TriangleNCT01611090 · OUTCOME
Progression-free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 5 years
What was measured
PFS was defined as the interval between the date of randomization and the date of disease progression or death, whichever was first reported. IWCLL 2008 criteria for PD: New enlarged nodes \>1.5 cm, new hepatomegaly or splenomegaly, or other new organ infiltrates, bone lesion, ascites, or pleural effusion confirmed due to chronic lymphocytic leukemia (CLL); \>=50% increase in existing lymph nodes; \>=50% increase in enlargement of liver or spleen; \>=50% increase from baseline in lymphocyte count (and to \>=5\*10\^9/L) or \>=50% increase from nadir count confirmed on \>=2 serial assessments if absolute lymphocyte count (ALC) \>=30,000 per microliter and lymphocyte doubling time is rapid, unless considered treatment-related lymphocytosis; new cytopenia (Hemoglobin b \[Hgb\] or platelets) attributable to CLL; and transformation to a more aggressive histology.
Analysis population: Intent to treat (ITT) population included all participants randomized into the study regardless of treatment actually received.
Groups in this outcome
Ibrutinib+BR
Participants received ibrutinib 420 milligram (mg) (3 \* 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.
Placebo+BR
Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Ibrutinib+BR | 289 |
| Placebo+BR | 289 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ibrutinib+BR | 65.12 | Not reported | 55.43 | NA | Here, NA indicates upper limit of confidence interval (CI) was not estimable due to insufficient number of events. |
| Placebo+BR | 14.32 | Not reported | 13.86 | 16.62 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.183
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.286
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.229
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.183
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.286
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.229
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- Here, NA indicates upper limit of confidence interval (CI) was not estimable due to insufficient number of events.
- group Id
- OG000
- lower Limit
- 55.43
- upper Limit
- NA
- value
- 65.12
- group Id
- OG001
- lower Limit
- 13.86
- upper Limit
- 16.62
- value
- 14.32
- denoms
- counts
- group Id
- OG000
- value
- 289
- group Id
- OG001
- value
- 289
- units
- Participants
- description
- PFS was defined as the interval between the date of randomization and the date of disease progression or death, whichever was first reported. IWCLL 2008 criteria for PD: New enlarged nodes \>1.5 cm, new hepatomegaly or splenomegaly, or other new organ infiltrates, bone lesion, ascites, or pleural effusion confirmed due to chronic lymphocytic leukemia (CLL); \>=50% increase in existing lymph nodes; \>=50% increase in enlargement of liver or spleen; \>=50% increase from baseline in lymphocyte count (and to \>=5\*10\^9/L) or \>=50% increase from nadir count confirmed on \>=2 serial assessments if absolute lymphocyte count (ALC) \>=30,000 per microliter and lymphocyte doubling time is rapid, unless considered treatment-related lymphocytosis; new cytopenia (Hemoglobin b \[Hgb\] or platelets) attributable to CLL; and transformation to a more aggressive histology.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received ibrutinib 420 milligram (mg) (3 \* 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.
- id
- OG000
- title
- Ibrutinib+BR
- description
- Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.
- id
- OG001
- title
- Placebo+BR
- param Type
- MEDIAN
- population Description
- Intent to treat (ITT) population included all participants randomized into the study regardless of treatment actually received.
- reporting Status
- POSTED
- time Frame
- Up to 5 years
- title
- Progression-free Survival (PFS)
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice