TriangleNCT01302834 · OUTCOME
EORTC QLQ-H&N35 Swallowing Score Change From Baseline at 6 Months From End of Treatment.
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
- Baseline and 6 months from end of treatment. Treatment lasts 6-7 weeks.
What was measured
The EORTC QLQ-H\&N35 swallowing score measures patient-reported difficulty with swallowing various foods and liquid and ranges from 0 (no swallowing problems) to 100 (maximum swallowing difficulty). A positive change from baseline indicates worsening swallowing function.
Analysis population: Eligible participants enrolled to the quality of life (QOL) substudy who received protocol treatment and had outcome measure data.
Groups in this outcome
IMRT + Cisplatin
Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
IMRT + Cetuximab
Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
| Group | Source count |
|---|---|
| IMRT + Cisplatin | 132 |
| IMRT + Cetuximab | 130 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| IMRT + Cisplatin | 8.65 | 23.94 | Not reported | Not reported | Not reported |
| IMRT + Cetuximab | 10.13 | 18.73 | Not reported | Not reported | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.7108
- p Value Comment
- One-sided significance level = 0.05
- statistical Method
- t-test, 1 sided
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.7108
- p Value Comment
- One-sided significance level = 0.05
- statistical Method
- t-test, 1 sided
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 23.94
- value
- 8.65
- group Id
- OG001
- spread
- 18.73
- value
- 10.13
- denoms
- counts
- group Id
- OG000
- value
- 132
- group Id
- OG001
- value
- 130
- units
- Participants
- description
- The EORTC QLQ-H\&N35 swallowing score measures patient-reported difficulty with swallowing various foods and liquid and ranges from 0 (no swallowing problems) to 100 (maximum swallowing difficulty). A positive change from baseline indicates worsening swallowing function.
- dispersion Type
- Standard Deviation
- groups
- description
- Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
- id
- OG000
- title
- IMRT + Cisplatin
- description
- Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
- id
- OG001
- title
- IMRT + Cetuximab
- param Type
- MEAN
- population Description
- Eligible participants enrolled to the quality of life (QOL) substudy who received protocol treatment and had outcome measure data.
- reporting Status
- POSTED
- time Frame
- Baseline and 6 months from end of treatment. Treatment lasts 6-7 weeks.
- title
- EORTC QLQ-H&N35 Swallowing Score Change From Baseline at 6 Months From End of Treatment.
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice