TriangleNCT01437787 · OUTCOME
Response Rate (RR): Percentage of Participants Who Had a >=35% Reduction From Baseline in Volume of Spleen Size at The End 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
Spleen volume was determined by magnetic resonance imaging (MRI) (or computed tomography scan in participants with contraindications for MRI) at baseline and at the end of cycle 6 with a confirmatory scan approximately 4 weeks after the end of Cycle 6. The MRI or CT imaging results reviewed in a blinded manner by an Independent Review Committee (IRC). Analysis was performed on intent-to-treat (ITT) population defined as all randomized participants who signed informed consent form (ICF).
Analysis population: All randomized participants.
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 | 96 |
| SAR302503 400 mg | 96 |
| SAR302503 500 mg | 97 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 1 | 0 | 0 | 3.1 | Not reported |
| SAR302503 400 mg | 36.5 | 26.8 | 26.8 | 46.1 | Not reported |
| SAR302503 500 mg | 40.2 | 30.4 | 30.4 | 50 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- spread
- 0
- upper Limit
- 3.1
- value
- 1
- group Id
- OG001
- lower Limit
- 26.8
- spread
- 26.8
- upper Limit
- 46.1
- value
- 36.5
- group Id
- OG002
- lower Limit
- 30.4
- spread
- 30.4
- upper Limit
- 50
- value
- 40.2
- denoms
- counts
- group Id
- OG000
- value
- 96
- group Id
- OG001
- value
- 96
- group Id
- OG002
- value
- 97
- units
- Participants
- description
- Spleen volume was determined by magnetic resonance imaging (MRI) (or computed tomography scan in participants with contraindications for MRI) at baseline and at the end of cycle 6 with a confirmatory scan approximately 4 weeks after the end of Cycle 6. The MRI or CT imaging results reviewed in a blinded manner by an Independent Review Committee (IRC). Analysis was performed on intent-to-treat (ITT) population defined as all randomized participants who signed informed consent form (ICF).
- 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 randomized participants.
- reporting Status
- POSTED
- time Frame
- Baseline, Week 24
- title
- Response Rate (RR): Percentage of Participants Who Had a >=35% Reduction From Baseline in Volume of Spleen Size at The End Cycle 6
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice