TriangleNCT02409342 · OUTCOME
Time to Deterioration (TTD) in Patient-reported Lung Cancer Symptoms Score as Assessed by the Symptoms in Lung Cancer (SILC) Scale Symptom Score in the TC3 or IC3-WT Populations
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline until data cut-off on 10 September 2018 (up to approximately 38 months)
What was measured
TTD in each of the patient-reported lung cancer symptoms with use of the SILC scale. The SILC scale is a nine-item content valid self-report measure of lung cancer symptoms. It measures severity of cough, dyspnea, and chest pain with a total symptom severity score. Each SILC symptom scale (dyspnea, cough, chest pain) score was calculated as the average of the component items (range 0 to 4). An increase in score suggested worsening in symptomatology. A symptom score change of 0.3 points for the dyspnea and cough scores was considered to be clinically significant; whereas a symptom score change of 0.5 points for the chest pain score was considered to be clinically significant.
Analysis population: Analysis was performed for the TC3 or IC3-WT Populations.
Groups in this outcome
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
Atezolizumab
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
| Group | Source count |
|---|---|
| Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine) | 98 |
| Atezolizumab | 107 |
Reported measurements
Cough
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine) | 3.4 | Not reported | 1.3 | 12.4 | Not reported |
| Atezolizumab | 3.5 | Not reported | 1.0 | 10.8 | Not reported |
Dyspnea
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine) | 1.0 | Not reported | 0.5 | 1.9 | Not reported |
| Atezolizumab | 1.3 | Not reported | 0.7 | 3.6 | Not reported |
Chest pain
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine) | 1.1 | Not reported | 0.7 | NA | Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events. |
| Atezolizumab | 1.7 | Not reported | 0.7 | 4.5 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.657
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.984
- group Description
- Cough in TC3 or IC3-WT Populations
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Stratified Analysis
- non Inferiority Type
- SUPERIORITY
- param Type
- Hazard Ratio (HR)
- param Value
- 1.142
- ci Lower Limit
- 0.555
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.430
- group Description
- Dyspnoea in TC3 or IC3-WT Populations
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Stratified analysis
- non Inferiority Type
- SUPERIORITY
- param Type
- Hazard Ratio (HR)
- param Value
- 0.891
- ci Lower Limit
- 0.737
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.049
- group Description
- Chest pain in TC3 or IC3-WT Populations
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Stratified analysis
- non Inferiority Type
- SUPERIORITY
- param Type
- Hazard Ratio (HR)
- param Value
- 1.229
Complete source fields
- analyses
- ci Lower Limit
- 0.657
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.984
- group Description
- Cough in TC3 or IC3-WT Populations
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Stratified Analysis
- non Inferiority Type
- SUPERIORITY
- param Type
- Hazard Ratio (HR)
- param Value
- 1.142
- ci Lower Limit
- 0.555
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.430
- group Description
- Dyspnoea in TC3 or IC3-WT Populations
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Stratified analysis
- non Inferiority Type
- SUPERIORITY
- param Type
- Hazard Ratio (HR)
- param Value
- 0.891
- ci Lower Limit
- 0.737
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.049
- group Description
- Chest pain in TC3 or IC3-WT Populations
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Stratified analysis
- non Inferiority Type
- SUPERIORITY
- param Type
- Hazard Ratio (HR)
- param Value
- 1.229
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.3
- upper Limit
- 12.4
- value
- 3.4
- group Id
- OG001
- lower Limit
- 1.0
- upper Limit
- 10.8
- value
- 3.5
- title
- Cough
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.5
- upper Limit
- 1.9
- value
- 1.0
- group Id
- OG001
- lower Limit
- 0.7
- upper Limit
- 3.6
- value
- 1.3
- title
- Dyspnea
- categories
- measurements
- comment
- Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.
- group Id
- OG000
- lower Limit
- 0.7
- upper Limit
- NA
- value
- 1.1
- group Id
- OG001
- lower Limit
- 0.7
- upper Limit
- 4.5
- value
- 1.7
- title
- Chest pain
- denoms
- counts
- group Id
- OG000
- value
- 98
- group Id
- OG001
- value
- 107
- units
- Participants
- description
- TTD in each of the patient-reported lung cancer symptoms with use of the SILC scale. The SILC scale is a nine-item content valid self-report measure of lung cancer symptoms. It measures severity of cough, dyspnea, and chest pain with a total symptom severity score. Each SILC symptom scale (dyspnea, cough, chest pain) score was calculated as the average of the component items (range 0 to 4). An increase in score suggested worsening in symptomatology. A symptom score change of 0.3 points for the dyspnea and cough scores was considered to be clinically significant; whereas a symptom score change of 0.5 points for the chest pain score was considered to be clinically significant.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
- id
- OG000
- title
- Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
- description
- Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
- id
- OG001
- title
- Atezolizumab
- param Type
- MEDIAN
- population Description
- Analysis was performed for the TC3 or IC3-WT Populations.
- reporting Status
- POSTED
- time Frame
- Baseline until data cut-off on 10 September 2018 (up to approximately 38 months)
- title
- Time to Deterioration (TTD) in Patient-reported Lung Cancer Symptoms Score as Assessed by the Symptoms in Lung Cancer (SILC) Scale Symptom Score in the TC3 or IC3-WT Populations
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice