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NCT02609828 · OUTCOME

Number of Participants With Abnormal Physical Examination at Screening

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: Screening (up to 37 days prior to Day 1)

What was measured

Physical examination included assessment of general, head, eyes, ears, nose, neck, thyroid, lungs, heart, abdomen, extremities, skin, throat and other. Investigator judged abnormality in physical examinations.

Analysis population: The safety analysis set included all subjects treated with tanezumab or placebo SC, including subjects who received tanezumab 10 mg prior to protocol amendment 3. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.

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

Group	Source count
Placebo	72
Tanezumab 10 mg	9
Tanezumab 10/20 mg	1
Tanezumab 20 mg	72

Reported measurements

General

Analysis denominator · Participants

Group	Source count
Placebo	72
Tanezumab 10 mg	9
Tanezumab 10/20 mg	1
Tanezumab 20 mg	72

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	3	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	1	Not reported	Not reported	Not reported	Not reported
Tanezumab 10/20 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	6	Not reported	Not reported	Not reported	Not reported

Head

Analysis denominator · Participants

Group	Source count
Placebo	72
Tanezumab 10 mg	9
Tanezumab 10/20 mg	1
Tanezumab 20 mg	72

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	2	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	1	Not reported	Not reported	Not reported	Not reported
Tanezumab 10/20 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	1	Not reported	Not reported	Not reported	Not reported

Eyes

Analysis denominator · Participants

Group	Source count
Placebo	72
Tanezumab 10 mg	9
Tanezumab 10/20 mg	1
Tanezumab 20 mg	72

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	4	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	1	Not reported	Not reported	Not reported	Not reported
Tanezumab 10/20 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	1	Not reported	Not reported	Not reported	Not reported

Ears

Analysis denominator · Participants

Group	Source count
Placebo	72
Tanezumab 10 mg	9
Tanezumab 10/20 mg	1
Tanezumab 20 mg	72

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	1	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 10/20 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	1	Not reported	Not reported	Not reported	Not reported

Nose

Analysis denominator · Participants

Group	Source count
Placebo	72
Tanezumab 10 mg	9
Tanezumab 10/20 mg	1
Tanezumab 20 mg	72

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 10/20 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	0	Not reported	Not reported	Not reported	Not reported

Neck

Analysis denominator · Participants

Group	Source count
Placebo	72
Tanezumab 10 mg	9
Tanezumab 10/20 mg	1
Tanezumab 20 mg	72

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	2	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	1	Not reported	Not reported	Not reported	Not reported
Tanezumab 10/20 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	2	Not reported	Not reported	Not reported	Not reported

Thyroid

Analysis denominator · Participants

Group	Source count
Placebo	72
Tanezumab 10 mg	9
Tanezumab 10/20 mg	1
Tanezumab 20 mg	71

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	2	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 10/20 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	0	Not reported	Not reported	Not reported	Not reported

Lungs

Analysis denominator · Participants

Group	Source count
Placebo	72
Tanezumab 10 mg	9
Tanezumab 10/20 mg	1
Tanezumab 20 mg	72

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	5	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	1	Not reported	Not reported	Not reported	Not reported
Tanezumab 10/20 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	3	Not reported	Not reported	Not reported	Not reported

Heart

Analysis denominator · Participants

Group	Source count
Placebo	72
Tanezumab 10 mg	9
Tanezumab 10/20 mg	1
Tanezumab 20 mg	72

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	2	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	2	Not reported	Not reported	Not reported	Not reported
Tanezumab 10/20 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	3	Not reported	Not reported	Not reported	Not reported

Abdomen

Analysis denominator · Participants

Group	Source count
Placebo	72
Tanezumab 10 mg	9
Tanezumab 10/20 mg	1
Tanezumab 20 mg	71

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	2	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	1	Not reported	Not reported	Not reported	Not reported
Tanezumab 10/20 mg	1	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	5	Not reported	Not reported	Not reported	Not reported

Extremities

Analysis denominator · Participants

Group	Source count
Placebo	72
Tanezumab 10 mg	9
Tanezumab 10/20 mg	1
Tanezumab 20 mg	71

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	14	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 10/20 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	10	Not reported	Not reported	Not reported	Not reported

Skin

Analysis denominator · Participants

Group	Source count
Placebo	72
Tanezumab 10 mg	9
Tanezumab 10/20 mg	1
Tanezumab 20 mg	72

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	15	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	2	Not reported	Not reported	Not reported	Not reported
Tanezumab 10/20 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	10	Not reported	Not reported	Not reported	Not reported

Throat

Analysis denominator · Participants

Group	Source count
Placebo	72
Tanezumab 10 mg	9
Tanezumab 10/20 mg	1
Tanezumab 20 mg	72

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	3	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	1	Not reported	Not reported	Not reported	Not reported
Tanezumab 10/20 mg	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	2	Not reported	Not reported	Not reported	Not reported

Other 1

Analysis denominator · Participants

Group	Source count
Placebo	15
Tanezumab 10 mg	5
Tanezumab 10/20 mg	0
Tanezumab 20 mg	10

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	9	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	3	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	6	Not reported	Not reported	Not reported	Not reported

Other 2

Analysis denominator · Participants

Group	Source count
Placebo	7
Tanezumab 10 mg	4
Tanezumab 10/20 mg	0
Tanezumab 20 mg	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	1	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	3	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	2	Not reported	Not reported	Not reported	Not reported

Other 3

Analysis denominator · Participants

Group	Source count
Placebo	6
Tanezumab 10 mg	3
Tanezumab 10/20 mg	0
Tanezumab 20 mg	4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	Not reported	Not reported	Not reported	Not reported
Tanezumab 10 mg	1	Not reported	Not reported	Not reported	Not reported
Tanezumab 20 mg	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
3
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
6
denoms
counts
group Id
OG000
value
72
group Id
OG001
value
9
group Id
OG002
value
1
group Id
OG003
value
72
units
Participants
title
General
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
1
denoms
counts
group Id
OG000
value
72
group Id
OG001
value
9
group Id
OG002
value
1
group Id
OG003
value
72
units
Participants
title
Head
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
1
denoms
counts
group Id
OG000
value
72
group Id
OG001
value
9
group Id
OG002
value
1
group Id
OG003
value
72
units
Participants
title
Eyes
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
1
denoms
counts
group Id
OG000
value
72
group Id
OG001
value
9
group Id
OG002
value
1
group Id
OG003
value
72
units
Participants
title
Ears
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
denoms
counts
group Id
OG000
value
72
group Id
OG001
value
9
group Id
OG002
value
1
group Id
OG003
value
72
units
Participants
title
Nose
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
2
denoms
counts
group Id
OG000
value
72
group Id
OG001
value
9
group Id
OG002
value
1
group Id
OG003
value
72
units
Participants
title
Neck
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
denoms
counts
group Id
OG000
value
72
group Id
OG001
value
9
group Id
OG002
value
1
group Id
OG003
value
71
units
Participants
title
Thyroid
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
3
denoms
counts
group Id
OG000
value
72
group Id
OG001
value
9
group Id
OG002
value
1
group Id
OG003
value
72
units
Participants
title
Lungs
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
2
group Id
OG002
value
0
group Id
OG003
value
3
denoms
counts
group Id
OG000
value
72
group Id
OG001
value
9
group Id
OG002
value
1
group Id
OG003
value
72
units
Participants
title
Heart
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
1
group Id
OG002
value
1
group Id
OG003
value
5
denoms
counts
group Id
OG000
value
72
group Id
OG001
value
9
group Id
OG002
value
1
group Id
OG003
value
71
units
Participants
title
Abdomen
categories
measurements
group Id
OG000
value
14
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
10
denoms
counts
group Id
OG000
value
72
group Id
OG001
value
9
group Id
OG002
value
1
group Id
OG003
value
71
units
Participants
title
Extremities
categories
measurements
group Id
OG000
value
15
group Id
OG001
value
2
group Id
OG002
value
0
group Id
OG003
value
10
denoms
counts
group Id
OG000
value
72
group Id
OG001
value
9
group Id
OG002
value
1
group Id
OG003
value
72
units
Participants
title
Skin

denoms

counts
group Id
OG000
value
72
group Id
OG001
value
9
group Id
OG002
value
1
group Id
OG003
value
72
units
Participants

description

Physical examination included assessment of general, head, eyes, ears, nose, neck, thyroid, lungs, heart, abdomen, extremities, skin, throat and other. Investigator judged abnormality in physical examinations.

groups

description
Participants received placebo matched to tanezumab SC once every 8 weeks for 24 weeks.
id
OG000
title
Placebo
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
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
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 subjects treated with tanezumab or placebo SC, including subjects who received tanezumab 10 mg prior to protocol amendment 3. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.

reporting Status

POSTED

time Frame

Screening (up to 37 days prior to Day 1)

title

Number of Participants With Abnormal Physical Examination at Screening

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice