NCT02609828 · OUTCOME
Number of Participants With Confirmed Orthostatic Hypotension
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), Weeks 8, 16, 24 and 48
What was measured
Orthostatic hypotension was defined as postural change (supine to standing) that met the following criteria: for systolic blood pressure (BP) less than or equal to (\<=) 150 millimeter of mercury (mmHg) (mean supine): reduction in systolic BP \>=20 mmHg or reduction in diastolic BP \>=10 mmHg at the 1 and/or 3 minute standing BP measurements. For systolic BP greater than (\>) 150 mmHg (mean supine): reduction in systolic BP \>=30 mmHg or reduction in diastolic BP \>=15 mmHg at the 1 and/or 3 minute standing BP measurements. If the 1 minute or 3 minute standing BP in a sequence met the orthostatic hypotension criteria, then that sequence was considered positive. If 2 of 2 or 2 of 3 sequences were positive, then orthostatic hypotension was considered confirmed.
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, "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 | 73 |
|---|
| Tanezumab 10 mg | 9 |
|---|
| Tanezumab 10/20 mg | 1 |
|---|
| Tanezumab 20 mg | 72 |
|---|
Reported measurements
Baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo | 73 |
|---|
| 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 |
|---|
Week 8
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo | 44 |
|---|
| Tanezumab 10 mg | 7 |
|---|
| Tanezumab 10/20 mg | 1 |
|---|
| Tanezumab 20 mg | 52 |
|---|
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 |
|---|
Week 16
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo | 34 |
|---|
| Tanezumab 10 mg | 6 |
|---|
| Tanezumab 10/20 mg | 0 |
|---|
| Tanezumab 20 mg | 43 |
|---|
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 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 24
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo | 33 |
|---|
| Tanezumab 10 mg | 5 |
|---|
| Tanezumab 10/20 mg | 0 |
|---|
| Tanezumab 20 mg | 37 |
|---|
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 |
|---|
Week 48
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo | 28 |
|---|
| Tanezumab 10 mg | 5 |
|---|
| Tanezumab 10/20 mg | 0 |
|---|
| Tanezumab 20 mg | 26 |
|---|
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 |
|---|
Complete source fields
- classes
- 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
- 73
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 72
- units
- Participants
- title
- Baseline
- 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
- 44
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 52
- units
- Participants
- title
- Week 8
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 43
- units
- Participants
- title
- Week 16
- 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
- 33
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 37
- units
- Participants
- title
- Week 24
- 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
- 28
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 26
- units
- Participants
- title
- Week 48
- denoms
- counts
- group Id
- OG000
- value
- 73
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 72
- units
- Participants
- description
- Orthostatic hypotension was defined as postural change (supine to standing) that met the following criteria: for systolic blood pressure (BP) less than or equal to (\<=) 150 millimeter of mercury (mmHg) (mean supine): reduction in systolic BP \>=20 mmHg or reduction in diastolic BP \>=10 mmHg at the 1 and/or 3 minute standing BP measurements. For systolic BP greater than (\>) 150 mmHg (mean supine): reduction in systolic BP \>=30 mmHg or reduction in diastolic BP \>=15 mmHg at the 1 and/or 3 minute standing BP measurements. If the 1 minute or 3 minute standing BP in a sequence met the orthostatic hypotension criteria, then that sequence was considered positive. If 2 of 2 or 2 of 3 sequences were positive, then orthostatic hypotension was considered confirmed.
- 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, "number analyzed" signifies participants evaluable at specific time points.
- reporting Status
- POSTED
- time Frame
- Baseline (Day 1, before dosing), Weeks 8, 16, 24 and 48
- title
- Number of Participants With Confirmed Orthostatic Hypotension
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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