TriangleNCT03052608 · OUTCOME
Time to Deterioration (TTD) in Participant Reported Pain in Chest, Dyspnea, or Cough From QLQ-LC13
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
- From Baseline up to 33 months
What was measured
The EORTC QLQ LC13 consists of 13 questions and includes 1 multi-item scale and 9 single items assessing symptoms (dyspnea, cough, haemoptysis, and site-specific pain), side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and pain medication use. The scale scores rang from 0 to 100, with higher scores indicating higher ("worse") level of symptoms. TTD in pain in chest, dyspnea, or cough was defined as the time from randomization to the first time the participant's score showed a 10 point or greater increase after baseline in any of the 3 symptoms. TTD in months was calculated as (date of deterioration or censoring - randomization date +1)/30.4375.
Analysis population: Participants in the EORTC QLQ-LC13 PRO analysis population with change from baseline scores within each treatment group and subscale.
Groups in this outcome
Lorlatinib
Lorlatinib monotherapy at the recommended Phase 2 dose of 100 mg, was administered orally once daily (QD) at approximately the same time of the day on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
Crizotinib
Crizotinib monotherapy at the registered dose of 250 mg, was administered orally twice daily (BID) at approximately the same time in the morning and evening (12 hours apart) on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
| Group | Source count |
|---|---|
| Lorlatinib | 146 |
| Crizotinib | 139 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lorlatinib | 3.3 | Not reported | 2.1 | 4.7 | Not reported |
| Crizotinib | 3.7 | Not reported | 2.0 | 5.5 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.822
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.444
- estimate Comment
- Based on Cox Proportional Hazards model stratified by the presence of brain metastases and ethnic origin at randomization. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Lorlatinib.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.7293
- param Type
- Hazard Ratio (HR)
- param Value
- 1.09
- statistical Comment
- Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.
- statistical Method
- one-sided stratified log-rank
Complete source fields
- analyses
- ci Lower Limit
- 0.822
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.444
- estimate Comment
- Based on Cox Proportional Hazards model stratified by the presence of brain metastases and ethnic origin at randomization. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Lorlatinib.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.7293
- param Type
- Hazard Ratio (HR)
- param Value
- 1.09
- statistical Comment
- Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.
- statistical Method
- one-sided stratified log-rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.1
- upper Limit
- 4.7
- value
- 3.3
- group Id
- OG001
- lower Limit
- 2.0
- upper Limit
- 5.5
- value
- 3.7
- denoms
- counts
- group Id
- OG000
- value
- 146
- group Id
- OG001
- value
- 139
- units
- Participants
- description
- The EORTC QLQ LC13 consists of 13 questions and includes 1 multi-item scale and 9 single items assessing symptoms (dyspnea, cough, haemoptysis, and site-specific pain), side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and pain medication use. The scale scores rang from 0 to 100, with higher scores indicating higher ("worse") level of symptoms. TTD in pain in chest, dyspnea, or cough was defined as the time from randomization to the first time the participant's score showed a 10 point or greater increase after baseline in any of the 3 symptoms. TTD in months was calculated as (date of deterioration or censoring - randomization date +1)/30.4375.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Lorlatinib monotherapy at the recommended Phase 2 dose of 100 mg, was administered orally once daily (QD) at approximately the same time of the day on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
- id
- OG000
- title
- Lorlatinib
- description
- Crizotinib monotherapy at the registered dose of 250 mg, was administered orally twice daily (BID) at approximately the same time in the morning and evening (12 hours apart) on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
- id
- OG001
- title
- Crizotinib
- param Type
- MEDIAN
- population Description
- Participants in the EORTC QLQ-LC13 PRO analysis population with change from baseline scores within each treatment group and subscale.
- reporting Status
- POSTED
- time Frame
- From Baseline up to 33 months
- title
- Time to Deterioration (TTD) in Participant Reported Pain in Chest, Dyspnea, or Cough From QLQ-LC13
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice