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NCT02511106 · OUTCOME

Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.

AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy. · Source last updated 2026-03-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEAN
Unit: Unit on a scale
Interval / dispersion: Standard Deviation
Time frame: Measured by SF-36 Questionnaire at baseline, 12 week, 24 week and then every 24 weeks until study complete, disease recurrence or other discontinuation criteria met, up to 3 years.

What was measured

Change from baseline will be calculated for each domain and summary scale at each scheduled post-baseline assessment. The SF-36 includes eight domains: Physical Functioning (PF); Role Limitations-Physical (RP), Vitality (VT), General Health Perceptions (GH), Bodily Pain (BP), Social Function (SF), Role Limitations-Emotional (RE), and Mental Health (MH) and two summary scores: The Physical Component Summary (PCS) and Mental Component Summary (MCS). Final scores for each scale range from 0-100 with higher scores indicating better health.

Analysis population: Full Analysis Set (FAS)

Groups in this outcome

AZD9291 80mg Tablet

Taken once daily

Placebo Tablet

Taken once daily

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
AZD9291 80mg Tablet	339
Placebo Tablet	343

Reported measurements

Week 12 - Bodily Pain

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	292
Placebo Tablet	300

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	1.026	9.448	Not reported	Not reported	Not reported
Placebo Tablet	1.442	8.854	Not reported	Not reported	Not reported

Week 24 - Bodily Pain

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	274
Placebo Tablet	276

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	1.521	9.171	Not reported	Not reported	Not reported
Placebo Tablet	1.462	9.279	Not reported	Not reported	Not reported

Week 48 - Bodily Pain

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	261
Placebo Tablet	219

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	2.032	10.226	Not reported	Not reported	Not reported
Placebo Tablet	2.438	10.077	Not reported	Not reported	Not reported

Week 72 - Bodily Pain

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	236
Placebo Tablet	190

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	2.471	9.787	Not reported	Not reported	Not reported
Placebo Tablet	2.335	9.566	Not reported	Not reported	Not reported

Week 96 - Bodily Pain

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	227
Placebo Tablet	165

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	2.326	10.865	Not reported	Not reported	Not reported
Placebo Tablet	2.921	10.153	Not reported	Not reported	Not reported

Week 120 - Bodily Pain

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	218
Placebo Tablet	152

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	2.906	10.181	Not reported	Not reported	Not reported
Placebo Tablet	2.778	11.295	Not reported	Not reported	Not reported

Week 144 - Bodily Pain

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	200
Placebo Tablet	132

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	3.045	11.410	Not reported	Not reported	Not reported
Placebo Tablet	3.324	10.258	Not reported	Not reported	Not reported

Week 156 - Bodily Pain

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	179
Placebo Tablet	106

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	2.552	11.994	Not reported	Not reported	Not reported
Placebo Tablet	3.116	10.692	Not reported	Not reported	Not reported

Week 12 - General Health Perceptions

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	294
Placebo Tablet	303

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	-0.597	8.319	Not reported	Not reported	Not reported
Placebo Tablet	0.343	7.497	Not reported	Not reported	Not reported

Week 24 - General Health Perceptions

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	279
Placebo Tablet	277

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	-0.079	8.910	Not reported	Not reported	Not reported
Placebo Tablet	0.763	8.122	Not reported	Not reported	Not reported

Week 48 - General Health Perceptions

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	264
Placebo Tablet	220

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	0.103	8.029	Not reported	Not reported	Not reported
Placebo Tablet	1.042	8.416	Not reported	Not reported	Not reported

Week 72 - General Health Perceptions

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	239
Placebo Tablet	191

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	0.275	7.958	Not reported	Not reported	Not reported
Placebo Tablet	2.339	8.197	Not reported	Not reported	Not reported

Week 96 - General Health Perceptions

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	230
Placebo Tablet	165

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	-0.119	8.195	Not reported	Not reported	Not reported
Placebo Tablet	1.818	7.903	Not reported	Not reported	Not reported

Week 120 - General Health Perceptions

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	221
Placebo Tablet	152

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	-0.368	8.461	Not reported	Not reported	Not reported
Placebo Tablet	0.964	8.518	Not reported	Not reported	Not reported

Week 144 - General Health Perceptions

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	202
Placebo Tablet	132

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	0.209	8.671	Not reported	Not reported	Not reported
Placebo Tablet	1.342	8.789	Not reported	Not reported	Not reported

Week 156 - General Health Perceptions

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	183
Placebo Tablet	106

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	-0.128	8.987	Not reported	Not reported	Not reported
Placebo Tablet	2.166	8.670	Not reported	Not reported	Not reported

Week 12 - Mental Health

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	291
Placebo Tablet	302

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	0.928	8.538	Not reported	Not reported	Not reported
Placebo Tablet	1.892	8.497	Not reported	Not reported	Not reported

Week 24 - Mental Health

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	276
Placebo Tablet	277

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	1.249	8.780	Not reported	Not reported	Not reported
Placebo Tablet	1.275	9.660	Not reported	Not reported	Not reported

Week 48 - Mental Health

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	262
Placebo Tablet	219

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	2.456	8.920	Not reported	Not reported	Not reported
Placebo Tablet	2.234	8.676	Not reported	Not reported	Not reported

Week 72 - Mental Health

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	237
Placebo Tablet	190

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	1.540	9.029	Not reported	Not reported	Not reported
Placebo Tablet	2.011	8.954	Not reported	Not reported	Not reported

Week 96 - Mental Health

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	228
Placebo Tablet	165

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	1.352	8.560	Not reported	Not reported	Not reported
Placebo Tablet	2.101	8.986	Not reported	Not reported	Not reported

Week 120 - Mental Health

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	219
Placebo Tablet	152

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	0.723	9.738	Not reported	Not reported	Not reported
Placebo Tablet	2.307	10.139	Not reported	Not reported	Not reported

Week 144 - Mental Health

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	200
Placebo Tablet	132

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	0.517	9.609	Not reported	Not reported	Not reported
Placebo Tablet	1.428	8.914	Not reported	Not reported	Not reported

Week 156 - Mental Health

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	180
Placebo Tablet	106

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	0.386	10.215	Not reported	Not reported	Not reported
Placebo Tablet	2.000	9.651	Not reported	Not reported	Not reported

Week 12 - Physical functioning

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	294
Placebo Tablet	302

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	-0.314	6.762	Not reported	Not reported	Not reported
Placebo Tablet	0.898	6.646	Not reported	Not reported	Not reported

Week 24 - Physical functioning

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	277
Placebo Tablet	275

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	0.494	6.783	Not reported	Not reported	Not reported
Placebo Tablet	0.923	7.014	Not reported	Not reported	Not reported

Week 48 - Physical functioning

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	263
Placebo Tablet	220

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	0.940	7.595	Not reported	Not reported	Not reported
Placebo Tablet	1.914	7.899	Not reported	Not reported	Not reported

Week 72 - Physical functioning

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	238
Placebo Tablet	191

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	1.079	6.725	Not reported	Not reported	Not reported
Placebo Tablet	2.042	7.283	Not reported	Not reported	Not reported

Week 96 - Physical functioning

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	229
Placebo Tablet	165

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	0.637	8.220	Not reported	Not reported	Not reported
Placebo Tablet	2.016	7.048	Not reported	Not reported	Not reported

Week 120 - Physical functioning

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	220
Placebo Tablet	152

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	1.449	7.207	Not reported	Not reported	Not reported
Placebo Tablet	2.540	7.424	Not reported	Not reported	Not reported

Week 144 - Physical functioning

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	202
Placebo Tablet	132

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	1.869	6.767	Not reported	Not reported	Not reported
Placebo Tablet	1.939	8.238	Not reported	Not reported	Not reported

Week 156 - Physical functioning

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	182
Placebo Tablet	105

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	0.997	7.537	Not reported	Not reported	Not reported
Placebo Tablet	2.187	8.293	Not reported	Not reported	Not reported

Week 12 - Role Limitations - Emotional

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	292
Placebo Tablet	303

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	0.381	10.413	Not reported	Not reported	Not reported
Placebo Tablet	2.333	11.168	Not reported	Not reported	Not reported

Week 24 - Role Limitations - Emotional

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	276
Placebo Tablet	276

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	0.858	11.317	Not reported	Not reported	Not reported
Placebo Tablet	1.678	11.571	Not reported	Not reported	Not reported

Week 48 - Role Limitations - Emotional

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	262
Placebo Tablet	220

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	2.179	11.131	Not reported	Not reported	Not reported
Placebo Tablet	2.628	10.952	Not reported	Not reported	Not reported

Week 72 - Role Limitations - Emotional

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	237
Placebo Tablet	191

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	1.410	11.861	Not reported	Not reported	Not reported
Placebo Tablet	1.860	11.424	Not reported	Not reported	Not reported

Week 96 - Role Limitations - Emotional

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	227
Placebo Tablet	165

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	1.657	12.405	Not reported	Not reported	Not reported
Placebo Tablet	1.899	12.379	Not reported	Not reported	Not reported

Week 120 - Role Limitations - Emotional

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	219
Placebo Tablet	152

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	1.765	11.966	Not reported	Not reported	Not reported
Placebo Tablet	2.360	12.663	Not reported	Not reported	Not reported

Week 144 - Role Limitations - Emotional

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	200
Placebo Tablet	132

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	1.654	12.081	Not reported	Not reported	Not reported
Placebo Tablet	2.532	13.113	Not reported	Not reported	Not reported

Week 156 - Role Limitations - Emotional

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	181
Placebo Tablet	106

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	0.519	12.351	Not reported	Not reported	Not reported
Placebo Tablet	2.201	13.022	Not reported	Not reported	Not reported

Week 12 - Role Limitations - Physical

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	292
Placebo Tablet	303

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	1.056	9.263	Not reported	Not reported	Not reported
Placebo Tablet	2.915	8.977	Not reported	Not reported	Not reported

Week 24 - Role Limitations - Physical

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	277
Placebo Tablet	276

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	1.727	10.265	Not reported	Not reported	Not reported
Placebo Tablet	4.063	9.295	Not reported	Not reported	Not reported

Week 48 - Role Limitations - Physical

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	262
Placebo Tablet	220

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	3.437	10.592	Not reported	Not reported	Not reported
Placebo Tablet	5.332	9.663	Not reported	Not reported	Not reported

Week 72 - Role Limitations - Physical

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	237
Placebo Tablet	191

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	3.581	11.037	Not reported	Not reported	Not reported
Placebo Tablet	5.424	9.670	Not reported	Not reported	Not reported

Week 96 - Role Limitations - Physical

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	228
Placebo Tablet	165

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	3.240	10.807	Not reported	Not reported	Not reported
Placebo Tablet	5.321	9.997	Not reported	Not reported	Not reported

Week 120 - Role Limitations - Physical

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	219
Placebo Tablet	152

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	4.717	11.238	Not reported	Not reported	Not reported
Placebo Tablet	5.348	11.395	Not reported	Not reported	Not reported

Week 144 - Role Limitations - Physical

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	200
Placebo Tablet	132

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	3.525	10.860	Not reported	Not reported	Not reported
Placebo Tablet	5.444	10.547	Not reported	Not reported	Not reported

Week 156 - Role Limitations - Physical

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	181
Placebo Tablet	106

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	3.151	11.378	Not reported	Not reported	Not reported
Placebo Tablet	5.572	10.954	Not reported	Not reported	Not reported

Week 12 - Social Function

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	292
Placebo Tablet	301

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	1.391	9.615	Not reported	Not reported	Not reported
Placebo Tablet	3.164	9.171	Not reported	Not reported	Not reported

Week 24 - Social Function

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	276
Placebo Tablet	276

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	2.634	9.526	Not reported	Not reported	Not reported
Placebo Tablet	3.433	10.348	Not reported	Not reported	Not reported

Week 48 - Social Function

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	262
Placebo Tablet	220

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	3.731	9.919	Not reported	Not reported	Not reported
Placebo Tablet	4.170	10.156	Not reported	Not reported	Not reported

Week 72 - Social Function

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	237
Placebo Tablet	190

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	3.025	10.094	Not reported	Not reported	Not reported
Placebo Tablet	4.802	10.351	Not reported	Not reported	Not reported

Week 96 - Social Function

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	228
Placebo Tablet	165

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	3.651	10.011	Not reported	Not reported	Not reported
Placebo Tablet	4.405	10.790	Not reported	Not reported	Not reported

Week 120 - Social Function

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	219
Placebo Tablet	152

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	3.297	10.723	Not reported	Not reported	Not reported
Placebo Tablet	4.386	11.355	Not reported	Not reported	Not reported

Week 144 - Social Function

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	200
Placebo Tablet	132

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	2.582	10.638	Not reported	Not reported	Not reported
Placebo Tablet	3.912	10.929	Not reported	Not reported	Not reported

Week 156 - Social Function

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	180
Placebo Tablet	106

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	2.423	10.658	Not reported	Not reported	Not reported
Placebo Tablet	4.351	12.144	Not reported	Not reported	Not reported

Week 12 - Vitality

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	290
Placebo Tablet	302

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	0.570	7.987	Not reported	Not reported	Not reported
Placebo Tablet	2.344	8.207	Not reported	Not reported	Not reported

Week 24 - Vitality

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	275
Placebo Tablet	277

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	0.630	8.996	Not reported	Not reported	Not reported
Placebo Tablet	2.463	9.461	Not reported	Not reported	Not reported

Week 48 - Vitality

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	261
Placebo Tablet	219

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	2.231	9.209	Not reported	Not reported	Not reported
Placebo Tablet	3.029	8.972	Not reported	Not reported	Not reported

Week 72 - Vitality

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	236
Placebo Tablet	190

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	1.082	9.387	Not reported	Not reported	Not reported
Placebo Tablet	3.815	8.869	Not reported	Not reported	Not reported

Week 96 - Vitality

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	228
Placebo Tablet	165

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	1.147	9.052	Not reported	Not reported	Not reported
Placebo Tablet	3.474	9.071	Not reported	Not reported	Not reported

Week 120 - Vitality

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	219
Placebo Tablet	152

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	1.139	9.458	Not reported	Not reported	Not reported
Placebo Tablet	3.224	9.122	Not reported	Not reported	Not reported

Week 144 - Vitality

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	200
Placebo Tablet	132

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	0.386	9.724	Not reported	Not reported	Not reported
Placebo Tablet	2.070	9.285	Not reported	Not reported	Not reported

Week 156 - Vitality

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	180
Placebo Tablet	106

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	0.825	9.342	Not reported	Not reported	Not reported
Placebo Tablet	2.970	8.831	Not reported	Not reported	Not reported

Week 12 - Mental Component Summary

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	291
Placebo Tablet	301

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	0.986	8.068	Not reported	Not reported	Not reported
Placebo Tablet	2.603	8.965	Not reported	Not reported	Not reported

Week 24 - Mental Component Summary

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	274
Placebo Tablet	275

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	1.333	8.919	Not reported	Not reported	Not reported
Placebo Tablet	1.936	10.152	Not reported	Not reported	Not reported

Week 48 - Mental Component Summary

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	261
Placebo Tablet	219

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	2.788	9.301	Not reported	Not reported	Not reported
Placebo Tablet	2.757	9.141	Not reported	Not reported	Not reported

Week 72 - Mental Component Summary

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	236
Placebo Tablet	190

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	1.434	9.635	Not reported	Not reported	Not reported
Placebo Tablet	2.577	9.116	Not reported	Not reported	Not reported

Week 96 - Mental Component Summary

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	227
Placebo Tablet	165

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	1.823	9.439	Not reported	Not reported	Not reported
Placebo Tablet	2.415	10.023	Not reported	Not reported	Not reported

Week 120 - Mental Component Summary

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	218
Placebo Tablet	152

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	1.027	10.286	Not reported	Not reported	Not reported
Placebo Tablet	2.554	10.548	Not reported	Not reported	Not reported

Week 144 - Mental Component Summary

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	200
Placebo Tablet	132

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	0.580	9.994	Not reported	Not reported	Not reported
Placebo Tablet	1.870	9.857	Not reported	Not reported	Not reported

Week 156 - Mental Component Summary

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	179
Placebo Tablet	106

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	0.322	10.077	Not reported	Not reported	Not reported
Placebo Tablet	2.269	10.647	Not reported	Not reported	Not reported

Week 12 - Physical Component Summary

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	291
Placebo Tablet	301

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	0.161	6.341	Not reported	Not reported	Not reported
Placebo Tablet	1.144	6.078	Not reported	Not reported	Not reported

Week 24 - Physical Component Summary

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	274
Placebo Tablet	275

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	0.878	7.009	Not reported	Not reported	Not reported
Placebo Tablet	1.938	6.643	Not reported	Not reported	Not reported

Week 48 - Physical Component Summary

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	261
Placebo Tablet	219

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	1.356	6.800	Not reported	Not reported	Not reported
Placebo Tablet	2.797	7.497	Not reported	Not reported	Not reported

Week 72 - Physical Component Summary

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	236
Placebo Tablet	190

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	1.989	6.941	Not reported	Not reported	Not reported
Placebo Tablet	3.360	6.985	Not reported	Not reported	Not reported

Week 96 - Physical Component Summary

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	227
Placebo Tablet	165

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	1.497	7.591	Not reported	Not reported	Not reported
Placebo Tablet	3.343	6.792	Not reported	Not reported	Not reported

Week 120 - Physical Component Summary

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	218
Placebo Tablet	152

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	2.611	7.291	Not reported	Not reported	Not reported
Placebo Tablet	3.175	8.210	Not reported	Not reported	Not reported

Week 144 - Physical Component Summary

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	200
Placebo Tablet	132

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	2.635	7.374	Not reported	Not reported	Not reported
Placebo Tablet	3.353	8.042	Not reported	Not reported	Not reported

Week 156 - Physical Component Summary

Analysis denominator · Participants

Group	Source count
AZD9291 80mg Tablet	179
Placebo Tablet	105

Values in Unit on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AZD9291 80mg Tablet	2.133	7.909	Not reported	Not reported	Not reported
Placebo Tablet	3.644	8.731	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
9.448
value
1.026
group Id
OG001
spread
8.854
value
1.442
denoms
counts
group Id
OG000
value
292
group Id
OG001
value
300
units
Participants
title
Week 12 - Bodily Pain
categories
measurements
group Id
OG000
spread
9.171
value
1.521
group Id
OG001
spread
9.279
value
1.462
denoms
counts
group Id
OG000
value
274
group Id
OG001
value
276
units
Participants
title
Week 24 - Bodily Pain
categories
measurements
group Id
OG000
spread
10.226
value
2.032
group Id
OG001
spread
10.077
value
2.438
denoms
counts
group Id
OG000
value
261
group Id
OG001
value
219
units
Participants
title
Week 48 - Bodily Pain
categories
measurements
group Id
OG000
spread
9.787
value
2.471
group Id
OG001
spread
9.566
value
2.335
denoms
counts
group Id
OG000
value
236
group Id
OG001
value
190
units
Participants
title
Week 72 - Bodily Pain
categories
measurements
group Id
OG000
spread
10.865
value
2.326
group Id
OG001
spread
10.153
value
2.921
denoms
counts
group Id
OG000
value
227
group Id
OG001
value
165
units
Participants
title
Week 96 - Bodily Pain
categories
measurements
group Id
OG000
spread
10.181
value
2.906
group Id
OG001
spread
11.295
value
2.778
denoms
counts
group Id
OG000
value
218
group Id
OG001
value
152
units
Participants
title
Week 120 - Bodily Pain
categories
measurements
group Id
OG000
spread
11.410
value
3.045
group Id
OG001
spread
10.258
value
3.324
denoms
counts
group Id
OG000
value
200
group Id
OG001
value
132
units
Participants
title
Week 144 - Bodily Pain
categories
measurements
group Id
OG000
spread
11.994
value
2.552
group Id
OG001
spread
10.692
value
3.116
denoms
counts
group Id
OG000
value
179
group Id
OG001
value
106
units
Participants
title
Week 156 - Bodily Pain
categories
measurements
group Id
OG000
spread
8.319
value
-0.597
group Id
OG001
spread
7.497
value
0.343
denoms
counts
group Id
OG000
value
294
group Id
OG001
value
303
units
Participants
title
Week 12 - General Health Perceptions
categories
measurements
group Id
OG000
spread
8.910
value
-0.079
group Id
OG001
spread
8.122
value
0.763
denoms
counts
group Id
OG000
value
279
group Id
OG001
value
277
units
Participants
title
Week 24 - General Health Perceptions
categories
measurements
group Id
OG000
spread
8.029
value
0.103
group Id
OG001
spread
8.416
value
1.042
denoms
counts
group Id
OG000
value
264
group Id
OG001
value
220
units
Participants
title
Week 48 - General Health Perceptions
categories
measurements
group Id
OG000
spread
7.958
value
0.275
group Id
OG001
spread
8.197
value
2.339
denoms
counts
group Id
OG000
value
239
group Id
OG001
value
191
units
Participants
title
Week 72 - General Health Perceptions

denoms

counts
group Id
OG000
value
339
group Id
OG001
value
343
units
Participants

description

Change from baseline will be calculated for each domain and summary scale at each scheduled post-baseline assessment. The SF-36 includes eight domains: Physical Functioning (PF); Role Limitations-Physical (RP), Vitality (VT), General Health Perceptions (GH), Bodily Pain (BP), Social Function (SF), Role Limitations-Emotional (RE), and Mental Health (MH) and two summary scores: The Physical Component Summary (PCS) and Mental Component Summary (MCS). Final scores for each scale range from 0-100 with higher scores indicating better health.

dispersion Type

Standard Deviation

groups

description
Taken once daily
id
OG000
title
AZD9291 80mg Tablet
description
Taken once daily
id
OG001
title
Placebo Tablet

param Type

MEAN

population Description

Full Analysis Set (FAS)

reporting Status

POSTED

time Frame

Measured by SF-36 Questionnaire at baseline, 12 week, 24 week and then every 24 weeks until study complete, disease recurrence or other discontinuation criteria met, up to 3 years.

title

Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.

type

SECONDARY

unit Of Measure

Unit on a scale

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice