TriangleNCT00556322 · OUTCOME
Time to Deterioration in Quality of Life Using FACT-L
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- weeks
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months
What was measured
The FACT-L measures health related QOL and composes of five domains: the four domains (physical well being, emotional well being, social well being, functional well being) from the FACT-G and the LCS. The FACT-L total score ranges from 0 to 136, higher scores represent better QOL. Time to deterioration of QoL or symptom progression is defined as time from randomization until either a clinically meaningful decline from baseline in Total FACT-L or, death on study, whichever occurs first. The clinically meaningful decline that was used to determine deterioration in QoL was ≥6-point decline from baseline. Participants without deterioration in QoL at the time of analysis were censored at the time of the last FACT-L assessment. Kaplan-Meier estimate was used to determine time to event.
Analysis population: FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.
Groups in this outcome
Comparator
Participants received either pemetrexed 500 mg/m\^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m\^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
Erlotinib
Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
| Group | Source count |
|---|---|
| Comparator | 165 |
| Erlotinib | 157 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Comparator | 9.0 | Not reported | 7.1 | 11.6 | Not reported |
| Erlotinib | 6.3 | Not reported | 6.1 | 8.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.93
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.59
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.1498
- param Type
- Hazard Ratio (HR)
- param Value
- 1.21
- statistical Method
- Log Rank
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Lower Limit
- 0.93
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.59
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.1498
- param Type
- Hazard Ratio (HR)
- param Value
- 1.21
- statistical Method
- Log Rank
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.1
- upper Limit
- 11.6
- value
- 9.0
- group Id
- OG001
- lower Limit
- 6.1
- upper Limit
- 8.0
- value
- 6.3
- denoms
- counts
- group Id
- OG000
- value
- 165
- group Id
- OG001
- value
- 157
- units
- Participants
- description
- The FACT-L measures health related QOL and composes of five domains: the four domains (physical well being, emotional well being, social well being, functional well being) from the FACT-G and the LCS. The FACT-L total score ranges from 0 to 136, higher scores represent better QOL. Time to deterioration of QoL or symptom progression is defined as time from randomization until either a clinically meaningful decline from baseline in Total FACT-L or, death on study, whichever occurs first. The clinically meaningful decline that was used to determine deterioration in QoL was ≥6-point decline from baseline. Participants without deterioration in QoL at the time of analysis were censored at the time of the last FACT-L assessment. Kaplan-Meier estimate was used to determine time to event.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received either pemetrexed 500 mg/m\^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m\^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
- id
- OG000
- title
- Comparator
- description
- Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
- id
- OG001
- title
- Erlotinib
- param Type
- MEDIAN
- population Description
- FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.
- reporting Status
- POSTED
- time Frame
- Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months
- title
- Time to Deterioration in Quality of Life Using FACT-L
- type
- SECONDARY
- unit Of Measure
- weeks
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice