Efficacy and Safety Study of R935788 Tablets to Treat Rhe... | NCT00665626

NCT00665626

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental	Fostamatinib disodium (R935788) 100 mg tablet, orally, twice-a-day	Drug: Fostamatinib disodium (R935788)
Arm 2	Placebo Comparator	Placebo, orally, twice-a-day	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Fostamatinib disodium (R935788)	Drug	R935788 100 mg tablet, orally, twice-a-day	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
American College of Rheumatology 20 (ACR20) Response at 3 Months	The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI); and CRP or ESR, after 3 months	3 months

Secondary Outcomes

Measure	Description	Time Frame
American College of Rheumatology 50 (ACR50) Response at 3 Months	The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and CRP or ESR, whichever was elevated at baseline, after 3 months	3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients must give written informed consent by signing an IRB/EC-approved Informed Consent Form (ICF) prior to admission to this study.
Males and females, 18 years of age or older, with active RA for at least 12 months prior to Day 1 dosing
Are currently receiving or previously had received a biologic therapy with an inhibitor of TNF, rituximab, abatacept, or anakinra at an approved labeled dose for ≥3 months prior to Day 1 dosing and are designated as biologic therapy failures for lack of efficacy, safety, or tolerability.
Patients may receive stable doses of methotrexate (MTX), azathioprine (not in combination with MTX), leflunomide (not in combination with MTX), sulfasalazine, chloroquine, hydroxychloroquine, gold, NSAIDs (including COX2 inhibitors), minocycline, or doxycycline. The dose must have been stable for at least 30 days prior to Day 1 dosing and must not be changed during the washout, screening and treatment periods, unless dictated by tolerability requirements. Patients who are taking MTX must have been receiving weekly MTX doses (7.5-25 mg/week) for a minimum of 3 months prior to Day 1 dosing and must be receiving a stable MTX dose, with no change in route, for the previous 6 weeks prior to Day 1 dosing. Patients who are receiving MTX must also be receiving folic or folinic acid supplementation at a stable dose for at least 6 weeks prior to Day 1 dosing.
Females of childbearing potential must be fully informed of the potential for R788 to adversely affect the fetus and, if sexually active, must agree to use a well established method of birth control during the study (oral contraceptive, mechanical barrier, long acting hormonal agent). These patients must not be lactating and must have a negative urine pregnancy test at the time of randomization and at each laboratory determination.
The patient must otherwise be in good health as determined by the Investigator on the basis of medical history, physical examination, and laboratory screening tests during the screening period. See exclusion criteria for specific exclusions.
In the Investigator's opinion, the patient has the ability to understand the nature of the study and any hazards of participation, and to communicate satisfactorily with the Investigator and to participate in, and to comply with, the requirements of the entire protocol.

Exclusion Criteria:

The patient has a history of, or a concurrent, clinically significant illness, medical condition (other than arthritis) or laboratory abnormality that, in the Investigator's opinion, could affect the conduct of the study. Specifically, excluded are patients with the following:
1. uncontrolled or poorly controlled hypertension;
2. other autoimmune disease (psoriatic arthritis, lupus, mixed connective disorder) or arthritis syndromes (gout, Lyme disease, Reiter's syndrome);
3. recent serious surgery or infectious disease;
4. recent history ( of, or treatment for, a malignancy other than nonmelanomatous skin cancer, or any history of lymphoma;
5. Hepatitis B;
6. Hepatitis C;
7. interstitial pneumonitis or active pulmonary infection on chest x-ray
8. Tuberculosis (TB)
9. known laboratory abnormalities
The patient has a history of substance abuse, drug addiction or alcoholism. Patients may consume up to 4 units of alcohol per week; however, alcohol should be avoided in the 72 hours prior to lab assessments. Patients who cannot reliably comply with this should be excluded. A unit of alcohol is defined as the following: Beer=12 oz or 355 mL; wine = 5 oz or 148 mL; sweet dessert wine=3 oz or 89 mL; 80 proof distilled spirits= 1.5 oz or 44 mL.
The patient has been treated previously treated with R788 under a different protocol.
The patient has a pacemaker, aneurysm clip or other contraindication to MRI.

Contacts/Locations Module

Name	Affiliation	Role
Daniel B Magilavy, MD	Rigel Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Arthritis & Rheumatic Disease Specialties		Aventura	California	33180	United States
Desert Medical Advances

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

ID	Title	Description
FG000	Placebo	Placebo to R788, oral tablets, twice daily, double-blind
FG001	R788 100 mg Bid	R788 100 mg, oral tablets, twice daily, double-blind

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

FG00073 subjectsParticipants randomized

FG001146 subjectsParticipants randomized

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Placebo	Placebo to R788, oral tablets, twice daily, double-blind
BG001	R788 100 mg Bid	R788 100 mg, oral tablets, twice daily, double-blind
BG002	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
	OG00027 OG00156

Secondary

American College of Rheumatology 50 (ACR50) Response at 3 Months

The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and CRP or ESR, whichever was elevated at baseline, after 3 months

Intent-to-treat population

Posted

Number

Participants

3 months

ID	Title	Description
OG000	Arm 1 - Placebo	Placebo to R788, oral tablets, twice daily, double-blind
OG001	Arm 2 - R788 100 mg Bid	R788 100 mg, oral tablets, twice daily, double-blind

Units	Counts
Participants	OG000

Secondary

American College of Rheumatology 70 (ACR70) Response at 3 Months

The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and CRP or ESR, whichever was elevated at baseline, after 3 months

Intent-to-treat population

Posted

Number

Participants

3 months

ID	Title	Description
OG000	Arm 1 - Placebo	Placebo to R788, oral tablets, twice daily, double-blind
OG001	Arm 2 - R788 100 mg Bid	R788 100 mg, oral tablets, twice daily, double-blind

Units	Counts
Participants	OG000

Secondary

American College of Rheumatology Index of Improvement (ACRn) at 3 Months

The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 3 months of treatment

Intent-to-treat population

Posted

Mean

Standard Deviation

Score

3 months

ID	Title	Description
OG000	Arm 1 - Placebo	Placebo to R788, oral tablets, twice daily, double-blind
OG001	Arm 2 - R788 100 mg Bid	R788 100 mg, oral tablets, twice daily, double-blind

Units	Counts
Participants	OG000

Secondary

Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 3 Months

Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms

Intent-to-Treat Population with CRP as Primary Phase Reactant

Posted

Number

Participants

3 months

ID	Title	Description
OG000	Arm 1 - Placebo	Placebo to R788, oral tablets, twice daily, double-blind
OG001	Arm 2 - R788 100 mg Bid	R788 100 mg, oral tablets, twice daily, double-blind

Units	Counts
Participants	OG000

Secondary

Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 3 Months

Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity.

Intent-to-Treat Population with CRP as Primary Phase Reactant

Posted

Number

Participants

3 months

ID	Title	Description
OG000	Arm 1 - Placebo	Placebo to R788, oral tablets, twice daily, double-blind
OG001	Arm 2 - R788 100 mg Bid	R788 100 mg, oral tablets, twice daily, double-blind

Units	Counts
Participants	OG000

Secondary

Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 3 Months

Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms

Intent-to-Treat Population with ESR as Primary Phase Reactant

Posted

Number

Participants

3 months

ID	Title	Description
OG000	Arm 1 - Placebo	Placebo to R788, oral tablets, twice daily, double-blind
OG001	Arm 2 - R788 100 mg Bid	R788 100 mg, oral tablets, twice daily, double-blind

Units	Counts
Participants	OG000

Secondary

Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 3 Months

Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity.

Intent-to-Treat Population with ESR as Primary Phase Reactant

Posted

Number

Participants

3 months

ID	Title	Description
OG000	Arm 1 - Placebo	Placebo to R788, oral tablets, twice daily, double-blind
OG001	Arm 2 - R788 100 mg Bid	R788 100 mg, oral tablets, twice daily, double-blind

Units	Counts
Participants	OG000

Secondary

American College of Rheumatology 20 (ACR20) Response at Week 1

The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and CRP or ESR, whichever was elevated at baseline, after 1 week.

Intent-to-treat population

Posted

Number

Participants

1 week

ID	Title	Description
OG000	Arm 1 - Placebo	Placebo to R788, oral tablets, twice daily, double-blind
OG001	Arm 2 - R788 100 mg Bid	R788 100 mg, oral tablets, twice daily, double-blind

Units	Counts
Participants	OG000

Secondary

American College of Rheumatology 20 (ACR20) Response at Week 2

The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and CRP or ESR, whichever was elevated at baseline, after 2 weeks

Intent-to-treat population

Posted

Number

Participants

2 weeks

ID	Title	Description
OG000	Arm 1 - Placebo	Placebo to R788, oral tablets, twice daily, double-blind
OG001	Arm 2 - R788 100 mg Bid	R788 100 mg, oral tablets, twice daily, double-blind

Units	Counts
Participants	OG000

Secondary

Rheumatoid Arthritis Magnetic Resonance Imaging Scoring (RAMRIS) Erosion Score at 3 Months

Change from baseline in RAMRIS erosion score (a measure of bone erosion in the hands and wrists), calculated as the score at 3 months minus the score at baseline. The erosion score runs from 0 to 250 with lower values indicating a better clinical condition. A negative change indicates an improvement in symptoms.

Intent-to-treat population with available data and received study drug. The discrepancy in the lower number of subjects than those in the ITT population is because 43 subjects either never had a complete set of MRIs (pre and post-study) or had uninterpretable results.

Posted

Mean

Standard Deviation

Score

Baseline to 3 months

ID	Title	Description
OG000	Arm 1 - Placebo	Placebo to R788, oral tablets, twice daily, double-blind
OG001	Arm 2 - R788 100 mg Bid	R788 100 mg, oral tablets, twice daily, double-blind

Units	Counts
Participants

Secondary

Rheumatoid Arthritis Magnetic Resonance Imaging Scoring (RAMRIS) Osteitis Score at 3 Months

Change from baseline in RAMRIS osteitis score (a measure of bone inflammation in the hands and wrists), calculated as the score at 3 months minus the score at baseline. The osteitis score runs from 0 to 75 with lower values indicating a better clinical condition. A negative change indicates an improvement in symptoms.

Posted

Mean

Standard Deviation

Score

Baseline to 3 months

ID	Title	Description
OG000	Arm 1 - Placebo	Placebo to R788, oral tablets, twice daily, double-blind
OG001	Arm 2 - R788 100 mg Bid	R788 100 mg, oral tablets, twice daily, double-blind

Units	Counts
Participants

Secondary

Rheumatoid Arthritis Magnetic Resonance Imaging Scoring (RAMRIS) Synovitis Score at 3 Months

Change from baseline in RAMRIS synovitis score (a measure of inflammation in the joints of the hands and wrists), calculated as the score at 3 months minus the score at baseline. The synovitis score runs from 0 to 24 with lower values indicating a better clinical condition. A negative change indicates an improvement in symptoms.

Posted

Mean

Standard Deviation

Score

Baseline to 3 months

ID	Title	Description
OG000	Arm 1 - Placebo	Placebo to R788, oral tablets, twice daily, double-blind
OG001	Arm 2 - R788 100 mg Bid	R788 100 mg, oral tablets, twice daily, double-blind

Units	Counts
Participants

Secondary

Alanine Aminotransferase (ALT) >1.5x Upper Limit of Normal (ULN)

The number of participants with ALT (a test of liver function) values greater than 1.5 times the ULN

Intent-to-treat population

Posted

Number

Participants

Any time between baseline and 3 months

ID	Title	Description
OG000	Arm 1 - Placebo	Placebo to R788, oral tablets, twice daily, double-blind
OG001	Arm 2 - R788 100 mg Bid	R788 100 mg, oral tablets, twice daily, double-blind

Units	Counts
Participants	OG000

Secondary

Alanine Aminotransferase (ALT) >1.5-2x Upper Limit of Normal (ULN)

The number of participants with ALT (a test of liver function) values greater than 1.5 to 2 times the ULN

Intent-to-treat population

Posted

Number

Participants

Any time between baseline and 3 months

ID	Title	Description
OG000	Arm 1 - Placebo	Placebo to R788, oral tablets, twice daily, double-blind
OG001	Arm 2 - R788 100 mg Bid	R788 100 mg, oral tablets, twice daily, double-blind

Units	Counts
Participants	OG000

Secondary

Alanine Aminotransferase (ALT) >2-3x Upper Limit of Normal (ULN)

The number of participants with ALT (a test of liver function) values greater than 2 to 3 times the ULN

Intent-to-treat population

Posted

Number

Participants

Any time between baseline and 3 months

ID	Title	Description
OG000	Arm 1 - Placebo	Placebo to R788, oral tablets, twice daily, double-blind
OG001	Arm 2 - R788 100 mg Bid	R788 100 mg, oral tablets, twice daily, double-blind

Units	Counts
Participants	OG000

Secondary

Alanine Aminotransferase (ALT) >3x Upper Limit of Normal (ULN)

The number of participants with ALT (a test of liver function) values greater than 3 times the ULN

Intent-to-treat population

Posted

Number

Participants

Any time between baseline and 3 months

ID	Title	Description
OG000	Arm 1 - Placebo	Placebo to R788, oral tablets, twice daily, double-blind
OG001	Arm 2 - R788 100 mg Bid	R788 100 mg, oral tablets, twice daily, double-blind

Units	Counts
Participants	OG000

Secondary

Alanine Aminotransferase (ALT) >3-5x Upper Limit of Normal (ULN)

The number of participants with ALT (a test of liver function) values greater than 3 to 5 times the ULN

Intent-to-treat population

Posted

Number

Participants

Any time between baseline and 3 months

ID	Title	Description
OG000	Arm 1 - Placebo	Placebo to R788, oral tablets, twice daily, double-blind
OG001	Arm 2 - R788 100 mg Bid	R788 100 mg, oral tablets, twice daily, double-blind

Units	Counts
Participants	OG000

Secondary

Alanine Aminotransferase (ALT) >5-10x Upper Limit of Normal (ULN)

The number of participants with ALT (a test of liver function) values greater than 5 to 10 times the ULN

Intent-to-treat population

Posted

Number

Participants

Any time between baseline and 3 months

ID	Title	Description
OG000	Arm 1 - Placebo	Placebo to R788, oral tablets, twice daily, double-blind
OG001	Arm 2 - R788 100 mg Bid	R788 100 mg, oral tablets, twice daily, double-blind

Units	Counts
Participants	OG000

Secondary

Alanine Aminotransferase (ALT) >10x Upper Limit of Normal (ULN)

The number of participants with ALT (a test of liver function) values greater than 10 times the ULN

Intent-to-treat population

Posted

Number

Participants

Any time between baseline and 3 months

ID	Title	Description
OG000	Arm 1 - Placebo	Placebo to R788, oral tablets, twice daily, double-blind
OG001	Arm 2 - R788 100 mg Bid	R788 100 mg, oral tablets, twice daily, double-blind

Units	Counts
Participants	OG000

Secondary

Aspartate Aminotransferase (AST) >1.5x Upper Limit of Normal (ULN)

The number of participants with AST (a test of liver function) values greater than 1.5 times the ULN

Intent-to-treat population

Posted

Number

Participants

Any time between baseline and 3 months

ID	Title	Description
OG000	Arm 1 - Placebo	Placebo to R788, oral tablets, twice daily, double-blind
OG001	Arm 2 - R788 100 mg Bid	R788 100 mg, oral tablets, twice daily, double-blind

Units	Counts
Participants	OG000

Secondary

Aspartate Aminotransferase (AST) >1.5-2x Upper Limit of Normal (ULN)

The number of participants with AST (a test of liver function) values greater than 1.5 to 2 times the ULN

Intent-to-treat population

Posted

Number

Participants

Any time between baseline and 3 months

ID	Title	Description
OG000	Arm 1 - Placebo	Placebo to R788, oral tablets, twice daily, double-blind
OG001	Arm 2 - R788 100 mg Bid	R788 100 mg, oral tablets, twice daily, double-blind

Units	Counts
Participants	OG000

Secondary

Aspartate Aminotransferase (AST) >2-3x Upper Limit of Normal (ULN)

The number of participants with AST (a test of liver function) values greater than 2 to 3 times the ULN

Intent-to-treat population

Posted

Number

Participants

Any time between baseline and 3 months

ID	Title	Description
OG000	Arm 1 - Placebo	Placebo to R788, oral tablets, twice daily, double-blind
OG001	Arm 2 - R788 100 mg Bid	R788 100 mg, oral tablets, twice daily, double-blind

Units	Counts
Participants	OG000

Secondary

Aspartate Aminotransferase (AST) >3x Upper Limit of Normal (ULN)

The number of participants with AST (a test of liver function) values greater than 3 times the ULN

Intent-to-treat population

Posted

Number

Participants

Any time between baseline and 3 months

ID	Title	Description
OG000	Arm 1 - Placebo	Placebo to R788, oral tablets, twice daily, double-blind
OG001	Arm 2 - R788 100 mg Bid	R788 100 mg, oral tablets, twice daily, double-blind

Units	Counts
Participants	OG000

Secondary

Aspartate Aminotransferase (AST) >3-5x Upper Limit of Normal (ULN)

The number of participants with AST (a test of liver function) values greater than 3 to 5 times the ULN

Intent-to-treat population

Posted

Number

Participants

Any time between baseline and 3 months

ID	Title	Description
OG000	Arm 1 - Placebo	Placebo to R788, oral tablets, twice daily, double-blind
OG001	Arm 2 - R788 100 mg Bid	R788 100 mg, oral tablets, twice daily, double-blind

Units	Counts
Participants	OG000

Secondary

Aspartate Aminotransferase (AST) >5-10x Upper Limit of Normal (ULN)

The number of participants with AST (a test of liver function) values greater than 5 to 10 times the ULN

Intent-to-treat population

Posted

Number

Participants

Any time between baseline and 3 months

ID	Title	Description
OG000	Arm 1 - Placebo	Placebo to R788, oral tablets, twice daily, double-blind
OG001	Arm 2 - R788 100 mg Bid	R788 100 mg, oral tablets, twice daily, double-blind

Units	Counts
Participants	OG000

Secondary

Aspartate Aminotransferase (AST) >10x Upper Limit of Normal (ULN)

The number of participants with AST (a test of liver function) values greater than 10 times the ULN

Intent-to-treat population

Posted

Number

Participants

Any time between baseline and 3 months

ID	Title	Description
OG000	Arm 1 - Placebo	Placebo to R788, oral tablets, twice daily, double-blind
OG001	Arm 2 - R788 100 mg Bid	R788 100 mg, oral tablets, twice daily, double-blind

Units	Counts
Participants	OG000

Secondary

Alkaline Phosphatase >1.5x Upper Limit of Normal (ULN) and >1.5x Baseline

The number of participants with alkaline phosphatase (a test of liver function) values greater than 1.5 times the ULN and greater than 1.5 times baseline

Intent-to-treat population

Posted

Number

Participants

Any time between baseline and 3 months

ID	Title	Description
OG000	Arm 1 - Placebo	Placebo to R788, oral tablets, twice daily, double-blind
OG001	Arm 2 - R788 100 mg Bid	R788 100 mg, oral tablets, twice daily, double-blind

Units	Counts
Participants	OG000

Secondary

Bilirubin >1.5x Upper Limit of Normal (ULN)

The number of participants with bilirubin (a test of liver function) values greater than 1.5 times the ULN

Intent-to-treat population

Posted

Number

Participants

Any time between baseline and 3 months

ID	Title	Description
OG000	Arm 1 - Placebo	Placebo to R788, oral tablets, twice daily, double-blind
OG001	Arm 2 - R788 100 mg Bid	R788 100 mg, oral tablets, twice daily, double-blind

Units	Counts
Participants	OG000

Secondary

Bilirubin >2x Upper Limit of Normal (ULN)

The number of participants with bilirubin (a test of liver function) values greater than 2 times the ULN

Intent-to-treat population

Posted

Number

Participants

Any time between baseline and 3 months

ID	Title	Description
OG000	Arm 1 - Placebo	Placebo to R788, oral tablets, twice daily, double-blind
OG001	Arm 2 - R788 100 mg Bid	R788 100 mg, oral tablets, twice daily, double-blind

Units	Counts
Participants	OG000

Secondary

Absolute Neutrophil Count (ANC) <1500/mm3

The number of participants with ANC values less than 1500/mm3

Intent-to-treat population

Posted

Number

Participants

Any time between baseline and 3 months

ID	Title	Description
OG000	Arm 1 - Placebo	Placebo to R788, oral tablets, twice daily, double-blind
OG001	Arm 2 - R788 100 mg Bid	R788 100 mg, oral tablets, twice daily, double-blind

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Placebo to R788, oral tablets, twice daily, double-blind			1	73	20	73
EG001	R788 100 mg Bid	R788 100 mg, oral tablets, twice daily, double-blind			13	146	74	146

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Coronary Artery Stenosis	Cardiac disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected146 at risk
Vomiting	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected146 at risk
Chest Pain	General disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0012 affected146 at risk
Asthenia	General disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected146 at risk
Pyrexia	General disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected146 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected146 at risk
Pneumonia	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0012 affected146 at risk
Osteomyelitis	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected146 at risk
Septic Shock	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0010 affected146 at risk
Ankle Fracture	Injury, poisoning and procedural complications	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected146 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected146 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected146 at risk
Sciatica	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected146 at risk
Transient Ischaemic Attack	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected146 at risk
Renal Failure Acute	Renal and urinary disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0011 affected146 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Neutropenia	Blood and lymphatic system disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0018 affected146 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0005 affected73 at risk EG00117 affected146 at risk
Nausea	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0002 affected73 at risk EG00113 affected146 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected73 at risk EG0019 affected146 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0004 affected73 at risk EG00112 affected146 at risk
Transaminases Increased	Investigations	MedDRA 9.0	Systematic Assessment	EG0000 affected73 at risk EG0018 affected146 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Systematic Assessment	EG0005 affected73 at risk EG0011 affected146 at risk
Headache	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0002 affected73 at risk EG00114 affected146 at risk
Hypertension	Vascular disorders	MedDRA 9.0	Systematic Assessment	EG0003 affected73 at risk EG00119 affected146 at risk

ID	Term
D001172	Arthritis, Rheumatoid

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

ID	Term
C523665	fostamatinib