TriangleNCT02609828 · OUTCOME
Change From Baseline in the Daily Average Pain Intensity Numerical Rating Score (NRS) in the Index Bone Metastasis Cancer Pain Site at Week 8
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- Units on a scale
- Interval / dispersion
- Standard Error
- Time frame
- Baseline, Week 8
What was measured
Daily average pain intensity in the index bone metastasis 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 recorded their daily average pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on interactive response technology (IRT) diaries. Baseline daily average pain intensity value was mean of the daily average pain intensity NRS scores during the baseline assessment period prior to randomization. Baseline assessment period was up to 5 days prior to dosing. The Week 8 daily average pain intensity value was the mean of the daily average pain intensity NRS scores recorded for each of the 7 days prior to the Week 8.
Analysis population: The modified intent to treat (mITT) analysis set: participants randomized to tanezumab 20 mg or placebo SC, received at least 1dose of SC study medication. Multiple imputation method was applied. As planned summarized efficacy data for tanezumab 10 mg and 10/20 mg arms not reported; for these 2 arms individual values are reported. Here, "Overall Number of Participants Analyzed" signifies 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 | Source count |
|---|---|
| Placebo | 73 |
| Tanezumab 10 mg | 8 |
| Tanezumab 10/20 mg | 1 |
| Tanezumab 20 mg | 72 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | -1.25 | 0.35 | Not reported | Not reported | Not reported |
| Tanezumab 10 mg | NA | NA | Not reported | Not reported | Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE. Individual values were -3, -1.8, -0.6, -3.66, -2.4, -3, -1 and -2. |
| Tanezumab 10/20 mg | NA | NA | Not reported | Not reported | Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE. Individual value was -0.48. |
| Tanezumab 20 mg | -2.03 | 0.35 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -1.52
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -0.04
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.37
- group Description
- Change at Week 8: Analysis of covariance (ANCOVA) model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.
- group Ids
- OG000
- OG003
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0381
- param Type
- Differences in least square (LS) mean
- param Value
- -0.78
- statistical Method
- ANCOVA
Complete source fields
- analyses
- ci Lower Limit
- -1.52
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -0.04
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.37
- group Description
- Change at Week 8: Analysis of covariance (ANCOVA) model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.
- group Ids
- OG000
- OG003
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0381
- param Type
- Differences in least square (LS) mean
- param Value
- -0.78
- statistical Method
- ANCOVA
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.35
- value
- -1.25
- comment
- Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE. Individual values were -3, -1.8, -0.6, -3.66, -2.4, -3, -1 and -2.
- group Id
- OG001
- spread
- NA
- value
- NA
- comment
- Data for this arm was not summarized per plan. Hence, not reported as LS mean and SE. Individual value was -0.48.
- group Id
- OG002
- spread
- NA
- value
- NA
- group Id
- OG003
- spread
- 0.35
- value
- -2.03
- denoms
- counts
- group Id
- OG000
- value
- 73
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 72
- units
- Participants
- description
- Daily average pain intensity in the index bone metastasis 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 recorded their daily average pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on interactive response technology (IRT) diaries. Baseline daily average pain intensity value was mean of the daily average pain intensity NRS scores during the baseline assessment period prior to randomization. Baseline assessment period was up to 5 days prior to dosing. The Week 8 daily average pain intensity value was the mean of the daily average pain intensity NRS scores recorded for each of the 7 days prior to the Week 8.
- dispersion Type
- Standard Error
- 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
- LEAST_SQUARES_MEAN
- population Description
- The modified intent to treat (mITT) analysis set: participants randomized to tanezumab 20 mg or placebo SC, received at least 1dose of SC study medication. Multiple imputation method was applied. As planned summarized efficacy data for tanezumab 10 mg and 10/20 mg arms not reported; for these 2 arms individual values are reported. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Baseline, Week 8
- title
- Change From Baseline in the Daily Average Pain Intensity Numerical Rating Score (NRS) in the Index Bone Metastasis Cancer Pain Site at Week 8
- type
- PRIMARY
- unit Of Measure
- Units on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice