TriangleNCT02181413 · OUTCOME
Number of Participants With Maintenance of MRD Negativity
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to EOT (up to 24 months)
What was measured
MRD negativity is defined as absence of MRD and MRD positivity is defined as presence of MRD. The maintenance of MRD negativity up to the end of treatment was assessed and reported in participants converting from MRD+ at Baseline to MRD negative. Bone marrow aspirates and blood samples were sent to a central laboratory and were assessed for MRD using flow cytometry and a sequencing methodology.
Analysis population: ITT population was defined as all participants who were randomized and had post randomization data. Overall number analyzed is the number of participants who converted from MRD+ at Baseline to MRD negative.
Groups in this outcome
Placebo
Ixazomib citrate placebo-matching capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 26 until progressive disease (PD), unacceptable toxicity, or discontinuation for alternate reasons.
Ixazomib Citrate
Ixazomib citrate 3 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib citrate 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons. Participants who had any dose reductions due to AEs were not dose escalated.
| Group | Source count |
|---|---|
| Placebo | 27 |
| Ixazomib Citrate | 39 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 25 | Not reported | Not reported | Not reported | Not reported |
| Ixazomib Citrate | 37 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.805
- p Value Comment
- P-value was based on fisher's exact test comparing conversion to MRD- at any time post study entry between treatment groups.
- statistical Method
- Fisher Exact
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.805
- p Value Comment
- P-value was based on fisher's exact test comparing conversion to MRD- at any time post study entry between treatment groups.
- statistical Method
- Fisher Exact
- classes
- categories
- measurements
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 37
- denoms
- counts
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 39
- units
- Participants
- description
- MRD negativity is defined as absence of MRD and MRD positivity is defined as presence of MRD. The maintenance of MRD negativity up to the end of treatment was assessed and reported in participants converting from MRD+ at Baseline to MRD negative. Bone marrow aspirates and blood samples were sent to a central laboratory and were assessed for MRD using flow cytometry and a sequencing methodology.
- groups
- description
- Ixazomib citrate placebo-matching capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 26 until progressive disease (PD), unacceptable toxicity, or discontinuation for alternate reasons.
- id
- OG000
- title
- Placebo
- description
- Ixazomib citrate 3 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib citrate 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons. Participants who had any dose reductions due to AEs were not dose escalated.
- id
- OG001
- title
- Ixazomib Citrate
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- ITT population was defined as all participants who were randomized and had post randomization data. Overall number analyzed is the number of participants who converted from MRD+ at Baseline to MRD negative.
- reporting Status
- POSTED
- time Frame
- Up to EOT (up to 24 months)
- title
- Number of Participants With Maintenance of MRD Negativity
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice