A Clinical Trial to Compare Efficacy and Tolerability of... | NCT00274469

ID	Type	Description	Link
FIRST

Label	Type	Description	Intervention Names
1	Experimental	Fulvestrant	Drug: fulvestrant
2	Active Comparator	Anastrozole	Drug: anastrozole

Name	Type	Description	Arm Group Labels	Other Names
fulvestrant	Drug	500 mg intramuscular injection	1	Faslodex

Measure	Description	Time Frame
Clinical Benefit Rate	A Clinical Benefit (CB) responder is defined as a patient having a best overall response of either complete response (CR), partial response (PR) or stable disease (SD) for at least 24 weeks evaluated according to modified RECIST. The Clinical Benefit Rate is the percentage of patients with CB.	From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled.

Measure	Description	Time Frame
Objective Response Rate	For each patient with measurable disease at baseline, the determination of the overall response for each visit was carried out using a SAS program per Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete Response (CR): Disappearance of all target lesion (TL) and non-target lesions (NTLs) and no new lesions. Partial Response (PR): At least a 30% decrease in the sum of longest diameter of TLs (compared to baseline), no progression of NTLs and no new lesions. Objective response rate is defined as percentage of patients with either CR or PR.

Name	Affiliation	Role
AstraZeneca Faslodex Medical Science Director, MD	AstraZeneca	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Frederick	Maryland	21701	United States
Research Site

Label	URL
CSR-D6995C00006.pdf	View source
D6995C00006FIRSToverall\_survivalRevisedCSP\_4\_10\_December\_2014\_Redacted	View source

ID	Title	Description
FG000	Fulvestrant 500 mg	Fulvestrant 500 mg
FG001	Anastrozole 1 mg	Anastrozole 1 mg

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

Clinical Benefit Rate

A Clinical Benefit (CB) responder is defined as a patient having a best overall response of either complete response (CR), partial response (PR) or stable disease (SD) for at least 24 weeks evaluated according to modified RECIST. The Clinical Benefit Rate is the percentage of patients with CB.

Full Analysis Set

Posted

Number

Percentage of Participants

From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled.

ID	Title	Description
OG000	Fulvestrant 500 mg	Fulvestrant 500 mg
OG001	Anastrozole 1 mg	Anastrozole 1 mg

Units	Counts
Participants	OG000102 OG001103

Title

Denominators

Categories

Title	Measurements
	OG00072.5 OG00167.0

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 OG001		Regression, Logistic		0.386	Null hypothesis: Fulvestrant has no difference with Anastrozole	Odds Ratio (OR)	1.302			2-Sided	95	0.717	2.380			OR>1 favours Fulvestrant		Non-Inferiority	Study is powered basing on 20% deficiency in benefit rate for Fulvestrant compared to Anastrozole.

Secondary

Objective Response Rate

For each patient with measurable disease at baseline, the determination of the overall response for each visit was carried out using a SAS program per Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete Response (CR): Disappearance of all target lesion (TL) and non-target lesions (NTLs) and no new lesions. Partial Response (PR): At least a 30% decrease in the sum of longest diameter of TLs (compared to baseline), no progression of NTLs and no new lesions. Objective response rate is defined as percentage of patients with either CR or PR.

Evaluable For Response Set

Posted

Number

Percentage of Participants

ID	Title	Description
OG000	Fulvestrant 500 mg	Fulvestrant 500 mg
OG001	Anastrozole 1 mg	Anastrozole 1 mg

Units	Counts
Participants

Secondary

Time to Progression

Time from randomization until earlier of disease progression or death. Progression was defined according to RECIST: a patient is determined to have progressed if they have progression of target lesions, clear progression of existing non-target lesions, or the appearance of one or more new lesions. Progression of target lesions is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum of LD recorded. Kaplan-Meier estimates of median for each treatment are reported.

Full Analysis Set.

Posted

Median

Inter-Quartile Range

Day

ID	Title	Description
OG000	Fulvestrant 500 mg	Fulvestrant 500 mg
OG001	Anastrozole 1 mg	Anastrozole 1 mg

Units	Counts
Participants

Secondary

Time to Treatment Failure

Time from randomization to treatment discontinuation

Full analysis set.

Posted

Median

Inter-Quartile Range

Day

From randomisation to data cut off (DCO) for 75% treatment failure. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007. The DCO for 75% treatment failure was on 26 Mar 2010, 32 months after the last patient was enrolled.

ID	Title	Description
OG000	Fulvestrant 500 mg	Fulvestrant 500 mg
OG001	Anastrozole 1 mg	Anastrozole 1 mg

Units	Counts
Participants	OG000

Secondary

Time to Progression (Investigator Assessed)

Time from randomization to disease progression (investigator assessed) or death from any cause. Progression was defined by investigator opinion, as patients did not have formal RECIST visits in the follow-up period after the data cut off for the primary analysis of the study.

Full Analysis Set.

Posted

Median

Inter-Quartile Range

Day

ID	Title	Description
OG000	Fulvestrant 500 mg	Fulvestrant 500 mg
OG001	Anastrozole 1 mg	Anastrozole 1 mg

Units	Counts
Participants	OG000

Post-Hoc

Overall Survival

Time from randomization to death (any cause)

Full Analysis Set

Posted

Median

Inter-Quartile Range

Month

From randomization to data cut off (DCO) for 65% OS analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for 65% OS analysis was on 15 Jul 2014, 7 years after the last patient was enrolled.

ID	Title	Description
OG000	Fulvestrant 500 mg	Fulvestrant 500 mg
OG001	Anastrozole 1 mg	Anastrozole 1 mg

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected101 at risk EG0011 events1 affected103 at risk
BRONCHITIS	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 events1 affected101 at risk EG0010 events0 affected103 at risk
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events1 affected101 at risk EG0010 events0 affected103 at risk
CONFUSIONAL STATE	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected101 at risk EG0010 events0 affected103 at risk
FALL	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
FEMUR FRACTURE	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected101 at risk EG0012 events2 affected103 at risk
GASTRIC ULCER	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
GASTROENTERITIS VIRAL	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
HUMERUS FRACTURE	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
LACRIMAL DISORDER	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
LYMPHADENOPATHY	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
NEURALGIA	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected101 at risk EG0011 events1 affected103 at risk
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
PLEURITIC PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
PNEUMONIA	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
RADIUS FRACTURE	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected101 at risk EG0012 events2 affected103 at risk
VOMITING	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
ARRHYTHMIA	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
CARDIAC FAILURE	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 events2 affected101 at risk EG0010 events0 affected103 at risk
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0012 events1 affected103 at risk
CORONARY OSTIAL STENOSIS	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
BLINDNESS	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
ANAL HAEMRROHAGE	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
SUBILEUS	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
ASTHENIA	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
DEATH	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0012 events2 affected103 at risk
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
ARTHRITIS BACTERIAL	Infections and infestations	MedDRA	Systematic Assessment	EG0003 events1 affected101 at risk EG0010 events0 affected103 at risk
EMPYEMA	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
FEMORAL NECK FRACTURE	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
HIP FRACTURE	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
RIB FRACTURE	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
ROAD TRAFFIC ACCIDENT	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
CACHEXIA	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 events2 affected101 at risk EG0010 events0 affected103 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0003 events2 affected101 at risk EG0010 events0 affected103 at risk
BONE PAIN	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
COLON CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
LUNG CANCERMETASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
METASTASES TO THORAX	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
SARCOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
SQUAMOUS CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
TUMOUR HAEMORRAGE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
SPINAL CORD COMPRESSION	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
ANGIOEDEMA	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
CHOLECYSTECTOMY	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
HYPERTENSION	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG00014 events10 affected101 at risk EG0018 events8 affected103 at risk
BONE PAIN	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG00019 events14 affected101 at risk EG00123 events10 affected103 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00012 events10 affected101 at risk EG0015 events5 affected103 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0006 events5 affected101 at risk EG0019 events8 affected103 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0007 events6 affected101 at risk EG0017 events7 affected103 at risk
DIZZINESS	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0004 events4 affected101 at risk EG0016 events6 affected103 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0008 events7 affected101 at risk EG0017 events7 affected103 at risk
FATIGUE	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected101 at risk EG0018 events8 affected103 at risk
HEADACHE	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG00026 events4 affected101 at risk EG00116 events13 affected103 at risk
HOT FLUSH	Vascular disorders	MedDRA 10.	Systematic Assessment	EG0008 events8 affected101 at risk EG00115 events14 affected103 at risk
HYPERTENSION	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0006 events6 affected101 at risk EG0015 events2 affected103 at risk
INFLUENZA	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected101 at risk EG0016 events6 affected103 at risk
INJECTION SITE PAIN	General disorders	MedDRA 10.0	Systematic Assessment	EG00014 events6 affected101 at risk EG0010 events0 affected103 at risk
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected101 at risk EG00110 events9 affected103 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00010 events10 affected101 at risk EG0018 events7 affected103 at risk
VOMITING	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00010 events8 affected101 at risk EG0014 events3 affected103 at risk
ASTHENIA	General disorders	MedDRA	Systematic Assessment	EG00014 events8 affected101 at risk EG0019 events8 affected103 at risk
DYSPEPSIA	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 events2 affected101 at risk EG0015 events5 affected103 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0004 events2 affected101 at risk EG0012 events2 affected103 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected101 at risk EG0012 events2 affected103 at risk
HIATUS HERNIA	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected101 at risk EG0012 events2 affected103 at risk
DRY MOUTH	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected101 at risk EG0011 events1 affected103 at risk
ANAL DISCOMFORT	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0012 events2 affected103 at risk
DIVERTICULUM INTESTINAL	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0012 events2 affected103 at risk
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0012 events2 affected103 at risk
STOMATITIS	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected101 at risk EG0010 events0 affected103 at risk
ABDOMINAL DISTENSION	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
ABDOMINAL PAIN LOWER	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
FLATULENCE	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
GASTRODUODENITIS	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
GASTROINTESTINAL PAIN	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
HAEMATEMESIS	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
HAEMORRHOIDAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
HAEMORRHOIDS	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
PROCTITIS	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
RETCHING	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0014 events4 affected103 at risk
PYREXIA	General disorders	MedDRA	Systematic Assessment	EG0002 events2 affected101 at risk EG0012 events2 affected103 at risk
INFLUENZA LIKE ILLNESS	General disorders	MedDRA	Systematic Assessment	EG0003 events3 affected101 at risk EG0010 events0 affected103 at risk
INJECTION SITE HAEMATOMA	General disorders	MedDRA	Systematic Assessment	EG0003 events1 affected101 at risk EG0010 events0 affected103 at risk
INJECTION SITE HAEMORRHAGE	General disorders	MedDRA	Systematic Assessment	EG0003 events1 affected101 at risk EG0010 events0 affected103 at risk
INJECTION SITE PRURITUS	General disorders	MedDRA	Systematic Assessment	EG0003 events2 affected101 at risk EG0010 events0 affected103 at risk
APPLICATION SITE PAIN	General disorders	MedDRA	Systematic Assessment	EG0002 events1 affected101 at risk EG0010 events0 affected103 at risk
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	MedDRA	Systematic Assessment	EG0002 events1 affected101 at risk EG0010 events0 affected103 at risk
CHILLS	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
GAIT DISTURBANCE	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
INJECTION SITE NODULE	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
IRRITABILITY	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
NON-CARDIAC CHEST PAIN	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
NEURALGIA	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0012 events2 affected103 at risk
DYSGEUSIA	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0012 events2 affected103 at risk
LETHARGY	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 events2 affected101 at risk EG0010 events0 affected103 at risk
SOMNOLENCE	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0012 events2 affected103 at risk
CEREBRAL ISCHAEMIA	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
DIABETIC NEUROPATHY	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
DISTURBANCE IN ATTENTION	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
MEMORY IMPAIRMENT	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
PARKINSON'S DISEASE	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
PAROSMIA	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
SYNCOPE	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
VITH NERVE PARALYSIS	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0005 events4 affected101 at risk EG0013 events1 affected103 at risk
BRONCHITIS	Infections and infestations	MedDRA	Systematic Assessment	EG0003 events3 affected101 at risk EG0013 events3 affected103 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0003 events3 affected101 at risk EG0013 events3 affected103 at risk
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events1 affected101 at risk EG0013 events3 affected103 at risk
CYSTITIS	Infections and infestations	MedDRA	Systematic Assessment	EG0003 events3 affected101 at risk EG0011 events1 affected103 at risk
HERPES ZOSTER	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected101 at risk EG0010 events0 affected103 at risk
ORAL CANDIDIASIS	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0011 events1 affected103 at risk
SINUSITIS	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0012 events2 affected103 at risk
TONSILLITIS	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0011 events1 affected103 at risk
VIRAL UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected101 at risk EG0010 events0 affected103 at risk
WOUND INFECTION STAPHYLOCOCCAL	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0011 events1 affected103 at risk
ACARIASIS	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
BACTERIAL INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
CANDIDIASIS	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
FUNGAL INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
IMPETIGO	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
NASOPHARYNGITIS	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
OSTEOMYELITIS	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
PNEUMONIA	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
RHINITIS	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
VIRAL INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
WOUND INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
DYSPHONIA	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0015 events5 affected103 at risk
PHARYNGOLARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected101 at risk EG0011 events1 affected103 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0011 events1 affected103 at risk
NASAL CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0011 events1 affected103 at risk
ALLERGIC SINUSITIS	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
BRONCHOSPASM	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
DYSPNOEA EXERTIONAL	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
LARYNGEAL DISORDER	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
LUNG INFILTRATION	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
NASAL DRYNESS	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
RALES	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
UPPER RESPIRATORY TRACT INFLAMMATION	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
HAEMATOMA	Vascular disorders	MedDRA	Systematic Assessment	EG0002 events2 affected101 at risk EG0010 events0 affected103 at risk
HYPERAEMIA	Vascular disorders	MedDRA	Systematic Assessment	EG0002 events2 affected101 at risk EG0010 events0 affected103 at risk
PHLEBITIS	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0011 events1 affected103 at risk
HYPOTENSION	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
ALOPECIA	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0003 events3 affected101 at risk EG0012 events2 affected103 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0002 events2 affected101 at risk EG0013 events1 affected103 at risk
HYPERHIDROSIS	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0004 events4 affected101 at risk EG0010 events0 affected103 at risk
DERMATITIS CONTACT	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0003 events2 affected101 at risk EG0010 events0 affected103 at risk
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0002 events2 affected101 at risk EG0011 events1 affected103 at risk
DRY SKIN	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0011 events1 affected103 at risk
NIGHT SWEATS	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0011 events1 affected103 at risk
COLD SWEAT	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
DERMATITIS ALLERGIC	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
ECZEMA	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
SCAR	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
SUBCUTANEOUS NODULE	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
DEPRESSION	Psychiatric disorders	MedDRA	Systematic Assessment	EG0002 events2 affected101 at risk EG0014 events4 affected103 at risk
ANXIETY	Psychiatric disorders	MedDRA	Systematic Assessment	EG0003 events3 affected101 at risk EG0012 events2 affected103 at risk
INSOMNIA	Psychiatric disorders	MedDRA	Systematic Assessment	EG0002 events2 affected101 at risk EG0011 events1 affected103 at risk
DEPRESSED MOOD	Psychiatric disorders	MedDRA	Systematic Assessment	EG0002 events2 affected101 at risk EG0010 events0 affected103 at risk
CRYING	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
LIBIDO DECREASED	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
NEUROSIS	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
ANOREXIA	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 events2 affected101 at risk EG0013 events3 affected103 at risk
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 events2 affected101 at risk EG0011 events1 affected103 at risk
DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0012 events1 affected103 at risk
FLUID RETENTION	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
HYPERURICAEMIA	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
HYPOALBUMINAEMIA	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
HYPOCALCAEMIA	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
VITAMIN D DEFICIENCY	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
CONTUSION	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0011 events1 affected103 at risk
THERMAL BURN	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events2 affected101 at risk EG0010 events0 affected103 at risk
ANAEMIA POSTOPERATIVE	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
CONTRAST MEDIA REACTION	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
FALL	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
FEMUR FRACTURE	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
JOINT INJURY	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
LACERATION	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
POST PROCEDURAL COMPLICATION	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
PUBIC RAMI FRACTURE	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
RADIATION SKIN INJURY	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
RIB FRACTURE	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
SKELETAL INJURY	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
BREAST PAIN	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0012 events2 affected103 at risk
VULVOVAGINAL DRYNESS	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0012 events2 affected103 at risk
BREAST HAEMORRHAGE	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
BREAST TENDERNESS	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
CERVICAL POLYP	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
DYSPAREUNIA	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
GENITAL DISCHARGE	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
GENITAL RASH	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
METRORRHAGIA	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA	Systematic Assessment	EG0003 events1 affected101 at risk EG0010 events0 affected103 at risk
BLOOD PRESSURE INCREASED	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0012 events2 affected103 at risk
BLOOD ALKALINE PHOSPHATASE INCREASED	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
GAMMA-GLUTAMYLTRANSFERASE INCREASED	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
HEPATIC ENZYME INCREASED	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
WEIGHT INCREASED	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
ACCOMMODATION DISORDER	Eye disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
CONJUNCTIVAL DISORDER	Eye disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
DIPLOPIA	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
ERYTHEMA OF EYELID	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
EXOPHTHALMOS	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
EYE PAIN	Eye disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
EYELID PTOSIS	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
MYOPIA	Eye disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
VISUAL ACUITY REDUCED	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
VERTIGO	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0014 events3 affected103 at risk
TINNITUS	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0012 events2 affected103 at risk
EAR PAIN	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
DYSURIA	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0012 events2 affected103 at risk
URINE ODOUR ABNORMAL	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
HAEMATURIA	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
NEPHROLITHIASIS	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
ANAEMIA	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0002 events2 affected101 at risk EG0011 events1 affected103 at risk
LYMPHADENOPATHY	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0002 events2 affected101 at risk EG0010 events0 affected103 at risk
HEPATIC PAIN	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0012 events2 affected103 at risk
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
HEPATIC FUNCTION ABNORMAL	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
LIVER TENDERNESS	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
CONTRAST MEDIA ALLERGY	Immune system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0011 events1 affected103 at risk
SEASONAL ALLERGY	Immune system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0012 events2 affected103 at risk
HYPERSENSITIVITY	Immune system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
CANCER PAIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
INFECTED NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
METASTASES TO CENTRAL NERVOUS SYSTEM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
TUMOUR PAIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
LEFT VENTRICULAR DYSFUNCTION	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
PALPITATIONS	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
GOITRE	Endocrine disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0004 events4 affected101 at risk EG0013 events3 affected103 at risk
MUSCULOSKELETAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0003 events2 affected101 at risk EG0012 events2 affected103 at risk
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0013 events2 affected103 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0014 events3 affected103 at risk
JOINT STIFFNESS	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0013 events1 affected103 at risk
MUSCULOSKELETAL CHEST PAIN	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0013 events3 affected103 at risk
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 events1 affected101 at risk EG0011 events1 affected103 at risk
BURSITIS	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected103 at risk
GROIN PAIN	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
MUSCLE CONTRACTURE	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk
SYMPATHETIC POSTERIOR CERVICAL SYNDROME	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected103 at risk

ID	Term
D009371	Neoplasms by Site
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D004958	Estradiol
D004963	Estrenes
D004962	Estranes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D045166	Estradiol Congeners
D012739	Gonadal Steroid Hormones
D042341	Gonadal Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D009570	Nitriles
D009930	Organic Chemicals
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Title	Description
BG000	Fulvestrant 500 mg	Fulvestrant 500 mg
BG001	Anastrozole 1 mg	Anastrozole 1 mg
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Fulvestrant 500 mg	Fulvestrant 500 mg	63	102	24	101	71	101
EG001	Anastrozole 1 mg	Anastrozole 1 mg	74	103	22	103	70	103