TriangleNCT01611090 · OUTCOME
Overall Response Rate (ORR)
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
ORR defined as number of participants achieving a complete response (CR), complete response with incomplete marrow recovery (CRi), nodular partial response (nPR) or partial response (PR). IWCLL 2008 criteria: CR- No lymphadenopathy and hepatosplenomegaly, no constitutional symptoms, neutrophils \>1.5\*10\^9/liter (L), platelets \>100\*10\^9/L, Hgb \>11 gram per deciliter (g/dL) and absolute lymphocyte count \<4000/microliter (mcL); CRi- CR with incomplete recovery of bone marrow; nPR- participants meet criteria for CR, but the bone marrow biopsy shows B-lymphoid nodules, may represent a clonal infiltrate; PR-2 of the following when abnormal at baseline: \>=50% decrease in ALC, \>=50% decrease in sum products of up to 6 lymph nodes, \>=50% decrease in enlargement of spleen or liver; and 1 of the following: neutrophils \>1.5\*10\^9/L, Platelets \>100\*10\^9/L and Hgb\>11 g/dL or \>=50% improvement over baseline in any of these; no new enlarged nodes or new hepatosplenomegaly.
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 | 87.2 | Not reported | Not reported | Not reported | Not reported |
| Placebo+BR | 66.1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 87.2
- group Id
- OG001
- value
- 66.1
- denoms
- counts
- group Id
- OG000
- value
- 289
- group Id
- OG001
- value
- 289
- units
- Participants
- description
- ORR defined as number of participants achieving a complete response (CR), complete response with incomplete marrow recovery (CRi), nodular partial response (nPR) or partial response (PR). IWCLL 2008 criteria: CR- No lymphadenopathy and hepatosplenomegaly, no constitutional symptoms, neutrophils \>1.5\*10\^9/liter (L), platelets \>100\*10\^9/L, Hgb \>11 gram per deciliter (g/dL) and absolute lymphocyte count \<4000/microliter (mcL); CRi- CR with incomplete recovery of bone marrow; nPR- participants meet criteria for CR, but the bone marrow biopsy shows B-lymphoid nodules, may represent a clonal infiltrate; PR-2 of the following when abnormal at baseline: \>=50% decrease in ALC, \>=50% decrease in sum products of up to 6 lymph nodes, \>=50% decrease in enlargement of spleen or liver; and 1 of the following: neutrophils \>1.5\*10\^9/L, Platelets \>100\*10\^9/L and Hgb\>11 g/dL or \>=50% improvement over baseline in any of these; no new enlarged nodes or new hepatosplenomegaly.
- 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
- Overall Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice