NCT00116688 · OUTCOME
Patient Global Assessment
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- scores on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Week 1 and Week 48
What was measured
The Patient Global Assessment is two questions which assess the overall health-related quality of life (HRQOL) and symptoms of the patient. Each item is answered on a 15-point Likert scale ranging from 'A very great deal worse' (1) to 'A very great deal better' (15). A higher score indicates that quality of life or symptoms have improved.
Analysis population: Full analysis set with available data. Patient reported outcomes were only analyzed in adult participants.
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.
| Group | Source count |
|---|---|
| Romiplostim in Adults | 292 |
Reported measurements
Week 1 (N=271)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Romiplostim in Adults | 7.61 | 2.02 | Not reported | Not reported | Not reported |
Week 48 (N=216)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Romiplostim in Adults | 8.18 | 1.78 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 2.02
- value
- 7.61
- title
- Week 1 (N=271)
- categories
- measurements
- group Id
- OG000
- spread
- 1.78
- value
- 8.18
- title
- Week 48 (N=216)
- denoms
- counts
- group Id
- OG000
- value
- 292
- units
- Participants
- description
- The Patient Global Assessment is two questions which assess the overall health-related quality of life (HRQOL) and symptoms of the patient. Each item is answered on a 15-point Likert scale ranging from 'A very great deal worse' (1) to 'A very great deal better' (15). A higher score indicates that quality of life or symptoms have improved.
- dispersion Type
- Standard Deviation
- 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
- param Type
- MEAN
- population Description
- Full analysis set with available data. Patient reported outcomes were only analyzed in adult participants.
- reporting Status
- POSTED
- time Frame
- Week 1 and Week 48
- title
- Patient Global Assessment
- type
- SECONDARY
- unit Of Measure
- scores on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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