TriangleNCT03425643 · OUTCOME
Change From Baseline in Adjuvant Phase in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) Score
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- Sore on a scale
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline (cycle 1 in neoadjuvant phase) and adjuvant week 10 (up to Study Week 30)
What was measured
Change from baseline in GHS/QoL score using the EORTC QLQ-C30 will be determined. The EORTC QLQ-C30 is the most widely used cancer-specific, health-related QoL instrument comprised of 30 individual items arranged as both multi-item scales and individual items. Specifically, these items are divided into 5 functional scales (15 items total), 3 symptom scales (7 items total), 6 individual items, and a GHS/QoL scale composed of 2 items: GHS and QoL. The GHS/QoL score measured here refers to only the composite score calculated for the GHS/QoL scale. Both items on the GHS/QoL scale are scored from 1 (very poor GHS/QoL) to 7 (excellent GHS/QoL) and scores for both items are averaged and a linear transformation applied to standardize the overall GHS/QoL score from 0 to 100, with higher overall scores indicating higher GHS/QoL.
Analysis population: All randomized participants who received at least one dose of study treatment and have at least one EORTC-QLQ-C30 Item 30 assessment data available.
Groups in this outcome
NAC + Neoadjuvant/Adjuvant Pembrolizumab
Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of pembrolizumab \[200 mg, intravenous (IV); given on cycle day 1\] in combination with platinum doublet neoadjuvant chemotherapy (NAC), consisting of cisplatin \[75 mg/m\^2, IV; given on cycle day 1\] and either Gemcitabine \[1000 mg/m\^2, IV; given on cycle days 1 and 8\] or Pemetrexed \[500 mg/m\^2, IV; given on cycle day 1\]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of pembrolizumab \[200 mg, IV; given on cycle day 1\].
NAC + Neoadjuvant/Adjuvant Placebo
Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of placebo \[normal saline, IV; given on cycle day 1\] in combination with platinum doublet NAC, consisting of cisplatin \[75 mg/m\^2, IV; given on cycle day 1\] and either Gemcitabine \[1000 mg/m\^2, IV; given on cycle days 1 and 8\] or Pemetrexed \[500 mg/m\^2, IV; given on cycle day 1\]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of placebo \[normal saline, IV; given on cycle day 1\].
| Group | Source count |
|---|---|
| NAC + Neoadjuvant/Adjuvant Pembrolizumab | 395 |
| NAC + Neoadjuvant/Adjuvant Placebo | 397 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| NAC + Neoadjuvant/Adjuvant Pembrolizumab | -1.52 | Not reported | -3.67 | 0.63 | Not reported |
| NAC + Neoadjuvant/Adjuvant Placebo | -3.74 | Not reported | -5.96 | -1.52 | Not reported |
Source statistical analyses
- ci Lower Limit
- -0.58
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 5.02
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Based on a constrained longitudinal data analysis (cLDA) model with the scores as the response variable with covariates for treatment by visit interaction and stratification factors (Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).
- non Inferiority Type
- OTHER
- p Value
- 0.1197
- param Type
- Difference in Least Square Means
- param Value
- 2.22
- statistical Method
- t-test, 2 sided
Complete source fields
- analyses
- ci Lower Limit
- -0.58
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 5.02
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Based on a constrained longitudinal data analysis (cLDA) model with the scores as the response variable with covariates for treatment by visit interaction and stratification factors (Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).
- non Inferiority Type
- OTHER
- p Value
- 0.1197
- param Type
- Difference in Least Square Means
- param Value
- 2.22
- statistical Method
- t-test, 2 sided
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -3.67
- upper Limit
- 0.63
- value
- -1.52
- group Id
- OG001
- lower Limit
- -5.96
- upper Limit
- -1.52
- value
- -3.74
- denoms
- counts
- group Id
- OG000
- value
- 395
- group Id
- OG001
- value
- 397
- units
- Participants
- description
- Change from baseline in GHS/QoL score using the EORTC QLQ-C30 will be determined. The EORTC QLQ-C30 is the most widely used cancer-specific, health-related QoL instrument comprised of 30 individual items arranged as both multi-item scales and individual items. Specifically, these items are divided into 5 functional scales (15 items total), 3 symptom scales (7 items total), 6 individual items, and a GHS/QoL scale composed of 2 items: GHS and QoL. The GHS/QoL score measured here refers to only the composite score calculated for the GHS/QoL scale. Both items on the GHS/QoL scale are scored from 1 (very poor GHS/QoL) to 7 (excellent GHS/QoL) and scores for both items are averaged and a linear transformation applied to standardize the overall GHS/QoL score from 0 to 100, with higher overall scores indicating higher GHS/QoL.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of pembrolizumab \[200 mg, intravenous (IV); given on cycle day 1\] in combination with platinum doublet neoadjuvant chemotherapy (NAC), consisting of cisplatin \[75 mg/m\^2, IV; given on cycle day 1\] and either Gemcitabine \[1000 mg/m\^2, IV; given on cycle days 1 and 8\] or Pemetrexed \[500 mg/m\^2, IV; given on cycle day 1\]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of pembrolizumab \[200 mg, IV; given on cycle day 1\].
- id
- OG000
- title
- NAC + Neoadjuvant/Adjuvant Pembrolizumab
- description
- Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of placebo \[normal saline, IV; given on cycle day 1\] in combination with platinum doublet NAC, consisting of cisplatin \[75 mg/m\^2, IV; given on cycle day 1\] and either Gemcitabine \[1000 mg/m\^2, IV; given on cycle days 1 and 8\] or Pemetrexed \[500 mg/m\^2, IV; given on cycle day 1\]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of placebo \[normal saline, IV; given on cycle day 1\].
- id
- OG001
- title
- NAC + Neoadjuvant/Adjuvant Placebo
- param Type
- LEAST_SQUARES_MEAN
- population Description
- All randomized participants who received at least one dose of study treatment and have at least one EORTC-QLQ-C30 Item 30 assessment data available.
- reporting Status
- POSTED
- time Frame
- Baseline (cycle 1 in neoadjuvant phase) and adjuvant week 10 (up to Study Week 30)
- title
- Change From Baseline in Adjuvant Phase in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) Score
- type
- SECONDARY
- unit Of Measure
- Sore on a scale
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Preserved source evidence · Not medical advice