NCT02279173 · OUTCOME
Percentage of Time With a Platelet Response During the First 6 Months of Treatment
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- percentage of time
- Interval / dispersion
- Inter-Quartile Range
- Time frame
- Week 2 to Month 6, platelet response was assessed every week.
What was measured
Platelet response was defined as a platelet count of ≥ 50 x 10⁹/L with no rescue medication use for ITP in the past 4 weeks. Monthly platelet response was calculated based on the median platelet count during each month. For each participant, the percentage of time with platelet response during the first 6 months was calculated as the number of months a platelet response was observed divided by the total number of months response was assessed.
Analysis population: The efficacy analysis set included all enrolled participants who received at least 1 dose of romiplostim
Groups in this outcome
Romiplostim
Participants received romiplostim administered weekly by subcutaneous injection for up to 3 years. The starting dose was 1 µg/kg titrated in 1 µg/kg increments up to a maximum of 10 µg/kg to reach a target platelet count ≥ 50 x 10⁹/L.
| Group | Source count |
|---|---|
| Romiplostim | 203 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Romiplostim | 50.00 | Not reported | 16.67 | 83.33 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 16.67
- upper Limit
- 83.33
- value
- 50.00
- denoms
- counts
- group Id
- OG000
- value
- 203
- units
- Participants
- description
- Platelet response was defined as a platelet count of ≥ 50 x 10⁹/L with no rescue medication use for ITP in the past 4 weeks. Monthly platelet response was calculated based on the median platelet count during each month. For each participant, the percentage of time with platelet response during the first 6 months was calculated as the number of months a platelet response was observed divided by the total number of months response was assessed.
- dispersion Type
- Inter-Quartile Range
- groups
- description
- Participants received romiplostim administered weekly by subcutaneous injection for up to 3 years. The starting dose was 1 µg/kg titrated in 1 µg/kg increments up to a maximum of 10 µg/kg to reach a target platelet count ≥ 50 x 10⁹/L.
- id
- OG000
- title
- Romiplostim
- param Type
- MEDIAN
- population Description
- The efficacy analysis set included all enrolled participants who received at least 1 dose of romiplostim
- reporting Status
- POSTED
- time Frame
- Week 2 to Month 6, platelet response was assessed every week.
- title
- Percentage of Time With a Platelet Response During the First 6 Months of Treatment
- type
- PRIMARY
- unit Of Measure
- percentage of time
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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