TriangleNCT02075840 · OUTCOME
Percentage of Participants With Deterioration by EORTC Quality Of Life Questionnaire Core 30 (C30)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline, every 4 weeks until disease progression (up to 33 months)
What was measured
The EORTC QLQ-30 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in global health status or function is defined as a \>or=10-point decrease from baseline in a symptom score that must be held for at least two consecutive assessments or an initial \>or=10-point decrease from baseline followed by death within 5 weeks from the last assessment.
Analysis population: ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.
Groups in this outcome
Alectinib
Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Crizotinib
Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
| Group | Source count |
|---|---|
| Alectinib | 152 |
| Crizotinib | 151 |
Reported measurements
Fatigue
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Alectinib | 21.7 | Not reported | Not reported | Not reported | Not reported |
| Crizotinib | 25.2 | Not reported | Not reported | Not reported | Not reported |
Dyspnea
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Alectinib | 17.1 | Not reported | Not reported | Not reported | Not reported |
| Crizotinib | 9.9 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 21.7
- group Id
- OG001
- value
- 25.2
- title
- Fatigue
- categories
- measurements
- group Id
- OG000
- value
- 17.1
- group Id
- OG001
- value
- 9.9
- title
- Dyspnea
- denoms
- counts
- group Id
- OG000
- value
- 152
- group Id
- OG001
- value
- 151
- units
- Participants
- description
- The EORTC QLQ-30 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in global health status or function is defined as a \>or=10-point decrease from baseline in a symptom score that must be held for at least two consecutive assessments or an initial \>or=10-point decrease from baseline followed by death within 5 weeks from the last assessment.
- groups
- description
- Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
- id
- OG000
- title
- Alectinib
- description
- Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
- id
- OG001
- title
- Crizotinib
- param Type
- NUMBER
- population Description
- ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Baseline, every 4 weeks until disease progression (up to 33 months)
- title
- Percentage of Participants With Deterioration by EORTC Quality Of Life Questionnaire Core 30 (C30)
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice