Trial Outcomes & Findings for Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (NCT NCT01264770)
NCT ID: NCT01264770
Last Updated: 2014-05-06
Results Overview
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. Mean changes from baseline in DAS28-CRP score are shown at each visit and are presented as decreases from baseline (defined as baseline minus post-baseline) with larger changes indicative of a better clinical condition. ANCOVA = analysis of covariance, BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, QD = once a day, SC = subcutaneous.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
644 participants
Primary outcome timeframe
Baseline and 6 weeks
Results posted on
2014-05-06
Participant Flow
452 patients were enrolled into the main study, with 198 patients enrolled into a separate MRI sub-study. Synovitis results for the MRI sub-study were reported later due to study delays and so are presented entirely separately.
A total of 173 patients failed screening to the main study.
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
|
FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
Dosing Group C
|
ADALIMUMAB 40 MG SC
Dosing Group D
|
PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
Dosing Group F
|
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
Dosing Group G
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
54
|
48
|
57
|
54
|
27
|
25
|
|
Overall Study
Randomised But Did Not Receive Treatment
|
2
|
5
|
2
|
3
|
2
|
0
|
|
Overall Study
COMPLETED
|
36
|
38
|
41
|
48
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
18
|
10
|
16
|
6
|
8
|
6
|
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
|
FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
Dosing Group C
|
ADALIMUMAB 40 MG SC
Dosing Group D
|
PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
Dosing Group F
|
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
Dosing Group G
|
|---|---|---|---|---|---|---|
|
Overall Study
Not reported
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
e.g., change in circumstances
|
8
|
3
|
3
|
3
|
4
|
4
|
|
Overall Study
Severe non-compliance to protocol
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
Lack of therapeutic response
|
1
|
0
|
2
|
1
|
1
|
0
|
|
Overall Study
Dev. of study specific discont. criteria
|
2
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
7
|
7
|
8
|
0
|
2
|
1
|
Baseline Characteristics
Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA)
Baseline characteristics by cohort
| Measure |
FOSTA 100 MG BID PO
n=54 Participants
Dosing Group A
|
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
n=48 Participants
Dosing Group B
|
FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
n=57 Participants
Dosing Group C
|
ADALIMUMAB 40 MG SC
n=54 Participants
Dosing Group D
|
PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
n=27 Participants
Dosing Group F
|
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
n=25 Participants
Dosing Group G
|
Total
n=265 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
50 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
50 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
48 years
STANDARD_DEVIATION 12.4 • n=4 Participants
|
50 years
STANDARD_DEVIATION 12.7 • n=21 Participants
|
53 years
STANDARD_DEVIATION 10.8 • n=8 Participants
|
50 years
STANDARD_DEVIATION 11.8 • n=8 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
210 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
55 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
48 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
240 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Indian or Pakistani
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 weeksPopulation: 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. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6.
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. Mean changes from baseline in DAS28-CRP score are shown at each visit and are presented as decreases from baseline (defined as baseline minus post-baseline) with larger changes indicative of a better clinical condition. ANCOVA = analysis of covariance, BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, QD = once a day, SC = subcutaneous.
Outcome measures
| Measure |
Dosing Group A
n=54 Participants
FOSTA 100 MG BID PO
|
Dosing Group B
n=48 Participants
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
|
Dosing Group C
n=57 Participants
FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
|
Dosing Group E
n=52 Participants
PLACEBO (COMBINED)
|
Dosing Group F
PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
|
Dosing Group G
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
|
Dosing Group G
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
|
|---|---|---|---|---|---|---|---|
|
DAS28-CRP Score - Change From Baseline to Week 6 Compared to Placebo
|
1.1 Units on a scale
Standard Deviation 0.92 • Interval 0.23 to
|
1.1 Units on a scale
Standard Deviation 1.01
|
0.8 Units on a scale
Standard Deviation 0.96
|
0.6 Units on a scale
Standard Deviation 1.14
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and 24 weeksPopulation: 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. In line with the study objectives, fostamatinib was compared with adalimumab (not placebo) at Week 24.
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. Mean changes from baseline in DAS28-CRP score are shown at each visit and are presented as decreases from baseline (defined as baseline minus post-baseline) with larger changes indicative of a better clinical condition. Non-responder imputation has been applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, QD = once a day, SC = subcutaneous.
Outcome measures
| Measure |
Dosing Group A
n=54 Participants
FOSTA 100 MG BID PO
|
Dosing Group B
n=48 Participants
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
|
Dosing Group C
n=57 Participants
FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
|
Dosing Group E
n=54 Participants
PLACEBO (COMBINED)
|
Dosing Group F
n=27 Participants
PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
|
Dosing Group G
n=25 Participants
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
|
Dosing Group G
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
|
|---|---|---|---|---|---|---|---|
|
DAS28-CRP Score - Change From Baseline to Week 24 Compared to Adalimumab
|
1.0 Units on a scale
Standard Deviation 1.31
|
1.1 Units on a scale
Standard Deviation 1.22
|
1.0 Units on a scale
Standard Deviation 1.25
|
1.8 Units on a scale
Standard Deviation 1.45
|
1.1 Units on a scale
Standard Deviation 1.26
|
1.4 Units on a scale
Standard Deviation 1.26
|
—
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: 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. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6.
Change in DAS28 was derived for each post baseline scheduled assessment and categorised using the European League Against Rheumatism (EULAR) response criteria. Non-responder imputation has been applied by carrying the baseline observation forward. 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, SC = subcutaneous.
Outcome measures
| Measure |
Dosing Group A
n=54 Participants
FOSTA 100 MG BID PO
|
Dosing Group B
n=48 Participants
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
|
Dosing Group C
n=57 Participants
FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
|
Dosing Group E
n=54 Participants
PLACEBO (COMBINED)
|
Dosing Group F
n=52 Participants
PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
|
Dosing Group G
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
|
Dosing Group G
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
|
|---|---|---|---|---|---|---|---|
|
DAS28 EULAR Response at Week 6
No response
|
37.0 Percentage of responders
1.46 • Interval 0.2 to 0.68
|
33.3 Percentage of responders
1.34 • Interval 0.26 to 0.89
|
57.9 Percentage of responders
1.30 • Interval 0.2 to 0.65
|
40.7 Percentage of responders
1.58
|
67.3 Percentage of responders
1.33
|
—
|
—
|
|
DAS28 EULAR Response at Week 6
Moderate response
|
53.7 Percentage of responders
|
47.9 Percentage of responders
|
35.1 Percentage of responders
|
38.9 Percentage of responders
|
25.0 Percentage of responders
|
—
|
—
|
|
DAS28 EULAR Response at Week 6
Good response
|
9.3 Percentage of responders
|
18.8 Percentage of responders
|
7.0 Percentage of responders
|
20.4 Percentage of responders
|
7.7 Percentage of responders
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: 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. In line with the study objectives, fostamatinib was compared with adalimumab (not placebo) at Week 24.
Change in DAS28 was derived for each post baseline scheduled assessment and categorised using the European League Against Rheumatism (EULAR) response criteria. Non-responder imputation has been applied by carrying the baseline observation forward. 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, SC = subcutaneous.
Outcome measures
| Measure |
Dosing Group A
n=54 Participants
FOSTA 100 MG BID PO
|
Dosing Group B
n=48 Participants
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
|
Dosing Group C
n=57 Participants
FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
|
Dosing Group E
n=54 Participants
PLACEBO (COMBINED)
|
Dosing Group F
n=27 Participants
PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
|
Dosing Group G
n=25 Participants
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
|
Dosing Group G
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
|
|---|---|---|---|---|---|---|---|
|
DAS28 EULAR Response at Week 24
No response
|
51.9 Percentage of responders
1.46 • Interval 0.2 to 0.68
|
41.7 Percentage of responders
1.34 • Interval 0.26 to 0.89
|
52.6 Percentage of responders
1.30 • Interval 0.2 to 0.65
|
31.5 Percentage of responders
1.58
|
55.6 Percentage of responders
1.33
|
40.0 Percentage of responders
1.48
|
—
|
|
DAS28 EULAR Response at Week 24
Moderate response
|
29.6 Percentage of responders
|
39.6 Percentage of responders
|
29.8 Percentage of responders
|
27.8 Percentage of responders
|
33.3 Percentage of responders
|
36.0 Percentage of responders
|
—
|
|
DAS28 EULAR Response at Week 24
Good response
|
18.5 Percentage of responders
|
18.8 Percentage of responders
|
17.5 Percentage of responders
|
40.7 Percentage of responders
|
11.1 Percentage of responders
|
24.0 Percentage of responders
|
—
|
SECONDARY outcome
Timeframe: 6 and 24 weeksPopulation: 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. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6 and with adalimumab (not placebo) at Week 24.
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. Non-responder imputation has been applied by carrying the baseline observation forward. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.
Outcome measures
| Measure |
Dosing Group A
n=54 Participants
FOSTA 100 MG BID PO
|
Dosing Group B
n=48 Participants
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
|
Dosing Group C
n=57 Participants
FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
|
Dosing Group E
n=54 Participants
PLACEBO (COMBINED)
|
Dosing Group F
n=52 Participants
PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
|
Dosing Group G
n=27 Participants
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
|
Dosing Group G
n=25 Participants
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
|
|---|---|---|---|---|---|---|---|
|
Proportion of Patients Achieving ACR20 up to Week 24
Week 6
|
48.1 Percentage of responders
|
47.9 Percentage of responders
|
38.6 Percentage of responders
|
53.7 Percentage of responders
|
19.2 Percentage of responders
|
NA Percentage of responders
Data appears under Group E at Week 6.
|
NA Percentage of responders
Data appears under Group E at Week 6.
|
|
Proportion of Patients Achieving ACR20 up to Week 24
Week 24
|
40.7 Percentage of responders
|
56.3 Percentage of responders
|
35.1 Percentage of responders
|
59.3 Percentage of responders
|
NA Percentage of responders
Data appears under Groups F and G at Week 24.
|
44.4 Percentage of responders
|
44.0 Percentage of responders
|
SECONDARY outcome
Timeframe: 6 and 24 weeksPopulation: 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. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6 and with adalimumab (not placebo) at Week 24.
ACR50: American College of Rheumatology 50% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.
Outcome measures
| Measure |
Dosing Group A
n=54 Participants
FOSTA 100 MG BID PO
|
Dosing Group B
n=48 Participants
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
|
Dosing Group C
n=57 Participants
FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
|
Dosing Group E
n=54 Participants
PLACEBO (COMBINED)
|
Dosing Group F
n=52 Participants
PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
|
Dosing Group G
n=27 Participants
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
|
Dosing Group G
n=25 Participants
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
|
|---|---|---|---|---|---|---|---|
|
Proportion of Patients Achieving ACR50 up to Week 24
Week 6
|
13.0 Percentage of responders
|
12.5 Percentage of responders
|
7.0 Percentage of responders
|
25.9 Percentage of responders
|
3.8 Percentage of responders
|
NA Percentage of responders
Data appears under Group E at Week 6.
|
NA Percentage of responders
Data appears under Group E at Week 6.
|
|
Proportion of Patients Achieving ACR50 up to Week 24
Week 24
|
20.4 Percentage of responders
|
18.8 Percentage of responders
|
12.3 Percentage of responders
|
31.5 Percentage of responders
|
NA Percentage of responders
Data appears under Groups F and G at Week 24.
|
22.2 Percentage of responders
|
24.0 Percentage of responders
|
SECONDARY outcome
Timeframe: 6 and 24 weeksPopulation: 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. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6 and with adalimumab (not placebo) at Week 24.
ACR70: American College of Rheumatology 70% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.
Outcome measures
| Measure |
Dosing Group A
n=54 Participants
FOSTA 100 MG BID PO
|
Dosing Group B
n=48 Participants
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
|
Dosing Group C
n=57 Participants
FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
|
Dosing Group E
n=54 Participants
PLACEBO (COMBINED)
|
Dosing Group F
n=52 Participants
PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
|
Dosing Group G
n=27 Participants
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
|
Dosing Group G
n=25 Participants
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
|
|---|---|---|---|---|---|---|---|
|
Proportion of Patients Achieving ACR70 up to Week 24
Week 6
|
1.9 Percentage of responders
|
4.2 Percentage of responders
|
1.8 Percentage of responders
|
7.4 Percentage of responders
|
3.8 Percentage of responders
|
NA Percentage of responders
Data appears under Group E at Week 6.
|
NA Percentage of responders
Data appears under Group E at Week 6.
|
|
Proportion of Patients Achieving ACR70 up to Week 24
Week 24
|
9.3 Percentage of responders
|
10.4 Percentage of responders
|
3.5 Percentage of responders
|
20.4 Percentage of responders
|
NA Percentage of responders
Data appears under Groups F and G at Week 24.
|
7.4 Percentage of responders
|
4.0 Percentage of responders
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: 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. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6.
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 and patient's own asessment 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. Non-responder imputation has been applied by carrying the baseline observation forward. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous. Mean refers to change at Week 6. Treatment difference: difference between fostamatinib and placebo groups.
Outcome measures
| Measure |
Dosing Group A
n=54 Participants
FOSTA 100 MG BID PO
|
Dosing Group B
n=48 Participants
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
|
Dosing Group C
n=57 Participants
FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
|
Dosing Group E
n=54 Participants
PLACEBO (COMBINED)
|
Dosing Group F
n=52 Participants
PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
|
Dosing Group G
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
|
Dosing Group G
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
|
|---|---|---|---|---|---|---|---|
|
ACRn - Comparison Between Fostamatinib and Placebo at Week 6
|
16.60 Percentage improvement from baseline
Standard Deviation 30.682
|
15.07 Percentage improvement from baseline
Standard Deviation 33.334
|
6.48 Percentage improvement from baseline
Standard Deviation 32.237
|
15.53 Percentage improvement from baseline
Standard Deviation 43.015
|
-6.49 Percentage improvement from baseline
Standard Deviation 35.159
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksPopulation: 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.In line with the study objectives, fostamatinib was compared with adalimumab (not placebo) at Week 24.
ACRn: American College of Rheumatology Index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints) or in blood test measures of inflammation (such as CRP) or the physician and patient's own asessment 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. Non-responder imputation has been applied by carrying the baseline observation forward. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous. Mean refers to change at Week 24. Treatment difference: difference between fostamatinib and adalimumab groups.
Outcome measures
| Measure |
Dosing Group A
n=54 Participants
FOSTA 100 MG BID PO
|
Dosing Group B
n=48 Participants
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
|
Dosing Group C
n=57 Participants
FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
|
Dosing Group E
n=54 Participants
PLACEBO (COMBINED)
|
Dosing Group F
PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
|
Dosing Group G
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
|
Dosing Group G
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
|
|---|---|---|---|---|---|---|---|
|
ACRn - Comparison Between Fostamatinib and Adalimumab at Week 24
|
18.35 Percentage improvement from baseline
Standard Deviation 34.355
|
22.03 Percentage improvement from baseline
Standard Deviation 32.361
|
11.49 Percentage improvement from baseline
Standard Deviation 26.916
|
31.21 Percentage improvement from baseline
Standard Deviation 39.187
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: 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. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6.
HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is 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. Non-responder imputation has been applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.
Outcome measures
| Measure |
Dosing Group A
n=54 Participants
FOSTA 100 MG BID PO
|
Dosing Group B
n=48 Participants
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
|
Dosing Group C
n=57 Participants
FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
|
Dosing Group E
n=54 Participants
PLACEBO (COMBINED)
|
Dosing Group F
n=52 Participants
PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
|
Dosing Group G
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
|
Dosing Group G
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
|
|---|---|---|---|---|---|---|---|
|
HAQ-DI - Comparison of the Change From Baseline Between Fostamatinib and Placebo at Week 6
|
0.3 Units on a scale
Standard Deviation 0.35
|
0.3 Units on a scale
Standard Deviation 0.54
|
0.2 Units on a scale
Standard Deviation 0.43
|
0.3 Units on a scale
Standard Deviation 0.45
|
0.1 Units on a scale
Standard Deviation 0.52
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksPopulation: 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. In line with the study objectives, fostamatinib was compared with adalimumab (not placebo) at Week 24.
HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is 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. Non-responder imputation has been applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.
Outcome measures
| Measure |
Dosing Group A
n=54 Participants
FOSTA 100 MG BID PO
|
Dosing Group B
n=48 Participants
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
|
Dosing Group C
n=57 Participants
FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
|
Dosing Group E
n=54 Participants
PLACEBO (COMBINED)
|
Dosing Group F
n=27 Participants
PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
|
Dosing Group G
n=25 Participants
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
|
Dosing Group G
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
|
|---|---|---|---|---|---|---|---|
|
HAQ-DI - Comparison of the Change From Baseline Between Fostamatinib and Adalimumab at Week 24
|
0.3 Units on a scale
Standard Deviation 0.57
|
0.4 Units on a scale
Standard Deviation 0.56
|
0.2 Units on a scale
Standard Deviation 0.45
|
0.5 Units on a scale
Standard Deviation 0.53
|
0.3 Units on a scale
Standard Deviation 0.47
|
0.1 Units on a scale
Standard Deviation 0.35
|
—
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksPopulation: 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. In line with the study objectives, fostamatinib was compared with adalimumab (not placebo) at Week 24.
SF-36: 36-item Short Form Health Survey, a measure of health-related QoL. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional \& Mental Health) are derived \& normalised to a scale of 0-100. Physical \& Mental Component Scores (PCS \& MCS) are derived by multiplying each of these 8 scores by a constant, summing them \& standardising against a population with mean of 50, standard deviation of 10. Higher scores represent a better QoL. Mean changes from baseline score are presented at each visit as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. Non-responder imputation applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, PO = orally, QD = once a day, QoL = quality of life, SC = subcutaneous.
Outcome measures
| Measure |
Dosing Group A
n=54 Participants
FOSTA 100 MG BID PO
|
Dosing Group B
n=48 Participants
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
|
Dosing Group C
n=57 Participants
FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
|
Dosing Group E
n=54 Participants
PLACEBO (COMBINED)
|
Dosing Group F
n=27 Participants
PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
|
Dosing Group G
n=25 Participants
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
|
Dosing Group G
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
|
|---|---|---|---|---|---|---|---|
|
SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Adalimumab at Week 24
|
4 Units on a scale
Standard Deviation 7.3
|
5 Units on a scale
Standard Deviation 7.2
|
4 Units on a scale
Standard Deviation 7.4
|
7 Units on a scale
Standard Deviation 8.4
|
4 Units on a scale
Standard Deviation 8.7
|
3 Units on a scale
Standard Deviation 5.0
|
—
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksPopulation: 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. In line with the study objectives, fostamatinib was compared with adalimumab (not placebo) at Week 24.
SF-36: 36-item Short Form Health Survey, a measure of health-related QoL. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional \& Mental Health) are derived \& normalised to a scale of 0-100. Physical \& Mental Component Scores (PCS \& MCS) are derived by multiplying each of these 8 scores by a constant, summing them \& standardising against a population with mean of 50, standard deviation of 10. Higher scores represent a better QoL. Mean changes from baseline score are presented at each visit as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. Non-responder imputation applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, PO = orally, QD = once a day, QoL = quality of life, SC = subcutaneous.
Outcome measures
| Measure |
Dosing Group A
n=54 Participants
FOSTA 100 MG BID PO
|
Dosing Group B
n=48 Participants
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
|
Dosing Group C
n=57 Participants
FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
|
Dosing Group E
n=54 Participants
PLACEBO (COMBINED)
|
Dosing Group F
n=27 Participants
PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
|
Dosing Group G
n=25 Participants
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
|
Dosing Group G
PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
|
|---|---|---|---|---|---|---|---|
|
SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Adalimumab at Week 24
|
3 Units on a scale
Standard Deviation 9.3
|
3 Units on a scale
Standard Deviation 11.5
|
2 Units on a scale
Standard Deviation 10.0
|
4 Units on a scale
Standard Deviation 9.8
|
3 Units on a scale
Standard Deviation 5.9
|
0 Units on a scale
Standard Deviation 10.1
|
—
|
Adverse Events
ADALIMUMAB 40 MG
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
FOSTA 100 MG BID
Serious events: 5 serious events
Other events: 30 other events
Deaths: 0 deaths
FOSTA 100 MG BID (4 WKS) THEN 100 MG QD
Serious events: 4 serious events
Other events: 19 other events
Deaths: 0 deaths
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
PLACEBO (6 WKS) FOSTA 100 MG BID (4 WKS) 150 MG QD-FOSTAperiod
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
PLACEBO (6 WKS) FOSTA 100 MG BID (4 WKS) 150 MG QD-PBO Period
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
PLACEBO (6 WKS) THEN FOSTA 100 MG BID - FOSTA Period
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
PLACEBO (6 WKS) THEN FOSTA 100 MG BID - Placebo Period
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ADALIMUMAB 40 MG
n=54 participants at risk
Dosing Group D
|
FOSTA 100 MG BID
n=54 participants at risk
Dosing Group A
|
FOSTA 100 MG BID (4 WKS) THEN 100 MG QD
n=57 participants at risk
Dosing Group C
|
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD
n=48 participants at risk
|
PLACEBO (6 WKS) FOSTA 100 MG BID (4 WKS) 150 MG QD-FOSTAperiod
n=25 participants at risk
|
PLACEBO (6 WKS) FOSTA 100 MG BID (4 WKS) 150 MG QD-PBO Period
n=25 participants at risk
|
PLACEBO (6 WKS) THEN FOSTA 100 MG BID - FOSTA Period
n=27 participants at risk
|
PLACEBO (6 WKS) THEN FOSTA 100 MG BID - Placebo Period
n=27 participants at risk
|
|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
LIGAMENT RUPTURE
|
0.00%
0/54 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/54 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/57 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
2.1%
1/48 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.00%
0/54 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
1.9%
1/54 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
1.8%
1/57 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/48 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Cardiac disorders
BUNDLE BRANCH BLOCK LEFT
|
0.00%
0/54 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/54 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
1.8%
1/57 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/48 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.00%
0/54 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/54 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
1.8%
1/57 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/48 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Cardiac disorders
COR PULMONALE ACUTE
|
0.00%
0/54 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/54 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
1.8%
1/57 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/48 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Cardiac disorders
PERICARDITIS
|
0.00%
0/54 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/54 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
1.8%
1/57 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/48 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Endocrine disorders
HYPERADRENALISM
|
1.9%
1/54 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/54 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/57 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/48 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/54 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/54 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
1.8%
1/57 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/48 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
1.9%
1/54 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/54 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/57 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/48 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Infections and infestations
CHRONIC SINUSITIS
|
0.00%
0/54 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
1.9%
1/54 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/57 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/48 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/54 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
1.9%
1/54 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/57 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/48 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Infections and infestations
PYELONEPHRITIS CHRONIC
|
0.00%
0/54 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
1.9%
1/54 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/57 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/48 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Injury, poisoning and procedural complications
CONCUSSION
|
1.9%
1/54 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/54 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/57 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/48 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Injury, poisoning and procedural complications
MENISCUS LESION
|
0.00%
0/54 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/54 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/57 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
2.1%
1/48 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CARDIAC MYXOMA
|
0.00%
0/54 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/54 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/57 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
2.1%
1/48 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MULTIPLE MYELOMA
|
0.00%
0/54 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/54 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/57 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/48 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
4.0%
1/25 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
1.9%
1/54 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/54 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/57 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/48 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/54 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/54 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
1.8%
1/57 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/48 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Vascular disorders
ESSENTIAL HYPERTENSION
|
0.00%
0/54 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
1.9%
1/54 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/57 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/48 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Vascular disorders
HYPERTENSIVE CRISIS
|
0.00%
0/54 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
1.9%
1/54 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/57 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/48 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
Other adverse events
| Measure |
ADALIMUMAB 40 MG
n=54 participants at risk
Dosing Group D
|
FOSTA 100 MG BID
n=54 participants at risk
Dosing Group A
|
FOSTA 100 MG BID (4 WKS) THEN 100 MG QD
n=57 participants at risk
Dosing Group C
|
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD
n=48 participants at risk
|
PLACEBO (6 WKS) FOSTA 100 MG BID (4 WKS) 150 MG QD-FOSTAperiod
n=25 participants at risk
|
PLACEBO (6 WKS) FOSTA 100 MG BID (4 WKS) 150 MG QD-PBO Period
n=25 participants at risk
|
PLACEBO (6 WKS) THEN FOSTA 100 MG BID - FOSTA Period
n=27 participants at risk
|
PLACEBO (6 WKS) THEN FOSTA 100 MG BID - Placebo Period
n=27 participants at risk
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
1.9%
1/54 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
16.7%
9/54 • Number of events 9 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
21.1%
12/57 • Number of events 12 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
27.1%
13/48 • Number of events 13 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
16.0%
4/25 • Number of events 4 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
11.1%
3/27 • Number of events 3 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.00%
0/54 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
5.6%
3/54 • Number of events 3 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/57 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/48 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/54 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
5.6%
3/54 • Number of events 3 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/57 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/48 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
7.4%
2/27 • Number of events 2 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Gastrointestinal disorders
DYSPEPSIA
|
5.6%
3/54 • Number of events 3 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/54 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
1.8%
1/57 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/48 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Gastrointestinal disorders
NAUSEA
|
1.9%
1/54 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
3.7%
2/54 • Number of events 2 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/57 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
4.2%
2/48 • Number of events 2 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
7.4%
2/27 • Number of events 2 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/54 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
5.6%
3/54 • Number of events 3 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/57 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/48 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
3.7%
1/27 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/54 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
1.9%
1/54 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/57 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/48 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
8.0%
2/25 • Number of events 2 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/54 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
1.9%
1/54 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/57 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/48 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
7.4%
2/27 • Number of events 2 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Infections and infestations
NASOPHARYNGITIS
|
7.4%
4/54 • Number of events 4 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
1.9%
1/54 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
1.8%
1/57 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
4.2%
2/48 • Number of events 2 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
4.0%
1/25 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
3.7%
1/27 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
1.9%
1/54 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
5.6%
3/54 • Number of events 3 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
3.5%
2/57 • Number of events 2 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
2.1%
1/48 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
4.0%
1/25 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Investigations
HEPATIC ENZYME INCREASED
|
1.9%
1/54 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
5.6%
3/54 • Number of events 3 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
3.5%
2/57 • Number of events 2 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
2.1%
1/48 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS
|
3.7%
2/54 • Number of events 2 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
5.6%
3/54 • Number of events 3 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/57 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
4.2%
2/48 • Number of events 2 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
4.0%
1/25 • Number of events 1 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
14.8%
4/27 • Number of events 4 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/54 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
5.6%
3/54 • Number of events 3 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/57 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/48 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
|
Vascular disorders
HYPERTENSION
|
9.3%
5/54 • Number of events 5 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
13.0%
7/54 • Number of events 7 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
8.8%
5/57 • Number of events 5 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
6.2%
3/48 • Number of events 3 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
28.0%
7/25 • Number of events 7 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/25 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
14.8%
4/27 • Number of events 4 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
0.00%
0/27 • 24 weeks
For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The disclosure restriction on the PI is that the sponsor can review and comment on results communications prior to publication. Sponsor will be allowed a review period of at least 60 days from submission but can request that publication be delayed for a period up to 6 months. Any reasonable comments made by the sponsor will be incorporated by the PI into the publication.
- Publication restrictions are in place
Restriction type: OTHER