TriangleNCT01437787 · OUTCOME
Symptom Response Rate (SRR): Percentage of Participants With >=50% Reduction From Baseline in the Total Symptom Score at End of Cycle 6
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
- Baseline, Week 24
What was measured
Total symptom score is the averaged value of the daily scores for each of 6 key Myelofibrosis (MF) associated Symptom items (night sweats, pruritus, abdominal discomfort, early satiety \[filling up quickly when you eat\], pain under ribs on left side, and bone or muscle pain), each item measured on a scale from 0 (absent) to 10 (worst imaginable). A higher score indicates worse symptoms. Analysis was performed on ITT population. Number of participants analysed= participants with available data at end of cycle 6.
Analysis population: All treated participants with available data at baseline and the end of cycle 6.
Groups in this outcome
Placebo
Placebo up to 6 cycles (1 cycle=28 days - median exposure= 24 weeks). At the end of cycle 6, participants were crossed-over to SAR302503 400 or 500 mg until disease progression or unacceptable toxicity.
SAR302503 400 mg
SAR302503 400 mg until disease progression and/or unacceptable toxicity (median exposure= 62.1 weeks).
SAR302503 500 mg
SAR302503 500 mg until disease progression and/or unacceptable toxicity (median exposure =59.7 weeks).
| Group | Source count |
|---|---|
| Placebo | 85 |
| SAR302503 400 mg | 91 |
| SAR302503 500 mg | 91 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 7.1 | 1.6 | 1.6 | 12.5 | Not reported |
| SAR302503 400 mg | 36.3 | 26.4 | 26.4 | 46.1 | Not reported |
| SAR302503 500 mg | 34.1 | 24.3 | 24.3 | 43.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.6
- spread
- 1.6
- upper Limit
- 12.5
- value
- 7.1
- group Id
- OG001
- lower Limit
- 26.4
- spread
- 26.4
- upper Limit
- 46.1
- value
- 36.3
- group Id
- OG002
- lower Limit
- 24.3
- spread
- 24.3
- upper Limit
- 43.8
- value
- 34.1
- denoms
- counts
- group Id
- OG000
- value
- 85
- group Id
- OG001
- value
- 91
- group Id
- OG002
- value
- 91
- units
- Participants
- description
- Total symptom score is the averaged value of the daily scores for each of 6 key Myelofibrosis (MF) associated Symptom items (night sweats, pruritus, abdominal discomfort, early satiety \[filling up quickly when you eat\], pain under ribs on left side, and bone or muscle pain), each item measured on a scale from 0 (absent) to 10 (worst imaginable). A higher score indicates worse symptoms. Analysis was performed on ITT population. Number of participants analysed= participants with available data at end of cycle 6.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Placebo up to 6 cycles (1 cycle=28 days - median exposure= 24 weeks). At the end of cycle 6, participants were crossed-over to SAR302503 400 or 500 mg until disease progression or unacceptable toxicity.
- id
- OG000
- title
- Placebo
- description
- SAR302503 400 mg until disease progression and/or unacceptable toxicity (median exposure= 62.1 weeks).
- id
- OG001
- title
- SAR302503 400 mg
- description
- SAR302503 500 mg until disease progression and/or unacceptable toxicity (median exposure =59.7 weeks).
- id
- OG002
- title
- SAR302503 500 mg
- param Type
- NUMBER
- population Description
- All treated participants with available data at baseline and the end of cycle 6.
- reporting Status
- POSTED
- time Frame
- Baseline, Week 24
- title
- Symptom Response Rate (SRR): Percentage of Participants With >=50% Reduction From Baseline in the Total Symptom Score at End of Cycle 6
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice