TriangleNCT01722487 · OUTCOME
PFS (Progression Free Survival)
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
- Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.
What was measured
The primary objective of this study was to evaluate the efficacy of Ibrutinib compared with Chlorambucil based on the independent review committee (IRC) assessment of PFS Progressive disease according to 2008 IWCLL guidelines was defined as: * Group A * Lymphadenopathy, increase ≥50% * Hepatomegaly, increase ≥50% * Splenomegaly, increase ≥50% * Blood lymphocytes, increase ≥ 50% over baseline * Group B * Platelets counts, decrease of ≥ 50% from baseline secondary to CLL * Hemoglobin, decrease of \> 2 g/dL from baseline secondary to CLL
Analysis population: Intention to treat
Groups in this outcome
Ibrutinib
Ibrutinib 420 mg daily.
Chlorambucil
Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles.
| Group | Source count |
|---|---|
| Ibrutinib | 136 |
| Chlorambucil | 133 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ibrutinib | NA | Not reported | NA | NA | IBR: Median PFS was not reached so 95% CI for median PFS is not applicable. |
| Chlorambucil | 18.9 | Not reported | 14.1 | 22.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.09
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.28
- group Ids
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.16
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.09
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.28
- group Ids
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.16
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- IBR: Median PFS was not reached so 95% CI for median PFS is not applicable.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG001
- lower Limit
- 14.1
- upper Limit
- 22.0
- value
- 18.9
- denoms
- counts
- group Id
- OG000
- value
- 136
- group Id
- OG001
- value
- 133
- units
- Participants
- description
- The primary objective of this study was to evaluate the efficacy of Ibrutinib compared with Chlorambucil based on the independent review committee (IRC) assessment of PFS Progressive disease according to 2008 IWCLL guidelines was defined as: * Group A * Lymphadenopathy, increase ≥50% * Hepatomegaly, increase ≥50% * Splenomegaly, increase ≥50% * Blood lymphocytes, increase ≥ 50% over baseline * Group B * Platelets counts, decrease of ≥ 50% from baseline secondary to CLL * Hemoglobin, decrease of \> 2 g/dL from baseline secondary to CLL
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Ibrutinib 420 mg daily.
- id
- OG000
- title
- Ibrutinib
- description
- Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles.
- id
- OG001
- title
- Chlorambucil
- param Type
- MEDIAN
- population Description
- Intention to treat
- reporting Status
- POSTED
- time Frame
- Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.
- title
- PFS (Progression Free Survival)
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice