TriangleNCT01444417 · OUTCOME
Percentage of Participants Who Received Rescue Medication During the Treatment Period
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
- 24 weeks
What was measured
Rescue medication is any medication (other than excluded medications) that is intended to increase platelet counts or prevent bleeding.
Analysis population: Efficacy analysis set
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 | 45.0 | Not reported | 23.1 | 68.5 | Not reported |
| Romiplostim | 40.5 | Not reported | 25.6 | 56.7 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.277
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.391
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.7103
- param Type
- Odds Ratio (OR)
- param Value
- 0.813
- 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
- 0.277
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.391
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.7103
- param Type
- Odds Ratio (OR)
- param Value
- 0.813
- 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
- 23.1
- upper Limit
- 68.5
- value
- 45.0
- group Id
- OG001
- lower Limit
- 25.6
- upper Limit
- 56.7
- value
- 40.5
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 42
- units
- Participants
- description
- Rescue medication is any medication (other than excluded medications) that is intended to increase platelet counts or prevent bleeding.
- 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
- reporting Status
- POSTED
- time Frame
- 24 weeks
- title
- Percentage of Participants Who Received Rescue Medication During the Treatment Period
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice