Evaluation of Effectiveness of Two Dosing Regimens of Fos... | NCT01197534

ID	Type	Description	Link
2010-020744-35	EudraCT Number

Evaluation of Effectiveness of Two Dosing Regimens of Fos... | NCT01197534 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dosing Regimen A	Experimental	Oral Treatment	Drug: fostamatinib
Dosing Regimen B	Experimental	Oral Treatment	Drug: fostamatinib
Dosing Regimen C	Placebo Comparator	Oral Treatment	Drug: placebo, fostamatinib

Name	Type	Description	Arm Group Labels	Other Names
fostamatinib	Drug	fostamatinib 100 mg twice daily	Dosing Regimen A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of Patients With ACR20 at Week 24, Comparison Between Fostamatinib and Placebo	ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.	24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Proportion of Patients Achieving ACR20, Comparison Between Fostamatinib and Placebo at Week 1	ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.

Contacts/Locations Module

Name	Affiliation	Role
Neil MacKillop, MD PhD	AstraZeneca	Study Director

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

Label	URL
Related Info	View source
Related Info	View source
Related Info

Results Section

Participant Flow Module

ID	Title	Description
FG000	FOSTA 100 MG BID PO	Dosing Group A
FG001	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO	Dosing Group B

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Not reported		FG00016 subjects FG00110 subjects FG00216 subjects
Enrolment in long term extension		FG00057 subjects FG00166 subjects FG002119 subjects
Severe non-compliance to protocol		FG0003 subjects FG0014 subjects FG0021 subjects
Lack of therapeutic response		FG0009 subjects FG0014 subjects FG0029 subjects
Dev. of study specific discont. criteria		FG00013 subjects FG0016 subjects FG0022 subjects
Lost to Follow-up		FG0001 subjects FG0014 subjects FG0022 subjects
Adverse Event		FG00035 subjects FG00136 subjects FG00224 subjects

Arm/Group Information

ID	Title	Description
BG000	FOSTA 100 MG BID PO	Dosing Group A
BG001	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO	Dosing Group B
BG002	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO	Dosing Group C
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00053± 12.3 BG00154± 11.6 BG00253± 11.8 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000245 BG001245 BG002

Race/Ethnicity, Customized

Number

Participants

Title

Denominators

Categories

White

Title	Measurements
	BG000254 BG001235 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Proportion of Patients With ACR20 at Week 24, Comparison Between Fostamatinib and Placebo

ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.

The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.

Posted

Number

Percentage of responders

24 weeks

ID	Title	Description
OG000	FOSTA 100 MG BID PO	Dosing Group A
OG001	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO	Dosing Group B
OG002	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO	Dosing Group C

Units	Counts
Participants	OG000308 OG001298 OG002302

Title

Denominators

Categories

Title	Measurements
	OG00039.6 OG00139.6 OG00224.5

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 OG002	Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.	Mantel Haenszel	Treatment difference in proportion of responders using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.	<0.001	Week 24	Weighted difference in proportions	0.15			2-Sided	95	0.08	0.22				No	Superiority or Other

Secondary

Proportion of Patients Achieving ACR20, Comparison Between Fostamatinib and Placebo at Week 1

ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.

Posted

Number

Percentage of responders

1 week

ID	Title	Description
OG000	FOSTA 100 MG BID PO (Combined)	Dosing Group A and B combined
OG001	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO	Dosing Group C

Units	Counts
Participants

Secondary

Proportion of Patients Achieving ACR50, Comparison Between Fostamatinib and Placebo at Week 24

ACR50: American College of Rheumatology 50% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.

Posted

Number

Percentage of responders

24 weeks

ID	Title	Description
OG000	FOSTA 100 MG BID PO	Dosing Group A
OG001	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO	Dosing Group B
OG002	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO	Dosing Group C

Units

Secondary

Proportion of Patients Achieving ACR70, Comparison Between Fostamatinib and Placebo at Week 24

ACR70: American College of Rheumatology 70% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.

Posted

Number

Percentage of responders

24 weeks

ID	Title	Description
OG000	FOSTA 100 MG BID PO	Dosing Group A
OG001	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO	Dosing Group B
OG002	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO	Dosing Group C

Units

Secondary

ACRn - Comparison Between Fostamatinib and Placebo at Week 24

ACRn: American College of Rheumatology index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints), or in blood test measures of inflammation (such as CRP) or the physician or patient's own assessments of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. BID = twice daily, CI = confidence interval, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, PO = orally, QD = once a day. Mean refers to change at Week 24.

Posted

Mean

Standard Deviation

Percentage improvement from baseline

Baseline and 24 weeks

ID	Title	Description
OG000	FOSTA 100 MG BID PO	Dosing Group A
OG001	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO	Dosing Group B
OG002	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO

Secondary

Proportion of Patients Achieving DAS28-CRP <2.6 at Week 12, Comparison Between Fostamatinib and Placebo

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. A DAS28-CRP score of <2.6 is indicative of remission of RA symptoms. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.

Posted

Number

Percentage of responders

12 weeks

ID	Title	Description
OG000	FOSTA 100 MG BID PO	Dosing Group A
OG001	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO	Dosing Group B
OG002	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO	Dosing Group C

Secondary

Proportion of Patients Achieving DAS28-CRP <2.6 at Week 24, Comparison Between Fostamatinib and Placebo

Posted

Number

Percentage of responders

24 weeks

ID	Title	Description
OG000	FOSTA 100 MG BID PO	Dosing Group A
OG001	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO	Dosing Group B
OG002	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO	Dosing Group C

Secondary

Proportion of Patients Achieving DAS28 EULAR Response at Week 24

Change in DAS28 was derived for each post baseline scheduled assessment and categorised using the European League Against Rheumatism (EULAR) response criteria. BID = twice daily, DAS28 = Disease Activity Score based on a 28-joint count, DMARD = disease-modifying anti-rheumatic drug, OR=odds ratio, PO = orally, QD = once a day.

Posted

Number

Percentage of responders

24 weeks

ID	Title	Description
OG000	FOSTA 100 MG BID PO	Dosing Group A
OG001	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO	Dosing Group B
OG002	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO	Dosing Group C

Units	Counts

Secondary

HAQ-DI Response - Comparison of the Change(>=0.22) From Baseline Between Fostamatinib and Placebo at Week 24

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. The HAQ-DI response is a reduction from baseline in HAQ-DI score greater than or equal to the minimally important difference (0.22). BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.

Posted

Number

Percentage of responders

Baseline and 24 weeks

ID	Title	Description
OG000	FOSTA 100 MG BID PO	Dosing Group A
OG001	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO	Dosing Group B
OG002	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO

Secondary

Change From Baseline to Week 24 in mTSS, Comparison Between Fostamatinib and Placebo

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 448. A higher value represents more serious progression of the disease. After disregarding ineligible records, patients with 2 or more non-missing values have had missing data imputed via linear extrapolation/interpolation methods. Patients with only 1 result were excluded from the analysis. ANCOVA = analysis of covariance, BID = twice daily, IP = investigational product, QD = once a day.

The full analysis set includes patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle. Measurements at 2 timepoints are required for a patient to be included in the analysis; therefore patients with only 1 result have been excluded from the analysis population.

Posted

Mean

Standard Deviation

Units on a scale

Baseline and 24 weeks

ID	Title	Description
OG000	FOSTA 100 MG BID PO	Dosing Group A
OG001	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO	Dosing Group B
OG002	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO

Secondary

SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 24

SF-36: 36-item Short Form Health Survey, a measure of health related quality of life. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0-100. Physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with mean of 50+/- 10. Higher scores represent a better quality of life. Mean changes from baseline score are presented as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease modifying antirheumatic drugs, PO = orally, QD = once a day.

Posted

Mean

Standard Deviation

Units on a scale

Baseline and 24 weeks

ID	Title	Description
OG000	FOSTA 100 MG BID PO	Dosing Group A
OG001	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO	Dosing Group B
OG002

Secondary

SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 24

Posted

Mean

Standard Deviation

Units on a scale

Baseline and 24 weeks

ID	Title	Description
OG000	FOSTA 100 MG BID PO	Dosing Group A
OG001	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO	Dosing Group B
OG002

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	FOSTA 100 MG BID	Dosing Group A	30	308	170	308
EG001	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD	Dosing Group B	25	298	152	298
EG002	PLACEBO (24 WKS) THEN FOSTA 100 MG BID - FOSTA Period	Dosing Group C	10	302	42	302
EG003	PLACEBO (24 WKS) THEN FOSTA 100 MG BID - Placebo Period		10	302	77	302

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0010 events0 affected298 at risk EG0021 events1 affected302 at risk EG0030 events0 affected302 at risk
ANGINA PECTORIS	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0011 events1 affected298 at risk EG0020 events0 affected302 at risk EG003
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected308 at risk EG0011 events1 affected298 at risk EG0020 events0 affected302 at risk EG003
ATRIAL FLUTTER	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0010 events0 affected298 at risk EG0021 events1 affected302 at risk EG003
CARDIAC ARREST	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
LEFT VENTRICULAR FAILURE	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0010 events0 affected298 at risk EG0021 events1 affected302 at risk EG003
VENTRICULAR FIBRILLATION	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
MACULAR HOLE	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0011 events1 affected298 at risk EG0020 events0 affected302 at risk EG003
COLITIS	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0011 events1 affected298 at risk EG0020 events0 affected302 at risk EG003
COLITIS ULCERATIVE	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
DIARRHOEA	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
GASTRITIS	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
GASTRITIS EROSIVE	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0010 events0 affected298 at risk EG0021 events1 affected302 at risk EG003
GASTRITIS HAEMORRHAGIC	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0010 events0 affected298 at risk EG0021 events1 affected302 at risk EG003
LOWER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
OESOPHAGITIS ULCERATIVE	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0010 events0 affected298 at risk EG0021 events1 affected302 at risk EG003
PANCREATITIS CHRONIC	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
STOMATITIS	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
VOMITING	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0011 events1 affected298 at risk EG0020 events0 affected302 at risk EG003
NON-CARDIAC CHEST PAIN	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
CHOLECYSTITIS ACUTE	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0011 events1 affected298 at risk EG0020 events0 affected302 at risk EG003
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0012 events2 affected298 at risk EG0020 events0 affected302 at risk EG003
HEPATOCELLULAR INJURY	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
NON-ALCOHOLIC STEATOHEPATITIS	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
ACUTE SINUSITIS	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
ARTHRITIS BACTERIAL	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0010 events0 affected298 at risk EG0021 events1 affected302 at risk EG003
ATYPICAL PNEUMONIA	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0010 events0 affected298 at risk EG0021 events1 affected302 at risk EG003
BRONCHITIS	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
BRONCHITIS BACTERIAL	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0011 events1 affected298 at risk EG0020 events0 affected302 at risk EG003
BRONCHITIS VIRAL	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0010 events0 affected298 at risk EG0021 events1 affected302 at risk EG003
BURSITIS INFECTIVE	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
DENGUE FEVER	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0011 events1 affected298 at risk EG0020 events0 affected302 at risk EG003
DEVICE RELATED INFECTION	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0011 events1 affected298 at risk EG0020 events0 affected302 at risk EG003
ENTEROCOLITIS BACTERIAL	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
ESCHERICHIA INFECTION	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
GASTROENTERITIS	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
GASTROENTERITIS BACTERIAL	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0011 events1 affected298 at risk EG0021 events1 affected302 at risk EG003
GASTROINTESTINAL BACTERIAL INFECTION	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
HERPES SIMPLEX	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
INFLUENZA	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0011 events1 affected298 at risk EG0020 events0 affected302 at risk EG003
PNEUMOCOCCAL SEPSIS	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
PNEUMONIA	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
PNEUMONIA STREPTOCOCCAL	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
URINARY TRACT INFECTION BACTERIAL	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0011 events1 affected298 at risk EG0020 events0 affected302 at risk EG003
CLAVICLE FRACTURE	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
FEMORAL NECK FRACTURE	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0010 events0 affected298 at risk EG0021 events1 affected302 at risk EG003
HIP FRACTURE	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0011 events1 affected298 at risk EG0020 events0 affected302 at risk EG003
HUMERUS FRACTURE	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
OVERDOSE	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
ULNA FRACTURE	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0011 events1 affected298 at risk EG0020 events0 affected302 at risk EG003
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0011 events1 affected298 at risk EG0020 events0 affected302 at risk EG003
BLOOD CREATINE PHOSPHOKINASE INCREASED	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
HYPOCALCAEMIA	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0011 events1 affected298 at risk EG0020 events0 affected302 at risk EG003
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0011 events1 affected298 at risk EG0020 events0 affected302 at risk EG003
OBESITY	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
MYOSITIS	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0011 events1 affected298 at risk EG0020 events0 affected302 at risk EG003
PATHOLOGICAL FRACTURE	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0010 events0 affected298 at risk EG0021 events1 affected302 at risk EG003
RHEUMATOID ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0012 events2 affected298 at risk EG0020 events0 affected302 at risk EG003
BONE NEOPLASM MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
METASTASES TO CENTRAL NERVOUS SYSTEM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
METASTATIC BRONCHIAL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
PARATHYROID TUMOUR BENIGN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
RENAL ONCOCYTOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
SQUAMOUS CELL CARCINOMA OF SKIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
CAROTID ARTERY STENOSIS	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
CONVULSION	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0011 events1 affected298 at risk EG0020 events0 affected302 at risk EG003
LUMBAR RADICULOPATHY	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
SYNCOPE	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0011 events1 affected298 at risk EG0020 events0 affected302 at risk EG003
ANXIETY	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
RENAL FAILURE ACUTE	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0011 events1 affected298 at risk EG0020 events0 affected302 at risk EG003
URINARY RETENTION	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0011 events1 affected298 at risk EG0020 events0 affected302 at risk EG003
ENDOMETRIOSIS	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0011 events1 affected298 at risk EG0020 events0 affected302 at risk EG003
MENORRHAGIA	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0011 events1 affected298 at risk EG0020 events0 affected302 at risk EG003
UTERINE HAEMORRHAGE	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
UTERINE POLYP	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
ACUTE RESPIRATORY DISTRESS SYNDROME	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
ALLERGIC BRONCHITIS	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0010 events0 affected298 at risk EG0021 events1 affected302 at risk EG003
ASTHMA	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0011 events1 affected298 at risk EG0020 events0 affected302 at risk EG003
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0010 events0 affected298 at risk EG0020 events0 affected302 at risk EG003
PULMONARY TOXICITY	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0011 events1 affected298 at risk EG0020 events0 affected302 at risk EG003
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected308 at risk EG0011 events1 affected298 at risk EG0020 events0 affected302 at risk EG003
DEEP VEIN THROMBOSIS	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0011 events1 affected298 at risk EG0020 events0 affected302 at risk EG003
MALIGNANT HYPERTENSION	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected308 at risk EG0011 events1 affected298 at risk EG0020 events0 affected302 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
DIARRHOEA	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00044 events44 affected308 at risk EG00147 events47 affected298 at risk EG00215 events15 affected302 at risk EG00313 events13 affected302 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00020 events20 affected308 at risk EG00117 events17 affected298 at risk EG0025 events5 affected302 at risk EG003
NASOPHARYNGITIS	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG00037 events37 affected308 at risk EG00129 events29 affected298 at risk EG0022 events2 affected302 at risk EG003
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 15.1	Systematic Assessment	EG00021 events21 affected308 at risk EG00114 events14 affected298 at risk EG0022 events2 affected302 at risk EG003
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 15.1	Systematic Assessment	EG00017 events17 affected308 at risk EG00113 events13 affected298 at risk EG0023 events3 affected302 at risk EG003
BLOOD PRESSURE INCREASED	Investigations	MedDRA 15.1	Systematic Assessment	EG00015 events15 affected308 at risk EG00115 events15 affected298 at risk EG0021 events1 affected302 at risk EG003
RHEUMATOID ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG00019 events19 affected308 at risk EG00123 events23 affected298 at risk EG0021 events1 affected302 at risk EG003
HEADACHE	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG00019 events19 affected308 at risk EG00112 events12 affected298 at risk EG0025 events5 affected302 at risk EG003
HYPERTENSION	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG00068 events68 affected308 at risk EG00155 events55 affected298 at risk EG00217 events17 affected302 at risk EG003

Ancestor Terms

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

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	Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.	Mantel Haenszel	95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.	<0.001		Weighted difference in proportion	0.08			2-Sided	95	0.04	0.12				No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.	Mantel Haenszel	95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.	<0.001		Weighted difference in proportions	0.13			2-Sided	95	0.07	0.18				No	Superiority or Other
OG001 OG002	Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.	Mantel Haenszel	95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.	<0.001		Weighted difference in proportions	0.10			2-Sided	95	0.05	0.15				No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.	Mantel Haenszel	95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.	<0.001		Weighted difference in proportions	0.07			2-Sided	95	0.03	0.10				No	Superiority or Other
OG001 OG002	Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.	Mantel Haenszel	95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.	0.033		Weighted difference in proportions	0.03			2-Sided	95	0.00	0.07				No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.	Van Elteren	P-values are estimated using the Van Elteren test stratified by background use of DMARD and pooled country.	<0.001	Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.												No	Superiority or Other
OG001 OG002	Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.	Van Elteren	P-values are estimated using the Van Elteren test stratified by background use of DMARD and pooled country.	<0.001	Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.												No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.	Regression, Logistic	Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.	<0.001		Odds Ratio (OR)	7.1			2-Sided	95	3.42	14.80			An odds ratio >1 indicates a benefit towards fostamatinib.	No	Superiority or Other
OG001 OG002	Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.	Regression, Logistic	Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.	<0.001		Odds Ratio (OR)	4.0			2-Sided	95	1.88	8.65			An odds ratio >1 indicates a benefit towards fostamatinib.	No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.	Regression, Logistic	Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.	<0.001		Odds Ratio (OR)	7.3			2-Sided	95	3.23	16.65			An odds ratio >1 indicates a benefit towards fostamatinib.	No	Superiority or Other
OG001 OG002	Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.	Regression, Logistic	Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.	<0.001		Odds Ratio (OR)	6.4			2-Sided	95	2.81	14.71			An odds ratio >1 indicates a benefit towards fostamatinib.	No	Superiority or Other

Title

Denominators

Categories

No response

Title	Measurements
	OG00042.9± 1.46(0.20 to 0.68) OG00145.3± 1.34(0.26 to 0.89) OG00264.6± 1.30(0.20 to 0.65)

Moderate response

Title	Measurements
	OG00033.8 OG00134.9 OG00229.1

Good response

Title	Measurements
	OG00023.4 OG00119.8 OG0026.3

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.	Proportional odds model	No Response, moderate response and good response are included in the model, with treatment, background use of DMARD and pooled country as factors.	<0.001	Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.	Odds Ratio (OR)	2.84			2-Sided	95	2.06	3.91			An odds ratio > 1 indicates a benefit towards fostamatinib.	No	Superiority or Other
OG001 OG002	Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.	Proportional odds model	No Response, moderate response and good response are included in the model, with treatment, background use of DMARD and pooled country as factors.	<0.001	Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.	Odds Ratio (OR)	2.44			2-Sided	95	1.77	3.37			An odds ratio > 1 indicates a benefit towards fostamatinib.	No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.	Regression, Logistic	Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.	<0.001		Odds Ratio (OR)	2.4			2-Sided	95	1.73	3.46			An odds ratio >1 indicates a benefit towards fostamatinib.	No	Superiority or Other
OG001 OG002	Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.	Regression, Logistic	Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.	<0.001		Odds Ratio (OR)	2.1			2-Sided	95	1.46	2.94			An odds ratio >1 indicates a benefit towards fostamatinib.	No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	This analysis is performed using an ANCOVA model on the ranks of the change from baseline, by pooled country and background use of DMARD, including a term for the ranks of the baseline score as a covariate.	Cochran-Mantel-Haenszel	Residuals from ANCOVA are analysed using a Cochran-Mantel-Haenszel approach, adjusting for the effects of pooled country and background use of DMARD.	0.904	As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.												No	Superiority or Other
OG001 OG002	This analysis is performed using an ANCOVA model on the ranks of the change from baseline, by pooled country and background use of DMARD, including a term for the ranks of the baseline score as a covariate.	Cochran-Mantel-Haenszel	Residuals from ANCOVA are analysed using a Cochran-Mantel-Haenszel approach, adjusting for the effects of pooled country and background use of DMARD.	0.342	As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.												No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.	ANCOVA	Including terms for baseline as continuous covariate and treatment, background use of DMARD and pooled country as factors.	<0.001	Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.	Treatment difference	2.47			2-Sided	95	1.47	3.48				No	Superiority or Other
OG001 OG002	Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.	ANCOVA	Including terms for baseline as continuous covariate and treatment, background use of DMARD and pooled country as factors.	0.001	Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.	Treatment difference	1.64			2-Sided	95	0.63	2.65				No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.	ANCOVA	Including terms for baseline as continuous covariate and treatment, background use of DMARD and pooled country as factors.	<0.001	Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.	Treatment difference	2.09			2-Sided	95	0.97	3.20				No	Superiority or Other
OG001 OG002	Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.	ANCOVA	Including terms for baseline as continuous covariate and treatment, background use of DMARD and pooled country as factors.	<0.001	Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.	Treatment difference	1.96			2-Sided	95	0.83	3.08				No	Superiority or Other