TriangleNCT01828099 · OUTCOME
Least Squares Mean Scores on the EQ-5D-5L Visual Analogue Score (VAS)
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 EQ-5D-5L questionnaire is a standardized measure of health status. The EQ-5D-5L descriptive system comprises of the 5 following dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Along with the five dimensions of health, the EQ-5D-5L includes a VAS where respondents rate their overall health status on a scale from 0 to 100, where 0 represents the worst possible health state and 100 represents the best possible health state. A positive change from baseline indicates improvement. The 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.
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 | Source count |
|---|---|
| Ceritinib | 180 |
| Chemotherapy | 156 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ceritinib | 77.2 | 0.65 | Not reported | Not reported | Not reported |
| Chemotherapy | 74.1 | 0.90 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.65
- value
- 77.2
- group Id
- OG001
- spread
- 0.90
- value
- 74.1
- denoms
- counts
- group Id
- OG000
- value
- 180
- group Id
- OG001
- value
- 156
- units
- Participants
- description
- The EQ-5D-5L questionnaire is a standardized measure of health status. The EQ-5D-5L descriptive system comprises of the 5 following dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Along with the five dimensions of health, the EQ-5D-5L includes a VAS where respondents rate their overall health status on a scale from 0 to 100, where 0 represents the worst possible health state and 100 represents the best possible health state. A positive change from baseline indicates improvement. The 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.
- 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 EQ-5D-5L Visual Analogue Score (VAS)
- type
- SECONDARY
- unit Of Measure
- Score on a Scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice