Study of Anastrozole +/- AZD8931 in Postmenopausal Women... | NCT01151215

NCT01151215

Status Module

Label	Type	Description	Intervention Names
1	Experimental	AZD8931 40mg (bd) plus anastrozole 1mg (od)	Drug: AZD8931 Drug: anastrozole
2	Experimental	AZD8931 20mg (bd) plus anastrozole 1mg (od)	Drug: AZD8931 Drug: anastrozole
3	Placebo Comparator	Placebo (bd) plus anastrozole 1mg (od)	Drug: anastrozole Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
AZD8931	Drug	Tablet, oral, bd	1 2
anastrozole

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression Free Survival as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1	Time from the date of randomization until the date of objective disease progression (as per RECIST 1.1) or the date of death (by any cause in the absence of progression). Disease progression is defined using RECIST 1.1 as >=20% increase in the sum of longest diameters of target lesions and an absolute increase of >=5mm, taking as reference the smallest sum of longest diameters of target lesions since study start, or unequivocal progression in non-target lesions, or appearance of any new lesions.	Tumour assessment by RECIST 1.1 every 12 weeks until data cut-off at 31 August 2012

Secondary Outcomes

Measure	Description	Time Frame
Compare the Overall Survival in Patients Treated With AZD8931 in Combination With Anastrozole Versus Anastrozole Alone	Time from the date of randomization to the date of death (by any cause)	Following progression, patients were contacted at 12 weekly intervals until data cut-off at 31 August 2012 to determine survival status

Eligibility Module

Name	Affiliation	Role
Dr Serban Ghiorghiu, MD	AstraZeneca	Study Director
Stephen Johnston, MA, PhD, FRCP	The Royal Marsden Hospital, London	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Lake Success	New York		United States
Research Site

PubMed Identifier	Type	Citation	Retractions
27654971	Derived	Johnston S, Basik M, Hegg R, Lausoontornsiri W, Grzeda L, Clemons M, Dreosti L, Mann H, Stuart M, Cristofanilli M. Inhibition of EGFR, HER2, and HER3 signaling with AZD8931 in combination with anastrozole as an anticancer approach: Phase II randomized study in women with endocrine-therapy-naive advanced breast cancer. Breast Cancer Res Treat. 2016 Nov;160(1):91-99. doi: 10.1007/s10549-016-3979-5. Epub 2016 Sep 21.

Results Section

Participant Flow Module

ID	Title	Description
FG000	AZD8931 40mg + Anastrozole 1mg	AZD8931 40mg (bd) plus anastrozole 1mg (od)
FG001	AZD8931 20mg + Anastrozole 1mg	AZD8931 20mg (bd) plus anastrozole 1mg (od)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00060.4± 10.69 BG00162.0± 11.23 BG00260.5± 10.29 BG003

Sex/Gender, Customized

Female only

Number

Participants

Title

Denominators

Categories

Title	Measurements
	BG000120 BG001118 BG002

Race/Ethnicity, Customized

Number

Participants

Title

Denominators

Categories

Ethnicity: Hispanic or Latino

Title	Measurements
	BG00051 BG00153 BG002

Race/Ethnicity, Customized

Number

Participants

Title

Denominators

Categories

Race: American Indian or Alaska Native

Title	Measurements
	BG0000 BG0010 BG002

Study Stratification: Disease Classification

Study was stratified by locally advanced / metastatic disease

Number

Participants

Title

Denominators

Categories

Locally advanced

Title	Measurements
	BG00028 BG00127 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Progression Free Survival as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1

Time from the date of randomization until the date of objective disease progression (as per RECIST 1.1) or the date of death (by any cause in the absence of progression). Disease progression is defined using RECIST 1.1 as >=20% increase in the sum of longest diameters of target lesions and an absolute increase of >=5mm, taking as reference the smallest sum of longest diameters of target lesions since study start, or unequivocal progression in non-target lesions, or appearance of any new lesions.

Full Analysis Set (all participants randomized, irrespective of whether treatment was received). Participants are analysed according to the treatment group they were randomized to.

Posted

Median

Inter-Quartile Range

Months

Tumour assessment by RECIST 1.1 every 12 weeks until data cut-off at 31 August 2012

Events

Participants

ID	Title	Description
OG000	AZD8931 40mg + Anastrozole 1mg	AZD8931 40mg (bd) plus anastrozole 1mg (od)
OG001	AZD8931 20mg + Anastrozole 1mg	AZD8931 20mg (bd) plus anastrozole 1mg (od)
OG002	Placebo + Anastrozole 1mg	Placebo (bd) plus anastrozole 1mg (od)

Units	Counts
Participants	OG000120 OG001118 OG002121
Events	OG000

Title

Denominators

Categories

Title	Measurements
	OG00013.8(5.5 to 22.1) OG00110.9(5.4 to NA)Upper limit of inter-quartile range is not calculable OG00214.0(6.7 to 21.8)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	345 patients were to be randomised to observe at least 233 progression events, based on HR=0.60, 90% power, 2-sided 5% significant level and a median of 9 months for the placebo arm. An interim analysis with futility boundary was introduced based on an IDMC recommendation.	Log Rank	The log rank test was stratified for the IVRS stratification factor of disease classification (locally advanced / metastatic disease)	0.485	Statistical significance threshold at this interim analysis was 5%	Hazard Ratio (HR)	1.16			2-Sided	95	0.77	1.75			The Hazard Ratio is for AZD8931 40mg + anastrozole 1mg / Placebo + anastrozole 1mg, ie a hazard ratio <1 favours AZD8931 40mg + anastrozole 1mg

Secondary

Compare the Overall Survival in Patients Treated With AZD8931 in Combination With Anastrozole Versus Anastrozole Alone

Time from the date of randomization to the date of death (by any cause)

Full Analysis Set (all participants randomized, irrespective of whether treatment was received). Participants are analysed according to the treatment group they were randomized to.

Posted

Median

Inter-Quartile Range

Months

Following progression, patients were contacted at 12 weekly intervals until data cut-off at 31 August 2012 to determine survival status

Events

Participants

ID	Title	Description
OG000	AZD8931 40mg + Anastrozole 1mg	AZD8931 40mg (bd) plus anastrozole 1mg (od)
OG001	AZD8931 20mg + Anastrozole 1mg	AZD8931 20mg (bd) plus anastrozole 1mg (od)
OG002	Placebo + Anastrozole 1mg	Placebo (bd) plus anastrozole 1mg (od)

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANGINA PECTORIS	Cardiac disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0010 events0 affected120 at risk EG0021 events1 affected121 at risk
DERMATITIS ACNEIFORM	Skin and subcutaneous tissue disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0012 events2 affected120 at risk EG0020 events0 affected121 at risk
ANAEMIA	Blood and lymphatic system disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0012 events1 affected120 at risk EG0020 events0 affected121 at risk
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0010 events0 affected120 at risk EG0021 events1 affected121 at risk
COR PULMONALE	Cardiac disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0010 events0 affected120 at risk EG0021 events1 affected121 at risk
VERTIGO	Ear and labyrinth disorders	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected120 at risk EG0020 events0 affected121 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected120 at risk EG0020 events0 affected121 at risk
CARDIAC FAILURE	Cardiac disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0010 events0 affected120 at risk EG0021 events1 affected121 at risk
MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0010 events0 affected120 at risk EG0021 events1 affected121 at risk
TACHYCARDIA	Cardiac disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected120 at risk EG0020 events0 affected121 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0011 events1 affected120 at risk EG0022 events2 affected121 at risk
GASTRIC HAEMORRHAGE	Gastrointestinal disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected120 at risk EG0020 events0 affected121 at risk
OESOPHAGEAL VARICES HAEMORRHAGE	Gastrointestinal disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0010 events0 affected120 at risk EG0021 events1 affected121 at risk
VOMITING	Gastrointestinal disorders	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0011 events1 affected120 at risk EG0020 events0 affected121 at risk
DEATH	General disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0010 events0 affected120 at risk EG0021 events1 affected121 at risk
GAIT DISTURBANCE	General disorders	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected120 at risk EG0020 events0 affected121 at risk
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected120 at risk EG0020 events0 affected121 at risk
PYREXIA	General disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected120 at risk EG0020 events0 affected121 at risk
HYPERBILIRUBINAEMIA	Hepatobiliary disorders	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected120 at risk EG0020 events0 affected121 at risk
HERPES ZOSTER	Infections and infestations	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected120 at risk EG0020 events0 affected121 at risk
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected120 at risk EG0020 events0 affected121 at risk
LUNG INFECTION	Infections and infestations	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0010 events0 affected120 at risk EG0021 events1 affected121 at risk
PNEUMONIA	Infections and infestations	MedDRA 15	Systematic Assessment	EG0002 events2 affected118 at risk EG0011 events1 affected120 at risk EG0020 events0 affected121 at risk
SEPSIS	Infections and infestations	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected120 at risk EG0020 events0 affected121 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected120 at risk EG0020 events0 affected121 at risk
FALL	Injury, poisoning and procedural complications	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected120 at risk EG0020 events0 affected121 at risk
FEMUR FRACTURE	Injury, poisoning and procedural complications	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected120 at risk EG0020 events0 affected121 at risk
RIB FRACTURE	Injury, poisoning and procedural complications	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected120 at risk EG0020 events0 affected121 at risk
EJECTION FRACTION DECREASED	Investigations	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected120 at risk EG0020 events0 affected121 at risk
HYPERCALCAEMIA	Metabolism and nutrition disorders	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected120 at risk EG0020 events0 affected121 at risk
HYPERKALAEMIA	Metabolism and nutrition disorders	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected120 at risk EG0020 events0 affected121 at risk
HYPOVOLAEMIA	Metabolism and nutrition disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected120 at risk EG0020 events0 affected121 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected120 at risk EG0021 events1 affected121 at risk
PATHOLOGICAL FRACTURE	Musculoskeletal and connective tissue disorders	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected120 at risk EG0020 events0 affected121 at risk
CEREBELLAR INFARCTION	Nervous system disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0010 events0 affected120 at risk EG0021 events1 affected121 at risk
COMA	Nervous system disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected120 at risk EG0020 events0 affected121 at risk
ISCHAEMIC STROKE	Nervous system disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected120 at risk EG0020 events0 affected121 at risk
MONOPARESIS	Nervous system disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected120 at risk EG0020 events0 affected121 at risk
RENAL FAILURE ACUTE	Renal and urinary disorders	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected120 at risk EG0020 events0 affected121 at risk
TUBULOINTERSTITIAL NEPHRITIS	Renal and urinary disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected120 at risk EG0020 events0 affected121 at risk
BREAST HAEMORRHAGE	Reproductive system and breast disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected120 at risk EG0020 events0 affected121 at risk
ACUTE RESPIRATORY DISTRESS SYNDROME	Respiratory, thoracic and mediastinal disorders	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected120 at risk EG0020 events0 affected121 at risk
BRONCHOSPASM	Respiratory, thoracic and mediastinal disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0010 events0 affected120 at risk EG0021 events1 affected121 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected120 at risk EG0021 events1 affected121 at risk
PLEURITIC PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected120 at risk EG0020 events0 affected121 at risk
PNEUMONIA ASPIRATION	Respiratory, thoracic and mediastinal disorders	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected120 at risk EG0020 events0 affected121 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0012 events2 affected120 at risk EG0020 events0 affected121 at risk
HAEMORRHAGE	Vascular disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected120 at risk EG0020 events0 affected121 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 15	Systematic Assessment	EG0007 events7 affected118 at risk EG00110 events10 affected120 at risk EG0026 events6 affected121 at risk
LYMPHADENOPATHY	Blood and lymphatic system disorders	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected120 at risk EG0022 events2 affected121 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 15	Systematic Assessment	EG0003 events3 affected118 at risk EG0011 events1 affected120 at risk EG0021 events1 affected121 at risk
CHEST PAIN	General disorders	MedDRA 15	Systematic Assessment	EG0003 events3 affected118 at risk EG0011 events1 affected120 at risk EG0020 events0 affected121 at risk
MUCOSAL DRYNESS	General disorders	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0012 events2 affected120 at risk EG0020 events0 affected121 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA 15	Systematic Assessment	EG00010 events10 affected118 at risk EG0016 events5 affected120 at risk EG0027 events7 affected121 at risk
PAIN	General disorders	MedDRA 15	Systematic Assessment	EG0002 events2 affected118 at risk EG0013 events3 affected120 at risk EG0022 events2 affected121 at risk
PYREXIA	General disorders	MedDRA 15	Systematic Assessment	EG0004 events3 affected118 at risk EG0019 events8 affected120 at risk EG00211 events5 affected121 at risk
SPINAL PAIN	General disorders	MedDRA 15	Systematic Assessment	EG0002 events2 affected118 at risk EG0010 events0 affected120 at risk EG0021 events1 affected121 at risk
SWELLING	General disorders	MedDRA 15	Systematic Assessment	EG0002 events2 affected118 at risk EG0010 events0 affected120 at risk EG0021 events1 affected121 at risk
XEROSIS	General disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0014 events4 affected120 at risk EG0020 events0 affected121 at risk
INFLUENZA	Infections and infestations	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0012 events2 affected120 at risk EG0023 events3 affected121 at risk
PARONYCHIA	Infections and infestations	MedDRA 15	Systematic Assessment	EG0009 events6 affected118 at risk EG00126 events22 affected120 at risk EG0020 events0 affected121 at risk
CONTUSION	Injury, poisoning and procedural complications	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0012 events2 affected120 at risk EG0020 events0 affected121 at risk
EJECTION FRACTION DECREASED	Investigations	MedDRA 15	Systematic Assessment	EG0002 events2 affected118 at risk EG0011 events1 affected120 at risk EG0020 events0 affected121 at risk
WEIGHT INCREASED	Investigations	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0012 events2 affected120 at risk EG0020 events0 affected121 at risk
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 15	Systematic Assessment	EG0004 events3 affected118 at risk EG0012 events2 affected120 at risk EG0029 events8 affected121 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA 15	Systematic Assessment	EG0002 events2 affected118 at risk EG0013 events3 affected120 at risk EG0020 events0 affected121 at risk
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0015 events5 affected120 at risk EG0024 events4 affected121 at risk
MUSCULOSKELETAL CHEST PAIN	Musculoskeletal and connective tissue disorders	MedDRA 15	Systematic Assessment	EG0002 events2 affected118 at risk EG0011 events1 affected120 at risk EG0020 events0 affected121 at risk
DIZZINESS	Nervous system disorders	MedDRA 15	Systematic Assessment	EG0008 events4 affected118 at risk EG00111 events11 affected120 at risk EG0024 events4 affected121 at risk
DEPRESSION	Psychiatric disorders	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0013 events3 affected120 at risk EG0021 events1 affected121 at risk
PRODUCTIVE COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0013 events3 affected120 at risk EG0021 events1 affected121 at risk
BLISTER	Skin and subcutaneous tissue disorders	MedDRA 15	Systematic Assessment	EG0003 events2 affected118 at risk EG0011 events1 affected120 at risk EG0020 events0 affected121 at risk
NAIL DISORDER	Skin and subcutaneous tissue disorders	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0012 events2 affected120 at risk EG0020 events0 affected121 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA 15	Systematic Assessment	EG0002 events2 affected118 at risk EG0011 events1 affected120 at risk EG0023 events3 affected121 at risk
ANGINA PECTORIS	Cardiac disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0010 events0 affected120 at risk EG0022 events2 affected121 at risk
BLEPHARITIS	Eye disorders	MedDRA 15	Systematic Assessment	EG0002 events2 affected118 at risk EG0017 events4 affected120 at risk EG0020 events0 affected121 at risk
DRY EYE	Eye disorders	MedDRA 15	Systematic Assessment	EG0005 events5 affected118 at risk EG0018 events8 affected120 at risk EG0022 events2 affected121 at risk
EYE PAIN	Eye disorders	MedDRA 15	Systematic Assessment	EG0002 events2 affected118 at risk EG0010 events0 affected120 at risk EG0023 events2 affected121 at risk
VITREOUS FLOATERS	Eye disorders	MedDRA 15	Systematic Assessment	EG0002 events2 affected118 at risk EG0010 events0 affected120 at risk EG0020 events0 affected121 at risk
ABDOMINAL DISTENSION	Gastrointestinal disorders	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected120 at risk EG0022 events2 affected121 at risk
DYSPEPSIA	Gastrointestinal disorders	MedDRA 15	Systematic Assessment	EG0005 events4 affected118 at risk EG00111 events11 affected120 at risk EG0020 events0 affected121 at risk
TOOTHACHE	Gastrointestinal disorders	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected120 at risk EG0022 events2 affected121 at risk
ASTHENIA	General disorders	MedDRA 15	Systematic Assessment	EG0005 events4 affected118 at risk EG0018 events7 affected120 at risk EG0029 events9 affected121 at risk
OEDEMA	General disorders	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0014 events4 affected120 at risk EG0020 events0 affected121 at risk
BREAST INFECTION	Infections and infestations	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0010 events0 affected120 at risk EG0022 events2 affected121 at risk
FUNGAL INFECTION	Infections and infestations	MedDRA 15	Systematic Assessment	EG0003 events3 affected118 at risk EG0011 events1 affected120 at risk EG0021 events1 affected121 at risk
GASTROENTERITIS	Infections and infestations	MedDRA 15	Systematic Assessment	EG0002 events2 affected118 at risk EG0011 events1 affected120 at risk EG0020 events0 affected121 at risk
WEIGHT DECREASED	Investigations	MedDRA 15	Systematic Assessment	EG0003 events3 affected118 at risk EG0014 events4 affected120 at risk EG0020 events0 affected121 at risk
HYPERCALCAEMIA	Metabolism and nutrition disorders	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected120 at risk EG0023 events3 affected121 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 15	Systematic Assessment	EG00015 events14 affected118 at risk EG00110 events10 affected120 at risk EG00213 events12 affected121 at risk
NECK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0011 events1 affected120 at risk EG0023 events3 affected121 at risk
PERIPHERAL SENSORY NEUROPATHY	Nervous system disorders	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0011 events1 affected120 at risk EG0022 events2 affected121 at risk
INSOMNIA	Psychiatric disorders	MedDRA 15	Systematic Assessment	EG0004 events4 affected118 at risk EG0015 events4 affected120 at risk EG00212 events11 affected121 at risk
DYSURIA	Renal and urinary disorders	MedDRA 15	Systematic Assessment	EG0003 events3 affected118 at risk EG00111 events5 affected120 at risk EG0020 events0 affected121 at risk
VULVOVAGINAL DRYNESS	Reproductive system and breast disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0012 events2 affected120 at risk EG0022 events2 affected121 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 15	Systematic Assessment	EG00010 events10 affected118 at risk EG00112 events10 affected120 at risk EG0026 events6 affected121 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 15	Systematic Assessment	EG0004 events4 affected118 at risk EG0014 events4 affected120 at risk EG0026 events5 affected121 at risk
NASAL DRYNESS	Respiratory, thoracic and mediastinal disorders	MedDRA 15	Systematic Assessment	EG0002 events2 affected118 at risk EG0013 events3 affected120 at risk EG0020 events0 affected121 at risk
OROPHARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0013 events3 affected120 at risk EG0022 events2 affected121 at risk
ALOPECIA	Skin and subcutaneous tissue disorders	MedDRA 15	Systematic Assessment	EG0006 events6 affected118 at risk EG0019 events9 affected120 at risk EG0025 events5 affected121 at risk
DRY SKIN	Skin and subcutaneous tissue disorders	MedDRA 15	Systematic Assessment	EG00024 events22 affected118 at risk EG00132 events30 affected120 at risk EG0023 events3 affected121 at risk
HYPERHIDROSIS	Skin and subcutaneous tissue disorders	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected120 at risk EG0022 events2 affected121 at risk
NAIL RIDGING	Skin and subcutaneous tissue disorders	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0012 events2 affected120 at risk EG0020 events0 affected121 at risk
ONYCHOMADESIS	Skin and subcutaneous tissue disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0012 events2 affected120 at risk EG0020 events0 affected121 at risk
PAPULE	Skin and subcutaneous tissue disorders	MedDRA 15	Systematic Assessment	EG0002 events2 affected118 at risk EG0011 events1 affected120 at risk EG0020 events0 affected121 at risk
RASH ERYTHEMATOUS	Skin and subcutaneous tissue disorders	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0012 events2 affected120 at risk EG0020 events0 affected121 at risk
SKIN EXFOLIATION	Skin and subcutaneous tissue disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0015 events5 affected120 at risk EG0021 events1 affected121 at risk
URTICARIA	Skin and subcutaneous tissue disorders	MedDRA 15	Systematic Assessment	EG0002 events2 affected118 at risk EG0010 events0 affected120 at risk EG0022 events2 affected121 at risk
LYMPHOEDEMA	Vascular disorders	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0011 events1 affected120 at risk EG0022 events2 affected121 at risk
PALPITATIONS	Cardiac disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0014 events4 affected120 at risk EG0021 events1 affected121 at risk
VERTIGO	Ear and labyrinth disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected120 at risk EG0022 events2 affected121 at risk
CONJUNCTIVITIS	Eye disorders	MedDRA 15	Systematic Assessment	EG0007 events6 affected118 at risk EG00113 events10 affected120 at risk EG0022 events2 affected121 at risk
EYE IRRITATION	Eye disorders	MedDRA 15	Systematic Assessment	EG0002 events2 affected118 at risk EG0019 events7 affected120 at risk EG0021 events1 affected121 at risk
EYE PRURITUS	Eye disorders	MedDRA 15	Systematic Assessment	EG0007 events6 affected118 at risk EG0013 events3 affected120 at risk EG0024 events4 affected121 at risk
OCULAR HYPERAEMIA	Eye disorders	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0012 events2 affected120 at risk EG0022 events2 affected121 at risk
VISION BLURRED	Eye disorders	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0014 events4 affected120 at risk EG0022 events2 affected121 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 15	Systematic Assessment	EG0005 events5 affected118 at risk EG00110 events8 affected120 at risk EG0029 events9 affected121 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 15	Systematic Assessment	EG0005 events5 affected118 at risk EG0016 events6 affected120 at risk EG0028 events8 affected121 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA 15	Systematic Assessment	EG0006 events6 affected118 at risk EG0015 events5 affected120 at risk EG0028 events7 affected121 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 15	Systematic Assessment	EG00070 events46 affected118 at risk EG001103 events61 affected120 at risk EG00216 events13 affected121 at risk
DRY MOUTH	Gastrointestinal disorders	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0012 events2 affected120 at risk EG0021 events1 affected121 at risk
GASTRITIS	Gastrointestinal disorders	MedDRA 15	Systematic Assessment	EG0003 events3 affected118 at risk EG0013 events3 affected120 at risk EG0020 events0 affected121 at risk
MOUTH ULCERATION	Gastrointestinal disorders	MedDRA 15	Systematic Assessment	EG0002 events2 affected118 at risk EG0014 events4 affected120 at risk EG0021 events1 affected121 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 15	Systematic Assessment	EG00018 events13 affected118 at risk EG00120 events16 affected120 at risk EG00214 events12 affected121 at risk
STOMATITIS	Gastrointestinal disorders	MedDRA 15	Systematic Assessment	EG0006 events6 affected118 at risk EG0019 events9 affected120 at risk EG0024 events4 affected121 at risk
TONGUE ULCERATION	Gastrointestinal disorders	MedDRA 15	Systematic Assessment	EG0002 events2 affected118 at risk EG0010 events0 affected120 at risk EG0020 events0 affected121 at risk
VOMITING	Gastrointestinal disorders	MedDRA 15	Systematic Assessment	EG00010 events9 affected118 at risk EG00116 events13 affected120 at risk EG00212 events11 affected121 at risk
FATIGUE	General disorders	MedDRA 15	Systematic Assessment	EG00011 events11 affected118 at risk EG0019 events8 affected120 at risk EG00211 events11 affected121 at risk
FEELING COLD	General disorders	MedDRA 15	Systematic Assessment	EG0002 events2 affected118 at risk EG0010 events0 affected120 at risk EG0020 events0 affected121 at risk
INFLUENZA LIKE ILLNESS	General disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0010 events0 affected120 at risk EG0022 events2 affected121 at risk
IRRITABILITY	General disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0010 events0 affected120 at risk EG0022 events2 affected121 at risk
MUCOSAL INFLAMMATION	General disorders	MedDRA 15	Systematic Assessment	EG0008 events6 affected118 at risk EG00113 events10 affected120 at risk EG0021 events1 affected121 at risk
NON-CARDIAC CHEST PAIN	General disorders	MedDRA 15	Systematic Assessment	EG0002 events2 affected118 at risk EG0012 events2 affected120 at risk EG0020 events0 affected121 at risk
HYPERSENSITIVITY	Immune system disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0012 events2 affected120 at risk EG0020 events0 affected121 at risk
CELLULITIS	Infections and infestations	MedDRA 15	Systematic Assessment	EG0004 events3 affected118 at risk EG0012 events2 affected120 at risk EG0021 events1 affected121 at risk
CYSTITIS	Infections and infestations	MedDRA 15	Systematic Assessment	EG0003 events3 affected118 at risk EG0010 events0 affected120 at risk EG0020 events0 affected121 at risk
FOLLICULITIS	Infections and infestations	MedDRA 15	Systematic Assessment	EG0002 events2 affected118 at risk EG0012 events2 affected120 at risk EG0020 events0 affected121 at risk
FURUNCLE	Infections and infestations	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0014 events2 affected120 at risk EG0020 events0 affected121 at risk
LOCALISED INFECTION	Infections and infestations	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0013 events3 affected120 at risk EG0020 events0 affected121 at risk
NAIL INFECTION	Infections and infestations	MedDRA 15	Systematic Assessment	EG0002 events2 affected118 at risk EG0013 events1 affected120 at risk EG0020 events0 affected121 at risk
NASOPHARYNGITIS	Infections and infestations	MedDRA 15	Systematic Assessment	EG0004 events3 affected118 at risk EG0018 events7 affected120 at risk EG0022 events2 affected121 at risk
ONYCHOMYCOSIS	Infections and infestations	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0013 events3 affected120 at risk EG0020 events0 affected121 at risk
RASH PUSTULAR	Infections and infestations	MedDRA 15	Systematic Assessment	EG0009 events7 affected118 at risk EG00117 events15 affected120 at risk EG0020 events0 affected121 at risk
SINUSITIS	Infections and infestations	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0012 events1 affected120 at risk EG0023 events3 affected121 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 15	Systematic Assessment	EG0005 events5 affected118 at risk EG0013 events3 affected120 at risk EG0022 events2 affected121 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 15	Systematic Assessment	EG00013 events11 affected118 at risk EG00115 events13 affected120 at risk EG00215 events10 affected121 at risk
PROCEDURAL PAIN	Injury, poisoning and procedural complications	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0012 events2 affected120 at risk EG0020 events0 affected121 at risk
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 15	Systematic Assessment	EG0003 events3 affected118 at risk EG0017 events5 affected120 at risk EG0020 events0 affected121 at risk
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 15	Systematic Assessment	EG0005 events3 affected118 at risk EG0016 events6 affected120 at risk EG0020 events0 affected121 at risk
BLOOD ALKALINE PHOSPHATASE INCREASED	Investigations	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0013 events3 affected120 at risk EG0020 events0 affected121 at risk
BLOOD CREATININE INCREASED	Investigations	MedDRA 15	Systematic Assessment	EG0004 events3 affected118 at risk EG0010 events0 affected120 at risk EG0020 events0 affected121 at risk
ELECTROCARDIOGRAM QT PROLONGED	Investigations	MedDRA 15	Systematic Assessment	EG0002 events2 affected118 at risk EG00110 events9 affected120 at risk EG0025 events4 affected121 at risk
GAMMA-GLUTAMYLTRANSFERASE INCREASED	Investigations	MedDRA 15	Systematic Assessment	EG0003 events3 affected118 at risk EG0015 events5 affected120 at risk EG0022 events2 affected121 at risk
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA 15	Systematic Assessment	EG00016 events14 affected118 at risk EG00111 events11 affected120 at risk EG0025 events5 affected121 at risk
DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected120 at risk EG0023 events3 affected121 at risk
HYPOALBUMINAEMIA	Metabolism and nutrition disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0013 events3 affected120 at risk EG0020 events0 affected121 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 15	Systematic Assessment	EG00015 events14 affected118 at risk EG00110 events10 affected120 at risk EG00227 events23 affected121 at risk
ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 15	Systematic Assessment	EG0002 events2 affected118 at risk EG0012 events2 affected120 at risk EG0022 events2 affected121 at risk
BONE PAIN	Musculoskeletal and connective tissue disorders	MedDRA 15	Systematic Assessment	EG0002 events2 affected118 at risk EG0017 events6 affected120 at risk EG0026 events6 affected121 at risk
MUSCULOSKELETAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA 15	Systematic Assessment	EG0007 events6 affected118 at risk EG0015 events5 affected120 at risk EG0025 events5 affected121 at risk
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected120 at risk EG0029 events9 affected121 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 15	Systematic Assessment	EG00015 events13 affected118 at risk EG0015 events5 affected120 at risk EG00210 events7 affected121 at risk
TUMOUR HAEMORRHAGE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15	Systematic Assessment	EG0002 events2 affected118 at risk EG0012 events1 affected120 at risk EG0020 events0 affected121 at risk
AGEUSIA	Nervous system disorders	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0012 events2 affected120 at risk EG0020 events0 affected121 at risk
DYSGEUSIA	Nervous system disorders	MedDRA 15	Systematic Assessment	EG0003 events3 affected118 at risk EG0011 events1 affected120 at risk EG0020 events0 affected121 at risk
HEADACHE	Nervous system disorders	MedDRA 15	Systematic Assessment	EG00012 events10 affected118 at risk EG00113 events10 affected120 at risk EG00223 events18 affected121 at risk
LETHARGY	Nervous system disorders	MedDRA 15	Systematic Assessment	EG0002 events2 affected118 at risk EG0011 events1 affected120 at risk EG0021 events1 affected121 at risk
NEUROPATHY PERIPHERAL	Nervous system disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0013 events3 affected120 at risk EG0020 events0 affected121 at risk
PARAESTHESIA	Nervous system disorders	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0014 events4 affected120 at risk EG0020 events0 affected121 at risk
ANXIETY	Psychiatric disorders	MedDRA 15	Systematic Assessment	EG0002 events2 affected118 at risk EG0011 events1 affected120 at risk EG0025 events4 affected121 at risk
MOOD SWINGS	Psychiatric disorders	MedDRA 15	Systematic Assessment	EG0002 events2 affected118 at risk EG0010 events0 affected120 at risk EG0021 events1 affected121 at risk
HAEMATURIA	Renal and urinary disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0012 events2 affected120 at risk EG0020 events0 affected121 at risk
LEUKOCYTURIA	Renal and urinary disorders	MedDRA 15	Systematic Assessment	EG0002 events1 affected118 at risk EG0016 events5 affected120 at risk EG0021 events1 affected121 at risk
PROTEINURIA	Renal and urinary disorders	MedDRA 15	Systematic Assessment	EG0002 events2 affected118 at risk EG0010 events0 affected120 at risk EG0020 events0 affected121 at risk
BREAST PAIN	Reproductive system and breast disorders	MedDRA 15	Systematic Assessment	EG0004 events4 affected118 at risk EG0016 events6 affected120 at risk EG00215 events6 affected121 at risk
VAGINAL HAEMORRHAGE	Reproductive system and breast disorders	MedDRA 15	Systematic Assessment	EG0002 events2 affected118 at risk EG0011 events1 affected120 at risk EG0022 events2 affected121 at risk
BRONCHOSPASM	Respiratory, thoracic and mediastinal disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected120 at risk EG0022 events2 affected121 at risk
DYSPHONIA	Respiratory, thoracic and mediastinal disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0010 events0 affected120 at risk EG0022 events2 affected121 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA 15	Systematic Assessment	EG0002 events2 affected118 at risk EG0016 events5 affected120 at risk EG0020 events0 affected121 at risk
NASAL INFLAMMATION	Respiratory, thoracic and mediastinal disorders	MedDRA 15	Systematic Assessment	EG0001 events1 affected118 at risk EG0012 events2 affected120 at risk EG0020 events0 affected121 at risk
RHINORRHOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected120 at risk EG0023 events3 affected121 at risk
ACNE	Skin and subcutaneous tissue disorders	MedDRA 15	Systematic Assessment	EG0002 events2 affected118 at risk EG0019 events6 affected120 at risk EG0021 events1 affected121 at risk
DERMATITIS	Skin and subcutaneous tissue disorders	MedDRA 15	Systematic Assessment	EG0002 events2 affected118 at risk EG0016 events6 affected120 at risk EG0020 events0 affected121 at risk
DERMATITIS ACNEIFORM	Skin and subcutaneous tissue disorders	MedDRA 15	Systematic Assessment	EG00023 events19 affected118 at risk EG00137 events31 affected120 at risk EG0022 events2 affected121 at risk
ERYTHEMA	Skin and subcutaneous tissue disorders	MedDRA 15	Systematic Assessment	EG0004 events4 affected118 at risk EG0019 events7 affected120 at risk EG00215 events3 affected121 at risk
NAIL DYSTROPHY	Skin and subcutaneous tissue disorders	MedDRA 15	Systematic Assessment	EG0000 events0 affected118 at risk EG0012 events2 affected120 at risk EG0020 events0 affected121 at risk
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME	Skin and subcutaneous tissue disorders	MedDRA 15	Systematic Assessment	EG0003 events3 affected118 at risk EG00113 events13 affected120 at risk EG0021 events1 affected121 at risk
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA 15	Systematic Assessment	EG00017 events15 affected118 at risk EG00113 events10 affected120 at risk EG0024 events4 affected121 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA 15	Systematic Assessment	EG00042 events38 affected118 at risk EG00178 events56 affected120 at risk EG00220 events15 affected121 at risk
RASH MACULO-PAPULAR	Skin and subcutaneous tissue disorders	MedDRA 15	Systematic Assessment	EG0007 events7 affected118 at risk EG0017 events6 affected120 at risk EG0022 events2 affected121 at risk
RASH PAPULAR	Skin and subcutaneous tissue disorders	MedDRA 15	Systematic Assessment	EG0002 events2 affected118 at risk EG0011 events1 affected120 at risk EG0021 events1 affected121 at risk
SKIN ULCER	Skin and subcutaneous tissue disorders	MedDRA 15	Systematic Assessment	EG0002 events2 affected118 at risk EG0013 events2 affected120 at risk EG0021 events1 affected121 at risk
HOT FLUSH	Vascular disorders	MedDRA 15	Systematic Assessment	EG0004 events4 affected118 at risk EG0011 events1 affected120 at risk EG00211 events11 affected121 at risk
HYPERTENSION	Vascular disorders	MedDRA 15	Systematic Assessment	EG0008 events7 affected118 at risk EG00110 events9 affected120 at risk EG0026 events3 affected121 at risk

ID	Term
D009369	Neoplasms
D001943	Breast Neoplasms
D009362	Neoplasm Metastasis

ID	Term
D009371	Neoplasms by Site
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D009385	Neoplastic Processes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D009570	Nitriles
D009930	Organic Chemicals
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Title	Description
BG000	AZD8931 40mg + Anastrozole 1mg	AZD8931 40mg (bd) plus anastrozole 1mg (od)
BG001	AZD8931 20mg + Anastrozole 1mg	AZD8931 20mg (bd) plus anastrozole 1mg (od)
BG002	Placebo + Anastrozole 1mg	Placebo (bd) plus anastrozole 1mg (od)
BG003	Total	Total of all reporting groups

ID	Title	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	AZD8931 20mg	14	118	112	118
EG001	AZD8931 40mg	17	120	115	120
EG002	Placebo	11	121	99	121