TriangleNCT00304031 · OUTCOME
Mean Neurocognitive Function (NCF) Composite Score at Cycle 10 for Participants Without Progression After 6 Months of Adjuvant Therapy
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- score on a scale
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline and cycle 10 (approximately 46 weeks)
What was measured
The NCF Composite score is the arithmetic mean of the Hopkins Verbal Learning Test - Revised (HVLT-R) (Free Recall, Delayed Recall, Delayed Recognition), Trail Making Test Part A (TMTA), Trail Making Test Part B (TMTB), and Controlled Oral Word Association (COWA) test scores, all of which are standardized, adjusting for age, education, and gender as necessary, such that mean is 0 and standard deviation is 1. A participant must have at least 5 of the 6 scores. A higher composite score indicates better neurocognitive function.
Analysis population: Cycle 10 questionnaires were not completed by all QOL population participants progression-free at 6 months. Therefore, only 17/96 on the conventional arm and 20/95 on the dose-dense arm had data.
Groups in this outcome
Conventional Adjuvant TMZ
Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle for 6 cycles, up to 12 cycles.
Dose-dense Adjuvant TMZ
Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle for 6 cycles, up to 12 cycles.
| Group | Source count |
|---|---|
| Conventional Adjuvant TMZ | 17 |
| Dose-dense Adjuvant TMZ | 20 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Conventional Adjuvant TMZ | -0.95 | Not reported | -2.12 | 0.21 | Not reported |
| Dose-dense Adjuvant TMZ | -1.19 | Not reported | -2.03 | -0.33 | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.73
- statistical Method
- t-test, 2 sided
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.73
- statistical Method
- t-test, 2 sided
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -2.12
- upper Limit
- 0.21
- value
- -0.95
- group Id
- OG001
- lower Limit
- -2.03
- upper Limit
- -0.33
- value
- -1.19
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 20
- units
- Participants
- description
- The NCF Composite score is the arithmetic mean of the Hopkins Verbal Learning Test - Revised (HVLT-R) (Free Recall, Delayed Recall, Delayed Recognition), Trail Making Test Part A (TMTA), Trail Making Test Part B (TMTB), and Controlled Oral Word Association (COWA) test scores, all of which are standardized, adjusting for age, education, and gender as necessary, such that mean is 0 and standard deviation is 1. A participant must have at least 5 of the 6 scores. A higher composite score indicates better neurocognitive function.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle for 6 cycles, up to 12 cycles.
- id
- OG000
- title
- Conventional Adjuvant TMZ
- description
- Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle for 6 cycles, up to 12 cycles.
- id
- OG001
- title
- Dose-dense Adjuvant TMZ
- param Type
- MEAN
- population Description
- Cycle 10 questionnaires were not completed by all QOL population participants progression-free at 6 months. Therefore, only 17/96 on the conventional arm and 20/95 on the dose-dense arm had data.
- reporting Status
- POSTED
- time Frame
- Baseline and cycle 10 (approximately 46 weeks)
- title
- Mean Neurocognitive Function (NCF) Composite Score at Cycle 10 for Participants Without Progression After 6 Months of Adjuvant Therapy
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice