TriangleNCT01010061 · OUTCOME
Event 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
- Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)
What was measured
Event-free survival (EFS) was defined as the time between date of randomization and the date of disease progression/relapse, death, or start of a new anti-leukemic therapy. Progressive disease as per IWCLL criteria required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (\>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels \>20 g/L or \<10 g/dL or a decrease of platelet counts \>50% or \<100 x 10\^9/L or by a decrease of neutrophil counts \>50% or \<1.0 x 10\^9/L).
Analysis population: Intent-to-treat population included all randomized participants. Patients without EFS events were censored.
Groups in this outcome
Obinutuzumab + Chlorambucil (GClb)
Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
Chlorambucil (Clb)
Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
| Group | Source count |
|---|---|
| Obinutuzumab + Chlorambucil (GClb) | 238 |
| Chlorambucil (Clb) | 118 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Obinutuzumab + Chlorambucil (GClb) | 28.7 | Not reported | 23.9 | 32.9 | Not reported |
| Chlorambucil (Clb) | 10.8 | Not reported | 8.0 | 11.1 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.15
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.26
- estimate Comment
- Stratified by Binet stage at Baseline.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.19
- statistical Method
- Log Rank, Stratified
Complete source fields
- analyses
- ci Lower Limit
- 0.15
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.26
- estimate Comment
- Stratified by Binet stage at Baseline.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.19
- statistical Method
- Log Rank, Stratified
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 23.9
- upper Limit
- 32.9
- value
- 28.7
- group Id
- OG001
- lower Limit
- 8.0
- upper Limit
- 11.1
- value
- 10.8
- denoms
- counts
- group Id
- OG000
- value
- 238
- group Id
- OG001
- value
- 118
- units
- Participants
- description
- Event-free survival (EFS) was defined as the time between date of randomization and the date of disease progression/relapse, death, or start of a new anti-leukemic therapy. Progressive disease as per IWCLL criteria required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (\>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels \>20 g/L or \<10 g/dL or a decrease of platelet counts \>50% or \<100 x 10\^9/L or by a decrease of neutrophil counts \>50% or \<1.0 x 10\^9/L).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
- id
- OG000
- title
- Obinutuzumab + Chlorambucil (GClb)
- description
- Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
- id
- OG001
- title
- Chlorambucil (Clb)
- param Type
- MEDIAN
- population Description
- Intent-to-treat population included all randomized participants. Patients without EFS events were censored.
- reporting Status
- POSTED
- time Frame
- Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)
- title
- Event Free Survival
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice