TriangleNCT01578707 · OUTCOME
PFS (Progression Free Survival) by Independent Review Committee (IRC), Limited to the Time of Primary Analysis 06 November 2013
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
- Analysis was conducted after observing approximately 117 PFS events, which occurred about 18 months after the first subject was enrolled.
What was measured
The primary objective of this study was to evaluate the efficacy of ibrutinib compared to ofatumumab based on independent review committee (IRC) assessment of progression-free survival (PFS) according to 2008 IWCLL guidelines.
Groups in this outcome
Ofatumumab (Arm A)
An anti-CD20 monoclonal antibody ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity. Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)
Ibrutinib (Arm B)
A Bruton Tyrosine Kinase Inhibitor ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity
| Group | Source count |
|---|---|
| Ofatumumab (Arm A) | 196 |
| Ibrutinib (Arm B) | 195 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ofatumumab (Arm A) | 8.1 | Not reported | 7.2 | 8.3 | Not reported |
| Ibrutinib (Arm B) | NA | Not reported | NA | NA | IBR: Median PFS was not reached so 95% CI for median PFS is not applicable. |
Source statistical analyses
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- statistical Method
- Log Rank
Complete source fields
- analyses
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.2
- upper Limit
- 8.3
- value
- 8.1
- comment
- IBR: Median PFS was not reached so 95% CI for median PFS is not applicable.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 196
- group Id
- OG001
- value
- 195
- units
- Participants
- description
- The primary objective of this study was to evaluate the efficacy of ibrutinib compared to ofatumumab based on independent review committee (IRC) assessment of progression-free survival (PFS) according to 2008 IWCLL guidelines.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- An anti-CD20 monoclonal antibody ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity. Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)
- id
- OG000
- title
- Ofatumumab (Arm A)
- description
- A Bruton Tyrosine Kinase Inhibitor ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity
- id
- OG001
- title
- Ibrutinib (Arm B)
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- Analysis was conducted after observing approximately 117 PFS events, which occurred about 18 months after the first subject was enrolled.
- title
- PFS (Progression Free Survival) by Independent Review Committee (IRC), Limited to the Time of Primary Analysis 06 November 2013
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice