TriangleNCT05546476 · OUTCOME
Part A: Change From Baseline in Total Vector Magnitude 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
- Total activity counts/100 per day
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- Baseline, Week 12
What was measured
Total vector magnitude is a measure of overall physical activity. 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 | -1919.02 | Not reported | -3450.37 | -387.68 | Not reported |
| Part A: Ponsegromab 100 mg | -331.76 | Not reported | -1679.81 | 1016.29 | Not reported |
| Part A: Ponsegromab 200 mg | -2017.57 | Not reported | -3387.48 | -647.65 | Not reported |
| Part A: Ponsegromab 400 mg | 284.15 | Not reported | -1175.46 | 1743.77 | Not reported |
Source statistical analyses
- ci Lower Limit
- -443.79
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 3618.31
- 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
- =0.0985
- param Type
- Difference in LS Mean
- param Value
- 1587.26
- statistical Method
- MMRM analysis; 1-sided
- ci Lower Limit
- -2169.67
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 1972.58
- 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
- =0.5315
- param Type
- Difference in LS Mean
- param Value
- -98.54
- statistical Method
- MMRM analysis; 1-sided
- ci Lower Limit
- 84.51
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 4321.85
- 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
- =0.0437
- param Type
- Difference in LS Mean
- param Value
- 2203.18
- statistical Method
- MMRM analysis; 1-sided
Complete source fields
- analyses
- ci Lower Limit
- -443.79
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 3618.31
- 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
- =0.0985
- param Type
- Difference in LS Mean
- param Value
- 1587.26
- statistical Method
- MMRM analysis; 1-sided
- ci Lower Limit
- -2169.67
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 1972.58
- 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
- =0.5315
- param Type
- Difference in LS Mean
- param Value
- -98.54
- statistical Method
- MMRM analysis; 1-sided
- ci Lower Limit
- 84.51
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 4321.85
- 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
- =0.0437
- param Type
- Difference in LS Mean
- param Value
- 2203.18
- statistical Method
- MMRM analysis; 1-sided
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -3450.37
- upper Limit
- -387.68
- value
- -1919.02
- group Id
- OG001
- lower Limit
- -1679.81
- upper Limit
- 1016.29
- value
- -331.76
- group Id
- OG002
- lower Limit
- -3387.48
- upper Limit
- -647.65
- value
- -2017.57
- group Id
- OG003
- lower Limit
- -1175.46
- upper Limit
- 1743.77
- value
- 284.15
- 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
- Total vector magnitude is a measure of overall physical activity. 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 Total Vector Magnitude at Week 12
- type
- SECONDARY
- unit Of Measure
- Total activity counts/100 per day
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Preserved source evidence · Not medical advice