TriangleNCT01143038 · OUTCOME
Percentage of Participants With Splenectomy During the 12-month 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
- 12 months
What was measured
If treatment with romiplostim was deemed ineffective or intolerable by the investigator, a splenectomy may have been performed.
Analysis population: Safety analysis set
Groups in this outcome
Romiplostim
Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10\^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10\^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10\^9/L could reinitiate romiplostim for up to 8 weeks.
| Group | Source count |
|---|---|
| Romiplostim | 75 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Romiplostim | 1.3 | Not reported | 0.0 | 7.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 7.2
- value
- 1.3
- denoms
- counts
- group Id
- OG000
- value
- 75
- units
- Participants
- description
- If treatment with romiplostim was deemed ineffective or intolerable by the investigator, a splenectomy may have been performed.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10\^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10\^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10\^9/L could reinitiate romiplostim for up to 8 weeks.
- id
- OG000
- title
- Romiplostim
- param Type
- NUMBER
- population Description
- Safety analysis set
- reporting Status
- POSTED
- time Frame
- 12 months
- title
- Percentage of Participants With Splenectomy During the 12-month Treatment Period
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice