Evaluation of Long-term Safety and Effectiveness of Fosta... | NCT01242514

NCT01242514

ID	Type	Description	Link
2010-020892-22	EudraCT Number

Status Module

Label	Type	Description	Intervention Names
A	Experimental	Oral treatment	Drug: Fostamatinib
B	Experimental	Oral treatment	Drug: Fostamatinib
C	Experimental	Oral treatment	Drug: Fostamatinib

Name	Type	Description	Arm Group Labels	Other Names
Fostamatinib	Drug	Fostamatinib 100mg twice daily	A
Fostamatinib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Patients Who Had at Least 1 Adverse Event in Any Category	AE = adverse event, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event	Entry in extension to end of study (variable duration; maximum 109 weeks)

Secondary Outcomes

Measure	Description	Time Frame
Mean DAS28-CRP Score	DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, CRP = C-reactive protein, qd = once daily

Eligibility Module

Name	Affiliation	Role
Chris O'Brien, MD PhD	AstraZeneca	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Anniston	Alabama		United States
Research Site

Results Section

Participant Flow Module

ID	Title	Description
FG000	Fostamatinib 100 mg Bid	Oral treatment
FG001	Fostamatinib 150 mg qd	Oral treatment

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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

Secondary

Mean DAS28-CRP Score

DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, CRP = C-reactive protein, qd = once daily

The full analysis set includes those patients who received at least 1 dose of investigational product, and were summarised according to treatment first received in this study (intention-to-treat principle).

Posted

Mean

Standard Deviation

Units on a scale

Weeks 0, 12, 24, 36 and 52

ID	Title	Description
OG000	Fostamatinib 100 mg Bid	Oral treatment
OG001	Fostamatinib 150 mg qd	Oral treatment
OG002	Fostamatinib 100 mg qd	Oral treatment

Units	Counts
Participants	OG0001247 OG001336 OG002198

Title

Denominators

Categories

Week 0 (n=1247, 336, 198)

Title	Measurements
	OG0004.5± 1.58(0.23 to 0.90) OG0013.8± 1.24(0.14 to 0.84) OG0023.9± 1.27(-0.12 to 0.56)

Primary

Percentage of Patients Who Had at Least 1 Adverse Event in Any Category

AE = adverse event, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event

Posted

Number

Percentage of patients

Entry in extension to end of study (variable duration; maximum 109 weeks)

ID	Title	Description
OG000	Fostamatinib 100 mg Bid	Oral treatment
OG001	Fostamatinib 150 mg qd	Oral treatment
OG002	Fostamatinib 100 mg qd	Oral treatment

Units	Counts
Participants

Secondary

Mean mTSS Score

mTSS: modified total sharp score, a measure of structural progression based upon X-rays. Hand and foot joints are scored for erosions and joint space narrowing and the results summed to give a value between 0 and 488. A higher value represents more serious progression of the disease. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, N/A = not applicable, qd = once daily

Posted

Mean

Standard Deviation

Units on a scale

Weeks 0 and 52

ID	Title	Description
OG000	Fostamatinib 100 mg Bid	Oral treatment
OG001	Fostamatinib 150 mg qd	Oral treatment
OG002	Fostamatinib 100 mg qd	Oral treatment

Units

Secondary

Mean HAQ-DI Score

HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is then calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, qd = once daily

Posted

Mean

Standard Deviation

Units on a scale

Weeks 0, 12, 24, 36 and 52

ID	Title	Description
OG000	Fostamatinib 100 mg Bid	Oral treatment
OG001	Fostamatinib 150 mg qd	Oral treatment
OG002	Fostamatinib 100 mg qd	Oral treatment

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
SPLENIC INFARCTION	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,343 at risk EG0010 events0 affected212 at risk EG0021 events1 affected357 at risk
ANGINA UNSTABLE	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
BRADYCARDIA	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,343 at risk EG0011 events1 affected212 at risk EG0020 events0 affected357 at risk
CARDIAC FAILURE CHRONIC	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
CARDIO-RESPIRATORY ARREST	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
CARDIOMYOPATHY	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
MYOCARDIAL ISCHAEMIA	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
GOITRE	Endocrine disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
RETINAL DETACHMENT	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,343 at risk EG0011 events1 affected212 at risk EG0020 events0 affected357 at risk
ACUTE ABDOMEN	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
BARRETT'S OESOPHAGUS	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,343 at risk EG0010 events0 affected212 at risk EG0021 events1 affected357 at risk
COLITIS	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
COLITIS MICROSCOPIC	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
COLONIC STENOSIS	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected1,343 at risk EG0011 events1 affected212 at risk EG0020 events0 affected357 at risk
DYSPEPSIA	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,343 at risk EG0010 events0 affected212 at risk EG0021 events1 affected357 at risk
GASTRIC ULCER	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
GASTRITIS	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,343 at risk EG0010 events0 affected212 at risk EG0021 events1 affected357 at risk
GASTRITIS EROSIVE	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
HAEMATEMESIS	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
ILEITIS	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
ILEUS	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
INGUINAL HERNIA	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,343 at risk EG0010 events0 affected212 at risk EG0021 events1 affected357 at risk
INTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
INTESTINAL ISCHAEMIA	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,343 at risk EG0010 events0 affected212 at risk EG0021 events1 affected357 at risk
OESOPHAGEAL ACHALASIA	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
PANCREATIC PSEUDOCYST	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,343 at risk EG0011 events1 affected212 at risk EG0020 events0 affected357 at risk
PANCREATITIS	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
PANCREATITIS ACUTE	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,343 at risk EG0011 events1 affected212 at risk EG0020 events0 affected357 at risk
DEVICE DISLOCATION	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
NON-CARDIAC CHEST PAIN	General disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,343 at risk EG0011 events1 affected212 at risk EG0020 events0 affected357 at risk
BILE DUCT OBSTRUCTION	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
BILIARY COLIC	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
CHOLECYSTITIS ACUTE	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,343 at risk EG0010 events0 affected212 at risk EG0021 events1 affected357 at risk
CHOLECYSTITIS CHRONIC	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,343 at risk EG0010 events0 affected212 at risk EG0021 events1 affected357 at risk
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
GALLBLADDER POLYP	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
POST CHOLECYSTECTOMY SYNDROME	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
ANAPHYLACTIC SHOCK	Immune system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
FOOD ALLERGY	Immune system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,343 at risk EG0010 events0 affected212 at risk EG0021 events1 affected357 at risk
HYPERSENSITIVITY	Immune system disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
ABSCESS LIMB	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
APPENDICITIS	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
ARTHRITIS BACTERIAL	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,343 at risk EG0011 events1 affected212 at risk EG0020 events0 affected357 at risk
BACTERAEMIA	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
BACTERIAL PYELONEPHRITIS	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
BACTERIAL SEPSIS	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
BRONCHITIS	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
BRONCHOPNEUMONIA	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,343 at risk EG0010 events0 affected212 at risk EG0021 events1 affected357 at risk
CELLULITIS	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0007 events6 affected1,343 at risk EG0011 events1 affected212 at risk EG0020 events0 affected357 at risk
CYTOMEGALOVIRUS INFECTION	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
DIVERTICULITIS	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,343 at risk EG0010 events0 affected212 at risk EG0021 events1 affected357 at risk
ENTEROCOLITIS BACTERIAL	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
ENTEROCOLITIS VIRAL	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
ERYSIPELAS	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
ESCHERICHIA URINARY TRACT INFECTION	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
GANGRENE	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
GASTROENTERITIS	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0011 events1 affected212 at risk EG0020 events0 affected357 at risk
GASTROENTERITIS BACTERIAL	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
GASTROENTERITIS VIRAL	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0021 events1 affected357 at risk
HERPES ZOSTER	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
INTERVERTEBRAL DISCITIS	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
LIVER ABSCESS	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
LUNG ABSCESS	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
OSTEOMYELITIS	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
OTITIS EXTERNA	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
PANCREATITIS VIRAL	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
PERITONITIS	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
PNEUMONIA	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected1,343 at risk EG0011 events1 affected212 at risk EG0021 events1 affected357 at risk
PNEUMONIA BACTERIAL	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
PNEUMONIA VIRAL	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
PULMONARY TUBERCULOSIS	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
STAPHYLOCOCCAL SEPSIS	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
SUBCUTANEOUS ABSCESS	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,343 at risk EG0010 events0 affected212 at risk EG0021 events1 affected357 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
URINARY TRACT INFECTION BACTERIAL	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
UROSEPSIS	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
VIRAL UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
WOUND INFECTION BACTERIAL	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,343 at risk EG0010 events0 affected212 at risk EG0021 events1 affected357 at risk
WOUND SEPSIS	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
ACCIDENTAL OVERDOSE	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,343 at risk EG0010 events0 affected212 at risk EG0022 events2 affected357 at risk
FACIAL BONES FRACTURE	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
FEMORAL NECK FRACTURE	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0011 events1 affected212 at risk EG0020 events0 affected357 at risk
FEMUR FRACTURE	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
FIBULA FRACTURE	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
HUMERUS FRACTURE	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,343 at risk EG0010 events0 affected212 at risk EG0021 events1 affected357 at risk
JOINT DISLOCATION	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
JOINT INJURY	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
PATELLA FRACTURE	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
TENDON RUPTURE	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
TIBIA FRACTURE	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,343 at risk EG0011 events1 affected212 at risk EG0020 events0 affected357 at risk
ULNA FRACTURE	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
UPPER LIMB FRACTURE	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,343 at risk EG0010 events0 affected212 at risk EG0021 events1 affected357 at risk
WOUND DEHISCENCE	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
WRIST FRACTURE	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,343 at risk EG0010 events0 affected212 at risk EG0021 events1 affected357 at risk
LIVER FUNCTION TEST ABNORMAL	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0011 events1 affected212 at risk EG0021 events1 affected357 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0021 events1 affected357 at risk
TYPE 2 DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,343 at risk EG0011 events1 affected212 at risk EG0020 events0 affected357 at risk
ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
HIP DEFORMITY	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
INTERVERTEBRAL DISC DISORDER	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,343 at risk EG0010 events0 affected212 at risk EG0021 events1 affected357 at risk
INTERVERTEBRAL DISC DISPLACEMENT	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
INTERVERTEBRAL DISC PROTRUSION	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected1,343 at risk EG0011 events1 affected212 at risk EG0020 events0 affected357 at risk
LUMBAR SPINAL STENOSIS	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
MUSCULOSKELETAL CHEST PAIN	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
OSTEITIS	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,343 at risk EG0011 events1 affected212 at risk EG0020 events0 affected357 at risk
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0008 events6 affected1,343 at risk EG0010 events0 affected212 at risk EG0022 events2 affected357 at risk
OSTEONECROSIS	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,343 at risk EG0010 events0 affected212 at risk EG0021 events1 affected357 at risk
PATHOLOGICAL FRACTURE	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
RHEUMATOID ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG00011 events9 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
SJOGREN'S SYNDROME	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
SPONDYLOLISTHESIS	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,343 at risk EG0010 events0 affected212 at risk EG0021 events1 affected357 at risk
SYNOVITIS	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,343 at risk EG0010 events0 affected212 at risk EG0021 events1 affected357 at risk
BASAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
BENIGN NEOPLASM OF PROSTATE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,343 at risk EG0010 events0 affected212 at risk EG0021 events1 affected357 at risk
BENIGN SOFT TISSUE NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
BREAST CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
CERVIX CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
COLORECTAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,343 at risk EG0010 events0 affected212 at risk EG0021 events1 affected357 at risk
GASTRIC CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
LIPOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
MALIGNANT MELANOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
PANCREATIC NEUROENDOCRINE TUMOUR	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
PROSTATE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
RECTAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,343 at risk EG0010 events0 affected212 at risk EG0021 events1 affected357 at risk
RENAL CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
RENAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,343 at risk EG0010 events0 affected212 at risk EG0021 events1 affected357 at risk
UTERINE LEIOMYOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,343 at risk EG0010 events0 affected212 at risk EG0021 events1 affected357 at risk
VAGINAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
APHASIA	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
CAROTID ARTERY STENOSIS	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
CONVULSION	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
DYSARTHRIA	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
HAEMORRHAGIC STROKE	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
HYPERTENSIVE ENCEPHALOPATHY	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
HYPOGLYCAEMIC COMA	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
ISCHAEMIC STROKE	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
LUMBAR RADICULOPATHY	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
RADICULITIS LUMBOSACRAL	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
SCIATICA	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,343 at risk EG0011 events1 affected212 at risk EG0020 events0 affected357 at risk
SYNCOPE	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,343 at risk EG0010 events0 affected212 at risk EG0022 events2 affected357 at risk
TENSION HEADACHE	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
VITH NERVE PARALYSIS	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
ADJUSTMENT DISORDER	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
ALCOHOL ABUSE	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
DEPRESSION	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
CALCULUS URETERIC	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
CALCULUS URINARY	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
NEPHROLITHIASIS	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0011 events1 affected212 at risk EG0020 events0 affected357 at risk
RENAL FAILURE ACUTE	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
RENAL IMPAIRMENT	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
URINARY BLADDER POLYP	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,343 at risk EG0010 events0 affected212 at risk EG0021 events1 affected357 at risk
ADENOMYOSIS	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
BENIGN PROSTATIC HYPERPLASIA	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
OVARIAN CYST	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
UTERINE POLYP	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,343 at risk EG0010 events0 affected212 at risk EG0021 events1 affected357 at risk
ACUTE RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0021 events1 affected357 at risk
HYPERVENTILATION	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,343 at risk EG0010 events0 affected212 at risk EG0021 events1 affected357 at risk
PNEUMONIA ASPIRATION	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
DIGITAL ULCER	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
ERYTHEMA MULTIFORME	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,343 at risk EG0010 events0 affected212 at risk EG0021 events1 affected357 at risk
TOXIC EPIDERMAL NECROLYSIS	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
AORTIC ANEURYSM RUPTURE	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
AORTIC STENOSIS	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,343 at risk EG0011 events1 affected212 at risk EG0020 events0 affected357 at risk
AORTIC THROMBOSIS	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
ARTERIAL THROMBOSIS	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
FEMORAL ARTERY OCCLUSION	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
PERIPHERAL ISCHAEMIA	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk
THROMBOPHLEBITIS SUPERFICIAL	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,343 at risk EG0010 events0 affected212 at risk EG0020 events0 affected357 at risk

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Title	Description
BG000	Fostamatinib 100 mg Bid	Oral treatment
BG001	Fostamatinib 150 mg qd	Oral treatment
BG002	Fostamatinib 100 mg qd	Oral treatment
BG003	Total	Total of all reporting groups

ID	Title	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	FOSTA 100 MG BID	153	1,343	466	1,343
EG001	FOSTA 100 MG QD	12	212	68	212
EG002	FOSTA 150 MG QD	31	357	98	357