TriangleNCT00090051 · OUTCOME
Final Analysis: Percentage of Participants With Complete Response
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
- Not reported
- Time frame
- Median observation time was approximately 5 years
What was measured
Complete response was defined as the disappearance of all signs of cancer in response to treatment.
Analysis population: Intent-to-treat population included all randomized participants.
Groups in this outcome
Fludarabine+Cyclophosphamide (FC)
Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
Fludarabine+Cyclophosphamide+Rituximab (FCR)
Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
| Group | Source count |
|---|---|
| Fludarabine+Cyclophosphamide (FC) | 276 |
| Fludarabine+Cyclophosphamide+Rituximab (FCR) | 276 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Fludarabine+Cyclophosphamide (FC) | 13.4 | Not reported | Not reported | Not reported | Not reported |
| Fludarabine+Cyclophosphamide+Rituximab (FCR) | 25.0 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.39
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.35
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0005
- param Type
- Odds Ratio (OR)
- param Value
- 2.15
- statistical Method
- Chi-squared
Complete source fields
- analyses
- ci Lower Limit
- 1.39
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.35
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0005
- param Type
- Odds Ratio (OR)
- param Value
- 2.15
- statistical Method
- Chi-squared
- classes
- categories
- measurements
- group Id
- OG000
- value
- 13.4
- group Id
- OG001
- value
- 25.0
- denoms
- counts
- group Id
- OG000
- value
- 276
- group Id
- OG001
- value
- 276
- units
- Participants
- description
- Complete response was defined as the disappearance of all signs of cancer in response to treatment.
- groups
- description
- Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
- id
- OG000
- title
- Fludarabine+Cyclophosphamide (FC)
- description
- Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
- id
- OG001
- title
- Fludarabine+Cyclophosphamide+Rituximab (FCR)
- param Type
- NUMBER
- population Description
- Intent-to-treat population included all randomized participants.
- reporting Status
- POSTED
- time Frame
- Median observation time was approximately 5 years
- title
- Final Analysis: Percentage of Participants With Complete Response
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice