TriangleNCT01399372 · OUTCOME
Percentage of Participants With Neurocognitive Failure
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
- 95% Confidence Interval
- Time frame
- Neurocognitive function tests were administered at baseline, after cycle 4 of treatment (4 months), then every six months after end of treatment (7 months) for five years. Two-year rates are provided here.
What was measured
Neurocognitive failure is defined as cognitive failure on two or more of the following tests: Hopkins Verbal Learning Test - Revised (HVLT-R) Free Recall, HVLT-R Delayed Recall, HVLT-R Delayed Recognition, Trail Making Test Part A, Trail Making Test Part B, and Controlled Oral Word Association. Cognitive failure for each test is defined as a change from baseline in raw score (post baseline score - baseline score) at or exceeding the minimally important difference reported in the literature \[determined by the reliable change index (RCI) method\] of -5, -3, -2,12, 26, and -12, respectively, indicating a worsening of neurocognitive function. Time to neurocognitive failure is defined as time from randomization to date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method and the distributions of failure times are compared between the arms. Two-year estimates are provided here.
Analysis population: Eligible, consented to neurocognitive function study component and has at least two completed neurocognitive tests at baseline and at least one post baseline visit.
Groups in this outcome
Chemotherapy
Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 3-5 weeks later by two 28-day cycles of cytarabine.
Chemotherapy + Low-Dose WBRT
Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 2-5 weeks later by 3 weeks of low-dose whole-brain radiotherapy (WBRT), followed 3-5 weeks later by two 28-day cycles of cytarabine.
| Group | Source count |
|---|---|
| Chemotherapy | 30 |
| Chemotherapy + Low-Dose WBRT | 32 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Chemotherapy | 31.6 | Not reported | 14.3 | 50.5 | Not reported |
| Chemotherapy + Low-Dose WBRT | 17.9 | Not reported | 6.3 | 34.1 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.21
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.31
- estimate Comment
- Reference arm = Chemotherapy arm
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.18
- param Type
- Hazard Ratio (HR)
- param Value
- 0.52
- statistical Method
- Gray's test
Complete source fields
- analyses
- ci Lower Limit
- 0.21
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.31
- estimate Comment
- Reference arm = Chemotherapy arm
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.18
- param Type
- Hazard Ratio (HR)
- param Value
- 0.52
- statistical Method
- Gray's test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 14.3
- upper Limit
- 50.5
- value
- 31.6
- group Id
- OG001
- lower Limit
- 6.3
- upper Limit
- 34.1
- value
- 17.9
- denoms
- counts
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 32
- units
- Participants
- description
- Neurocognitive failure is defined as cognitive failure on two or more of the following tests: Hopkins Verbal Learning Test - Revised (HVLT-R) Free Recall, HVLT-R Delayed Recall, HVLT-R Delayed Recognition, Trail Making Test Part A, Trail Making Test Part B, and Controlled Oral Word Association. Cognitive failure for each test is defined as a change from baseline in raw score (post baseline score - baseline score) at or exceeding the minimally important difference reported in the literature \[determined by the reliable change index (RCI) method\] of -5, -3, -2,12, 26, and -12, respectively, indicating a worsening of neurocognitive function. Time to neurocognitive failure is defined as time from randomization to date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method and the distributions of failure times are compared between the arms. Two-year estimates are provided here.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 3-5 weeks later by two 28-day cycles of cytarabine.
- id
- OG000
- title
- Chemotherapy
- description
- Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 2-5 weeks later by 3 weeks of low-dose whole-brain radiotherapy (WBRT), followed 3-5 weeks later by two 28-day cycles of cytarabine.
- id
- OG001
- title
- Chemotherapy + Low-Dose WBRT
- param Type
- NUMBER
- population Description
- Eligible, consented to neurocognitive function study component and has at least two completed neurocognitive tests at baseline and at least one post baseline visit.
- reporting Status
- POSTED
- time Frame
- Neurocognitive function tests were administered at baseline, after cycle 4 of treatment (4 months), then every six months after end of treatment (7 months) for five years. Two-year rates are provided here.
- title
- Percentage of Participants With Neurocognitive Failure
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice