TriangleNCT01578707 · OUTCOME
OS (Overall Survival)
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
- OS analysis was conducted at the time of study closure, including up to 6 years of study follow-up
What was measured
OS analysis was conducted at the time of study closure, with no adjustment for crossover from the ofatumumab arm to the ibrutinib arm
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) | 65.1 | Not reported | 50.6 | NA | OFA: Upper limit of 95% CI for median OS is not estimable due to sparse events in the data / insufficient number of participants with events. |
| Ibrutinib (Arm B) | 67.7 | Not reported | 61.0 | NA | IBR: Upper limit of 95% CI for median OS is not estimable due to sparse events in the data / insufficient number of participants with events. |
Source statistical analyses
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.1653
- statistical Method
- Log Rank
Complete source fields
- analyses
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.1653
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- OFA: Upper limit of 95% CI for median OS is not estimable due to sparse events in the data / insufficient number of participants with events.
- group Id
- OG000
- lower Limit
- 50.6
- upper Limit
- NA
- value
- 65.1
- comment
- IBR: Upper limit of 95% CI for median OS is not estimable due to sparse events in the data / insufficient number of participants with events.
- group Id
- OG001
- lower Limit
- 61.0
- upper Limit
- NA
- value
- 67.7
- denoms
- counts
- group Id
- OG000
- value
- 196
- group Id
- OG001
- value
- 195
- units
- Participants
- description
- OS analysis was conducted at the time of study closure, with no adjustment for crossover from the ofatumumab arm to the ibrutinib arm
- 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
- OS analysis was conducted at the time of study closure, including up to 6 years of study follow-up
- title
- OS (Overall Survival)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice