TriangleNCT04200443 · OUTCOME
Subject-reported Outcomes
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- score on a scale
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Outcomes are measured at Cycle 1 to Cycle 4 between responders and non-responders
What was measured
Will be assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) symptom score. The QLQ-C30 questionnaire is made up of 30 questions and contains five functional scales (physical, role, emotional, cognitive, and social functioning), a global QoL scale, three symptom scales (fatigue, nausea and vomiting, and pain), and six single items (appetite loss, diarrhea, dyspnea, constipation, insomnia, and financial impact). The questionnaire uses a four-point response scale ("not at all", "a little", "quite a bit", and "very much"), with the exception of the global QoL scale, which has a seven-point response format. The scores were linearly transformed to a score between 0 and 100. For the functioning and the global QoL scales, a higher score indicates better health. For the symptoms scales, a higher score indicates more symptom burden. Linearly transformed scores for the nausea and vomiting item are reported here.
Analysis population: This objective was analyzed differently to investigate the link between symptom burden and treatment response; therefore, results are reported by response status (responders vs non-responders).
Groups in this outcome
Responders
Responders were defined as patients who reached an objective tumour response (eg, partial or complete response) according to RECIST by cycle four
Non-responders
Non-responders were defined as patients who did not reach an objective tumour response (eg, partial or complete response) according to RECIST by cycle four
| Group | Source count |
|---|---|
| Responders | 9 |
| Non-responders | 36 |
Reported measurements
Cycle 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Responders | 5.8 | Not reported | 0 | 15.9 | Not reported |
| Non-responders | 7.1 | Not reported | 3.5 | 10.8 | Not reported |
Cycle 2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Responders | 5.6 | Not reported | 0 | 15.8 | Not reported |
| Non-responders | 12.9 | Not reported | 8.8 | 17.0 | Not reported |
Cycle 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Responders | 7.4 | Not reported | 0 | 19.0 | Not reported |
| Non-responders | 15.9 | Not reported | 10.5 | 21.2 | Not reported |
Cycle 4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Responders | 14.8 | Not reported | 1.2 | 28.4 | Not reported |
| Non-responders | 19.7 | Not reported | 13.3 | 26.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 15.9
- value
- 5.8
- group Id
- OG001
- lower Limit
- 3.5
- upper Limit
- 10.8
- value
- 7.1
- title
- Cycle 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 15.8
- value
- 5.6
- group Id
- OG001
- lower Limit
- 8.8
- upper Limit
- 17.0
- value
- 12.9
- title
- Cycle 2
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 19.0
- value
- 7.4
- group Id
- OG001
- lower Limit
- 10.5
- upper Limit
- 21.2
- value
- 15.9
- title
- Cycle 3
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.2
- upper Limit
- 28.4
- value
- 14.8
- group Id
- OG001
- lower Limit
- 13.3
- upper Limit
- 26.1
- value
- 19.7
- title
- Cycle 4
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 36
- units
- Participants
- description
- Will be assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) symptom score. The QLQ-C30 questionnaire is made up of 30 questions and contains five functional scales (physical, role, emotional, cognitive, and social functioning), a global QoL scale, three symptom scales (fatigue, nausea and vomiting, and pain), and six single items (appetite loss, diarrhea, dyspnea, constipation, insomnia, and financial impact). The questionnaire uses a four-point response scale ("not at all", "a little", "quite a bit", and "very much"), with the exception of the global QoL scale, which has a seven-point response format. The scores were linearly transformed to a score between 0 and 100. For the functioning and the global QoL scales, a higher score indicates better health. For the symptoms scales, a higher score indicates more symptom burden. Linearly transformed scores for the nausea and vomiting item are reported here.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Responders were defined as patients who reached an objective tumour response (eg, partial or complete response) according to RECIST by cycle four
- id
- OG000
- title
- Responders
- description
- Non-responders were defined as patients who did not reach an objective tumour response (eg, partial or complete response) according to RECIST by cycle four
- id
- OG001
- title
- Non-responders
- param Type
- MEAN
- population Description
- This objective was analyzed differently to investigate the link between symptom burden and treatment response; therefore, results are reported by response status (responders vs non-responders).
- reporting Status
- POSTED
- time Frame
- Outcomes are measured at Cycle 1 to Cycle 4 between responders and non-responders
- title
- Subject-reported Outcomes
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice