TriangleNCT01444417 · OUTCOME
Percentage of Participants With a Durable Platelet Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Week 18 to week 25
What was measured
A participant with durable platelet response was defined as achieving at least 6 weekly platelet counts of ≥ 50 x 10\^9/L during the last 8 weeks of treatment (platelet counts obtained from week 18 to week 25). If a platelet count from a participant was not available (missing) in a certain week, that week was imputed as non-response for that participant. Platelet counts were not deemed as a positive response for 4 weeks after the administration of rescue medication.
Analysis population: Efficacy analysis set (all randomized participants)
Groups in this outcome
Placebo
Participants received weekly subcutaneous placebo for 24 weeks.
Romiplostim
Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10\^9/L.
| Group | Source count |
|---|---|
| Placebo | 20 |
| Romiplostim | 42 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 10.0 | Not reported | 1.2 | 31.7 | Not reported |
| Romiplostim | 52.4 | Not reported | 36.4 | 68.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.896
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 43.199
- group Description
- The incidence of durable platelet response was compared by the Cochran-Mantel-Haenszel test stratified by the baseline age group. The Mantel-Haenszel common odds ratio (romiplostim vs placebo) was estimated along with its 95% confidence interval.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0018
- param Type
- Odds Ratio (OR)
- param Value
- 9.0497
- statistical Comment
- P-value from Cochran-Mantel-Haenszel test stratified by baseline age group.
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 1.896
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 43.199
- group Description
- The incidence of durable platelet response was compared by the Cochran-Mantel-Haenszel test stratified by the baseline age group. The Mantel-Haenszel common odds ratio (romiplostim vs placebo) was estimated along with its 95% confidence interval.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0018
- param Type
- Odds Ratio (OR)
- param Value
- 9.0497
- statistical Comment
- P-value from Cochran-Mantel-Haenszel test stratified by baseline age group.
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.2
- upper Limit
- 31.7
- value
- 10.0
- group Id
- OG001
- lower Limit
- 36.4
- upper Limit
- 68.0
- value
- 52.4
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 42
- units
- Participants
- description
- A participant with durable platelet response was defined as achieving at least 6 weekly platelet counts of ≥ 50 x 10\^9/L during the last 8 weeks of treatment (platelet counts obtained from week 18 to week 25). If a platelet count from a participant was not available (missing) in a certain week, that week was imputed as non-response for that participant. Platelet counts were not deemed as a positive response for 4 weeks after the administration of rescue medication.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received weekly subcutaneous placebo for 24 weeks.
- id
- OG000
- title
- Placebo
- description
- Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10\^9/L.
- id
- OG001
- title
- Romiplostim
- param Type
- NUMBER
- population Description
- Efficacy analysis set (all randomized participants)
- reporting Status
- POSTED
- time Frame
- Week 18 to week 25
- title
- Percentage of Participants With a Durable Platelet Response
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice