NCT04334759 · OUTCOME
Health-Related QOL: EQ-5D-5L
DuRvalumab With chEmotherapy as First Line treAtment in Advanced Pleural Mesothelioma · Source last updated 2026-10-01
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
- Standard Deviation
- Time frame
- Performed at baseline, then at weeks 6, 12, 18, 26, 34, 42, 50, then every 12 weeks and at first progression visit until disease progression (minimum follow-up is 24 months after randomisation).
What was measured
Euro-Quality of Life (EuroQoL) 5 dimension 5 level (EQ-5D-5L) questionnaire, comprising of 5 questions with a score from 1 (no problem) to 5 (extreme problem) and a visual analog scale from 0 (worst) to 100 (best).
Analysis population: The number analyzed for each row reflects the number of participants who completed the question at the corresponding time point.
Groups in this outcome
Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance
Durvalumab + Standard Chemotherapy for 4 to 6 cycles, followed by Maintenance with Durvalumab
Control Arm for Chemo Cohort: Chemotherapy, Then Observation
Standard Chemotherapy for 4 to 6 cycles, followed by Observation
Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance
Durvalumab + Standard Chemotherapy for 4 to 6 cycles, followed by Maintenance with Durvalumab
Control Arm for IO Cohort: Ipilimumab and Nivolumab
Ipilimumab every 6 weeks and Nivolumab every 2 or 3 weeks for up to 2 years.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 69 |
|---|
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 33 |
|---|
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 7 |
|---|
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 20 |
|---|
Reported measurements
At baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 69 |
|---|
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 33 |
|---|
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 7 |
|---|
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 20 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 80.7 | 12.7 | Not reported | Not reported | Not reported |
|---|
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 72.5 | 21.6 | Not reported | Not reported | Not reported |
|---|
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 73.6 | 15.5 | Not reported | Not reported | Not reported |
|---|
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 71.4 | 15.6 | Not reported | Not reported | Not reported |
|---|
At week 6
Analysis denominator · Participants
| Group | Source count |
|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 61 |
|---|
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 30 |
|---|
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 7 |
|---|
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 17 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 75.6 | 16.6 | Not reported | Not reported | Not reported |
|---|
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 76.3 | 16.9 | Not reported | Not reported | Not reported |
|---|
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 73.6 | 17.5 | Not reported | Not reported | Not reported |
|---|
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 74.7 | 11.9 | Not reported | Not reported | Not reported |
|---|
At week 12
Analysis denominator · Participants
| Group | Source count |
|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 60 |
|---|
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 24 |
|---|
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 6 |
|---|
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 16 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 75.8 | 14.8 | Not reported | Not reported | Not reported |
|---|
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 77.4 | 17 | Not reported | Not reported | Not reported |
|---|
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 80 | 12.2 | Not reported | Not reported | Not reported |
|---|
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 72.4 | 15.5 | Not reported | Not reported | Not reported |
|---|
At week 18
Analysis denominator · Participants
| Group | Source count |
|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 59 |
|---|
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 20 |
|---|
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 7 |
|---|
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 17 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 75.2 | 16 | Not reported | Not reported | Not reported |
|---|
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 73 | 15.5 | Not reported | Not reported | Not reported |
|---|
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 77.9 | 13.5 | Not reported | Not reported | Not reported |
|---|
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 77.1 | 11.7 | Not reported | Not reported | Not reported |
|---|
At week 26
Analysis denominator · Participants
| Group | Source count |
|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 58 |
|---|
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 19 |
|---|
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 5 |
|---|
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 15 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 76 | 18.2 | Not reported | Not reported | Not reported |
|---|
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 73.4 | 16.7 | Not reported | Not reported | Not reported |
|---|
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 84 | 16.4 | Not reported | Not reported | Not reported |
|---|
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 73 | 15.3 | Not reported | Not reported | Not reported |
|---|
At week 34
Analysis denominator · Participants
| Group | Source count |
|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 45 |
|---|
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 14 |
|---|
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 5 |
|---|
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 13 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 78.7 | 14.6 | Not reported | Not reported | Not reported |
|---|
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 68.9 | 19.7 | Not reported | Not reported | Not reported |
|---|
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 81.5 | 15.6 | Not reported | Not reported | Not reported |
|---|
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 73.8 | 12.9 | Not reported | Not reported | Not reported |
|---|
At week 42
Analysis denominator · Participants
| Group | Source count |
|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 34 |
|---|
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 8 |
|---|
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 3 |
|---|
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 12 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 80.1 | 11.3 | Not reported | Not reported | Not reported |
|---|
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 69 | 21.8 | Not reported | Not reported | Not reported |
|---|
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 77.3 | 15.5 | Not reported | Not reported | Not reported |
|---|
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 75.7 | 15.3 | Not reported | Not reported | Not reported |
|---|
At week 50
Analysis denominator · Participants
| Group | Source count |
|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 27 |
|---|
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 7 |
|---|
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 4 |
|---|
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 11 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 78 | 10.6 | Not reported | Not reported | Not reported |
|---|
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 77.4 | 15.3 | Not reported | Not reported | Not reported |
|---|
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 78.8 | 21 | Not reported | Not reported | Not reported |
|---|
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 71.3 | 13.5 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 12.7
- value
- 80.7
- group Id
- OG001
- spread
- 21.6
- value
- 72.5
- group Id
- OG002
- spread
- 15.5
- value
- 73.6
- group Id
- OG003
- spread
- 15.6
- value
- 71.4
- denoms
- counts
- group Id
- OG000
- value
- 69
- group Id
- OG001
- value
- 33
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 20
- units
- Participants
- title
- At baseline
- categories
- measurements
- group Id
- OG000
- spread
- 16.6
- value
- 75.6
- group Id
- OG001
- spread
- 16.9
- value
- 76.3
- group Id
- OG002
- spread
- 17.5
- value
- 73.6
- group Id
- OG003
- spread
- 11.9
- value
- 74.7
- denoms
- counts
- group Id
- OG000
- value
- 61
- group Id
- OG001
- value
- 30
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 17
- units
- Participants
- title
- At week 6
- categories
- measurements
- group Id
- OG000
- spread
- 14.8
- value
- 75.8
- group Id
- OG001
- spread
- 17
- value
- 77.4
- group Id
- OG002
- spread
- 12.2
- value
- 80
- group Id
- OG003
- spread
- 15.5
- value
- 72.4
- denoms
- counts
- group Id
- OG000
- value
- 60
- group Id
- OG001
- value
- 24
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 16
- units
- Participants
- title
- At week 12
- categories
- measurements
- group Id
- OG000
- spread
- 16
- value
- 75.2
- group Id
- OG001
- spread
- 15.5
- value
- 73
- group Id
- OG002
- spread
- 13.5
- value
- 77.9
- group Id
- OG003
- spread
- 11.7
- value
- 77.1
- denoms
- counts
- group Id
- OG000
- value
- 59
- group Id
- OG001
- value
- 20
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 17
- units
- Participants
- title
- At week 18
- categories
- measurements
- group Id
- OG000
- spread
- 18.2
- value
- 76
- group Id
- OG001
- spread
- 16.7
- value
- 73.4
- group Id
- OG002
- spread
- 16.4
- value
- 84
- group Id
- OG003
- spread
- 15.3
- value
- 73
- denoms
- counts
- group Id
- OG000
- value
- 58
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 15
- units
- Participants
- title
- At week 26
- categories
- measurements
- group Id
- OG000
- spread
- 14.6
- value
- 78.7
- group Id
- OG001
- spread
- 19.7
- value
- 68.9
- group Id
- OG002
- spread
- 15.6
- value
- 81.5
- group Id
- OG003
- spread
- 12.9
- value
- 73.8
- denoms
- counts
- group Id
- OG000
- value
- 45
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 13
- units
- Participants
- title
- At week 34
- categories
- measurements
- group Id
- OG000
- spread
- 11.3
- value
- 80.1
- group Id
- OG001
- spread
- 21.8
- value
- 69
- group Id
- OG002
- spread
- 15.5
- value
- 77.3
- group Id
- OG003
- spread
- 15.3
- value
- 75.7
- denoms
- counts
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 12
- units
- Participants
- title
- At week 42
- categories
- measurements
- group Id
- OG000
- spread
- 10.6
- value
- 78
- group Id
- OG001
- spread
- 15.3
- value
- 77.4
- group Id
- OG002
- spread
- 21
- value
- 78.8
- group Id
- OG003
- spread
- 13.5
- value
- 71.3
- denoms
- counts
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 11
- units
- Participants
- title
- At week 50
- denoms
- counts
- group Id
- OG000
- value
- 69
- group Id
- OG001
- value
- 33
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 20
- units
- Participants
- description
- Euro-Quality of Life (EuroQoL) 5 dimension 5 level (EQ-5D-5L) questionnaire, comprising of 5 questions with a score from 1 (no problem) to 5 (extreme problem) and a visual analog scale from 0 (worst) to 100 (best).
- dispersion Type
- Standard Deviation
- groups
- description
- Durvalumab + Standard Chemotherapy for 4 to 6 cycles, followed by Maintenance with Durvalumab
- id
- OG000
- title
- Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance
- description
- Standard Chemotherapy for 4 to 6 cycles, followed by Observation
- id
- OG001
- title
- Control Arm for Chemo Cohort: Chemotherapy, Then Observation
- description
- Durvalumab + Standard Chemotherapy for 4 to 6 cycles, followed by Maintenance with Durvalumab
- id
- OG002
- title
- Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance
- description
- Ipilimumab every 6 weeks and Nivolumab every 2 or 3 weeks for up to 2 years.
- id
- OG003
- title
- Control Arm for IO Cohort: Ipilimumab and Nivolumab
- param Type
- MEAN
- population Description
- The number analyzed for each row reflects the number of participants who completed the question at the corresponding time point.
- reporting Status
- POSTED
- time Frame
- Performed at baseline, then at weeks 6, 12, 18, 26, 34, 42, 50, then every 12 weeks and at first progression visit until disease progression (minimum follow-up is 24 months after randomisation).
- title
- Health-Related QOL: EQ-5D-5L
- type
- SECONDARY
- unit Of Measure
- score on a scale
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Preserved source evidence · Not medical advice
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