Summary of Electrocardiogram (ECG) (QTC) Data
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice