TriangleNCT04221945 · OUTCOME
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24) Score
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- Score on a scale
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline and Week 36
What was measured
The EORTC QLQ-CX24 is a questionnaire that rates the symptoms common to women with cervical cancer and evaluates the impact of disease and/or treatments. The 24 items use a 4-point scale (1=not at all to 4=very much) and are classified into 3 multi-item scales, 11 items with symptom experience, 3 items with body image, and 4 items with sexual/ vaginal functioning. The other items of the questionnaire are lymphedema, peripheral neuropathy, menopausal symptom, sexual worry, sexual activity, and sexual enjoyment. Total scores are linearly transformed and range from 0 (no symptoms) to 100 (most severe symptoms). The change from baseline in EORTC QLQ-CX24 score is presented, with negative scores representing an improvement from baseline and vice versa.
Analysis population: Randomized participants who have at least 1 PRO assessment for QLQ-CX24 available and have received at least 1 dose of study medication.
Groups in this outcome
Chemoradiotherapy + Pembrolizumab
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by pembrolizumab 400 mg IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of pembrolizumab, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).
Chemoradiotherapy + Placebo for Pembrolizumab
Participants received placebo for pembrolizumab IV on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of placebo, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).
| Group | Source count |
|---|---|
| Chemoradiotherapy + Pembrolizumab | 503 |
| Chemoradiotherapy + Placebo for Pembrolizumab | 504 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Chemoradiotherapy + Pembrolizumab | -8.86 | Not reported | -10.03 | -7.69 | Not reported |
| Chemoradiotherapy + Placebo for Pembrolizumab | -9.60 | Not reported | -10.78 | -8.43 | Not reported |
Source statistical analyses
- ci Lower Limit
- -0.65
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.15
- estimate Comment
- Pembrolizumab minus placebo
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- other Analysis Description
- Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratified by planned type of EBRT.
- p Value
- 0.2953
- param Type
- Difference LS Means
- param Value
- 0.75
- statistical Method
- cLDA model
Complete source fields
- analyses
- ci Lower Limit
- -0.65
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.15
- estimate Comment
- Pembrolizumab minus placebo
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- other Analysis Description
- Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratified by planned type of EBRT.
- p Value
- 0.2953
- param Type
- Difference LS Means
- param Value
- 0.75
- statistical Method
- cLDA model
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -10.03
- upper Limit
- -7.69
- value
- -8.86
- group Id
- OG001
- lower Limit
- -10.78
- upper Limit
- -8.43
- value
- -9.60
- denoms
- counts
- group Id
- OG000
- value
- 503
- group Id
- OG001
- value
- 504
- units
- Participants
- description
- The EORTC QLQ-CX24 is a questionnaire that rates the symptoms common to women with cervical cancer and evaluates the impact of disease and/or treatments. The 24 items use a 4-point scale (1=not at all to 4=very much) and are classified into 3 multi-item scales, 11 items with symptom experience, 3 items with body image, and 4 items with sexual/ vaginal functioning. The other items of the questionnaire are lymphedema, peripheral neuropathy, menopausal symptom, sexual worry, sexual activity, and sexual enjoyment. Total scores are linearly transformed and range from 0 (no symptoms) to 100 (most severe symptoms). The change from baseline in EORTC QLQ-CX24 score is presented, with negative scores representing an improvement from baseline and vice versa.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by pembrolizumab 400 mg IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of pembrolizumab, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).
- id
- OG000
- title
- Chemoradiotherapy + Pembrolizumab
- description
- Participants received placebo for pembrolizumab IV on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of placebo, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).
- id
- OG001
- title
- Chemoradiotherapy + Placebo for Pembrolizumab
- param Type
- LEAST_SQUARES_MEAN
- population Description
- Randomized participants who have at least 1 PRO assessment for QLQ-CX24 available and have received at least 1 dose of study medication.
- reporting Status
- POSTED
- time Frame
- Baseline and Week 36
- title
- Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24) Score
- type
- SECONDARY
- unit Of Measure
- Score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice