TriangleNCT05546476 · OUTCOME
Part A: Change From Baseline in Gait at Week 12
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- Meter per second (m/s)
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- Baseline, Week 12
What was measured
Gait was monitored using accelerometry (wearable digital sensors). Analysis was performed using MMRM model. Gait included: gait speed and 95th percentile of gait speed. Baseline was defined as the mean taken over the 8 days of wear during screening. Mean taken over the 8 days of wear before Week 12 was considered. Analysis was performed using MMRM model.
Analysis population: Censored analysis set:all evaluable participants.For participants who discontinued study intervention/received prohibited procedure/ prohibited medication,all observations post-discontinuation/post-procedure,were censored and treated as missing data.For participants who missed dose/received incomplete dose,all observations post-missed/incomplete dose were censored and treated as missing data.''Overall Number of Participants Analyzed'' =participants evaluable for this outcome measure at Week 12.
Groups in this outcome
Part A: Placebo
Part A: Participants were randomized to receive placebo matching to Ponsegromab SC Q4W up to 12 weeks (total of 3 doses).
Part A: Ponsegromab 100 mg
Part A: Participants were randomized to receive Ponsegromab 100 mg SC Q4W up to 12 weeks (total of 3 doses).
Part A: Ponsegromab 200 mg
Part A: Participants were randomized to receive Ponsegromab 200 mg SC Q4W up to 12 weeks (total of 3 doses).
Part A: Ponsegromab 400 mg
Part A: Participants were randomized to receive Ponsegromab 400 mg SC Q4W up to 12 weeks (total of 3 doses).
| Group | Source count |
|---|---|
| Part A: Placebo | 15 |
| Part A: Ponsegromab 100 mg | 19 |
| Part A: Ponsegromab 200 mg | 18 |
| Part A: Ponsegromab 400 mg | 14 |
Reported measurements
Gait Speed
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: Placebo | -0.008 | Not reported | -0.042 | 0.026 | Not reported |
| Part A: Ponsegromab 100 mg | -0.009 | Not reported | -0.040 | 0.023 | Not reported |
| Part A: Ponsegromab 200 mg | -0.012 | Not reported | -0.044 | 0.019 | Not reported |
| Part A: Ponsegromab 400 mg | 0.009 | Not reported | -0.024 | 0.042 | Not reported |
95th percentile of gait speed
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: Placebo | 0.011 | Not reported | -0.041 | 0.064 | Not reported |
| Part A: Ponsegromab 100 mg | 0.011 | Not reported | -0.037 | 0.059 | Not reported |
| Part A: Ponsegromab 200 mg | -0.015 | Not reported | -0.063 | 0.033 | Not reported |
| Part A: Ponsegromab 400 mg | 0.021 | Not reported | -0.030 | 0.072 | Not reported |
Source statistical analyses
- ci Lower Limit
- -0.046
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 0.045
- group Description
- Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.5052
- param Type
- Difference in LS Mean
- param Value
- 0
- statistical Method
- MMRM analysis; 1-sided
- ci Lower Limit
- -0.050
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 0.042
- group Description
- Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.5599
- param Type
- Difference in LS Mean
- param Value
- -0.004
- statistical Method
- MMRM analysis; 1-sided
- ci Lower Limit
- -0.030
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 0.064
- group Description
- Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.
- group Ids
- OG000
- OG003
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.2770
- param Type
- Difference in LS Mean
- param Value
- 0.017
- statistical Method
- MMRM analysis; 1-sided
- ci Lower Limit
- -0.071
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 0.070
- group Description
- 95th Percentile of Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.5047
- param Type
- Difference in LS Mean
- param Value
- 0
- statistical Method
- MMRM analysis; 1-sided
- ci Lower Limit
- -0.097
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 0.045
- group Description
- 95th Percentile of Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.7316
- param Type
- Difference in LS Mean
- param Value
- -0.026
- statistical Method
- MMRM analysis; 1-sided
- ci Lower Limit
- -0.063
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 0.082
- group Description
- 95th Percentile of Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.
- group Ids
- OG000
- OG003
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.4145
- param Type
- Difference in LS Mean
- param Value
- 0.01
- statistical Method
- MMRM analysis; 1-sided
Complete source fields
- analyses
- ci Lower Limit
- -0.046
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 0.045
- group Description
- Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.5052
- param Type
- Difference in LS Mean
- param Value
- 0
- statistical Method
- MMRM analysis; 1-sided
- ci Lower Limit
- -0.050
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 0.042
- group Description
- Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.5599
- param Type
- Difference in LS Mean
- param Value
- -0.004
- statistical Method
- MMRM analysis; 1-sided
- ci Lower Limit
- -0.030
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 0.064
- group Description
- Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.
- group Ids
- OG000
- OG003
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.2770
- param Type
- Difference in LS Mean
- param Value
- 0.017
- statistical Method
- MMRM analysis; 1-sided
- ci Lower Limit
- -0.071
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 0.070
- group Description
- 95th Percentile of Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.5047
- param Type
- Difference in LS Mean
- param Value
- 0
- statistical Method
- MMRM analysis; 1-sided
- ci Lower Limit
- -0.097
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 0.045
- group Description
- 95th Percentile of Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.7316
- param Type
- Difference in LS Mean
- param Value
- -0.026
- statistical Method
- MMRM analysis; 1-sided
- ci Lower Limit
- -0.063
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 0.082
- group Description
- 95th Percentile of Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.
- group Ids
- OG000
- OG003
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.4145
- param Type
- Difference in LS Mean
- param Value
- 0.01
- statistical Method
- MMRM analysis; 1-sided
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -0.042
- upper Limit
- 0.026
- value
- -0.008
- group Id
- OG001
- lower Limit
- -0.040
- upper Limit
- 0.023
- value
- -0.009
- group Id
- OG002
- lower Limit
- -0.044
- upper Limit
- 0.019
- value
- -0.012
- group Id
- OG003
- lower Limit
- -0.024
- upper Limit
- 0.042
- value
- 0.009
- title
- Gait Speed
- categories
- measurements
- group Id
- OG000
- lower Limit
- -0.041
- upper Limit
- 0.064
- value
- 0.011
- group Id
- OG001
- lower Limit
- -0.037
- upper Limit
- 0.059
- value
- 0.011
- group Id
- OG002
- lower Limit
- -0.063
- upper Limit
- 0.033
- value
- -0.015
- group Id
- OG003
- lower Limit
- -0.030
- upper Limit
- 0.072
- value
- 0.021
- title
- 95th percentile of gait speed
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 18
- group Id
- OG003
- value
- 14
- units
- Participants
- description
- Gait was monitored using accelerometry (wearable digital sensors). Analysis was performed using MMRM model. Gait included: gait speed and 95th percentile of gait speed. Baseline was defined as the mean taken over the 8 days of wear during screening. Mean taken over the 8 days of wear before Week 12 was considered. Analysis was performed using MMRM model.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Part A: Participants were randomized to receive placebo matching to Ponsegromab SC Q4W up to 12 weeks (total of 3 doses).
- id
- OG000
- title
- Part A: Placebo
- description
- Part A: Participants were randomized to receive Ponsegromab 100 mg SC Q4W up to 12 weeks (total of 3 doses).
- id
- OG001
- title
- Part A: Ponsegromab 100 mg
- description
- Part A: Participants were randomized to receive Ponsegromab 200 mg SC Q4W up to 12 weeks (total of 3 doses).
- id
- OG002
- title
- Part A: Ponsegromab 200 mg
- description
- Part A: Participants were randomized to receive Ponsegromab 400 mg SC Q4W up to 12 weeks (total of 3 doses).
- id
- OG003
- title
- Part A: Ponsegromab 400 mg
- param Type
- LEAST_SQUARES_MEAN
- population Description
- Censored analysis set:all evaluable participants.For participants who discontinued study intervention/received prohibited procedure/ prohibited medication,all observations post-discontinuation/post-procedure,were censored and treated as missing data.For participants who missed dose/received incomplete dose,all observations post-missed/incomplete dose were censored and treated as missing data.''Overall Number of Participants Analyzed'' =participants evaluable for this outcome measure at Week 12.
- reporting Status
- POSTED
- time Frame
- Baseline, Week 12
- title
- Part A: Change From Baseline in Gait at Week 12
- type
- SECONDARY
- unit Of Measure
- Meter per second (m/s)
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice