TriangleNCT02609828 · OUTCOME
Number of Participants With Clinically Significant Findings in Weight Measurement, Counted as an AE
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
- Day 1 of dosing up to maximum of Week 48
What was measured
The number of participants with clinically significant findings in weight measurement and were counted as an AE in the study were reported in this outcome measure.
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.
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 | Source count |
|---|---|
| Placebo | 73 |
| Tanezumab 10 mg | 9 |
| Tanezumab 10/20 mg | 1 |
| Tanezumab 20 mg | 72 |
Reported measurements
Source class 1
| 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 | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- 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
- The number of participants with clinically significant findings in weight measurement and were counted as an AE in the study were reported in this outcome measure.
- 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.
- reporting Status
- POSTED
- time Frame
- Day 1 of dosing up to maximum of Week 48
- title
- Number of Participants With Clinically Significant Findings in Weight Measurement, Counted as an AE
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice