NCT02511106 · ADVERSE EVENTS

Adverse events

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Other-event reporting threshold: 5%

Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
AZD9291 Description (Arm-group)	68 / 337	312 / 337	42 / 339
Placebo Description (Arm-group)	47 / 343	262 / 343	82 / 343

Group identifiers: EG000: AZD9291 · EG001: Placebo

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
337
num Events
1
group Id
EG001
num Affected
1
num At Risk
343
num Events
1
term
Coronary artery disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
337
num Events
0
group Id
EG001
num Affected
1
num At Risk
343
num Events
1
term
Neck mass
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
337
num Events
1
group Id
EG001
num Affected
1
num At Risk
343
num Events
1
term
Osteoarthritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
337
num Events
1
group Id
EG001
num Affected
0
num At Risk
343
num Events
0
term
Osteoporosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
337
num Events
0
group Id
EG001
num Affected
1
num At Risk
343
num Events
1
term
Pathological fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
337
num Events
0
group Id
EG001
num Affected
1
num At Risk
343
num Events
1
term
Rotator cuff syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
337
num Events
1
group Id
EG001
num Affected
0
num At Risk
343
num Events
0
term
Bladder cancer stage 0, with cancer in situ
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
337
num Events
0
group Id
EG001
num Affected
1
num At Risk
343
num Events
1
term
Cancer pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
337
num Events
1
group Id
EG001
num Affected
0
num At Risk
343
num Events
0
term
Chronic lymphocytic leukaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
337
num Events
0
group Id
EG001
num Affected
1
num At Risk
343
num Events
1
term
Invasive ductal breast carcinoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
337
num Events
1
group Id
EG001
num Affected
1
num At Risk
343
num Events
1
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
337
num Events
0
group Id
EG001
num Affected
1
num At Risk
343
num Events
1
term
Lung adenocarcinoma

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
26
num At Risk
337
num Events
29
group Id
EG001
num Affected
5
num At Risk
343
num Events
5
term
Muscle spasms
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
28
num At Risk
337
num Events
38
group Id
EG001
num Affected
27
num At Risk
343
num Events
31
term
Dizziness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
27
num At Risk
337
num Events
31
group Id
EG001
num Affected
33
num At Risk
343
num Events
49
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
18
num At Risk
337
num Events
20
group Id
EG001
num Affected
17
num At Risk
343
num Events
18
term
Insomnia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
66
num At Risk
337
num Events
86
group Id
EG001
num Affected
61
num At Risk
343
num Events
74
term
Cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
21
num At Risk
337
num Events
26
group Id
EG001
num Affected
5
num At Risk
343
num Events
5
term
Epistaxis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
21
num At Risk
337
num Events
22
group Id
EG001
num Affected
8
num At Risk
343
num Events
8
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
41
num At Risk
337
num Events
49
group Id
EG001
num Affected
16
num At Risk
343
num Events
20
term
Dermatitis acneiform
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
84
num At Risk
337
num Events
95
group Id
EG001
num Affected
23
num At Risk
343
num Events
25
term
Dry skin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
22
num At Risk
337
num Events
22
group Id
EG001
num Affected
3
num At Risk
343
num Events
3
term
Nail disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
70
num At Risk
337
num Events
88
group Id
EG001
num Affected
30
num At Risk
343
num Events
42
term
Pruritus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
34
num At Risk
337
num Events
47
group Id
EG001
num Affected
12
num At Risk
343
num Events
13
term
Rash

Complete source fields

description

event Groups

deaths Num Affected
42
deaths Num At Risk
339
description
Description (Arm-group)
id
EG000
other Num Affected
312
other Num At Risk
337
serious Num Affected
68
serious Num At Risk
337
title
AZD9291
deaths Num Affected
82
deaths Num At Risk
343
description
Description (Arm-group)
id
EG001
other Num Affected
262
other Num At Risk
343
serious Num Affected
47
serious Num At Risk
343
title
Placebo

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
26
num At Risk
337
num Events
29
group Id
EG001
num Affected
5
num At Risk
343
num Events
5
term
Muscle spasms
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
28
num At Risk
337
num Events
38
group Id
EG001
num Affected
27
num At Risk
343
num Events
31
term
Dizziness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
27
num At Risk
337
num Events
31
group Id
EG001
num Affected
33
num At Risk
343
num Events
49
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
18
num At Risk
337
num Events
20
group Id
EG001
num Affected
17
num At Risk
343
num Events
18
term
Insomnia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
66
num At Risk
337
num Events
86
group Id
EG001
num Affected
61
num At Risk
343
num Events
74
term
Cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
21
num At Risk
337
num Events
26
group Id
EG001
num Affected
5
num At Risk
343
num Events
5
term
Epistaxis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
21
num At Risk
337
num Events
22
group Id
EG001
num Affected
8
num At Risk
343
num Events
8
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
41
num At Risk
337
num Events
49
group Id
EG001
num Affected
16
num At Risk
343
num Events
20
term
Dermatitis acneiform
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
84
num At Risk
337
num Events
95
group Id
EG001
num Affected
23
num At Risk
343
num Events
25
term
Dry skin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
22
num At Risk
337
num Events
22
group Id
EG001
num Affected
3
num At Risk
343
num Events
3
term
Nail disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
70
num At Risk
337
num Events
88
group Id
EG001
num Affected
30
num At Risk
343
num Events
42
term
Pruritus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
34
num At Risk
337
num Events
47
group Id
EG001
num Affected
12
num At Risk
343
num Events
13
term
Rash

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
337
num Events
1
group Id
EG001
num Affected
1
num At Risk
343
num Events
1
term
Coronary artery disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
337
num Events
0
group Id
EG001
num Affected
1
num At Risk
343
num Events
1
term
Neck mass
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
337
num Events
1
group Id
EG001
num Affected
1
num At Risk
343
num Events
1
term
Osteoarthritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
337
num Events
1
group Id
EG001
num Affected
0
num At Risk
343
num Events
0
term
Osteoporosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
337
num Events
0
group Id
EG001
num Affected
1
num At Risk
343
num Events
1
term
Pathological fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
337
num Events
0
group Id
EG001
num Affected
1
num At Risk
343
num Events
1
term
Rotator cuff syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
337
num Events
1
group Id
EG001
num Affected
0
num At Risk
343
num Events
0
term
Bladder cancer stage 0, with cancer in situ
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
337
num Events
0
group Id
EG001
num Affected
1
num At Risk
343
num Events
1
term
Cancer pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
337
num Events
1
group Id
EG001
num Affected
0
num At Risk
343
num Events
0
term
Chronic lymphocytic leukaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
337
num Events
0
group Id
EG001
num Affected
1
num At Risk
343
num Events
1
term
Invasive ductal breast carcinoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
337
num Events
1
group Id
EG001
num Affected
1
num At Risk
343
num Events
1
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
337
num Events
0
group Id
EG001
num Affected
1
num At Risk
343
num Events
1
term
Lung adenocarcinoma

time Frame

Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.

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