NCT02609828 · OUTCOME

Change From Baseline in the Daily Average 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 average pain intensity in the non-index visceral 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 described their pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline is defined as the mean average daily pain intensity NRS score during the baseline assessment period prior to randomization. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 pain intensity value is the mean of the daily average 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 20 mg

Participants received tanezumab 20 mg 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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Placebo	0
Tanezumab 20 mg	0
Tanezumab 10 mg	0
Tanezumab 10/20 mg	0

Reported measurements

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

Complete source fields

denoms

counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
units
Participants

description

groups

description
Participants received placebo matched to tanezumab SC once every 8 weeks for 24 weeks.
id
OG000
title
Placebo
description
Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks.
id
OG001
title
Tanezumab 20 mg
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
OG002
title
Tanezumab 10 mg
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
OG003
title
Tanezumab 10/20 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 Average 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