TriangleNCT03258554 · OUTCOME
Change in PSS HN Understandability of Speech Score at One Year
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 one year after end of radiation therapy (approximately 7 weeks)
What was measured
The PSS HN Understandability of Speech score measures clinician rated speech. Possible scores range from 0 to 100, with higher scores indicating better speech function. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate worsening function.
Analysis population: Randomized participants with baseline and one-year data.
Groups in this outcome
RT + Cetuximab
IMRT for seven weeks, 5 fractions/week. Cetuximab 400 mg/m\^2 IV starts one week prior to RT, then 250 mg/m\^2 weekly for seven additional cycles in the absence of disease progression or unacceptable toxicity.
RT + Durvalumab
IMRT for seven weeks, 5 fractions/week. Durvalumab 1500 mg IV starts two weeks prior to RT and continues every 4 weeks for a total of seven cycles in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| RT + Cetuximab | 22 |
| RT + Durvalumab | 51 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| RT + Cetuximab | -3.41 | Not reported | -9.62 | 2.80 | Not reported |
| RT + Durvalumab | -8.82 | Not reported | -16.11 | -1.54 | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.2531
- p Value Comment
- Two-sided significance level = 0.05
- statistical Comment
- Welch t-test (unequal variances)
- statistical Method
- t-test, 2 sided
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.2531
- p Value Comment
- Two-sided significance level = 0.05
- statistical Comment
- Welch t-test (unequal variances)
- statistical Method
- t-test, 2 sided
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -9.62
- upper Limit
- 2.80
- value
- -3.41
- group Id
- OG001
- lower Limit
- -16.11
- upper Limit
- -1.54
- value
- -8.82
- denoms
- counts
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 51
- units
- Participants
- description
- The PSS HN Understandability of Speech score measures clinician rated speech. Possible scores range from 0 to 100, with higher scores indicating better speech function. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate worsening function.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- IMRT for seven weeks, 5 fractions/week. Cetuximab 400 mg/m\^2 IV starts one week prior to RT, then 250 mg/m\^2 weekly for seven additional cycles in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- RT + Cetuximab
- description
- IMRT for seven weeks, 5 fractions/week. Durvalumab 1500 mg IV starts two weeks prior to RT and continues every 4 weeks for a total of seven cycles in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- RT + Durvalumab
- param Type
- MEAN
- population Description
- Randomized participants with baseline and one-year data.
- reporting Status
- POSTED
- time Frame
- Baseline and one year after end of radiation therapy (approximately 7 weeks)
- title
- Change in PSS HN Understandability of Speech Score at One Year
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice