TriangleNCT00101582 · OUTCOME
Patient-Reported Mouth and Throat Soreness Score
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Assessed twice a week for up to 15 weeks.
What was measured
The average patient-reported mouth and throat soreness (MTS) score as reported on question 3 of the Oral Mucositis Weekly Questionnaire for Head and Neck Cancer \[OMWQ-HN\]): "How much mouth and throat soreness did you experience in the past 24 hours?" Participants answered on a scale from 0 (no soreness) to 4 (extreme soreness). For each participant, an average patient-reported mouth and throat soreness score was calculated by dividing the sum of the MTS scores at each assessment by the total number of assessments.
Analysis population: The Patient Reported Outcome-evaluable analysis set included all randomized patients with a valid Baseline assessment for MTS question 3 of the OMWQ-HN and either: * At least 1 completed assessment each week for MTS up to withdrawal/Week 8, whichever came first, or * 70% or greater overall compliance for MTS until withdrawal/Week 8.
Groups in this outcome
Placebo
Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
Palifermin
Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
| Group | Source count |
|---|---|
| Placebo | 88 |
| Palifermin | 89 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 1.86 | 0.65 | Not reported | Not reported | Not reported |
| Palifermin | 1.66 | 0.73 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Pct Value
- 95
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0712
- p Value Comment
- Generalized Cochran-Mantel-Haenszel test for mean score difference using modified ridit score
- param Type
- Chi-Square Statistic
- param Value
- 3.2548
- statistical Comment
- Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).
- statistical Method
- Cochran-Mantel-Haenszel
- tested Non Inferiority
- false
- ci Pct Value
- 95
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.2849
- p Value Comment
- Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.
- statistical Method
- Cochran-Mantel-Haenszel
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Pct Value
- 95
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0712
- p Value Comment
- Generalized Cochran-Mantel-Haenszel test for mean score difference using modified ridit score
- param Type
- Chi-Square Statistic
- param Value
- 3.2548
- statistical Comment
- Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).
- statistical Method
- Cochran-Mantel-Haenszel
- tested Non Inferiority
- false
- ci Pct Value
- 95
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.2849
- p Value Comment
- Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.
- statistical Method
- Cochran-Mantel-Haenszel
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.65
- value
- 1.86
- group Id
- OG001
- spread
- 0.73
- value
- 1.66
- denoms
- counts
- group Id
- OG000
- value
- 88
- group Id
- OG001
- value
- 89
- units
- Participants
- description
- The average patient-reported mouth and throat soreness (MTS) score as reported on question 3 of the Oral Mucositis Weekly Questionnaire for Head and Neck Cancer \[OMWQ-HN\]): "How much mouth and throat soreness did you experience in the past 24 hours?" Participants answered on a scale from 0 (no soreness) to 4 (extreme soreness). For each participant, an average patient-reported mouth and throat soreness score was calculated by dividing the sum of the MTS scores at each assessment by the total number of assessments.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
- id
- OG000
- title
- Placebo
- description
- Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
- id
- OG001
- title
- Palifermin
- param Type
- MEAN
- population Description
- The Patient Reported Outcome-evaluable analysis set included all randomized patients with a valid Baseline assessment for MTS question 3 of the OMWQ-HN and either: * At least 1 completed assessment each week for MTS up to withdrawal/Week 8, whichever came first, or * 70% or greater overall compliance for MTS until withdrawal/Week 8.
- reporting Status
- POSTED
- time Frame
- Assessed twice a week for up to 15 weeks.
- title
- Patient-Reported Mouth and Throat Soreness Score
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice