TriangleNCT02123511 · OUTCOME
GRIX Xerostomia Nighttime AUC
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
- Standard Deviation
- Time frame
- Up to 90 days after completion of radiation therapy
What was measured
GRIX Xerostomia Nighttime AUC. The GRIX questionnaire is a 14-item questionnaire with four subscales on 0-100 scales with higher scores representing worse symptoms. The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the end of radiotherapy. For example; for each patient and each subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to the end of their radiotherapy are averaged to yield the aAUCpa per patient per subscale. AUC will be calculated for each patient from baseline to two weeks following radiotherapy. The AUC values will be compared between the two arms using t-test (equal variance).
Analysis population: Patients who completed the GRIX Xerostomia Nighttime at all specified time points are included in this analysis.
Groups in this outcome
Arm A (Placebo)
Patients receive a placebo oral rinse and gargle or swish for 60 seconds and then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
Arm B (Rincinol)
Patients receive acetylcysteine oral rinse and gargle or swish for 60 seconds then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
| Group | Source count |
|---|---|
| Arm A (Placebo) | 16 |
| Arm B (Rincinol) | 12 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Placebo) | 39.8 | 16.4 | Not reported | Not reported | Not reported |
| Arm B (Rincinol) | 31.3 | 19.6 | Not reported | Not reported | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.22
- statistical Method
- t-test, 1 sided
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.22
- statistical Method
- t-test, 1 sided
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 16.4
- value
- 39.8
- group Id
- OG001
- spread
- 19.6
- value
- 31.3
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 12
- units
- Participants
- description
- GRIX Xerostomia Nighttime AUC. The GRIX questionnaire is a 14-item questionnaire with four subscales on 0-100 scales with higher scores representing worse symptoms. The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the end of radiotherapy. For example; for each patient and each subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to the end of their radiotherapy are averaged to yield the aAUCpa per patient per subscale. AUC will be calculated for each patient from baseline to two weeks following radiotherapy. The AUC values will be compared between the two arms using t-test (equal variance).
- dispersion Type
- Standard Deviation
- groups
- description
- Patients receive a placebo oral rinse and gargle or swish for 60 seconds and then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
- id
- OG000
- title
- Arm A (Placebo)
- description
- Patients receive acetylcysteine oral rinse and gargle or swish for 60 seconds then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
- id
- OG001
- title
- Arm B (Rincinol)
- param Type
- MEAN
- population Description
- Patients who completed the GRIX Xerostomia Nighttime at all specified time points are included in this analysis.
- reporting Status
- POSTED
- time Frame
- Up to 90 days after completion of radiation therapy
- title
- GRIX Xerostomia Nighttime AUC
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice