NCT02004522 · 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
- From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
What was measured
The primary efficacy endpoint for the study was PFS, defined as time from randomization to the first documentation of PD as determined by blinded independent review or death due to any cause.
Analysis population: Intent to Treat
Groups in this outcome
Duvelisib
Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules.
Ofatumumab
Ofatumumab is administered as an IV infusion and is supplied in single-use vials at two strengths, 100 mg/5 mL and 1000 mg/50 mL.
| Group | Source count |
|---|---|
| Duvelisib | 160 |
| Ofatumumab | 159 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Duvelisib | 13.3 | Not reported | 12.1 | 16.8 | Not reported |
| Ofatumumab | 9.9 | Not reported | 9.2 | 11.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 12.1
- upper Limit
- 16.8
- value
- 13.3
- group Id
- OG001
- lower Limit
- 9.2
- upper Limit
- 11.3
- value
- 9.9
- denoms
- counts
- group Id
- OG000
- value
- 160
- group Id
- OG001
- value
- 159
- units
- Participants
- description
- The primary efficacy endpoint for the study was PFS, defined as time from randomization to the first documentation of PD as determined by blinded independent review or death due to any cause.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules.
- id
- OG000
- title
- Duvelisib
- description
- Ofatumumab is administered as an IV infusion and is supplied in single-use vials at two strengths, 100 mg/5 mL and 1000 mg/50 mL.
- id
- OG001
- title
- Ofatumumab
- param Type
- MEDIAN
- population Description
- Intent to Treat
- reporting Status
- POSTED
- time Frame
- From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
- 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
Triangle