TriangleNCT01143038 · OUTCOME
Number of Months With Platelet Response 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
- MEAN
- Unit
- months
- Interval / dispersion
- Standard Error
- Time frame
- 12 months
What was measured
The primary endpoint was the number of months a participant achieved a platelet response during the 12-month treatment period. A platelet response for any 1 month was defined as the median of platelet counts measured in the month ≥ 50 x 10\^9/L. Platelet counts within 4 weeks following a rescue medication use or following splenectomy were considered non-response. Months without any platelet count measurement were considered as months with no platelet response.
Analysis population: Safety Analysis Set includes all participants who received at least 1 dose of romiplostim.
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 | 9.2 | 0.4 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 8.3
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 10.1
- estimate Comment
- Based on the t-distribution
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- param Type
- Mean
- param Value
- 9.2
- ci Lower Limit
- 8.3
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 10.0
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.4
- estimate Comment
- Estimates are based on bootstrap method with 1000 samples with replacement.
- group Description
- Bootstrap analysis
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- param Type
- Bootstrap mean
- param Value
- 9.1
Complete source fields
- analyses
- ci Lower Limit
- 8.3
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 10.1
- estimate Comment
- Based on the t-distribution
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- param Type
- Mean
- param Value
- 9.2
- ci Lower Limit
- 8.3
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 10.0
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.4
- estimate Comment
- Estimates are based on bootstrap method with 1000 samples with replacement.
- group Description
- Bootstrap analysis
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- param Type
- Bootstrap mean
- param Value
- 9.1
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.4
- value
- 9.2
- denoms
- counts
- group Id
- OG000
- value
- 75
- units
- Participants
- description
- The primary endpoint was the number of months a participant achieved a platelet response during the 12-month treatment period. A platelet response for any 1 month was defined as the median of platelet counts measured in the month ≥ 50 x 10\^9/L. Platelet counts within 4 weeks following a rescue medication use or following splenectomy were considered non-response. Months without any platelet count measurement were considered as months with no platelet response.
- dispersion Type
- Standard Error
- 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
- MEAN
- population Description
- Safety Analysis Set includes all participants who received at least 1 dose of romiplostim.
- reporting Status
- POSTED
- time Frame
- 12 months
- title
- Number of Months With Platelet Response During the 12-Month Treatment Period
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice