TriangleNCT03517449 · OUTCOME
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) in All-comer Participants
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
- 95% Confidence Interval
- Time frame
- Baseline, Week 12
What was measured
EORTC QLQ-C30 was a questionnaire which included 30 questions that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Scores are transformed to a range of 0 to 100 using a standard EORTC algorithm. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/quality of life (QoL) represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problem.
Analysis population: Analysis population consisted of ITT population which included all randomized participants. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Groups in this outcome
Lenvatinib 20 mg + Pembrolizumab 200 mg
Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study
Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel
Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
| Group | Source count |
|---|---|
| Lenvatinib 20 mg + Pembrolizumab 200 mg | 386 |
| Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel | 363 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lenvatinib 20 mg + Pembrolizumab 200 mg | -5.97 | -8.36 | -8.36 | -3.58 | Not reported |
| Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel | -6.98 | -9.63 | -9.63 | -4.33 | Not reported |
Source statistical analyses
- ci Lower Limit
- -2.28
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.31
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- = 0.5460
- param Type
- Difference in LS Means
- param Value
- 1.01
- statistical Method
- cLDA model
Complete source fields
- analyses
- ci Lower Limit
- -2.28
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.31
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- = 0.5460
- param Type
- Difference in LS Means
- param Value
- 1.01
- statistical Method
- cLDA model
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -8.36
- spread
- -8.36
- upper Limit
- -3.58
- value
- -5.97
- group Id
- OG001
- lower Limit
- -9.63
- spread
- -9.63
- upper Limit
- -4.33
- value
- -6.98
- denoms
- counts
- group Id
- OG000
- value
- 386
- group Id
- OG001
- value
- 363
- units
- Participants
- description
- EORTC QLQ-C30 was a questionnaire which included 30 questions that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Scores are transformed to a range of 0 to 100 using a standard EORTC algorithm. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/quality of life (QoL) represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problem.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study
- id
- OG000
- title
- Lenvatinib 20 mg + Pembrolizumab 200 mg
- description
- Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
- id
- OG001
- title
- Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel
- param Type
- LEAST_SQUARES_MEAN
- population Description
- Analysis population consisted of ITT population which included all randomized participants. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Baseline, Week 12
- title
- Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) in All-comer Participants
- type
- SECONDARY
- unit Of Measure
- Score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice