TriangleNCT05546476 · OUTCOME
Part A: Change From Baseline in Mean Activity Level During Maximum 6 Minutes 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
- Arbitrary units per day (au/day)
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- Baseline, Week 12
What was measured
Physical activity was monitored using accelerometry (wearable digital sensors). In this outcome measure mean activity level during maximum 6 minutes was considered. 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 | 12 |
| Part A: Ponsegromab 100 mg | 17 |
| Part A: Ponsegromab 200 mg | 16 |
| Part A: Ponsegromab 400 mg | 13 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: Placebo | 70.81 | Not reported | -785.82 | 927.45 | Not reported |
| Part A: Ponsegromab 100 mg | -59.46 | Not reported | -794.41 | 675.49 | Not reported |
| Part A: Ponsegromab 200 mg | 794.96 | Not reported | 39.43 | 1550.48 | Not reported |
| Part A: Ponsegromab 400 mg | 256.43 | Not reported | -561.29 | 1074.16 | Not reported |
Source statistical analyses
- ci Lower Limit
- -1257.31
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 996.77
- group Description
- 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
- =0.5762
- param Type
- Difference in LS Mean
- param Value
- -130.27
- statistical Method
- MMRM analysis; 1-sided
- ci Lower Limit
- -425.81
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 1874.09
- group Description
- 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
- =0.1486
- param Type
- Difference in LS Mean
- param Value
- 724.14
- statistical Method
- MMRM analysis; 1-sided
- ci Lower Limit
- -997.94
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 1369.18
- group Description
- 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
- =0.3972
- param Type
- Difference in LS Mean
- param Value
- 185.62
- statistical Method
- MMRM analysis; 1-sided
Complete source fields
- analyses
- ci Lower Limit
- -1257.31
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 996.77
- group Description
- 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
- =0.5762
- param Type
- Difference in LS Mean
- param Value
- -130.27
- statistical Method
- MMRM analysis; 1-sided
- ci Lower Limit
- -425.81
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 1874.09
- group Description
- 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
- =0.1486
- param Type
- Difference in LS Mean
- param Value
- 724.14
- statistical Method
- MMRM analysis; 1-sided
- ci Lower Limit
- -997.94
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 1369.18
- group Description
- 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
- =0.3972
- param Type
- Difference in LS Mean
- param Value
- 185.62
- statistical Method
- MMRM analysis; 1-sided
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -785.82
- upper Limit
- 927.45
- value
- 70.81
- group Id
- OG001
- lower Limit
- -794.41
- upper Limit
- 675.49
- value
- -59.46
- group Id
- OG002
- lower Limit
- 39.43
- upper Limit
- 1550.48
- value
- 794.96
- group Id
- OG003
- lower Limit
- -561.29
- upper Limit
- 1074.16
- value
- 256.43
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 17
- group Id
- OG002
- value
- 16
- group Id
- OG003
- value
- 13
- units
- Participants
- description
- Physical activity was monitored using accelerometry (wearable digital sensors). In this outcome measure mean activity level during maximum 6 minutes was considered. 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 Mean Activity Level During Maximum 6 Minutes at Week 12
- type
- SECONDARY
- unit Of Measure
- Arbitrary units per day (au/day)
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice