Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period
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
Change categories for sitting systolic blood pressure measured in millimeter of mercury (mm Hg) were as follows: change \<=-40, change \>-40 to -30, change \>-30 to -20, change \>-20 to -10, change \>-10 to 0, change \>0 to \<10, change \>=10 to \<20, change \>=20 to \<30, change \>=30 to \<40 and change \>=40. Change categories for sitting diastolic blood pressure measured in mm Hg were as follow: change \<=-30, change \>-30 to -20, change \>-20 to -10, change \>-10 to 0, change \>0 to \<10, change \>=10 to \<20, change \>=20 to \<30 and change \>=30. Rows with only non-zero data/values, for at least 1 reporting arm, are reported below.
Analysis population: The safety analysis set was defined as all participants treated with tanezumab or placebo SC, including participants 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.
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.
Sitting Systolic Blood Pressure (mmHg) Change >-40 to -30
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
3
title
Sitting Systolic Blood Pressure (mmHg) Change >-30 to -20
categories
measurements
group Id
OG000
value
10
group Id
OG001
value
3
group Id
OG002
value
0
group Id
OG003
value
14
title
Sitting Systolic Blood Pressure (mmHg) Change >-20 to -10
categories
measurements
group Id
OG000
value
26
group Id
OG001
value
2
group Id
OG002
value
0
group Id
OG003
value
25
title
Sitting Systolic Blood Pressure (mmHg) Change >-10 to 0
categories
measurements
group Id
OG000
value
12
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
9
title
Sitting Systolic Blood Pressure (mmHg) Change >0 to <10
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
3
group Id
OG002
value
0
group Id
OG003
value
10
title
Sitting Systolic Blood Pressure (mmHg) Change >=10 to <20
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
3
title
Sitting Systolic Blood Pressure (mmHg) Change >=20 to <30
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
1
title
Sitting Systolic Blood Pressure (mmHg) Change >=30 to <40
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
1
title
Sitting Diastolic Blood Pressure (mmHg) Change >-30 to -20
categories
measurements
group Id
OG000
value
10
group Id
OG001
value
1
group Id
OG002
value
1
group Id
OG003
value
13
title
Sitting Diastolic Blood Pressure (mmHg) Change >-20 to -10
categories
measurements
group Id
OG000
value
39
group Id
OG001
value
4
group Id
OG002
value
0
group Id
OG003
value
26
title
Sitting Diastolic Blood Pressure (mmHg) Change >-10 to 0
denoms
counts
group Id
OG000
value
67
group Id
OG001
value
9
group Id
OG002
value
1
group Id
OG003
value
68
units
Participants
description
Change categories for sitting systolic blood pressure measured in millimeter of mercury (mm Hg) were as follows: change \<=-40, change \>-40 to -30, change \>-30 to -20, change \>-20 to -10, change \>-10 to 0, change \>0 to \<10, change \>=10 to \<20, change \>=20 to \<30, change \>=30 to \<40 and change \>=40. Change categories for sitting diastolic blood pressure measured in mm Hg were as follow: change \<=-30, change \>-30 to -20, change \>-20 to -10, change \>-10 to 0, change \>0 to \<10, change \>=10 to \<20, change \>=20 to \<30 and change \>=30. Rows with only non-zero data/values, for at least 1 reporting arm, are reported below.
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 was defined as all participants treated with tanezumab or placebo SC, including participants 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.
reporting Status
POSTED
time Frame
Baseline (Day 1, before dosing) up to Week 24
title
Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period
Triangle