Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Items (EORTC QLQ-C30)
AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer · Source last updated 2026-04-21
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
LEAST_SQUARES_MEAN
Unit
Unit on scale
Interval / dispersion
95% Confidence Interval
Time frame
Questionnaires completed at baseline, first 9 months, and at week 6, 12, 18, 24, 30, and 36.
What was measured
The EORTC QLQ-C30 cancer-specific questionnaire consisted of 30 questions, combined to produce 5 functional scales, 3 symptom scales, 6 individual items, and a global measure of health status/QoL. An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items, the functional scales, and the global health status/QoL scale in the EORTC QLQ-C30. Higher scores on the global health status and functioning scales indicated better health status/function. Higher scores on the symptoms scales indicated greater symptom burden. The analysis was performed using a Mixed-effects model for repeated measures analysis on the change from baseline in PRO symptom score at each visit up to 9 months (281 days), including participants, treatment, visit and treatment by visit interaction as explanatory variables, the baseline PRO score as a covariate along with the baseline PRO score by visit interaction, using an unstructured covariance structure.
Analysis population: The full analysis set (FAS) and China-only FAS. FAS included all randomized participants prior to the end of global recruitment. The China-only FAS included all China participants randomized in mainland-China as part of the global study and all additional China participants recruited in mainland China after global recruitment was completed.
Groups in this outcome
Osimertinib 80 mg (Global Cohort)
Randomized participants received Osimertinib 80 mg orally once daily (QD)
SoC EGFR-TKI (Global Cohort)
Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.
Osimertinib 80 mg (China Cohort)
Randomized participants received Osimertinib 80 mg orally once daily (QD)
SoC EGFR-TKI (China Cohort)
Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFRTKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.
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
Osimertinib 80 mg (Global Cohort)
279
SoC EGFR-TKI (Global Cohort)
277
Osimertinib 80 mg (China Cohort)
71
SoC EGFR-TKI (China Cohort)
65
Reported measurements
Fatigue, First 9 months
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
252
SoC EGFR-TKI (Global Cohort)
247
Osimertinib 80 mg (China Cohort)
68
SoC EGFR-TKI (China Cohort)
63
Values in Unit on scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Osimertinib 80 mg (Global Cohort)
-5.48
Not reported
-7.45
-3.52
Not reported
SoC EGFR-TKI (Global Cohort)
-4.72
Not reported
-6.74
-2.69
Not reported
Osimertinib 80 mg (China Cohort)
-5.65
Not reported
-9.33
-1.98
Not reported
SoC EGFR-TKI (China Cohort)
-5.79
Not reported
-9.58
-2.00
Not reported
Fatigue, week 6
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
239
SoC EGFR-TKI (Global Cohort)
236
Osimertinib 80 mg (China Cohort)
68
SoC EGFR-TKI (China Cohort)
63
Values in Unit on scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Osimertinib 80 mg (Global Cohort)
-4.13
Not reported
-6.35
-1.91
Not reported
SoC EGFR-TKI (Global Cohort)
-5.78
Not reported
-8.02
-3.54
Not reported
Osimertinib 80 mg (China Cohort)
-1.73
Not reported
-6.05
2.58
Not reported
SoC EGFR-TKI (China Cohort)
-6.81
Not reported
-11.30
-2.33
Not reported
Fatigue, week 12
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
237
SoC EGFR-TKI (Global Cohort)
210
Osimertinib 80 mg (China Cohort)
65
SoC EGFR-TKI (China Cohort)
61
Values in Unit on scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Osimertinib 80 mg (Global Cohort)
-5.11
Not reported
-7.31
-2.91
Not reported
SoC EGFR-TKI (Global Cohort)
-6.52
Not reported
-8.81
-4.23
Not reported
Osimertinib 80 mg (China Cohort)
-5.40
Not reported
-9.51
-1.29
Not reported
SoC EGFR-TKI (China Cohort)
-6.36
Not reported
-10.61
-2.12
Not reported
Fatigue, week 18
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
229
SoC EGFR-TKI (Global Cohort)
214
Osimertinib 80 mg (China Cohort)
61
SoC EGFR-TKI (China Cohort)
60
Values in Unit on scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Osimertinib 80 mg (Global Cohort)
-6.83
Not reported
-9.21
-4.44
Not reported
SoC EGFR-TKI (Global Cohort)
-5.77
Not reported
-8.23
-3.31
Not reported
Osimertinib 80 mg (China Cohort)
-6.64
Not reported
-11.26
-2.03
Not reported
SoC EGFR-TKI (China Cohort)
-7.90
Not reported
-12.61
-3.19
Not reported
Fatigue, week 24
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
216
SoC EGFR-TKI (Global Cohort)
195
Osimertinib 80 mg (China Cohort)
57
SoC EGFR-TKI (China Cohort)
57
Values in Unit on scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Osimertinib 80 mg (Global Cohort)
-6.18
Not reported
-8.75
-3.61
Not reported
SoC EGFR-TKI (Global Cohort)
-4.96
Not reported
-7.63
-2.28
Not reported
Osimertinib 80 mg (China Cohort)
-8.92
Not reported
-13.30
-4.54
Not reported
SoC EGFR-TKI (China Cohort)
-3.87
Not reported
-8.32
0.58
Not reported
Fatigue, week 30
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
207
SoC EGFR-TKI (Global Cohort)
178
Osimertinib 80 mg (China Cohort)
57
SoC EGFR-TKI (China Cohort)
56
Values in Unit on scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Osimertinib 80 mg (Global Cohort)
-5.19
Not reported
-7.94
-2.43
Not reported
SoC EGFR-TKI (Global Cohort)
-3.26
Not reported
-6.16
-0.35
Not reported
Osimertinib 80 mg (China Cohort)
-4.43
Not reported
-9.53
0.68
Not reported
SoC EGFR-TKI (China Cohort)
-6.31
Not reported
-11.53
-1.10
Not reported
Fatigue, week 36
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
193
SoC EGFR-TKI (Global Cohort)
158
Osimertinib 80 mg (China Cohort)
55
SoC EGFR-TKI (China Cohort)
50
Values in Unit on scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Osimertinib 80 mg (Global Cohort)
-5.47
Not reported
-8.31
-2.63
Not reported
SoC EGFR-TKI (Global Cohort)
-2.00
Not reported
-2.00
1.04
Not reported
Osimertinib 80 mg (China Cohort)
-6.78
Not reported
-12.38
-1.19
Not reported
SoC EGFR-TKI (China Cohort)
-3.46
Not reported
-9.28
2.36
Not reported
Appetite Loss, First 9 months
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
252
SoC EGFR-TKI (Global Cohort)
247
Osimertinib 80 mg (China Cohort)
68
SoC EGFR-TKI (China Cohort)
63
Values in Unit on scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Osimertinib 80 mg (Global Cohort)
-6.15
Not reported
-8.39
-3.90
Not reported
SoC EGFR-TKI (Global Cohort)
-5.64
Not reported
-7.96
-3.32
Not reported
Osimertinib 80 mg (China Cohort)
1.18
Not reported
-2.78
5.14
Not reported
SoC EGFR-TKI (China Cohort)
-1.73
Not reported
-5.80
2.34
Not reported
Appetite Loss, week 6
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
239
SoC EGFR-TKI (Global Cohort)
236
Osimertinib 80 mg (China Cohort)
68
SoC EGFR-TKI (China Cohort)
63
Values in Unit on scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Osimertinib 80 mg (Global Cohort)
-4.54
Not reported
-7.36
-1.72
Not reported
SoC EGFR-TKI (Global Cohort)
-5.67
Not reported
-8.52
-2.83
Not reported
Osimertinib 80 mg (China Cohort)
3.20
Not reported
-1.60
8.01
Not reported
SoC EGFR-TKI (China Cohort)
-6.27
Not reported
-11.26
-1.27
Not reported
Appetite Loss, week 12
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
237
SoC EGFR-TKI (Global Cohort)
210
Osimertinib 80 mg (China Cohort)
65
SoC EGFR-TKI (China Cohort)
61
Values in Unit on scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Osimertinib 80 mg (Global Cohort)
-6.52
Not reported
-9.43
-3.62
Not reported
SoC EGFR-TKI (Global Cohort)
-6.95
Not reported
-9.98
-3.91
Not reported
Osimertinib 80 mg (China Cohort)
1.58
Not reported
-3.23
6.39
Not reported
SoC EGFR-TKI (China Cohort)
-1.44
Not reported
-6.41
3.53
Not reported
Appetite Loss, week 18
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
229
SoC EGFR-TKI (Global Cohort)
214
Osimertinib 80 mg (China Cohort)
61
SoC EGFR-TKI (China Cohort)
60
Values in Unit on scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Osimertinib 80 mg (Global Cohort)
-7.27
Not reported
-10.09
-4.45
Not reported
SoC EGFR-TKI (Global Cohort)
-6.84
Not reported
-9.75
-3.92
Not reported
Osimertinib 80 mg (China Cohort)
1.42
Not reported
-4.38
7.22
Not reported
SoC EGFR-TKI (China Cohort)
-4.43
Not reported
-10.35
1.48
Not reported
Appetite Loss, week 24
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
216
SoC EGFR-TKI (Global Cohort)
195
Osimertinib 80 mg (China Cohort)
57
SoC EGFR-TKI (China Cohort)
57
Values in Unit on scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Osimertinib 80 mg (Global Cohort)
-7.14
Not reported
-10.27
-4.01
Not reported
SoC EGFR-TKI (Global Cohort)
-5.08
Not reported
-8.35
-1.81
Not reported
Osimertinib 80 mg (China Cohort)
-2.26
Not reported
-7.74
3.22
Not reported
SoC EGFR-TKI (China Cohort)
0.24
Not reported
-5.29
5.78
Not reported
Appetite Loss, week 30
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
207
SoC EGFR-TKI (Global Cohort)
178
Osimertinib 80 mg (China Cohort)
57
SoC EGFR-TKI (China Cohort)
56
Values in Unit on scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Osimertinib 80 mg (Global Cohort)
-4.50
Not reported
-7.74
-1.26
Not reported
SoC EGFR-TKI (Global Cohort)
-4.17
Not reported
-7.60
-0.74
Not reported
Osimertinib 80 mg (China Cohort)
2.19
Not reported
-3.28
7.65
Not reported
SoC EGFR-TKI (China Cohort)
-1.83
Not reported
-7.36
3.70
Not reported
Appetite Loss, week 36
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
193
SoC EGFR-TKI (Global Cohort)
158
Osimertinib 80 mg (China Cohort)
55
SoC EGFR-TKI (China Cohort)
50
Values in Unit on scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Osimertinib 80 mg (Global Cohort)
-6.90
Not reported
-10.00
-3.81
Not reported
SoC EGFR-TKI (Global Cohort)
-5.15
Not reported
-8.49
-1.81
Not reported
Osimertinib 80 mg (China Cohort)
0.98
Not reported
-5.28
7.24
Not reported
SoC EGFR-TKI (China Cohort)
3.36
Not reported
-3.15
9.86
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
lower Limit
-7.45
upper Limit
-3.52
value
-5.48
group Id
OG001
lower Limit
-6.74
upper Limit
-2.69
value
-4.72
group Id
OG002
lower Limit
-9.33
upper Limit
-1.98
value
-5.65
group Id
OG003
lower Limit
-9.58
upper Limit
-2.00
value
-5.79
denoms
counts
group Id
OG000
value
252
group Id
OG001
value
247
group Id
OG002
value
68
group Id
OG003
value
63
units
Participants
title
Fatigue, First 9 months
categories
measurements
group Id
OG000
lower Limit
-6.35
upper Limit
-1.91
value
-4.13
group Id
OG001
lower Limit
-8.02
upper Limit
-3.54
value
-5.78
group Id
OG002
lower Limit
-6.05
upper Limit
2.58
value
-1.73
group Id
OG003
lower Limit
-11.30
upper Limit
-2.33
value
-6.81
denoms
counts
group Id
OG000
value
239
group Id
OG001
value
236
group Id
OG002
value
68
group Id
OG003
value
63
units
Participants
title
Fatigue, week 6
categories
measurements
group Id
OG000
lower Limit
-7.31
upper Limit
-2.91
value
-5.11
group Id
OG001
lower Limit
-8.81
upper Limit
-4.23
value
-6.52
group Id
OG002
lower Limit
-9.51
upper Limit
-1.29
value
-5.40
group Id
OG003
lower Limit
-10.61
upper Limit
-2.12
value
-6.36
denoms
counts
group Id
OG000
value
237
group Id
OG001
value
210
group Id
OG002
value
65
group Id
OG003
value
61
units
Participants
title
Fatigue, week 12
categories
measurements
group Id
OG000
lower Limit
-9.21
upper Limit
-4.44
value
-6.83
group Id
OG001
lower Limit
-8.23
upper Limit
-3.31
value
-5.77
group Id
OG002
lower Limit
-11.26
upper Limit
-2.03
value
-6.64
group Id
OG003
lower Limit
-12.61
upper Limit
-3.19
value
-7.90
denoms
counts
group Id
OG000
value
229
group Id
OG001
value
214
group Id
OG002
value
61
group Id
OG003
value
60
units
Participants
title
Fatigue, week 18
categories
measurements
group Id
OG000
lower Limit
-8.75
upper Limit
-3.61
value
-6.18
group Id
OG001
lower Limit
-7.63
upper Limit
-2.28
value
-4.96
group Id
OG002
lower Limit
-13.30
upper Limit
-4.54
value
-8.92
group Id
OG003
lower Limit
-8.32
upper Limit
0.58
value
-3.87
denoms
counts
group Id
OG000
value
216
group Id
OG001
value
195
group Id
OG002
value
57
group Id
OG003
value
57
units
Participants
title
Fatigue, week 24
categories
measurements
group Id
OG000
lower Limit
-7.94
upper Limit
-2.43
value
-5.19
group Id
OG001
lower Limit
-6.16
upper Limit
-0.35
value
-3.26
group Id
OG002
lower Limit
-9.53
upper Limit
0.68
value
-4.43
group Id
OG003
lower Limit
-11.53
upper Limit
-1.10
value
-6.31
denoms
counts
group Id
OG000
value
207
group Id
OG001
value
178
group Id
OG002
value
57
group Id
OG003
value
56
units
Participants
title
Fatigue, week 30
categories
measurements
group Id
OG000
lower Limit
-8.31
upper Limit
-2.63
value
-5.47
group Id
OG001
lower Limit
-2.00
upper Limit
1.04
value
-2.00
group Id
OG002
lower Limit
-12.38
upper Limit
-1.19
value
-6.78
group Id
OG003
lower Limit
-9.28
upper Limit
2.36
value
-3.46
denoms
counts
group Id
OG000
value
193
group Id
OG001
value
158
group Id
OG002
value
55
group Id
OG003
value
50
units
Participants
title
Fatigue, week 36
categories
measurements
group Id
OG000
lower Limit
-8.39
upper Limit
-3.90
value
-6.15
group Id
OG001
lower Limit
-7.96
upper Limit
-3.32
value
-5.64
group Id
OG002
lower Limit
-2.78
upper Limit
5.14
value
1.18
group Id
OG003
lower Limit
-5.80
upper Limit
2.34
value
-1.73
denoms
counts
group Id
OG000
value
252
group Id
OG001
value
247
group Id
OG002
value
68
group Id
OG003
value
63
units
Participants
title
Appetite Loss, First 9 months
categories
measurements
group Id
OG000
lower Limit
-7.36
upper Limit
-1.72
value
-4.54
group Id
OG001
lower Limit
-8.52
upper Limit
-2.83
value
-5.67
group Id
OG002
lower Limit
-1.60
upper Limit
8.01
value
3.20
group Id
OG003
lower Limit
-11.26
upper Limit
-1.27
value
-6.27
denoms
counts
group Id
OG000
value
239
group Id
OG001
value
236
group Id
OG002
value
68
group Id
OG003
value
63
units
Participants
title
Appetite Loss, week 6
categories
measurements
group Id
OG000
lower Limit
-9.43
upper Limit
-3.62
value
-6.52
group Id
OG001
lower Limit
-9.98
upper Limit
-3.91
value
-6.95
group Id
OG002
lower Limit
-3.23
upper Limit
6.39
value
1.58
group Id
OG003
lower Limit
-6.41
upper Limit
3.53
value
-1.44
denoms
counts
group Id
OG000
value
237
group Id
OG001
value
210
group Id
OG002
value
65
group Id
OG003
value
61
units
Participants
title
Appetite Loss, week 12
categories
measurements
group Id
OG000
lower Limit
-10.09
upper Limit
-4.45
value
-7.27
group Id
OG001
lower Limit
-9.75
upper Limit
-3.92
value
-6.84
group Id
OG002
lower Limit
-4.38
upper Limit
7.22
value
1.42
group Id
OG003
lower Limit
-10.35
upper Limit
1.48
value
-4.43
denoms
counts
group Id
OG000
value
229
group Id
OG001
value
214
group Id
OG002
value
61
group Id
OG003
value
60
units
Participants
title
Appetite Loss, week 18
categories
measurements
group Id
OG000
lower Limit
-10.27
upper Limit
-4.01
value
-7.14
group Id
OG001
lower Limit
-8.35
upper Limit
-1.81
value
-5.08
group Id
OG002
lower Limit
-7.74
upper Limit
3.22
value
-2.26
group Id
OG003
lower Limit
-5.29
upper Limit
5.78
value
0.24
denoms
counts
group Id
OG000
value
216
group Id
OG001
value
195
group Id
OG002
value
57
group Id
OG003
value
57
units
Participants
title
Appetite Loss, week 24
denoms
counts
group Id
OG000
value
279
group Id
OG001
value
277
group Id
OG002
value
71
group Id
OG003
value
65
units
Participants
description
The EORTC QLQ-C30 cancer-specific questionnaire consisted of 30 questions, combined to produce 5 functional scales, 3 symptom scales, 6 individual items, and a global measure of health status/QoL. An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items, the functional scales, and the global health status/QoL scale in the EORTC QLQ-C30. Higher scores on the global health status and functioning scales indicated better health status/function. Higher scores on the symptoms scales indicated greater symptom burden. The analysis was performed using a Mixed-effects model for repeated measures analysis on the change from baseline in PRO symptom score at each visit up to 9 months (281 days), including participants, treatment, visit and treatment by visit interaction as explanatory variables, the baseline PRO score as a covariate along with the baseline PRO score by visit interaction, using an unstructured covariance structure.
dispersion Type
95% Confidence Interval
groups
description
Randomized participants received Osimertinib 80 mg orally once daily (QD)
id
OG000
title
Osimertinib 80 mg (Global Cohort)
description
Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.
id
OG001
title
SoC EGFR-TKI (Global Cohort)
description
Randomized participants received Osimertinib 80 mg orally once daily (QD)
id
OG002
title
Osimertinib 80 mg (China Cohort)
description
Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFRTKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.
id
OG003
title
SoC EGFR-TKI (China Cohort)
param Type
LEAST_SQUARES_MEAN
population Description
The full analysis set (FAS) and China-only FAS. FAS included all randomized participants prior to the end of global recruitment. The China-only FAS included all China participants randomized in mainland-China as part of the global study and all additional China participants recruited in mainland China after global recruitment was completed.
reporting Status
POSTED
time Frame
Questionnaires completed at baseline, first 9 months, and at week 6, 12, 18, 24, 30, and 36.
title
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Items (EORTC QLQ-C30)