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NCT02609828 · OUTCOME

Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Anti-Drug Antibodies (NAb)

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 48

What was measured

Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using a semi quantitative enzyme linked immunosorbent assay (ELISA). Number of participants with presence of anti-tanezumab antibodies and neutralizing anti-drug antibodies are reported.

Analysis population: The safety analysis set included all participants treated with tanezumab or placebo SC, including participants who received tanezumab 10 mg prior to protocol amendment 3.

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

ADA
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo0Not reportedNot reportedNot reportedNot reported
Tanezumab 10 mg0Not reportedNot reportedNot reportedNot reported
Tanezumab 10/20 mg0Not reportedNot reportedNot reportedNot reported
Tanezumab 20 mg1Not reportedNot reportedNot reportedNot reported
NAb
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo0Not reportedNot reportedNot reportedNot reported
Tanezumab 10 mg0Not reportedNot reportedNot reportedNot reported
Tanezumab 10/20 mg0Not 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
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
    title
    ADA
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
    title
    NAb
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
Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using a semi quantitative enzyme linked immunosorbent assay (ELISA). Number of participants with presence of anti-tanezumab antibodies and neutralizing anti-drug antibodies are reported.
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 included all participants treated with tanezumab or placebo SC, including participants who received tanezumab 10 mg prior to protocol amendment 3.
reporting Status
POSTED
time Frame
Baseline (Day 1, before dosing) up to Week 48
title
Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Anti-Drug Antibodies (NAb)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice