TriangleNCT00116688 · OUTCOME
Number of Participants With a Reduction or Discontinuation of Concurrent ITP Therapies
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Duration of treatment (up to 277 weeks)
What was measured
The number of participants with a reduction or discontinuation of concurrent immune (idiopathic) thrombocytopenic purpura (ITP) therapies (corticosteroids, danazol, azathioprine) during the study.
Analysis population: Subset of Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim and with baseline concurrent ITP therapy.
Groups in this outcome
Romiplostim in Adults
Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving \>10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to \>10 µg/kg.
Romiplostim in Pediatric Population
Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
| Group | Source count |
|---|---|
| Romiplostim in Adults | 37 |
| Romiplostim in Pediatric Population | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Romiplostim in Adults | 30 | Not reported | Not reported | Not reported | Not reported |
| Romiplostim in Pediatric Population | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 37
- group Id
- OG001
- value
- 2
- units
- Participants
- description
- The number of participants with a reduction or discontinuation of concurrent immune (idiopathic) thrombocytopenic purpura (ITP) therapies (corticosteroids, danazol, azathioprine) during the study.
- groups
- description
- Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving \>10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to \>10 µg/kg.
- id
- OG000
- title
- Romiplostim in Adults
- description
- Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
- id
- OG001
- title
- Romiplostim in Pediatric Population
- param Type
- NUMBER
- population Description
- Subset of Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim and with baseline concurrent ITP therapy.
- reporting Status
- POSTED
- time Frame
- Duration of treatment (up to 277 weeks)
- title
- Number of Participants With a Reduction or Discontinuation of Concurrent ITP Therapies
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice