NCT01087970 · OUTCOME
Change From Baseline in Participant-Reported European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L)
A Study for Participants With Recurrent or Metastatic Squamous Cell Head and Neck Cancer · Source last updated 2014-05-19
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline, Day 1 of Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4 (21-day cycle)
What was measured
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. A regression equation defines a utility value for these health states to generate an index score. The possible values for index score range from -0.594 (severe problems in all 5 dimensions) to 1 (no problem in all dimensions) on a scale where 1 represents the best possible health state. The EQ-5D Visual Analog Scale (VAS) is used to record a participant's rating for his/her current health-related quality of life state on the day of questionnaire administration and is captured on a scale of 0 (worst imaginable health state) to 100 (best imaginable health state).
Analysis population: All treated participants who completed the EQ-5D-3L and VAS at baseline and in Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4. Exclude those from a noncompliant study site.
Groups in this outcome
Cetuximab + Pemetrexed + Carboplatin/Cisplatin
Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.
Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.
Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.
Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.
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 |
|---|
| Cetuximab + Pemetrexed + Carboplatin/Cisplatin | 43 |
|---|
Reported measurements
Change in Index Score at Cycle 2 (n=43)
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cetuximab + Pemetrexed + Carboplatin/Cisplatin | 0.038 | 0.233 | Not reported | Not reported | Not reported |
|---|
Change in Index Score at Cycle 4 (n=29)
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cetuximab + Pemetrexed + Carboplatin/Cisplatin | 0.070 | 0.147 | Not reported | Not reported | Not reported |
|---|
Change in Index Score at Cycle 6 (n=24)
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cetuximab + Pemetrexed + Carboplatin/Cisplatin | -0.063 | 0.249 | Not reported | Not reported | Not reported |
|---|
Change in Index Score at monotherapy Cycle2 (n=14)
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cetuximab + Pemetrexed + Carboplatin/Cisplatin | 0.016 | 0.098 | Not reported | Not reported | Not reported |
|---|
Change in Index Score at monotherapy Cycle 4 (n=7)
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cetuximab + Pemetrexed + Carboplatin/Cisplatin | 0.059 | 0.080 | Not reported | Not reported | Not reported |
|---|
Change in VAS Score at Cycle 2 (n=41)
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cetuximab + Pemetrexed + Carboplatin/Cisplatin | 3.854 | 21.600 | Not reported | Not reported | Not reported |
|---|
Change in VAS Score at Cycle 4 (n=28)
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cetuximab + Pemetrexed + Carboplatin/Cisplatin | 2.107 | 24.894 | Not reported | Not reported | Not reported |
|---|
Change in VAS Score at Cycle 6 (n=21)
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cetuximab + Pemetrexed + Carboplatin/Cisplatin | 0.333 | 16.716 | Not reported | Not reported | Not reported |
|---|
Change in VAS Score at monotherapy Cycle 2 (n=14)
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cetuximab + Pemetrexed + Carboplatin/Cisplatin | -1.500 | 16.919 | Not reported | Not reported | Not reported |
|---|
Change in VAS Score at monotherapy Cycle 4 (n=7)
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cetuximab + Pemetrexed + Carboplatin/Cisplatin | 0.571 | 13.377 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.233
- value
- 0.038
- title
- Change in Index Score at Cycle 2 (n=43)
- categories
- measurements
- group Id
- OG000
- spread
- 0.147
- value
- 0.070
- title
- Change in Index Score at Cycle 4 (n=29)
- categories
- measurements
- group Id
- OG000
- spread
- 0.249
- value
- -0.063
- title
- Change in Index Score at Cycle 6 (n=24)
- categories
- measurements
- group Id
- OG000
- spread
- 0.098
- value
- 0.016
- title
- Change in Index Score at monotherapy Cycle2 (n=14)
- categories
- measurements
- group Id
- OG000
- spread
- 0.080
- value
- 0.059
- title
- Change in Index Score at monotherapy Cycle 4 (n=7)
- categories
- measurements
- group Id
- OG000
- spread
- 21.600
- value
- 3.854
- title
- Change in VAS Score at Cycle 2 (n=41)
- categories
- measurements
- group Id
- OG000
- spread
- 24.894
- value
- 2.107
- title
- Change in VAS Score at Cycle 4 (n=28)
- categories
- measurements
- group Id
- OG000
- spread
- 16.716
- value
- 0.333
- title
- Change in VAS Score at Cycle 6 (n=21)
- categories
- measurements
- group Id
- OG000
- spread
- 16.919
- value
- -1.500
- title
- Change in VAS Score at monotherapy Cycle 2 (n=14)
- categories
- measurements
- group Id
- OG000
- spread
- 13.377
- value
- 0.571
- title
- Change in VAS Score at monotherapy Cycle 4 (n=7)
- description
- EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. A regression equation defines a utility value for these health states to generate an index score. The possible values for index score range from -0.594 (severe problems in all 5 dimensions) to 1 (no problem in all dimensions) on a scale where 1 represents the best possible health state. The EQ-5D Visual Analog Scale (VAS) is used to record a participant's rating for his/her current health-related quality of life state on the day of questionnaire administration and is captured on a scale of 0 (worst imaginable health state) to 100 (best imaginable health state).
- dispersion Type
- Standard Deviation
- groups
- description
- Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.
Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.
Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.
Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.
- id
- OG000
- title
- Cetuximab + Pemetrexed + Carboplatin/Cisplatin
- param Type
- MEAN
- population Description
- All treated participants who completed the EQ-5D-3L and VAS at baseline and in Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4. Exclude those from a noncompliant study site.
- reporting Status
- POSTED
- time Frame
- Baseline, Day 1 of Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4 (21-day cycle)
- title
- Change From Baseline in Participant-Reported European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L)
- type
- SECONDARY
- unit Of Measure
- units on a scale
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Preserved source evidence · Not medical advice
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