NCT01828099 · OUTCOME
Least Squares Mean Scores on the Lung Cancer Symptom Scale (LCSS)
LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer · Source last updated 2025-01-16
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
- Standard Error
- Time frame
- Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months
What was measured
The LCSS consisted of 9 individual items; 6 measured lung cancer symptoms (appetite, fatigue, cough, dyspnea, hemoptysis, and pain); the remaining 3 items measured general lung cancer symptom distress, interference with daily activities and overall QoL. Each item was scored on a 100-millimeter Visual Analogue Scale (VAS), with scores ranging from 0 to 100 (0 = best outcome).
Total score was calculated as the average of the aggregate score of all 9 items. Scores ranged from 0 to 100, with higher total scores indicating a greater overall impact of symptoms on the patient's QoL. The Symptom Burden Index (SBI) was calculated as the average of the six symptom items. It also ranged from 0 to 100, with higher scores indicating greater symptom burden.
Scores were analyzed using repeated measurement model for longitudinal data, including terms for visit, treatment, treatment by time interaction, strata and baseline score. Overall mean and standard error were obtained.
Analysis population: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Participants with a baseline assessment for at least one of the domain scores
Groups in this outcome
Ceritinib
Ceritinib administered continuously through oral dosing at a dosage of 750 mg once daily in fasted state
Chemotherapy
Pemetrexed plus cisplatin or carboplatin (based on Investigator's choice) for 4 cycles (Induction) followed by pemetrexed as single agent (Maintenance)
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Ceritinib | 183 |
|---|
| Chemotherapy | 161 |
|---|
Reported measurements
Appetite Loss
Analysis denominator · Participants
| Group | Source count |
|---|
| Ceritinib | 183 |
|---|
| Chemotherapy | 161 |
|---|
Values in Score on a Scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ceritinib | 20.9 | 1.35 | Not reported | Not reported | Not reported |
|---|
| Chemotherapy | 25.1 | 1.58 | Not reported | Not reported | Not reported |
|---|
Fatigue
Analysis denominator · Participants
| Group | Source count |
|---|
| Ceritinib | 183 |
|---|
| Chemotherapy | 161 |
|---|
Values in Score on a Scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ceritinib | 27.4 | 1.50 | Not reported | Not reported | Not reported |
|---|
| Chemotherapy | 33.9 | 1.74 | Not reported | Not reported | Not reported |
|---|
Cough
Analysis denominator · Participants
| Group | Source count |
|---|
| Ceritinib | 183 |
|---|
| Chemotherapy | 161 |
|---|
Values in Score on a Scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ceritinib | 8.0 | 0.87 | Not reported | Not reported | Not reported |
|---|
| Chemotherapy | 15.1 | 1.02 | Not reported | Not reported | Not reported |
|---|
Shortness of Breath
Analysis denominator · Participants
| Group | Source count |
|---|
| Ceritinib | 183 |
|---|
| Chemotherapy | 161 |
|---|
Values in Score on a Scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ceritinib | 18.8 | 1.40 | Not reported | Not reported | Not reported |
|---|
| Chemotherapy | 25.5 | 1.62 | Not reported | Not reported | Not reported |
|---|
Hemoptysis
Analysis denominator · Participants
| Group | Source count |
|---|
| Ceritinib | 183 |
|---|
| Chemotherapy | 160 |
|---|
Values in Score on a Scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ceritinib | 0.7 | 0.37 | Not reported | Not reported | Not reported |
|---|
| Chemotherapy | 1.9 | 0.44 | Not reported | Not reported | Not reported |
|---|
Pain
Analysis denominator · Participants
| Group | Source count |
|---|
| Ceritinib | 183 |
|---|
| Chemotherapy | 161 |
|---|
Values in Score on a Scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ceritinib | 11.6 | 1.16 | Not reported | Not reported | Not reported |
|---|
| Chemotherapy | 14.9 | 1.35 | Not reported | Not reported | Not reported |
|---|
Total Symptom Distress
Analysis denominator · Participants
| Group | Source count |
|---|
| Ceritinib | 182 |
|---|
| Chemotherapy | 161 |
|---|
Values in Score on a Scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ceritinib | 20.5 | 1.75 | Not reported | Not reported | Not reported |
|---|
| Chemotherapy | 29.3 | 2.02 | Not reported | Not reported | Not reported |
|---|
Normal Activity Status
Analysis denominator · Participants
| Group | Source count |
|---|
| Ceritinib | 183 |
|---|
| Chemotherapy | 161 |
|---|
Values in Score on a Scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ceritinib | 23.6 | 1.59 | Not reported | Not reported | Not reported |
|---|
| Chemotherapy | 33.5 | 1.84 | Not reported | Not reported | Not reported |
|---|
Overall Quality of Life
Analysis denominator · Participants
| Group | Source count |
|---|
| Ceritinib | 182 |
|---|
| Chemotherapy | 161 |
|---|
Values in Score on a Scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ceritinib | 27.4 | 1.56 | Not reported | Not reported | Not reported |
|---|
| Chemotherapy | 35.3 | 1.75 | Not reported | Not reported | Not reported |
|---|
Symptom Burden Index
Analysis denominator · Participants
| Group | Source count |
|---|
| Ceritinib | 183 |
|---|
| Chemotherapy | 160 |
|---|
Values in Score on a Scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ceritinib | 14.7 | 0.91 | Not reported | Not reported | Not reported |
|---|
| Chemotherapy | 19.4 | 1.05 | Not reported | Not reported | Not reported |
|---|
Total Score
Analysis denominator · Participants
| Group | Source count |
|---|
| Ceritinib | 181 |
|---|
| Chemotherapy | 160 |
|---|
Values in Score on a Scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ceritinib | 19.1 | 1.18 | Not reported | Not reported | Not reported |
|---|
| Chemotherapy | 24.7 | 1.31 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.35
- value
- 20.9
- group Id
- OG001
- spread
- 1.58
- value
- 25.1
- denoms
- counts
- group Id
- OG000
- value
- 183
- group Id
- OG001
- value
- 161
- units
- Participants
- title
- Appetite Loss
- categories
- measurements
- group Id
- OG000
- spread
- 1.50
- value
- 27.4
- group Id
- OG001
- spread
- 1.74
- value
- 33.9
- denoms
- counts
- group Id
- OG000
- value
- 183
- group Id
- OG001
- value
- 161
- units
- Participants
- title
- Fatigue
- categories
- measurements
- group Id
- OG000
- spread
- 0.87
- value
- 8.0
- group Id
- OG001
- spread
- 1.02
- value
- 15.1
- denoms
- counts
- group Id
- OG000
- value
- 183
- group Id
- OG001
- value
- 161
- units
- Participants
- title
- Cough
- categories
- measurements
- group Id
- OG000
- spread
- 1.40
- value
- 18.8
- group Id
- OG001
- spread
- 1.62
- value
- 25.5
- denoms
- counts
- group Id
- OG000
- value
- 183
- group Id
- OG001
- value
- 161
- units
- Participants
- title
- Shortness of Breath
- categories
- measurements
- group Id
- OG000
- spread
- 0.37
- value
- 0.7
- group Id
- OG001
- spread
- 0.44
- value
- 1.9
- denoms
- counts
- group Id
- OG000
- value
- 183
- group Id
- OG001
- value
- 160
- units
- Participants
- title
- Hemoptysis
- categories
- measurements
- group Id
- OG000
- spread
- 1.16
- value
- 11.6
- group Id
- OG001
- spread
- 1.35
- value
- 14.9
- denoms
- counts
- group Id
- OG000
- value
- 183
- group Id
- OG001
- value
- 161
- units
- Participants
- title
- Pain
- categories
- measurements
- group Id
- OG000
- spread
- 1.75
- value
- 20.5
- group Id
- OG001
- spread
- 2.02
- value
- 29.3
- denoms
- counts
- group Id
- OG000
- value
- 182
- group Id
- OG001
- value
- 161
- units
- Participants
- title
- Total Symptom Distress
- categories
- measurements
- group Id
- OG000
- spread
- 1.59
- value
- 23.6
- group Id
- OG001
- spread
- 1.84
- value
- 33.5
- denoms
- counts
- group Id
- OG000
- value
- 183
- group Id
- OG001
- value
- 161
- units
- Participants
- title
- Normal Activity Status
- categories
- measurements
- group Id
- OG000
- spread
- 1.56
- value
- 27.4
- group Id
- OG001
- spread
- 1.75
- value
- 35.3
- denoms
- counts
- group Id
- OG000
- value
- 182
- group Id
- OG001
- value
- 161
- units
- Participants
- title
- Overall Quality of Life
- categories
- measurements
- group Id
- OG000
- spread
- 0.91
- value
- 14.7
- group Id
- OG001
- spread
- 1.05
- value
- 19.4
- denoms
- counts
- group Id
- OG000
- value
- 183
- group Id
- OG001
- value
- 160
- units
- Participants
- title
- Symptom Burden Index
- categories
- measurements
- group Id
- OG000
- spread
- 1.18
- value
- 19.1
- group Id
- OG001
- spread
- 1.31
- value
- 24.7
- denoms
- counts
- group Id
- OG000
- value
- 181
- group Id
- OG001
- value
- 160
- units
- Participants
- title
- Total Score
- denoms
- counts
- group Id
- OG000
- value
- 183
- group Id
- OG001
- value
- 161
- units
- Participants
- description
- The LCSS consisted of 9 individual items; 6 measured lung cancer symptoms (appetite, fatigue, cough, dyspnea, hemoptysis, and pain); the remaining 3 items measured general lung cancer symptom distress, interference with daily activities and overall QoL. Each item was scored on a 100-millimeter Visual Analogue Scale (VAS), with scores ranging from 0 to 100 (0 = best outcome).
Total score was calculated as the average of the aggregate score of all 9 items. Scores ranged from 0 to 100, with higher total scores indicating a greater overall impact of symptoms on the patient's QoL. The Symptom Burden Index (SBI) was calculated as the average of the six symptom items. It also ranged from 0 to 100, with higher scores indicating greater symptom burden.
Scores were analyzed using repeated measurement model for longitudinal data, including terms for visit, treatment, treatment by time interaction, strata and baseline score. Overall mean and standard error were obtained.
- dispersion Type
- Standard Error
- groups
- description
- Ceritinib administered continuously through oral dosing at a dosage of 750 mg once daily in fasted state
- id
- OG000
- title
- Ceritinib
- description
- Pemetrexed plus cisplatin or carboplatin (based on Investigator's choice) for 4 cycles (Induction) followed by pemetrexed as single agent (Maintenance)
- id
- OG001
- title
- Chemotherapy
- param Type
- LEAST_SQUARES_MEAN
- population Description
- The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Participants with a baseline assessment for at least one of the domain scores
- reporting Status
- POSTED
- time Frame
- Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months
- title
- Least Squares Mean Scores on the Lung Cancer Symptom Scale (LCSS)
- type
- SECONDARY
- unit Of Measure
- Score on a Scale
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