TriangleNCT01611090 · OUTCOME
Percentage of Participants With Minimal Residual Disease (MRD)-Negative Response
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
- Up to 5 years
What was measured
MRD-negative response was defined as the percentage of participants who reach MRD negative disease status (less than 1 chronic lymphocytic leukemia \[CLL\] cell per 10,000 leukocytes) in either bone marrow or peripheral blood. All randomized participants were included in this analysis. Participants with missing MRD data were considered non-responders.
Analysis population: Intent to treat (ITT) population included all participants randomized into the study regardless of treatment actually received.
Groups in this outcome
Ibrutinib+BR
Participants received ibrutinib 420 milligram (mg) (3 \* 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.
Placebo+BR
Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Ibrutinib+BR | 289 |
| Placebo+BR | 289 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ibrutinib+BR | 28.7 | Not reported | Not reported | Not reported | Not reported |
| Placebo+BR | 5.9 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 28.7
- group Id
- OG001
- value
- 5.9
- denoms
- counts
- group Id
- OG000
- value
- 289
- group Id
- OG001
- value
- 289
- units
- Participants
- description
- MRD-negative response was defined as the percentage of participants who reach MRD negative disease status (less than 1 chronic lymphocytic leukemia \[CLL\] cell per 10,000 leukocytes) in either bone marrow or peripheral blood. All randomized participants were included in this analysis. Participants with missing MRD data were considered non-responders.
- groups
- description
- Participants received ibrutinib 420 milligram (mg) (3 \* 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.
- id
- OG000
- title
- Ibrutinib+BR
- description
- Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.
- id
- OG001
- title
- Placebo+BR
- param Type
- NUMBER
- population Description
- Intent to treat (ITT) population included all participants randomized into the study regardless of treatment actually received.
- reporting Status
- POSTED
- time Frame
- Up to 5 years
- title
- Percentage of Participants With Minimal Residual Disease (MRD)-Negative Response
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice