Open-Label Study Of Exemestane With Or Without Celecoxib... | NCT00038103

ID	Type	Description	Link
A3191139

Label	Type	Description	Intervention Names
1.	Active Comparator		Drug: Exemestane
2.	Experimental		Drug: Celecoxib + Exemestane

Name	Type	Description	Arm Group Labels	Other Names
Exemestane	Drug	Patient will be instructed to take a 25 mg exemestane tablet, once a day, every day, with food.	1.

Measure	Description	Time Frame
Number of Subjects With Clinical Benefit	Clinical benefit was based on objective tumor assessments made according to Response Evaluation Criteria (RECIST) system of unidimensional evaluation. Includes subjects with complete response (CR), partial response (PR), and long term disease stabilization (SD) for at least 24 weeks.	Baseline, Week 8, 16, 24, and every 12 weeks beyond 24 up to Week 108 and every 24 weeks thereafter until 9 months following last subject last visit (LSLV)

Measure	Description	Time Frame
Number of Subjects With Objective Response	Objective tumor response includes subjects with CR or PR according to RECIST.	Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV
Duration of Clinical Benefit

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Dallas	Texas	75204	United States
Pfizer Investigational Site

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	Exemestane (Exemestane Alone)	oral dose exemestane taken with food (25 mg tablet once daily)
FG001	Combination (Exemestane + Celecoxib)	oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)

ID	Title	Description
BG000	Exemestane (Exemestane Alone)	oral dose exemestane taken with food (25 mg tablet once daily)
BG001	Combination (Exemestane + Celecoxib)	oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00055 BG00156 BG002111

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

Number of Subjects With Clinical Benefit

Clinical benefit was based on objective tumor assessments made according to Response Evaluation Criteria (RECIST) system of unidimensional evaluation. Includes subjects with complete response (CR), partial response (PR), and long term disease stabilization (SD) for at least 24 weeks.

Evaluable population

Posted

Number

participants

Baseline, Week 8, 16, 24, and every 12 weeks beyond 24 up to Week 108 and every 24 weeks thereafter until 9 months following last subject last visit (LSLV)

ID	Title	Description
OG000	Exemestane (Exemestane Alone)	oral dose exemestane taken with food (25 mg tablet once daily)
OG001	Combination (Exemestane + Celecoxib)	oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)

Units	Counts
Participants	OG00049 OG00151

Title

Denominators

Categories

Title	Measurements
	OG00024 OG00124

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						Clinical Benefit Rate	49.0				95	34.4	63.7			Number of subjects showing clinical benefits out of the number of subjects in the evaluable set.	No	Superiority or Other
OG001

Secondary

Number of Subjects With Objective Response

Objective tumor response includes subjects with CR or PR according to RECIST.

Evaluable population

Posted

Number

participants

Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV

ID	Title	Description
OG000	Exemestane (Exemestane Alone)	oral dose exemestane taken with food (25 mg tablet once daily)
OG001	Combination (Exemestane + Celecoxib)	oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)

Units	Counts
Participants	OG000

Secondary

Duration of Clinical Benefit

Time from randomization date to first objective documentation of tumor progression or death due to tumor progression in the absence of previous documentation of tumor progression.

Evaluable population. Number of participants analyzed = number of subjects with clinical benefit.

Posted

Median

95% Confidence Interval

weeks

Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV

ID	Title	Description
OG000	Exemestane (Exemestane Alone)	oral dose exemestane taken with food (25 mg tablet once daily)
OG001	Combination (Exemestane + Celecoxib)	oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)

Units	Counts
Participants	OG000

Secondary

Duration of Objective Response (in Subjects With CR or PR)

Time from the first objective documentation of response until the first objective documentation of tumor progression.

Evaluable population. Number of participants analyzed = number of subjects with objective response.

Posted

Median

95% Confidence Interval

weeks

Baseline, Weeks 8, 16, 24, every 12 weeks beyond 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV

ID	Title	Description
OG000	Exemestane (Exemestane Alone)	oral dose exemestane taken with food (25 mg tablet once daily)
OG001	Combination (Exemestane + Celecoxib)	oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)

Units	Counts
Participants	OG000

Secondary

Duration of Long-Term SD

Time from start of treatment until the first objective documentation of tumor progression or death due to tumor progression in the absence of previous documentation of tumor progression in subjects with long-term SD.

Evaluable population. Number of participants analyzed = number of subjects with long-term SD.

Posted

Median

95% Confidence Interval

weeks

Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months LSLV

ID	Title	Description
OG000	Exemestane (Exemestane Alone)	oral dose exemestane taken with food (25 mg tablet once daily)
OG001	Combination (Exemestane + Celecoxib)	oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)

Units	Counts
Participants	OG000

Secondary

Time to Tumor Progression

Time from randomization to first objective tumor recurrence or progression or death due to tumor progression in the absence of previous documentation of tumor progression.

Evaluable population

Posted

Median

95% Confidence Interval

weeks

Baseline, Weeks 8, 16, 24, every 12 weeks beyond Week 24 up to Week 108 and every 24 weeks thereafter until 9 months following LSLV

ID	Title	Description
OG000	Exemestane (Exemestane Alone)	oral dose exemestane taken with food (25 mg tablet once daily)
OG001	Combination (Exemestane + Celecoxib)	oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)

Units	Counts
Participants	OG000

Secondary

Time to Treatment Failure

Time from randomization to first objective tumor recurrence or progression or death due to any cause or withdrawal from study treatment due to any reason, whichever was the earliest.

Evaluable population

Posted

Median

95% Confidence Interval

Weeks

Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV

ID	Title	Description
OG000	Exemestane (Exemestane Alone)	oral dose exemestane taken with food (25 mg tablet once daily)
OG001	Combination (Exemestane + Celecoxib)	oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)

Units	Counts
Participants	OG000

Secondary

Survival

Time from randomization to date of death (any cause).

Evaluable population

Posted

Median

95% Confidence Interval

weeks

Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV or death

ID	Title	Description
OG000	Exemestane (Exemestane Alone)	oral dose exemestane taken with food (25 mg tablet once daily)
OG001	Combination (Exemestane + Celecoxib)	oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Jaundice	Hepatobiliary disorders	Systematic Assessment	EG0002 affected53 at risk EG0010 affected56 at risk
Pain	General disorders	Systematic Assessment	EG0001 affected53 at risk EG0011 affected56 at risk
Post procedural complication	Reproductive system and breast disorders	Systematic Assessment	EG0001 affected53 at risk EG0010 affected56 at risk
Death	General disorders	Systematic Assessment	EG0001 affected53 at risk EG0011 affected56 at risk
Ascites	Gastrointestinal disorders	Systematic Assessment	EG0001 affected53 at risk EG0010 affected56 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0001 affected53 at risk EG0010 affected56 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0002 affected53 at risk EG0010 affected56 at risk
General physical health deterioration	General disorders	Systematic Assessment	EG0001 affected53 at risk EG0011 affected56 at risk
Asterixis	Nervous system disorders	Systematic Assessment	EG0001 affected53 at risk EG0010 affected56 at risk
Deep Vein Thrombosis	Vascular disorders	Systematic Assessment	EG0001 affected53 at risk EG0011 affected56 at risk
Neck Pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected53 at risk EG0010 affected56 at risk
Gait Disturbance	General disorders	Systematic Assessment	EG0001 affected53 at risk EG0011 affected56 at risk
Disorientation	Psychiatric disorders	Systematic Assessment	EG0001 affected53 at risk EG0010 affected56 at risk
Asthenia	General disorders	Systematic Assessment	EG0002 affected53 at risk EG0010 affected56 at risk
Dizziness	Psychiatric disorders	Systematic Assessment	EG0001 affected53 at risk EG0010 affected56 at risk
Lung Disorder	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected53 at risk EG0010 affected56 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 affected53 at risk EG0013 affected56 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected53 at risk EG0010 affected56 at risk
Intestinal Obstruction	Gastrointestinal disorders	Systematic Assessment	EG0001 affected53 at risk EG0010 affected56 at risk
Knee Arthroplasty	Surgical and medical procedures	Systematic Assessment	EG0000 affected53 at risk EG0011 affected56 at risk
Scleroderma	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected53 at risk EG0011 affected56 at risk
Miller Fisher Syndrome	Nervous system disorders	Systematic Assessment	EG0000 affected53 at risk EG0011 affected56 at risk
Polyneuropathy	Nervous system disorders	Systematic Assessment	EG0000 affected53 at risk EG0011 affected56 at risk
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0000 affected53 at risk EG0011 affected56 at risk
Fatigue	General disorders	Systematic Assessment	EG0000 affected53 at risk EG0011 affected56 at risk
Paresis	Nervous system disorders	Systematic Assessment	EG0000 affected53 at risk EG0011 affected56 at risk
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected53 at risk EG0011 affected56 at risk
Back Pain	General disorders	Systematic Assessment	EG0000 affected53 at risk EG0011 affected56 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected53 at risk EG0011 affected56 at risk
Metastatic Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected53 at risk EG0011 affected56 at risk
Dermatitis Allergic	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected53 at risk EG0011 affected56 at risk
Cardiac Failure Congestive	Cardiac disorders	Systematic Assessment	EG0000 affected53 at risk EG0011 affected56 at risk
Wrist Fracture	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected53 at risk EG0011 affected56 at risk
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected53 at risk EG0011 affected56 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Tinnitus	Ear and labyrinth disorders	MedDRA (v5.1)	Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Vertigo	Ear and labyrinth disorders		Systematic Assessment	EG0001 affected53 at risk EG0011 affected53 at risk
Conjunctivitis	Eye disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Abdominal pain	Gastrointestinal disorders		Systematic Assessment	EG0002 affected53 at risk EG0013 affected53 at risk
Abdominal pain upper	Gastrointestinal disorders		Systematic Assessment	EG0002 affected53 at risk EG0013 affected53 at risk
Ascites	Gastrointestinal disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Cheilitis	Gastrointestinal disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Constipation	Gastrointestinal disorders		Systematic Assessment	EG0004 affected53 at risk EG0010 affected53 at risk
Diarrhoea	Gastrointestinal disorders		Systematic Assessment	EG0003 affected53 at risk EG0015 affected53 at risk
Dysphagia	Gastrointestinal disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Faecal incontinence	Gastrointestinal disorders		Systematic Assessment	EG0001 affected53 at risk EG0011 affected53 at risk
Gastritis	Gastrointestinal disorders		Systematic Assessment	EG0001 affected53 at risk EG0012 affected53 at risk
Intestinal obstruction	Gastrointestinal disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Nausea	Gastrointestinal disorders		Systematic Assessment	EG0005 affected53 at risk EG0013 affected53 at risk
Odynophagia	Gastrointestinal disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Oesophagitis	Gastrointestinal disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Peptic ulcer	Gastrointestinal disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Toothache	Gastrointestinal disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Vomiting	Gastrointestinal disorders		Systematic Assessment	EG0008 affected53 at risk EG0012 affected53 at risk
Asthenia	General disorders		Systematic Assessment	EG0004 affected53 at risk EG0016 affected53 at risk
Axillary pain	General disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Chest pain	General disorders		Systematic Assessment	EG0002 affected53 at risk EG0012 affected53 at risk
Death	General disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Fatigue	General disorders		Systematic Assessment	EG0004 affected53 at risk EG0013 affected53 at risk
Gait disturbance	General disorders		Systematic Assessment	EG0002 affected53 at risk EG0012 affected53 at risk
General physical health deterioration	General disorders		Systematic Assessment	EG0001 affected53 at risk EG0011 affected53 at risk
Inflammation	General disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Oedema	General disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Oedema peripheral	General disorders		Systematic Assessment	EG0002 affected53 at risk EG0012 affected53 at risk
Pain	General disorders		Systematic Assessment	EG0002 affected53 at risk EG0012 affected53 at risk
Pyrexia	General disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Ulcer haemorrhage	General disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Jaundice	Hepatobiliary disorders		Systematic Assessment	EG0002 affected53 at risk EG0011 affected53 at risk
Hypersensitivity	Immune system disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Fungal infection	Infections and infestations		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Gastroenteritis	Infections and infestations		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Lymphangitis	Infections and infestations		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Respiratory tract infection	Infections and infestations		Systematic Assessment	EG0002 affected53 at risk EG0010 affected53 at risk
Sinusitis	Infections and infestations		Systematic Assessment	EG0001 affected53 at risk EG0011 affected53 at risk
Upper respiratory tract infection	Infections and infestations		Systematic Assessment	EG0001 affected53 at risk EG0011 affected53 at risk
Urinary tract infection	Infections and infestations		Systematic Assessment	EG0001 affected53 at risk EG0015 affected53 at risk
Fall	Injury, poisoning and procedural complications		Systematic Assessment	EG0001 affected53 at risk EG0011 affected53 at risk
Joint dislocation	Injury, poisoning and procedural complications		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Medical device complication	Injury, poisoning and procedural complications		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Post procedural complication	Injury, poisoning and procedural complications		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Wound	Injury, poisoning and procedural complications		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Alanine aminotransferase increased	Investigations		Systematic Assessment	EG0001 affected53 at risk EG0011 affected53 at risk
Aspartate aminotransferase	Investigations		Systematic Assessment	EG0001 affected53 at risk EG0011 affected53 at risk
Blood alkaline phosphatase	Investigations		Systematic Assessment	EG0002 affected53 at risk EG0010 affected53 at risk
Blood alkaline phosphatase increased	Investigations		Systematic Assessment	EG0002 affected53 at risk EG0010 affected53 at risk
Gamma-glutamyltransferase	Investigations		Systematic Assessment	EG0001 affected53 at risk EG0011 affected53 at risk
Low density lipoprotein	Investigations		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Neutrophil count decreased	Investigations		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Platelet count decreased	Investigations		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Weight decreased	Investigations		Systematic Assessment	EG0002 affected53 at risk EG0011 affected53 at risk
Weight increased	Investigations		Systematic Assessment	EG0002 affected53 at risk EG0010 affected53 at risk
White blood cell count decreased	Investigations		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Anorexia	Metabolism and nutrition disorders		Systematic Assessment	EG0007 affected53 at risk EG0013 affected53 at risk
Diabetes mellitus	Metabolism and nutrition disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Hypercalcaemia	Metabolism and nutrition disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders		Systematic Assessment	EG0002 affected53 at risk EG0010 affected53 at risk
Hyperglycaemia	Metabolism and nutrition disorders		Systematic Assessment	EG0003 affected53 at risk EG0011 affected53 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders		Systematic Assessment	EG0002 affected53 at risk EG0010 affected53 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Hypocalcaemia	Metabolism and nutrition disorders		Systematic Assessment	EG0004 affected53 at risk EG0010 affected53 at risk
Hypoglycaemia	Metabolism and nutrition disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Arthralgia	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0005 affected53 at risk EG0016 affected53 at risk
Back pain	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0008 affected53 at risk EG00110 affected53 at risk
Bone pain	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0002 affected53 at risk EG0015 affected53 at risk
Joint stiffness	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0001 affected53 at risk EG0012 affected53 at risk
Myalgia	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0003 affected53 at risk EG0012 affected53 at risk
Neck pain	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0001 affected53 at risk EG0011 affected53 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0007 affected53 at risk EG0015 affected53 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)		Systematic Assessment	EG0002 affected53 at risk EG0010 affected53 at risk
Asterixis	Nervous system disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Ataxia	Nervous system disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Dizziness	Nervous system disorders		Systematic Assessment	EG0002 affected53 at risk EG0010 affected53 at risk
Headache	Nervous system disorders		Systematic Assessment	EG0005 affected53 at risk EG0014 affected53 at risk
Hypoaesthesia	Nervous system disorders		Systematic Assessment	EG0001 affected53 at risk EG0011 affected53 at risk
Paraesthesia	Nervous system disorders		Systematic Assessment	EG0002 affected53 at risk EG0012 affected53 at risk
Peripheral sensory neuropathy	Nervous system disorders		Systematic Assessment	EG0001 affected53 at risk EG0013 affected53 at risk
Peroneal nerve palsy	Nervous system disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Sensory loss	Nervous system disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Anxiety	Psychiatric disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Confusional state	Psychiatric disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Disorientation	Psychiatric disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Insomnia	Psychiatric disorders		Systematic Assessment	EG0003 affected53 at risk EG0011 affected53 at risk
Dysuria	Renal and urinary disorders		Systematic Assessment	EG0002 affected53 at risk EG0010 affected53 at risk
Proteinuria	Renal and urinary disorders		Systematic Assessment	EG0003 affected53 at risk EG0010 affected53 at risk
Pyuria	Renal and urinary disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Urinary incontinence	Renal and urinary disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Breast pain	Reproductive system and breast disorders		Systematic Assessment	EG0001 affected53 at risk EG0012 affected53 at risk
Pelvic pain	Reproductive system and breast disorders		Systematic Assessment	EG0001 affected53 at risk EG0011 affected53 at risk
Vaginal discharge	Reproductive system and breast disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Vaginal haemorrhage	Reproductive system and breast disorders		Systematic Assessment	EG0002 affected53 at risk EG0010 affected53 at risk
Vulvovaginal pruritus	Reproductive system and breast disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Cough	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0009 affected53 at risk EG0014 affected53 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0002 affected53 at risk EG0010 affected53 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0004 affected53 at risk EG0017 affected53 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0002 affected53 at risk EG0010 affected53 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0001 affected53 at risk EG0011 affected53 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders		Systematic Assessment	EG0002 affected53 at risk EG0011 affected53 at risk
Pruritus	Skin and subcutaneous tissue disorders		Systematic Assessment	EG0003 affected53 at risk EG0010 affected53 at risk
Rash	Skin and subcutaneous tissue disorders		Systematic Assessment	EG0003 affected53 at risk EG0012 affected53 at risk
Deep vein thrombosis	Vascular disorders		Systematic Assessment	EG0001 affected53 at risk EG0011 affected53 at risk
Hot flush	Vascular disorders		Systematic Assessment	EG0006 affected53 at risk EG0018 affected53 at risk
Hypertension	Vascular disorders		Systematic Assessment	EG0001 affected53 at risk EG0012 affected53 at risk
Lymphoedema	Vascular disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Pallor	Vascular disorders		Systematic Assessment	EG0001 affected53 at risk EG0011 affected53 at risk
Phlebitis	Vascular disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Vasodilatation	Vascular disorders		Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk
Anaemia	Blood and lymphatic system disorders		Systematic Assessment	EG0000 affected53 at risk EG0012 affected53 at risk
Cardiac failure congestive	Cardiac disorders		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Visual impairment	Eye disorders		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Abdominal discomfort	Gastrointestinal disorders		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Gastrointestinal pain	Gastrointestinal disorders		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Mouth ulceration	Gastrointestinal disorders		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Malaise	General disorders		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Acarodermatitis	Infections and infestations		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Breast cellulitis	Infections and infestations		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Bronchitis	Infections and infestations		Systematic Assessment	EG0000 affected53 at risk EG0013 affected53 at risk
Bronchitis viral	Infections and infestations		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Ear infection	Infections and infestations		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Influenza	Infections and infestations		Systematic Assessment	EG0000 affected53 at risk EG0012 affected53 at risk
Nasopharyngitis	Infections and infestations		Systematic Assessment	EG0000 affected53 at risk EG0012 affected53 at risk
Tinea pedis	Infections and infestations		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Tooth infection	Infections and infestations		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Tracheitis	Infections and infestations		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Wrist fracture	Injury, poisoning and procedural complications		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Alanine aminotransferase	Investigations		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Hepatic enzyme increased	Investigations		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Pulse pressure increased	Investigations		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Hypoproteinaemia	Metabolism and nutrition disorders		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Flank pain	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0000 affected53 at risk EG0012 affected53 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Osteitis deformans	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Scleroderma	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Brachial plexopathy	Nervous system disorders		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Carpal tunnel syndrome	Nervous system disorders		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Dysaesthesia	Nervous system disorders		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Dysarthria	Nervous system disorders		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Miller Fisher syndrome	Nervous system disorders		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Paresis	Nervous system disorders		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Polyneuropathy	Nervous system disorders		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Somnolence	Nervous system disorders		Systematic Assessment	EG0000 affected53 at risk EG0012 affected53 at risk
Urge incontinence	Renal and urinary disorders		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Alopecia	Skin and subcutaneous tissue disorders		Systematic Assessment	EG0000 affected53 at risk EG0012 affected53 at risk
Dermatitis	Skin and subcutaneous tissue disorders		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Eczema	Skin and subcutaneous tissue disorders		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Skin lesion	Skin and subcutaneous tissue disorders		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Cholecystectomy	Surgical and medical procedures		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Knee arthroplasty	Surgical and medical procedures		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Hypotension	Vascular disorders		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Varicose vein	Vascular disorders		Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk
Dyspepsia	Gastrointestinal disorders		Systematic Assessment	EG0000 affected53 at risk EG0012 affected53 at risk

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D013450	Sulfones
D013457	Sulfur Compounds
D011720	Pyrazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Exemestane (Exemestane Alone)	oral dose exemestane taken with food (25 mg tablet once daily)			9		45
EG001	Combination (Exemestane + Celecoxib)	oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)			14		43