TriangleNCT01010061 · OUTCOME
Percentage of Participants With Progression Free Survival Events Based on Independent Review Committee (IRC) Data
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
- Randomization to clinical cutoff date of 9 May 2013 (median observation 22.8 months)
What was measured
Percentage of Participants with Progression Free Survival Events: progression, relapse, or death from any cause as assessed by an Independent Review Committee.
Analysis population: Intent-to-treat population included all randomized participants. Participants 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) | 37.4 | Not reported | Not reported | Not reported | Not reported |
| Chlorambucil (Clb) | 76.3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 37.4
- group Id
- OG001
- value
- 76.3
- denoms
- counts
- group Id
- OG000
- value
- 238
- group Id
- OG001
- value
- 118
- units
- Participants
- description
- Percentage of Participants with Progression Free Survival Events: progression, relapse, or death from any cause as assessed by an Independent Review Committee.
- 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
- NUMBER
- population Description
- Intent-to-treat population included all randomized participants. Participants without PFS events were censored.
- reporting Status
- POSTED
- time Frame
- Randomization to clinical cutoff date of 9 May 2013 (median observation 22.8 months)
- title
- Percentage of Participants With Progression Free Survival Events Based on Independent Review Committee (IRC) Data
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice