Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ) Questionnaires Lung Cancer 13 (QLQ-LC13)
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 1, 2, 3, 4, 5, 6, 12, 18, 24, 30 and 36
What was measured
The EORTC QLQ-LC13 was a lung-cancer-specific module comprising 13 questions to assess lung cancer symptoms (cough, haemoptysis, dyspnoea, and site-specific pain); treatment related side-effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia); and pain medication. An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items. Higher scores on the global health status/QoL and functioning scales indicated better health status/QoL and 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
Dyspnoea, First 9 months
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
248
SoC EGFR-TKI (Global Cohort)
252
Osimertinib 80 mg (China Cohort)
67
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)
-4.04
Not reported
-5.63
-2.45
Not reported
SoC EGFR-TKI (Global Cohort)
-4.14
Not reported
-5.73
-2.54
Not reported
Osimertinib 80 mg (China Cohort)
-4.87
Not reported
-7.81
-1.92
Not reported
SoC EGFR-TKI (China Cohort)
-4.82
Not reported
-8.01
-1.63
Not reported
Dyspnoea, week 1
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
241
SoC EGFR-TKI (Global Cohort)
246
Osimertinib 80 mg (China Cohort)
67
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)
-3.46
Not reported
-5.12
-1.81
Not reported
SoC EGFR-TKI (Global Cohort)
-3.60
Not reported
-5.24
-1.96
Not reported
Osimertinib 80 mg (China Cohort)
-1.61
Not reported
-5.03
1.81
Not reported
SoC EGFR-TKI (China Cohort)
0.68
Not reported
-3.03
4.39
Not reported
Dyspnoea, week 2
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
236
SoC EGFR-TKI (Global Cohort)
236
Osimertinib 80 mg (China Cohort)
66
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)
-3.94
Not reported
-5.87
-2.00
Not reported
SoC EGFR-TKI (Global Cohort)
-3.64
Not reported
-5.57
-1.70
Not reported
Osimertinib 80 mg (China Cohort)
-2.27
Not reported
-6.01
1.48
Not reported
SoC EGFR-TKI (China Cohort)
-5.03
Not reported
-9.08
-0.98
Not reported
Dyspnoea, week 3
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
239
SoC EGFR-TKI (Global Cohort)
237
Osimertinib 80 mg (China Cohort)
63
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)
-3.99
Not reported
-5.85
-2.12
Not reported
SoC EGFR-TKI (Global Cohort)
-3.27
Not reported
-5.14
-1.41
Not reported
Osimertinib 80 mg (China Cohort)
-3.09
Not reported
-6.96
0.77
Not reported
SoC EGFR-TKI (China Cohort)
-5.55
Not reported
-9.69
-1.42
Not reported
Dyspnoea, week 4
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
206
SoC EGFR-TKI (Global Cohort)
211
Osimertinib 80 mg (China Cohort)
63
SoC EGFR-TKI (China Cohort)
53
Values in Unit on scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Osimertinib 80 mg (Global Cohort)
-4.81
Not reported
-6.59
-3.02
Not reported
SoC EGFR-TKI (Global Cohort)
-4.11
Not reported
-5.88
-2.34
Not reported
Osimertinib 80 mg (China Cohort)
-5.35
Not reported
-8.72
-1.99
Not reported
SoC EGFR-TKI (China Cohort)
-5.55
Not reported
-9.20
-1.89
Not reported
Dyspnoea, week 5
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
199
SoC EGFR-TKI (Global Cohort)
196
Osimertinib 80 mg (China Cohort)
57
SoC EGFR-TKI (China Cohort)
55
Values in Unit on scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Osimertinib 80 mg (Global Cohort)
-3.51
Not reported
-5.53
-1.50
Not reported
SoC EGFR-TKI (Global Cohort)
-5.19
Not reported
-7.22
-3.17
Not reported
Osimertinib 80 mg (China Cohort)
-5.72
Not reported
-10.06
-1.39
Not reported
SoC EGFR-TKI (China Cohort)
-5.76
Not reported
-10.32
-1.20
Not reported
Dyspnoea, week 6
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
222
SoC EGFR-TKI (Global Cohort)
214
Osimertinib 80 mg (China Cohort)
64
SoC EGFR-TKI (China Cohort)
53
Values in Unit on scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Osimertinib 80 mg (Global Cohort)
-4.51
Not reported
-6.47
-2.56
Not reported
SoC EGFR-TKI (Global Cohort)
-4.45
Not reported
-6.42
-2.48
Not reported
Osimertinib 80 mg (China Cohort)
-4.83
Not reported
-8.53
-1.12
Not reported
SoC EGFR-TKI (China Cohort)
-6.37
Not reported
-10.40
-2.33
Not reported
Dyspnoea, week 12
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
225
SoC EGFR-TKI (Global Cohort)
203
Osimertinib 80 mg (China Cohort)
61
SoC EGFR-TKI (China Cohort)
52
Values in Unit on scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Osimertinib 80 mg (Global Cohort)
-3.83
Not reported
-5.99
-1.68
Not reported
SoC EGFR-TKI (Global Cohort)
-5.75
Not reported
-7.96
-3.54
Not reported
Osimertinib 80 mg (China Cohort)
-5.38
Not reported
-9.41
-1.35
Not reported
SoC EGFR-TKI (China Cohort)
-6.67
Not reported
-11.04
-2.30
Not reported
Dyspnoea, week 18
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
214
SoC EGFR-TKI (Global Cohort)
199
Osimertinib 80 mg (China Cohort)
59
SoC EGFR-TKI (China Cohort)
52
Values in Unit on scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Osimertinib 80 mg (Global Cohort)
-4.97
Not reported
-7.18
-2.76
Not reported
SoC EGFR-TKI (Global Cohort)
-5.21
Not reported
-7.46
-2.95
Not reported
Osimertinib 80 mg (China Cohort)
-7.67
Not reported
-11.54
-3.79
Not reported
SoC EGFR-TKI (China Cohort)
-7.48
Not reported
-11.66
-3.30
Not reported
Dyspnoea, week 24
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
202
SoC EGFR-TKI (Global Cohort)
185
Osimertinib 80 mg (China Cohort)
55
SoC EGFR-TKI (China Cohort)
47
Values in Unit on scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Osimertinib 80 mg (Global Cohort)
-4.65
Not reported
-7.06
-2.25
Not reported
SoC EGFR-TKI (Global Cohort)
-4.56
Not reported
-7.02
-2.09
Not reported
Osimertinib 80 mg (China Cohort)
-7.59
Not reported
-11.84
-3.34
Not reported
SoC EGFR-TKI (China Cohort)
-5.67
Not reported
-10.27
-1.08
Not reported
Dyspnoea, week 30
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
195
SoC EGFR-TKI (Global Cohort)
172
Osimertinib 80 mg (China Cohort)
55
SoC EGFR-TKI (China Cohort)
49
Values in Unit on scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Osimertinib 80 mg (Global Cohort)
-3.89
Not reported
-6.34
-1.45
Not reported
SoC EGFR-TKI (Global Cohort)
-3.68
Not reported
-6.22
-1.15
Not reported
Osimertinib 80 mg (China Cohort)
-5.81
Not reported
-10.59
-1.02
Not reported
SoC EGFR-TKI (China Cohort)
-3.46
Not reported
-8.58
1.65
Not reported
Dyspnoea, week 36
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
184
SoC EGFR-TKI (Global Cohort)
151
Osimertinib 80 mg (China Cohort)
52
SoC EGFR-TKI (China Cohort)
43
Values in Unit on scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Osimertinib 80 mg (Global Cohort)
-2.88
Not reported
-5.52
-0.24
Not reported
SoC EGFR-TKI (Global Cohort)
-2.04
Not reported
-4.83
0.75
Not reported
Osimertinib 80 mg (China Cohort)
-4.21
Not reported
-8.91
0.48
Not reported
SoC EGFR-TKI (China Cohort)
-2.18
Not reported
-7.28
2.93
Not reported
Cough, First 9 months
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
248
SoC EGFR-TKI (Global Cohort)
252
Osimertinib 80 mg (China Cohort)
67
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)
-10.97
Not reported
-12.77
-9.17
Not reported
SoC EGFR-TKI (Global Cohort)
-11.65
Not reported
-13.47
-9.84
Not reported
Osimertinib 80 mg (China Cohort)
-13.75
Not reported
-17.17
-10.33
Not reported
SoC EGFR-TKI (China Cohort)
-8.49
Not reported
-12.19
-4.79
Not reported
Cough, week 1
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
241
SoC EGFR-TKI (Global Cohort)
246
Osimertinib 80 mg (China Cohort)
67
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)
-6.90
Not reported
-9.30
-4.51
Not reported
SoC EGFR-TKI (Global Cohort)
-4.83
Not reported
-7.20
-2.46
Not reported
Osimertinib 80 mg (China Cohort)
-4.60
Not reported
-9.00
-0.20
Not reported
SoC EGFR-TKI (China Cohort)
-3.69
Not reported
-8.46
1.07
Not reported
Cough, week 2
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
236
SoC EGFR-TKI (Global Cohort)
236
Osimertinib 80 mg (China Cohort)
66
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)
-9.04
Not reported
-11.58
-6.49
Not reported
SoC EGFR-TKI (Global Cohort)
-9.52
Not reported
-12.05
-6.98
Not reported
Osimertinib 80 mg (China Cohort)
-12.26
Not reported
-17.15
-7.37
Not reported
SoC EGFR-TKI (China Cohort)
-3.73
Not reported
-9.01
1.54
Not reported
Cough, week 3
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
239
SoC EGFR-TKI (Global Cohort)
237
Osimertinib 80 mg (China Cohort)
63
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)
-9.78
Not reported
-12.37
-7.20
Not reported
SoC EGFR-TKI (Global Cohort)
-10.24
Not reported
-12.82
-7.65
Not reported
Osimertinib 80 mg (China Cohort)
-11.95
Not reported
-16.66
-7.24
Not reported
SoC EGFR-TKI (China Cohort)
-5.56
Not reported
-10.57
-0.54
Not reported
Cough, week 4
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
206
SoC EGFR-TKI (Global Cohort)
211
Osimertinib 80 mg (China Cohort)
63
SoC EGFR-TKI (China Cohort)
53
Values in Unit on scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Osimertinib 80 mg (Global Cohort)
-11.25
Not reported
-13.87
-8.63
Not reported
SoC EGFR-TKI (Global Cohort)
-13.36
Not reported
-15.96
-10.76
Not reported
Osimertinib 80 mg (China Cohort)
-12.78
Not reported
-17.80
-7.77
Not reported
SoC EGFR-TKI (China Cohort)
-10.32
Not reported
-15.75
-4.90
Not reported
Cough, week 5
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
199
SoC EGFR-TKI (Global Cohort)
196
Osimertinib 80 mg (China Cohort)
57
SoC EGFR-TKI (China Cohort)
55
Values in Unit on scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Osimertinib 80 mg (Global Cohort)
-12.98
Not reported
-15.64
-10.31
Not reported
SoC EGFR-TKI (Global Cohort)
-13.55
Not reported
-16.21
-10.88
Not reported
Osimertinib 80 mg (China Cohort)
-17.74
Not reported
-23.11
-12.38
Not reported
SoC EGFR-TKI (China Cohort)
-9.20
Not reported
-14.84
-3.55
Not reported
Cough, week 6
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
222
SoC EGFR-TKI (Global Cohort)
214
Osimertinib 80 mg (China Cohort)
64
SoC EGFR-TKI (China Cohort)
53
Values in Unit on scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Osimertinib 80 mg (Global Cohort)
-11.88
Not reported
-14.56
-9.19
Not reported
SoC EGFR-TKI (Global Cohort)
-11.92
Not reported
-14.63
-9.21
Not reported
Osimertinib 80 mg (China Cohort)
-16.92
Not reported
-22.36
-11.48
Not reported
SoC EGFR-TKI (China Cohort)
-10.58
Not reported
-16.52
-4.64
Not reported
Cough, week 12
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
225
SoC EGFR-TKI (Global Cohort)
203
Osimertinib 80 mg (China Cohort)
61
SoC EGFR-TKI (China Cohort)
52
Values in Unit on scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Osimertinib 80 mg (Global Cohort)
-13.36
Not reported
-15.95
-10.78
Not reported
SoC EGFR-TKI (Global Cohort)
-13.57
Not reported
-16.24
-10.90
Not reported
Osimertinib 80 mg (China Cohort)
-15.51
Not reported
-21.39
-9.64
Not reported
SoC EGFR-TKI (China Cohort)
-8.04
Not reported
-14.41
-1.67
Not reported
Cough, week 18
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
214
SoC EGFR-TKI (Global Cohort)
199
Osimertinib 80 mg (China Cohort)
59
SoC EGFR-TKI (China Cohort)
52
Values in Unit on scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Osimertinib 80 mg (Global Cohort)
-12.31
Not reported
-15.25
-9.37
Not reported
SoC EGFR-TKI (Global Cohort)
-11.00
Not reported
-14.03
-7.98
Not reported
Osimertinib 80 mg (China Cohort)
-11.79
Not reported
-17.19
-6.40
Not reported
SoC EGFR-TKI (China Cohort)
-9.44
Not reported
-15.23
-3.65
Not reported
Cough, week 24
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
202
SoC EGFR-TKI (Global Cohort)
185
Osimertinib 80 mg (China Cohort)
55
SoC EGFR-TKI (China Cohort)
47
Values in Unit on scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Osimertinib 80 mg (Global Cohort)
-11.34
Not reported
-14.24
-8.43
Not reported
SoC EGFR-TKI (Global Cohort)
-13.16
Not reported
-16.17
-10.14
Not reported
Osimertinib 80 mg (China Cohort)
-17.61
Not reported
-22.84
-12.39
Not reported
SoC EGFR-TKI (China Cohort)
-14.92
Not reported
-20.56
-9.29
Not reported
Cough, week 30
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
195
SoC EGFR-TKI (Global Cohort)
172
Osimertinib 80 mg (China Cohort)
55
SoC EGFR-TKI (China Cohort)
49
Values in Unit on scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Osimertinib 80 mg (Global Cohort)
-10.34
Not reported
-13.21
-7.46
Not reported
SoC EGFR-TKI (Global Cohort)
-12.43
Not reported
-15.44
-9.41
Not reported
Osimertinib 80 mg (China Cohort)
-15.45
Not reported
-21.46
-9.45
Not reported
SoC EGFR-TKI (China Cohort)
-9.35
Not reported
-15.75
-2.94
Not reported
Cough, week 36
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
184
SoC EGFR-TKI (Global Cohort)
151
Osimertinib 80 mg (China Cohort)
52
SoC EGFR-TKI (China Cohort)
43
Values in Unit on scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Osimertinib 80 mg (Global Cohort)
-11.49
Not reported
-14.48
-8.49
Not reported
SoC EGFR-TKI (Global Cohort)
-14.62
Not reported
-17.85
-11.39
Not reported
Osimertinib 80 mg (China Cohort)
-14.62
Not reported
-20.65
-8.58
Not reported
SoC EGFR-TKI (China Cohort)
-8.55
Not reported
-15.14
-1.96
Not reported
Pain in Chest, First 9 months
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
248
SoC EGFR-TKI (Global Cohort)
252
Osimertinib 80 mg (China Cohort)
67
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)
-6.62
Not reported
-8.24
-5.01
Not reported
SoC EGFR-TKI (Global Cohort)
-6.41
Not reported
-8.04
-4.78
Not reported
Osimertinib 80 mg (China Cohort)
-2.79
Not reported
-5.84
0.26
Not reported
SoC EGFR-TKI (China Cohort)
-4.74
Not reported
-8.05
-1.44
Not reported
Pain in Chest, week 1
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
241
SoC EGFR-TKI (Global Cohort)
246
Osimertinib 80 mg (China Cohort)
67
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)
-1.93
Not reported
-4.19
0.32
Not reported
SoC EGFR-TKI (Global Cohort)
-4.26
Not reported
-6.50
-2.03
Not reported
Osimertinib 80 mg (China Cohort)
-1.79
Not reported
-5.98
2.40
Not reported
SoC EGFR-TKI (China Cohort)
-4.16
Not reported
-8.71
0.38
Not reported
Pain in Chest, week 2
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
236
SoC EGFR-TKI (Global Cohort)
236
Osimertinib 80 mg (China Cohort)
66
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)
-5.94
Not reported
-8.13
-3.74
Not reported
SoC EGFR-TKI (Global Cohort)
-6.32
Not reported
-8.51
-4.13
Not reported
Osimertinib 80 mg (China Cohort)
-4.76
Not reported
-8.63
-0.89
Not reported
SoC EGFR-TKI (China Cohort)
-3.00
Not reported
-7.18
1.17
Not reported
Pain in Chest, week 3
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
239
SoC EGFR-TKI (Global Cohort)
237
Osimertinib 80 mg (China Cohort)
63
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)
-7.17
Not reported
-9.31
-5.04
Not reported
SoC EGFR-TKI (Global Cohort)
-5.36
Not reported
-7.49
-3.23
Not reported
Osimertinib 80 mg (China Cohort)
-0.76
Not reported
-4.90
3.39
Not reported
SoC EGFR-TKI (China Cohort)
-4.77
Not reported
-9.18
-0.36
Not reported
Pain in Chest, week 4
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
206
SoC EGFR-TKI (Global Cohort)
211
Osimertinib 80 mg (China Cohort)
63
SoC EGFR-TKI (China Cohort)
53
Values in Unit on scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Osimertinib 80 mg (Global Cohort)
-7.45
Not reported
-9.60
-5.29
Not reported
SoC EGFR-TKI (Global Cohort)
-6.40
Not reported
-8.54
-4.26
Not reported
Osimertinib 80 mg (China Cohort)
-2.13
Not reported
-6.32
2.07
Not reported
SoC EGFR-TKI (China Cohort)
-4.22
Not reported
-8.78
0.34
Not reported
Pain in Chest, week 5
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
199
SoC EGFR-TKI (Global Cohort)
196
Osimertinib 80 mg (China Cohort)
57
SoC EGFR-TKI (China Cohort)
55
Values in Unit on scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Osimertinib 80 mg (Global Cohort)
-7.33
Not reported
-9.54
-5.11
Not reported
SoC EGFR-TKI (Global Cohort)
-6.98
Not reported
-9.20
-4.76
Not reported
Osimertinib 80 mg (China Cohort)
-0.62
Not reported
-4.67
3.42
Not reported
SoC EGFR-TKI (China Cohort)
-6.82
Not reported
-11.05
-2.60
Not reported
Pain in Chest, week 6
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
222
SoC EGFR-TKI (Global Cohort)
214
Osimertinib 80 mg (China Cohort)
64
SoC EGFR-TKI (China Cohort)
53
Values in Unit on scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Osimertinib 80 mg (Global Cohort)
-4.99
Not reported
-7.30
-2.68
Not reported
SoC EGFR-TKI (Global Cohort)
-7.08
Not reported
-9.41
-4.75
Not reported
Osimertinib 80 mg (China Cohort)
0.94
Not reported
-3.40
5.29
Not reported
SoC EGFR-TKI (China Cohort)
-6.26
Not reported
-11.00
-1.52
Not reported
Pain in Chest, week 12
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
225
SoC EGFR-TKI (Global Cohort)
203
Osimertinib 80 mg (China Cohort)
61
SoC EGFR-TKI (China Cohort)
52
Values in Unit on scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Osimertinib 80 mg (Global Cohort)
-7.28
Not reported
-9.56
-5.01
Not reported
SoC EGFR-TKI (Global Cohort)
-6.70
Not reported
-9.05
-4.35
Not reported
Osimertinib 80 mg (China Cohort)
-3.71
Not reported
-8.77
1.35
Not reported
SoC EGFR-TKI (China Cohort)
-5.13
Not reported
-10.62
0.36
Not reported
Pain in Chest, week 18
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
214
SoC EGFR-TKI (Global Cohort)
199
Osimertinib 80 mg (China Cohort)
59
SoC EGFR-TKI (China Cohort)
52
Values in Unit on scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Osimertinib 80 mg (Global Cohort)
-6.79
Not reported
-9.22
-4.36
Not reported
SoC EGFR-TKI (Global Cohort)
-7.90
Not reported
-10.40
-5.41
Not reported
Osimertinib 80 mg (China Cohort)
-4.40
Not reported
-9.05
0.26
Not reported
SoC EGFR-TKI (China Cohort)
-7.24
Not reported
-12.23
-2.25
Not reported
Pain in Chest, week 24
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
202
SoC EGFR-TKI (Global Cohort)
185
Osimertinib 80 mg (China Cohort)
55
SoC EGFR-TKI (China Cohort)
47
Values in Unit on scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Osimertinib 80 mg (Global Cohort)
-7.72
Not reported
-10.26
-5.18
Not reported
SoC EGFR-TKI (Global Cohort)
-7.34
Not reported
-9.95
-4.72
Not reported
Osimertinib 80 mg (China Cohort)
-5.66
Not reported
-10.48
-0.84
Not reported
SoC EGFR-TKI (China Cohort)
-3.15
Not reported
-8.36
2.07
Not reported
Pain in Chest, week 30
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
195
SoC EGFR-TKI (Global Cohort)
172
Osimertinib 80 mg (China Cohort)
55
SoC EGFR-TKI (China Cohort)
49
Values in Unit on scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Osimertinib 80 mg (Global Cohort)
-8.33
Not reported
-10.80
-5.87
Not reported
SoC EGFR-TKI (Global Cohort)
-6.60
Not reported
-9.18
-4.02
Not reported
Osimertinib 80 mg (China Cohort)
-4.25
Not reported
-9.62
1.12
Not reported
SoC EGFR-TKI (China Cohort)
-4.02
Not reported
-9.76
1.72
Not reported
Pain in Chest, week 36
Analysis denominator · Participants
Group
Source count
Osimertinib 80 mg (Global Cohort)
184
SoC EGFR-TKI (Global Cohort)
151
Osimertinib 80 mg (China Cohort)
52
SoC EGFR-TKI (China Cohort)
43
Values in Unit on scale · Interval/dispersion: 95% Confidence Interval
Group
Value
Spread
Lower
Upper
Comment
Osimertinib 80 mg (Global Cohort)
-7.94
Not reported
-10.59
-5.30
Not reported
SoC EGFR-TKI (Global Cohort)
-5.58
Not reported
-8.43
-2.73
Not reported
Osimertinib 80 mg (China Cohort)
-3.56
Not reported
-9.42
2.30
Not reported
SoC EGFR-TKI (China Cohort)
-3.40
Not reported
-9.80
3.00
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
lower Limit
-5.63
upper Limit
-2.45
value
-4.04
group Id
OG001
lower Limit
-5.73
upper Limit
-2.54
value
-4.14
group Id
OG002
lower Limit
-7.81
upper Limit
-1.92
value
-4.87
group Id
OG003
lower Limit
-8.01
upper Limit
-1.63
value
-4.82
denoms
counts
group Id
OG000
value
248
group Id
OG001
value
252
group Id
OG002
value
67
group Id
OG003
value
57
units
Participants
title
Dyspnoea, First 9 months
categories
measurements
group Id
OG000
lower Limit
-5.12
upper Limit
-1.81
value
-3.46
group Id
OG001
lower Limit
-5.24
upper Limit
-1.96
value
-3.60
group Id
OG002
lower Limit
-5.03
upper Limit
1.81
value
-1.61
group Id
OG003
lower Limit
-3.03
upper Limit
4.39
value
0.68
denoms
counts
group Id
OG000
value
241
group Id
OG001
value
246
group Id
OG002
value
67
group Id
OG003
value
57
units
Participants
title
Dyspnoea, week 1
categories
measurements
group Id
OG000
lower Limit
-5.87
upper Limit
-2.00
value
-3.94
group Id
OG001
lower Limit
-5.57
upper Limit
-1.70
value
-3.64
group Id
OG002
lower Limit
-6.01
upper Limit
1.48
value
-2.27
group Id
OG003
lower Limit
-9.08
upper Limit
-0.98
value
-5.03
denoms
counts
group Id
OG000
value
236
group Id
OG001
value
236
group Id
OG002
value
66
group Id
OG003
value
57
units
Participants
title
Dyspnoea, week 2
categories
measurements
group Id
OG000
lower Limit
-5.85
upper Limit
-2.12
value
-3.99
group Id
OG001
lower Limit
-5.14
upper Limit
-1.41
value
-3.27
group Id
OG002
lower Limit
-6.96
upper Limit
0.77
value
-3.09
group Id
OG003
lower Limit
-9.69
upper Limit
-1.42
value
-5.55
denoms
counts
group Id
OG000
value
239
group Id
OG001
value
237
group Id
OG002
value
63
group Id
OG003
value
57
units
Participants
title
Dyspnoea, week 3
categories
measurements
group Id
OG000
lower Limit
-6.59
upper Limit
-3.02
value
-4.81
group Id
OG001
lower Limit
-5.88
upper Limit
-2.34
value
-4.11
group Id
OG002
lower Limit
-8.72
upper Limit
-1.99
value
-5.35
group Id
OG003
lower Limit
-9.20
upper Limit
-1.89
value
-5.55
denoms
counts
group Id
OG000
value
206
group Id
OG001
value
211
group Id
OG002
value
63
group Id
OG003
value
53
units
Participants
title
Dyspnoea, week 4
categories
measurements
group Id
OG000
lower Limit
-5.53
upper Limit
-1.50
value
-3.51
group Id
OG001
lower Limit
-7.22
upper Limit
-3.17
value
-5.19
group Id
OG002
lower Limit
-10.06
upper Limit
-1.39
value
-5.72
group Id
OG003
lower Limit
-10.32
upper Limit
-1.20
value
-5.76
denoms
counts
group Id
OG000
value
199
group Id
OG001
value
196
group Id
OG002
value
57
group Id
OG003
value
55
units
Participants
title
Dyspnoea, week 5
categories
measurements
group Id
OG000
lower Limit
-6.47
upper Limit
-2.56
value
-4.51
group Id
OG001
lower Limit
-6.42
upper Limit
-2.48
value
-4.45
group Id
OG002
lower Limit
-8.53
upper Limit
-1.12
value
-4.83
group Id
OG003
lower Limit
-10.40
upper Limit
-2.33
value
-6.37
denoms
counts
group Id
OG000
value
222
group Id
OG001
value
214
group Id
OG002
value
64
group Id
OG003
value
53
units
Participants
title
Dyspnoea, week 6
categories
measurements
group Id
OG000
lower Limit
-5.99
upper Limit
-1.68
value
-3.83
group Id
OG001
lower Limit
-7.96
upper Limit
-3.54
value
-5.75
group Id
OG002
lower Limit
-9.41
upper Limit
-1.35
value
-5.38
group Id
OG003
lower Limit
-11.04
upper Limit
-2.30
value
-6.67
denoms
counts
group Id
OG000
value
225
group Id
OG001
value
203
group Id
OG002
value
61
group Id
OG003
value
52
units
Participants
title
Dyspnoea, week 12
categories
measurements
group Id
OG000
lower Limit
-7.18
upper Limit
-2.76
value
-4.97
group Id
OG001
lower Limit
-7.46
upper Limit
-2.95
value
-5.21
group Id
OG002
lower Limit
-11.54
upper Limit
-3.79
value
-7.67
group Id
OG003
lower Limit
-11.66
upper Limit
-3.30
value
-7.48
denoms
counts
group Id
OG000
value
214
group Id
OG001
value
199
group Id
OG002
value
59
group Id
OG003
value
52
units
Participants
title
Dyspnoea, week 18
categories
measurements
group Id
OG000
lower Limit
-7.06
upper Limit
-2.25
value
-4.65
group Id
OG001
lower Limit
-7.02
upper Limit
-2.09
value
-4.56
group Id
OG002
lower Limit
-11.84
upper Limit
-3.34
value
-7.59
group Id
OG003
lower Limit
-10.27
upper Limit
-1.08
value
-5.67
denoms
counts
group Id
OG000
value
202
group Id
OG001
value
185
group Id
OG002
value
55
group Id
OG003
value
47
units
Participants
title
Dyspnoea, week 24
categories
measurements
group Id
OG000
lower Limit
-6.34
upper Limit
-1.45
value
-3.89
group Id
OG001
lower Limit
-6.22
upper Limit
-1.15
value
-3.68
group Id
OG002
lower Limit
-10.59
upper Limit
-1.02
value
-5.81
group Id
OG003
lower Limit
-8.58
upper Limit
1.65
value
-3.46
denoms
counts
group Id
OG000
value
195
group Id
OG001
value
172
group Id
OG002
value
55
group Id
OG003
value
49
units
Participants
title
Dyspnoea, week 30
categories
measurements
group Id
OG000
lower Limit
-5.52
upper Limit
-0.24
value
-2.88
group Id
OG001
lower Limit
-4.83
upper Limit
0.75
value
-2.04
group Id
OG002
lower Limit
-8.91
upper Limit
0.48
value
-4.21
group Id
OG003
lower Limit
-7.28
upper Limit
2.93
value
-2.18
denoms
counts
group Id
OG000
value
184
group Id
OG001
value
151
group Id
OG002
value
52
group Id
OG003
value
43
units
Participants
title
Dyspnoea, week 36
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-LC13 was a lung-cancer-specific module comprising 13 questions to assess lung cancer symptoms (cough, haemoptysis, dyspnoea, and site-specific pain); treatment related side-effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia); and pain medication. An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items. Higher scores on the global health status/QoL and functioning scales indicated better health status/QoL and 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 1, 2, 3, 4, 5, 6, 12, 18, 24, 30 and 36
title
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ) Questionnaires Lung Cancer 13 (QLQ-LC13)
Triangle