TriangleNCT03765918 · OUTCOME
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥1 at Week 51
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 51
What was measured
EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.
Analysis population: All randomized participants with PD-L1 CPS ≥1 who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 51.
Groups in this outcome
Pembrolizumab + Standard of Care (SOC)
Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).
Standard of Care (SOC)
Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).
| Group | Source count |
|---|---|
| Pembrolizumab + Standard of Care (SOC) | 340 |
| Standard of Care (SOC) | 291 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab + Standard of Care (SOC) | 6.10 | Not reported | 2.27 | 9.92 | Not reported |
| Standard of Care (SOC) | 5.10 | Not reported | 1.10 | 9.11 | Not reported |
Source statistical analyses
- ci Lower Limit
- -4.23
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 6.21
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.
- non Inferiority Type
- OTHER
- p Value
- 0.7087
- p Value Comment
- Two-sided p-value based on cLDA model.
- param Type
- Difference in Least Square Means
- param Value
- 0.99
- statistical Method
- cLDA model
Complete source fields
- analyses
- ci Lower Limit
- -4.23
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 6.21
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.
- non Inferiority Type
- OTHER
- p Value
- 0.7087
- p Value Comment
- Two-sided p-value based on cLDA model.
- param Type
- Difference in Least Square Means
- param Value
- 0.99
- statistical Method
- cLDA model
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.27
- upper Limit
- 9.92
- value
- 6.10
- group Id
- OG001
- lower Limit
- 1.10
- upper Limit
- 9.11
- value
- 5.10
- denoms
- counts
- group Id
- OG000
- value
- 340
- group Id
- OG001
- value
- 291
- units
- Participants
- description
- EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).
- id
- OG000
- title
- Pembrolizumab + Standard of Care (SOC)
- description
- Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).
- id
- OG001
- title
- Standard of Care (SOC)
- param Type
- LEAST_SQUARES_MEAN
- population Description
- All randomized participants with PD-L1 CPS ≥1 who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 51.
- reporting Status
- POSTED
- time Frame
- Baseline and Week 51
- title
- Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥1 at Week 51
- type
- SECONDARY
- unit Of Measure
- Score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice