TriangleNCT02257567 · OUTCOME
Phase II NF Cohort: PFS Based on PET-CT or CT Only as Determined by the Investigator
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
- From the date of randomization or first treatment to the first occurrence of progression or relapse, or death from any cause (from Month 37 to Month 84 [up to approximately 47 months])
What was measured
PFS was defined as the time from randomization or from first study treatment (for obinuzumab arms) to the first occurrence of disease progression, relapse or death, from any cause based on PET-CT or CT only, as determined by the investigators assessment. As pre-specified in the protocol data reported is combined for Arms G and H.
Analysis population: ITT population included all randomized participants in Phase II NF Cohort irrespective of whether or not they received the study treatment.
Groups in this outcome
Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL
Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
| Group | Source count |
|---|---|
| Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL | 106 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL | 5.881 | Not reported | 4.764 | 7.524 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.764
- upper Limit
- 7.524
- value
- 5.881
- denoms
- counts
- group Id
- OG000
- value
- 106
- units
- Participants
- description
- PFS was defined as the time from randomization or from first study treatment (for obinuzumab arms) to the first occurrence of disease progression, relapse or death, from any cause based on PET-CT or CT only, as determined by the investigators assessment. As pre-specified in the protocol data reported is combined for Arms G and H.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
- id
- OG000
- title
- Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL
- param Type
- MEDIAN
- population Description
- ITT population included all randomized participants in Phase II NF Cohort irrespective of whether or not they received the study treatment.
- reporting Status
- POSTED
- time Frame
- From the date of randomization or first treatment to the first occurrence of progression or relapse, or death from any cause (from Month 37 to Month 84 [up to approximately 47 months])
- title
- Phase II NF Cohort: PFS Based on PET-CT or CT Only as Determined by the Investigator
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice