TriangleNCT01010061 · 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
- Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)
What was measured
PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by the investigator. Progressive disease (PD) 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 PFS 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) | 31.1 | Not reported | 26.5 | 35.6 | Not reported |
| Chlorambucil (Clb) | 11.1 | Not reported | 10.7 | 11.3 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.16
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.28
- estimate Comment
- Stratified by Binet stage at Baseline.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- p Value Comment
- Type I error controlled through closed test procedure.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.21
- statistical Method
- Log Rank, Stratified
Complete source fields
- analyses
- ci Lower Limit
- 0.16
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.28
- estimate Comment
- Stratified by Binet stage at Baseline.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- p Value Comment
- Type I error controlled through closed test procedure.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.21
- statistical Method
- Log Rank, Stratified
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 26.5
- upper Limit
- 35.6
- value
- 31.1
- group Id
- OG001
- lower Limit
- 10.7
- upper Limit
- 11.3
- value
- 11.1
- denoms
- counts
- group Id
- OG000
- value
- 238
- group Id
- OG001
- value
- 118
- units
- Participants
- description
- PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by the investigator. Progressive disease (PD) 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 PFS 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
- Progression-free Survival (PFS)
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice