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NCT02609828 · OUTCOME

Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Non-Index Visceral Cancer Pain Sites 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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24

What was measured

Daily worst pain intensity in the index bone metastasis cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores signified more severity of pain. The participants recorded their daily worst pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline pain intensity value was mean of the daily worst pain intensity NRS scores during the baseline assessment period prior to randomization. Baseline assessment period was up to 5 days prior to dosing. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 pain intensity value is the mean of the daily worst pain intensity scores for the 7 days prior to the each specified week.

Analysis population: Participant with non-index visceral cancer pain sites were less than 10, hence data was not collected and analysis was not performed 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
Placebo0
Tanezumab 10 mg0
Tanezumab 10/20 mg0
Tanezumab 20 mg0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    units
    Participants
description
Daily worst pain intensity in the index bone metastasis cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores signified more severity of pain. The participants recorded their daily worst pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline pain intensity value was mean of the daily worst pain intensity NRS scores during the baseline assessment period prior to randomization. Baseline assessment period was up to 5 days prior to dosing. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 pain intensity value is the mean of the daily worst pain intensity scores for the 7 days prior to the each specified week.
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
population Description
Participant with non-index visceral cancer pain sites were less than 10, hence data was not collected and analysis was not performed for this outcome measure.
reporting Status
POSTED
time Frame
Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24
title
Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Non-Index Visceral Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24
type
SECONDARY

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

Preserved source evidence · Not medical advice