Trial Outcomes & Findings for Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding. (NCT NCT01197534)

NCT ID: NCT01197534

Last Updated: 2014-04-17

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

913 participants

Primary outcome timeframe

24 weeks

Results posted on

2014-04-17

Participant Flow

A total of 1632 patients were enrolled: 308, 300 \& 305 were randomised to Groups A, B \& C, respectively (308, 298 \& 302 received at least 1 dose of investigational product).

A total of 719 patients failed screening.

Participant milestones

Participant milestones
Measure	FOSTA 100 MG BID PO Dosing Group A	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO Dosing Group B	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO Dosing Group C
Overall Study STARTED	308	298	302
Overall Study Randomised But Did Not Receive Treatment	0	2	3
Overall Study COMPLETED	174	168	129
Overall Study NOT COMPLETED	134	130	173

Reasons for withdrawal

Reasons for withdrawal
Measure	FOSTA 100 MG BID PO Dosing Group A	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO Dosing Group B	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO Dosing Group C
Overall Study Not reported	16	10	16
Overall Study Enrolment in long term extension	57	66	119
Overall Study Severe non-compliance to protocol	3	4	1
Overall Study Lack of therapeutic response	9	4	9
Overall Study Dev. of study specific discont. criteria	13	6	2
Overall Study Lost to Follow-up	1	4	2
Overall Study Adverse Event	35	36	24

Baseline Characteristics

Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FOSTA 100 MG BID PO n=308 Participants Dosing Group A	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO n=298 Participants Dosing Group B	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO n=302 Participants Dosing Group C	Total n=908 Participants Total of all reporting groups
Age, Continuous	53 years STANDARD_DEVIATION 12.3 • n=5 Participants	54 years STANDARD_DEVIATION 11.6 • n=7 Participants	53 years STANDARD_DEVIATION 11.8 • n=5 Participants	53 years STANDARD_DEVIATION 11.9 • n=4 Participants
Sex: Female, Male Female	245 Participants n=5 Participants	245 Participants n=7 Participants	252 Participants n=5 Participants	742 Participants n=4 Participants
Sex: Female, Male Male	63 Participants n=5 Participants	53 Participants n=7 Participants	50 Participants n=5 Participants	166 Participants n=4 Participants
Race/Ethnicity, Customized White	254 Participants n=5 Participants	235 Participants n=7 Participants	241 Participants n=5 Participants	730 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	6 Participants n=5 Participants	15 Participants n=7 Participants	8 Participants n=5 Participants	29 Participants n=4 Participants
Race/Ethnicity, Customized Asian	16 Participants n=5 Participants	13 Participants n=7 Participants	20 Participants n=5 Participants	49 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Indian or Pakistani	25 Participants n=5 Participants	31 Participants n=7 Participants	28 Participants n=5 Participants	84 Participants n=4 Participants
Race/Ethnicity, Customized Other	7 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	13 Participants n=4 Participants

PRIMARY outcome

Timeframe: 24 weeks

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

Outcome measures

Outcome measures
Measure	FOSTA 100 MG BID PO n=308 Participants Dosing Group A	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO n=298 Participants Dosing Group B	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO n=302 Participants Dosing Group C
Proportion of Patients With ACR20 at Week 24, Comparison Between Fostamatinib and Placebo	39.6 Percentage of responders	39.6 Percentage of responders	24.5 Percentage of responders

SECONDARY outcome

Timeframe: 1 week

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

Outcome measures

Outcome measures
Measure	FOSTA 100 MG BID PO n=606 Participants Dosing Group A	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO n=302 Participants Dosing Group B	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO Dosing Group C
Proportion of Patients Achieving ACR20, Comparison Between Fostamatinib and Placebo at Week 1	16.0 Percentage of responders	8.3 Percentage of responders	—

SECONDARY outcome

Timeframe: 24 weeks

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

Outcome measures

Outcome measures
Measure	FOSTA 100 MG BID PO n=308 Participants Dosing Group A	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO n=298 Participants Dosing Group B	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO n=302 Participants Dosing Group C
Proportion of Patients Achieving ACR50, Comparison Between Fostamatinib and Placebo at Week 24	20.8 Percentage of responders	18.1 Percentage of responders	8.3 Percentage of responders

SECONDARY outcome

Timeframe: 24 weeks

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

Outcome measures

Outcome measures
Measure	FOSTA 100 MG BID PO n=308 Participants Dosing Group A	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO n=298 Participants Dosing Group B	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO n=302 Participants Dosing Group C
Proportion of Patients Achieving ACR70, Comparison Between Fostamatinib and Placebo at Week 24	9.1 Percentage of responders	6.0 Percentage of responders	2.6 Percentage of responders

SECONDARY outcome

Timeframe: Baseline and 24 weeks

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

Outcome measures

Outcome measures
Measure	FOSTA 100 MG BID PO n=308 Participants Dosing Group A	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO n=298 Participants Dosing Group B	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO n=302 Participants Dosing Group C
ACRn - Comparison Between Fostamatinib and Placebo at Week 24	20.75 Percentage improvement from baseline Standard Deviation 31.203	18.31 Percentage improvement from baseline Standard Deviation 28.427	9.84 Percentage improvement from baseline Standard Deviation 23.219

SECONDARY outcome

Timeframe: 12 weeks

DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. A DAS28-CRP score of \<2.6 is indicative of remission of RA symptoms. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.

Outcome measures

Outcome measures
Measure	FOSTA 100 MG BID PO n=308 Participants Dosing Group A	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO n=298 Participants Dosing Group B	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO n=302 Participants Dosing Group C
Proportion of Patients Achieving DAS28-CRP <2.6 at Week 12, Comparison Between Fostamatinib and Placebo	17.2 Percentage of responders	10.7 Percentage of responders	3.0 Percentage of responders

SECONDARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome measures
Measure	FOSTA 100 MG BID PO n=308 Participants Dosing Group A	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO n=298 Participants Dosing Group B	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO n=302 Participants Dosing Group C
Proportion of Patients Achieving DAS28-CRP <2.6 at Week 24, Comparison Between Fostamatinib and Placebo	41.3 Percentage of responders	12.8 Percentage of responders	2.3 Percentage of responders

SECONDARY outcome

Timeframe: 24 weeks

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

Outcome measures

Outcome measures
Measure	FOSTA 100 MG BID PO n=308 Participants Dosing Group A	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO n=298 Participants Dosing Group B	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO n=302 Participants Dosing Group C
Proportion of Patients Achieving DAS28 EULAR Response at Week 24 No response	42.9 Percentage of responders 1.46 • Interval 0.2 to 0.68	45.3 Percentage of responders 1.34 • Interval 0.26 to 0.89	64.6 Percentage of responders 1.30 • Interval 0.2 to 0.65
Proportion of Patients Achieving DAS28 EULAR Response at Week 24 Moderate response	33.8 Percentage of responders	34.9 Percentage of responders	29.1 Percentage of responders
Proportion of Patients Achieving DAS28 EULAR Response at Week 24 Good response	23.4 Percentage of responders	19.8 Percentage of responders	6.3 Percentage of responders

SECONDARY outcome

Timeframe: Baseline and 24 weeks

HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is then calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. The HAQ-DI response is a reduction from baseline in HAQ-DI score greater than or equal to the minimally important difference (0.22). BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.

Outcome measures

Outcome measures
Measure	FOSTA 100 MG BID PO n=308 Participants Dosing Group A	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO n=298 Participants Dosing Group B	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO n=302 Participants Dosing Group C
HAQ-DI Response - Comparison of the Change(>=0.22) From Baseline Between Fostamatinib and Placebo at Week 24	46.1 Percentage of responders	42.3 Percentage of responders	26.5 Percentage of responders

SECONDARY outcome

Timeframe: Baseline and 24 weeks

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

mTSS: modified total sharp score, a measure of structural progression based upon X-rays. Hand and foot joints are scored for erosions and joint space narrowing and the results summed to give a value between 0 and 448. A higher value represents more serious progression of the disease. After disregarding ineligible records, patients with 2 or more non-missing values have had missing data imputed via linear extrapolation/interpolation methods. Patients with only 1 result were excluded from the analysis. ANCOVA = analysis of covariance, BID = twice daily, IP = investigational product, QD = once a day.

Outcome measures

Outcome measures
Measure	FOSTA 100 MG BID PO n=308 Participants Dosing Group A	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO n=298 Participants Dosing Group B	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO n=302 Participants Dosing Group C
Change From Baseline to Week 24 in mTSS, Comparison Between Fostamatinib and Placebo	0.64 Units on a scale Standard Deviation 3.130	0.37 Units on a scale Standard Deviation 3.095	1.16 Units on a scale Standard Deviation 5.849

SECONDARY outcome

Timeframe: Baseline and 24 weeks

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

Outcome measures

Outcome measures
Measure	FOSTA 100 MG BID PO n=308 Participants Dosing Group A	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO n=298 Participants Dosing Group B	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO n=302 Participants Dosing Group C
SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 24	5 Units on a scale Standard Deviation 7.2	4 Units on a scale Standard Deviation 6.6	2 Units on a scale Standard Deviation 5.7

SECONDARY outcome

Timeframe: Baseline and 24 weeks

Outcome measures

Outcome measures
Measure	FOSTA 100 MG BID PO n=308 Participants Dosing Group A	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO n=298 Participants Dosing Group B	PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO n=302 Participants Dosing Group C
SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 24	3 Units on a scale Standard Deviation 7.5	3 Units on a scale Standard Deviation 8.4	1 Units on a scale Standard Deviation 6.3

Adverse Events

FOSTA 100 MG BID

Serious events: 30 serious events

Other events: 170 other events

Deaths: 0 deaths

FOSTA 100 MG BID (4 WKS) THEN 150 MG QD

Serious events: 25 serious events

Other events: 152 other events

Deaths: 0 deaths

PLACEBO (24 WKS) THEN FOSTA 100 MG BID - FOSTA Period

Serious events: 10 serious events

Other events: 42 other events

Deaths: 0 deaths

PLACEBO (24 WKS) THEN FOSTA 100 MG BID - Placebo Period

Serious events: 10 serious events

Other events: 77 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	FOSTA 100 MG BID n=308 participants at risk Dosing Group A	FOSTA 100 MG BID (4 WKS) THEN 150 MG QD n=298 participants at risk Dosing Group B	PLACEBO (24 WKS) THEN FOSTA 100 MG BID - FOSTA Period n=302 participants at risk Dosing Group C	PLACEBO (24 WKS) THEN FOSTA 100 MG BID - Placebo Period n=302 participants at risk
Gastrointestinal disorders DIARRHOEA	14.3% 44/308 • Number of events 44 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 11 SAEs occurred during the 24 week placebo treated period.	15.8% 47/298 • Number of events 47 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 11 SAEs occurred during the 24 week placebo treated period.	5.0% 15/302 • Number of events 15 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 11 SAEs occurred during the 24 week placebo treated period.	4.3% 13/302 • Number of events 13 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 11 SAEs occurred during the 24 week placebo treated period.
Gastrointestinal disorders NAUSEA	6.5% 20/308 • Number of events 20 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 11 SAEs occurred during the 24 week placebo treated period.	5.7% 17/298 • Number of events 17 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 11 SAEs occurred during the 24 week placebo treated period.	1.7% 5/302 • Number of events 5 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 11 SAEs occurred during the 24 week placebo treated period.	2.3% 7/302 • Number of events 7 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 11 SAEs occurred during the 24 week placebo treated period.
Infections and infestations NASOPHARYNGITIS	12.0% 37/308 • Number of events 37 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 11 SAEs occurred during the 24 week placebo treated period.	9.7% 29/298 • Number of events 29 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 11 SAEs occurred during the 24 week placebo treated period.	0.66% 2/302 • Number of events 2 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 11 SAEs occurred during the 24 week placebo treated period.	5.3% 16/302 • Number of events 16 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 11 SAEs occurred during the 24 week placebo treated period.
Investigations ALANINE AMINOTRANSFERASE INCREASED	6.8% 21/308 • Number of events 21 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 11 SAEs occurred during the 24 week placebo treated period.	4.7% 14/298 • Number of events 14 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 11 SAEs occurred during the 24 week placebo treated period.	0.66% 2/302 • Number of events 2 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 11 SAEs occurred during the 24 week placebo treated period.	1.3% 4/302 • Number of events 4 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 11 SAEs occurred during the 24 week placebo treated period.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	5.5% 17/308 • Number of events 17 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 11 SAEs occurred during the 24 week placebo treated period.	4.4% 13/298 • Number of events 13 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 11 SAEs occurred during the 24 week placebo treated period.	0.99% 3/302 • Number of events 3 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 11 SAEs occurred during the 24 week placebo treated period.	1.3% 4/302 • Number of events 4 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 11 SAEs occurred during the 24 week placebo treated period.
Investigations BLOOD PRESSURE INCREASED	4.9% 15/308 • Number of events 15 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 11 SAEs occurred during the 24 week placebo treated period.	5.0% 15/298 • Number of events 15 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 11 SAEs occurred during the 24 week placebo treated period.	0.33% 1/302 • Number of events 1 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 11 SAEs occurred during the 24 week placebo treated period.	3.3% 10/302 • Number of events 10 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 11 SAEs occurred during the 24 week placebo treated period.
Musculoskeletal and connective tissue disorders RHEUMATOID ARTHRITIS	6.2% 19/308 • Number of events 19 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 11 SAEs occurred during the 24 week placebo treated period.	7.7% 23/298 • Number of events 23 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 11 SAEs occurred during the 24 week placebo treated period.	0.33% 1/302 • Number of events 1 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 11 SAEs occurred during the 24 week placebo treated period.	3.3% 10/302 • Number of events 10 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 11 SAEs occurred during the 24 week placebo treated period.
Nervous system disorders HEADACHE	6.2% 19/308 • Number of events 19 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 11 SAEs occurred during the 24 week placebo treated period.	4.0% 12/298 • Number of events 12 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 11 SAEs occurred during the 24 week placebo treated period.	1.7% 5/302 • Number of events 5 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 11 SAEs occurred during the 24 week placebo treated period.	3.0% 9/302 • Number of events 9 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 11 SAEs occurred during the 24 week placebo treated period.
Vascular disorders HYPERTENSION	22.1% 68/308 • Number of events 68 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 11 SAEs occurred during the 24 week placebo treated period.	18.5% 55/298 • Number of events 55 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 11 SAEs occurred during the 24 week placebo treated period.	5.6% 17/302 • Number of events 17 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 11 SAEs occurred during the 24 week placebo treated period.	5.3% 16/302 • Number of events 16 • 52 weeks For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 11 SAEs occurred during the 24 week placebo treated period.

Additional Information

Dave Goldstraw

AstraZeneca Pharmaceuticals

Phone: +44 (0)1625 512415

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60