Efficacy and Safety Study of R935788 Tablets to Treat Rhe... | NCT00665925

Status Module

Label	Type	Description	Intervention Names
1	Experimental	R788, 100 mg tablet, orally, twice-a-day	Drug: Fostamatinib disodium (R935788)
2	Experimental	R788, 150 mg tablet, orally, once a day	Drug: Fostamatinib disodium (R935788)
3	Placebo Comparator	Placebo, orally, either once a day, or twice a day	Drug: Placebo

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
American College of Rheumatology 20 (ACR20) Response at 6 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, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 months	6 months

Secondary Outcomes

Measure	Description	Time Frame
American College of Rheumatology 20 (ACR20) Response at 1 Week	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 C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 week

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 6 months prior to Day 1 dosing.
Patients must have been receiving weekly methotrexate 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 must be receiving a 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 (within past 2 months prior to Day 1 dosing) serious surgery or infectious disease;
4. recent history (past 5 years prior to Day 1 dosing) 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): the TB skin test should be negative.
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.

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

Facility	Status	City	State	ZIP	Country	Contacts
Divison of Rheumatology Allergy and Immunology		La Jolla	California	92037	United States
Desert Medical Advances

PubMed Identifier	Type	Citation	Retractions
20879879	Derived	Weinblatt ME, Kavanaugh A, Genovese MC, Musser TK, Grossbard EB, Magilavy DB. An oral spleen tyrosine kinase (Syk) inhibitor for rheumatoid arthritis. N Engl J Med. 2010 Sep 30;363(14):1303-12. doi: 10.1056/NEJMoa1000500. Epub 2010 Sep 22.

Results Section

Participant Flow Module

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

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Please note, baseline data were only calculated for the placebo qd and placebo bid groups. Data from the placebo groups were only pooled for the efficacy analyses.

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	OG00253 OG00387 OG004101

Secondary

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

Intent-to-treat population with available data and received study drug.

Posted

Number

Participants

1 week

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

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

Intent-to-treat population with available data and received study drug.

Posted

Number

Participants

2 weeks

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

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

Intent-to-treat population with available data and received study drug.

Posted

Number

Participants

1 month

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

American College of Rheumatology 20 (ACR20) Response at 6 Weeks

Intent-to-treat population with available data and received study drug.

Posted

Number

Participants

6 weeks

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

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

Intent-to-treat population with available data and received study drug.

Posted

Number

Participants

2 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

American College of Rheumatology 20 (ACR20) Response at 3 Months

Intent-to-treat population with available data and received study drug.

Posted

Number

Participants

3 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

American College of Rheumatology 20 (ACR20) Response at 4 Months

Intent-to-treat population with available data and received study drug.

Posted

Number

Participants

4 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

American College of Rheumatology 20 (ACR20) Response at 5 Months

Intent-to-treat population with available data and received study drug.

Posted

Number

Participants

5 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

American College of Rheumatology 50 (ACR50) Response at 1 Week

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 C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 week

Intent-to-treat population with available data and received study drug.

Posted

Number

Participants

1 week

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

American College of Rheumatology 50 (ACR50) Response at 2 Weeks

Intent-to-treat population with available data and received study drug.

Posted

Number

Participants

2 weeks

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

American College of Rheumatology 50 (ACR50) Response at 1 Month

Intent-to-treat population with available data and received study drug.

Posted

Number

Participants

1 month

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

American College of Rheumatology 50 (ACR50) Response at 6 Weeks

Intent-to-treat population with available data and received study drug.

Posted

Number

Participants

6 weeks

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

American College of Rheumatology 50 (ACR50) Response at 2 Months

Intent-to-treat population with available data and received study drug.

Posted

Number

Participants

2 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

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

Intent-to-treat population with available data and received study drug.

Posted

Number

Participants

3 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

American College of Rheumatology 50 (ACR50) Response at 4 Months

Intent-to-treat population with available data and received study drug.

Posted

Number

Participants

4 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

American College of Rheumatology 50 (ACR50) Response at 5 Months

Intent-to-treat population with available data and received study drug.

Posted

Number

Participants

5 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

American College of Rheumatology 50 (ACR50) Response at 6 Months

Intent-to-treat population with available data and received study drug.

Posted

Number

Participants

6 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

American College of Rheumatology 70 (ACR70) Response at 1 Week

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 C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 week

Intent-to-treat population with available data and received study drug.

Posted

Number

Participants

1 week

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

American College of Rheumatology 70 (ACR70) Response at 2 Weeks

Intent-to-treat population with available data and received study drug.

Posted

Number

Participants

2 weeks

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

American College of Rheumatology 70 (ACR70) Response at 1 Month

Intent-to-treat population with available data and received study drug.

Posted

Number

Participants

1 month

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

American College of Rheumatology 70 (ACR70) Response at 6 Weeks

Intent-to-treat population with available data and received study drug.

Posted

Number

Participants

6 weeks

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

American College of Rheumatology 70 (ACR70) Response at 2 Months

Intent-to-treat population with available data and received study drug.

Posted

Number

Participants

2 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

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

Intent-to-treat population with available data and received study drug.

Posted

Number

Participants

3 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

American College of Rheumatology 70 (ACR70) Response at 4 Months

Intent-to-treat population with available data and received study drug.

Posted

Number

Participants

4 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

American College of Rheumatology 70 (ACR70) Response at 5 Months

Intent-to-treat population with available data and received study drug.

Posted

Number

Participants

5 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

American College of Rheumatology 70 (ACR70) Response at 6 Months

Intent-to-treat population with available data and received study drug.

Posted

Number

Participants

6 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

American College of Rheumatology Index of Improvement (ACRn) at 1 Week

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 1 week of treatment

Intent-to-treat population with available data and received study drug.

Posted

Mean

Standard Deviation

Score

1 week

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind
OG004	Arm 5 - R788 100 mg Bid

Secondary

American College of Rheumatology Index of Improvement (ACRn) at 2 Weeks

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 2 weeks of treatment

Intent-to-treat population with available data and received study drug.

Posted

Mean

Standard Deviation

Score

2 weeks

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind
OG004	Arm 5 - R788 100 mg Bid

Secondary

American College of Rheumatology Index of Improvement (ACRn) at 1 Month

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 1 month of treatment

Intent-to-treat population with available data and received study drug.

Posted

Mean

Standard Deviation

Score

1 month

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind
OG004	Arm 5 - R788 100 mg Bid

Secondary

American College of Rheumatology Index of Improvement (ACRn) at 6 Weeks

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 6 weeks of treatment

Intent-to-treat population with available data and received study drug.

Posted

Mean

Standard Deviation

Score

6 weeks

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind
OG004	Arm 5 - R788 100 mg Bid

Secondary

American College of Rheumatology Index of Improvement (ACRn) at 2 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 2 months of treatment

Intent-to-treat population with available data and received study drug.

Posted

Mean

Standard Deviation

Score

2 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind
OG004	Arm 5 - R788 100 mg Bid

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 with available data and received study drug.

Posted

Mean

Standard Deviation

Score

3 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind
OG004	Arm 5 - R788 100 mg Bid

Secondary

American College of Rheumatology Index of Improvement (ACRn) at 4 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 4 months of treatment

Intent-to-treat population with available data and received study drug.

Posted

Mean

Standard Deviation

Score

4 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind
OG004	Arm 5 - R788 100 mg Bid

Secondary

American College of Rheumatology Index of Improvement (ACRn) at 5 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 5 months of treatment

Intent-to-treat population with available data and received study drug.

Posted

Mean

Standard Deviation

Score

5 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind
OG004	Arm 5 - R788 100 mg Bid

Secondary

American College of Rheumatology Index of Improvement (ACRn) at 6 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 6 months of treatment

Intent-to-treat population with available data and received study drug.

Posted

Mean

Standard Deviation

Score

6 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind
OG004	Arm 5 - R788 100 mg Bid

Secondary

Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 1 Month

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 with available data and received study drug.

Posted

Number

Participants

1 month

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 2 Months

Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.

Posted

Number

Participants

2 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

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

Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.

Posted

Number

Participants

3 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 4 Months

Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.

Posted

Number

Participants

4 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 5 Months

Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.

Posted

Number

Participants

5 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 6 Months

Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.

Posted

Number

Participants

6 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 1 Month

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 with available data and received study drug.

Posted

Number

Participants

1 month

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 2 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 with available data and received study drug.

Posted

Number

Participants

2 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

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 with available data and received study drug.

Posted

Number

Participants

3 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 4 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 with available data and received study drug.

Posted

Number

Participants

4 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 5 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 with available data and received study drug.

Posted

Number

Participants

5 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 6 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 with available data and received study drug.

Posted

Number

Participants

6 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 1 Month

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 with available data and received study drug.

Posted

Number

Participants

1 month

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 2 Months

Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.

Posted

Number

Participants

2 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

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

Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.

Posted

Number

Participants

3 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 4 Months

Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.

Posted

Number

Participants

4 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 5 Months

Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.

Posted

Number

Participants

5 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 6 Months

Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.

Posted

Number

Participants

6 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 1 Month

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 with available data and received study drug.

Posted

Number

Participants

1 month

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 2 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 with available data and received study drug.

Posted

Number

Participants

2 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

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 with available data and received study drug.

Posted

Number

Participants

3 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 4 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 with available data and received study drug.

Posted

Number

Participants

4 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 5 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 with available data and received study drug.

Posted

Number

Participants

5 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 6 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 with available data and received study drug.

Posted

Number

Participants

6 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at 6 Months

Change from baseline in FACIT-F, which is a patient-reported 13-item questionnaire that assesses fatigue, calculated as the score at 6 months minus the score at baseline. The FACIT-F runs from 0 to 52 with lower scores indicating higher fatigue. A positive change from baseline indicates an improvement in fatigue after treatment.

Intent-to-treat population with available data and received study drug.

Posted

Mean

Standard Deviation

Score

Baseline to 6 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

Short Form Health Survey (SF-36) Physical Component Summary (PCS) at 6 Months

Change from baseline in the PCS of the SF-36 (which assesses health and wellbeing), calculated as the score at 6 months minus the score at baseline. The PCS ranges from 0 to 100 with 100 indicating the highest level of functioning possible. A positive change indicates an improvement in PCS after treatment

Intent-to-treat population with available data and received study drug.

Posted

Mean

Standard Deviation

Score

Baseline to 6 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

Secondary

Short Form Health Survey (SF-36) Mental Component Summary (MCS) at 6 Months

Change from baseline in the MCS of the SF-36 (which assesses health and wellbeing), calculated as the score at 6 months minus the score at baseline. The MCS ranges from 0 to 100 with 100 indicating the highest level of functioning possible. A positive change indicates an improvement in MCS after treatment

Intent-to-treat population with available data and received study drug.

Posted

Mean

Standard Deviation

Score

Baseline to 6 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind

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 with available data and received study drug.

Posted

Number

Participants

Any time between baseline and 6 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind
OG004	Arm 5 - R788 100 mg Bid

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 with available data and received study drug.

Posted

Number

Participants

Any time between baseline and 6 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind
OG004	Arm 5 - R788 100 mg Bid

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 with available data and received study drug.

Posted

Number

Participants

Any time between baseline and 6 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind
OG004	Arm 5 - R788 100 mg Bid

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 with available data and received study drug.

Posted

Number

Participants

Any time between baseline and 6 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind
OG004	Arm 5 - R788 100 mg Bid

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 with available data and received study drug.

Posted

Number

Participants

Any time between baseline and 6 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind
OG004	Arm 5 - R788 100 mg Bid

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 with available data and received study drug.

Posted

Number

Participants

Any time between baseline and 6 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind
OG004	Arm 5 - R788 100 mg Bid

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 with available data and received study drug.

Posted

Number

Participants

Any time between baseline and 6 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind
OG004	Arm 5 - R788 100 mg Bid

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 with available data and received study drug.

Posted

Number

Participants

Any time between baseline and 6 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind
OG004	Arm 5 - R788 100 mg Bid

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 1.5-2 times the ULN

Intent-to-treat population with available data and received study drug.

Posted

Number

Participants

Any time between baseline and 6 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind
OG004	Arm 5 - R788 100 mg Bid

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 with available data and received study drug.

Posted

Number

Participants

Any time between baseline and 6 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind
OG004	Arm 5 - R788 100 mg Bid

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 with available data and received study drug.

Posted

Number

Participants

Any time between baseline and 6 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind
OG004	Arm 5 - R788 100 mg Bid

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 with available data and received study drug.

Posted

Number

Participants

Any time between baseline and 6 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind
OG004	Arm 5 - R788 100 mg Bid

Secondary

Aspartate Aminotransferase (AST) >5-10 x 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 with available data and received study drug.

Posted

Number

Participants

Any time between baseline and 6 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind
OG004	Arm 5 - R788 100 mg Bid

Secondary

Aspartate Aminotransferase (AST) >10 x 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 with available data and received study drug.

Posted

Number

Participants

Any time between baseline and 6 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind
OG004	Arm 5 - R788 100 mg Bid

Secondary

Alkaline Phosphatase >1.5 x Upper Limit of Normal (ULN) and >1.5 Times 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 with available data and received study drug.

Posted

Number

Participants

Any time between baseline and 6 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind
OG004	Arm 5 - R788 100 mg Bid

Secondary

Bilirubin >1.5 x 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 with available data and received study drug.

Posted

Number

Participants

Any time between baseline and 6 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind
OG004	Arm 5 - R788 100 mg Bid

Secondary

Bilirubin >2 x 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 with available data and received study drug.

Posted

Number

Participants

Any time between baseline and 6 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind
OG004	Arm 5 - R788 100 mg Bid

Secondary

Absolute Neutrophil Count (ANC) <1500/mm3

The number of participants with ANC (a test of liver function) values lower than 1500/mm3

Intent-to-treat population with available data and received study drug.

Posted

Number

Participants

Any time between baseline and 6 months

ID	Title	Description
OG000	Arm 1 - Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
OG001	Arm 2 - Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
OG002	Arm 3 - Placebo Pooled	Placebo to R788, oral tablets once and twice daily pooled
OG003	Arm 4 - R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind
OG004	Arm 5 - R788 100 mg Bid	R788 100 mg, oral tablets, twice daily, double-blind

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANGINA UNSTABLE	Cardiac disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected77 at risk EG0010 affected76 at risk EG0021 affected152 at risk EG0030 affected152 at risk
DUODENAL ULCER	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected77 at risk EG0010 affected76 at risk EG0020 affected152 at risk EG003
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected77 at risk EG0010 affected76 at risk EG0020 affected152 at risk EG003
PANCREATITIS	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected77 at risk EG0010 affected76 at risk EG0021 affected152 at risk EG003
VOMITING	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected77 at risk EG0010 affected76 at risk EG0020 affected152 at risk EG003
ARTHRITIS INFECTIVE	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0000 affected77 at risk EG0011 affected76 at risk EG0020 affected152 at risk EG003
BURSITIS INFECTIVE	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0001 affected77 at risk EG0010 affected76 at risk EG0020 affected152 at risk EG003
CELLULITIS	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0000 affected77 at risk EG0011 affected76 at risk EG0020 affected152 at risk EG003
ERYSIPELAS	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0000 affected77 at risk EG0010 affected76 at risk EG0021 affected152 at risk EG003
GALLBLADDER EMPYEMA	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0000 affected77 at risk EG0010 affected76 at risk EG0020 affected152 at risk EG003
HERPES ZOSTER OPHTHALMIC	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0000 affected77 at risk EG0010 affected76 at risk EG0020 affected152 at risk EG003
OSTEOMYELITIS	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0000 affected77 at risk EG0010 affected76 at risk EG0020 affected152 at risk EG003
PYELONEPHRITIS	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0000 affected77 at risk EG0010 affected76 at risk EG0021 affected152 at risk EG003
SOFT TISSUE INFECTION	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0000 affected77 at risk EG0011 affected76 at risk EG0020 affected152 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0000 affected77 at risk EG0010 affected76 at risk EG0020 affected152 at risk EG003
SUBDURAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 9.0	Systematic Assessment	EG0000 affected77 at risk EG0010 affected76 at risk EG0020 affected152 at risk EG003
ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected77 at risk EG0011 affected76 at risk EG0020 affected152 at risk EG003
CARCINOMA IN SITU OF PENIS	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.0	Systematic Assessment	EG0000 affected77 at risk EG0010 affected76 at risk EG0021 affected152 at risk EG003
RENAL CELL CARCINOMA STAGE UNSPECIFIED	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.0	Systematic Assessment	EG0000 affected77 at risk EG0010 affected76 at risk EG0020 affected152 at risk EG003
SQUAMOUS CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.0	Systematic Assessment	EG0000 affected77 at risk EG0010 affected76 at risk EG0020 affected152 at risk EG003
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected77 at risk EG0011 affected76 at risk EG0020 affected152 at risk EG003
STILLBIRTH	Pregnancy, puerperium and perinatal conditions	MedDRA 9.0	Systematic Assessment	EG0000 affected77 at risk EG0010 affected76 at risk EG0020 affected152 at risk EG003
HYDRONEPHROSIS	Renal and urinary disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected77 at risk EG0010 affected76 at risk EG0021 affected152 at risk EG003
ASTHMATIC CRISIS	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected77 at risk EG0010 affected76 at risk EG0020 affected152 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
DIARRHOEA	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0004 affected77 at risk EG0011 affected76 at risk EG00218 affected152 at risk EG00329 affected152 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected77 at risk EG0016 affected76 at risk EG0029 affected152 at risk EG003
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0003 affected77 at risk EG0012 affected76 at risk EG0023 affected152 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0002 affected77 at risk EG0015 affected76 at risk EG0025 affected152 at risk EG003
INFLUENZA	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0002 affected77 at risk EG0014 affected76 at risk EG0023 affected152 at risk EG003
TRANSAMINASES INCREASED	Investigations	MedDRA 9.0	Systematic Assessment	EG0003 affected77 at risk EG0012 affected76 at risk EG0027 affected152 at risk EG003
DYSLIPIDAEMIA	Metabolism and nutrition disorders	MedDRA 9.0	Systematic Assessment	EG0003 affected77 at risk EG0012 affected76 at risk EG0028 affected152 at risk EG003
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Systematic Assessment	EG0004 affected77 at risk EG0011 affected76 at risk EG0021 affected152 at risk EG003
HEADACHE	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0003 affected77 at risk EG0015 affected76 at risk EG00210 affected152 at risk EG003
RASH	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG0005 affected77 at risk EG0010 affected76 at risk EG0022 affected152 at risk EG003
HYPERTENSION	Vascular disorders	MedDRA 9.0	Systematic Assessment	EG0004 affected77 at risk EG0013 affected76 at risk EG00218 affected152 at risk EG003

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	Placebo qd	Placebo to R788, oral tablets, once daily, double-blind
BG001	Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind
BG002	R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind
BG003	R788 100 mg Bid	R788 100 mg, oral tablets, twice daily, double-blind
BG004	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo qd	Placebo to R788, oral tablets, once daily, double-blind	2	77	26	77
EG001	Placebo Bid	Placebo to R788, oral tablets, twice daily, double-blind	4	76	20	76
EG002	R788 150 mg qd	R788 150 mg, oral tablets, once daily, double-blind	5	152	62	152
EG003	R788 100 mg Bid	R788 100 mg, oral tablets, twice daily, double-blind	1	152	73	152