Trial Outcomes & Findings for Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate and Have Had Inadequate Response to Single TNF-alpha Antagonist (NCT NCT01197755)
NCT ID: NCT01197755
Last Updated: 2014-04-07
Results Overview
ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once daily.
COMPLETED
PHASE3
323 participants
24 weeks
2014-04-07
Participant Flow
A total of 638 patients were enrolled: 105, 108 \& 110 were randomised to Groups A, B \& C respectively (105, 108 \& 109 received at least 1 dose of investigational product).
A total of 315 patients failed screening.
Participant milestones
| Measure |
FOSTA 100 MG BID PO
Dosing Group A
|
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
Dosing Group B
|
PLACEBO PO
Dosing Group C
|
|---|---|---|---|
|
Overall Study
STARTED
|
105
|
108
|
109
|
|
Overall Study
Randomised But Did Not Receive Treatment
|
0
|
0
|
1
|
|
Overall Study
COMPLETED
|
67
|
65
|
55
|
|
Overall Study
NOT COMPLETED
|
38
|
43
|
54
|
Reasons for withdrawal
| Measure |
FOSTA 100 MG BID PO
Dosing Group A
|
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
Dosing Group B
|
PLACEBO PO
Dosing Group C
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
8
|
10
|
10
|
|
Overall Study
Study-specific discontinuation criteria
|
2
|
1
|
0
|
|
Overall Study
Entered the long-term extension study
|
18
|
21
|
35
|
|
Overall Study
Lack of therapeutic response
|
0
|
7
|
4
|
|
Overall Study
Severe non-compliance to the protocol
|
2
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
eg, change in circumstances
|
7
|
3
|
2
|
Baseline Characteristics
Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate and Have Had Inadequate Response to Single TNF-alpha Antagonist
Baseline characteristics by cohort
| Measure |
FOSTA 100 MG BID PO
n=105 Participants
Dosing Group A
|
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
n=108 Participants
Dosing Group B
|
PLACEBO PO
n=109 Participants
Dosing Group C
|
Total
n=322 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
51 years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
53 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
53 years
STANDARD_DEVIATION 12.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
261 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
86 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
269 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Indian or Pakistani
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
PRIMARY 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.
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 C-Reactive Protein) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once daily.
Outcome measures
| Measure |
FOSTA 100 MG BID PO
n=105 Participants
Dosing Group A
|
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
n=108 Participants
Dosing Group B
|
PLACEBO PO
n=109 Participants
Dosing Group C
|
|---|---|---|---|
|
Proportion of Patients Achieving ACR20 at Week 24, Comparison Between Fostamatinib and Placebo
|
36.2 Percentage of responders
|
27.8 Percentage of responders
|
21.1 Percentage of responders
|
SECONDARY outcome
Timeframe: 1 weekPopulation: 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.
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 C-Reactive Protein) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once daily.
Outcome measures
| Measure |
FOSTA 100 MG BID PO
n=109 Participants
Dosing Group A
|
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
n=213 Participants
Dosing Group B
|
PLACEBO PO
Dosing Group C
|
|---|---|---|---|
|
Proportion of Patients Achieving ACR20 at Week 1, Comparison Between Fostamatinib and Placebo
|
3.7 Percentage of responders
|
25.4 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.
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 C-Reactive Protein) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once daily.
Outcome measures
| Measure |
FOSTA 100 MG BID PO
n=105 Participants
Dosing Group A
|
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
n=108 Participants
Dosing Group B
|
PLACEBO PO
n=109 Participants
Dosing Group C
|
|---|---|---|---|
|
Proportion of Patients Achieving ACR50 at Week 24, Comparison Between Fostamatinib and Placebo
|
18.1 Percentage of responders
|
13.0 Percentage of responders
|
8.3 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.
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 C-Reactive Protein) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once daily.
Outcome measures
| Measure |
FOSTA 100 MG BID PO
n=105 Participants
Dosing Group A
|
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
n=108 Participants
Dosing Group B
|
PLACEBO PO
n=109 Participants
Dosing Group C
|
|---|---|---|---|
|
Proportion of Patients Achieving ACR70 at Week 24, Comparison Between Fostamatinib and Placebo
|
14.3 Percentage of responders
|
2.8 Percentage of responders
|
2.8 Percentage of responders
|
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.
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 C-Reactive Protein) or the physician or patient's own assessments of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. Mean refers to change at Week 24. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.
Outcome measures
| Measure |
FOSTA 100 MG BID PO
n=105 Participants
Dosing Group A
|
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
n=108 Participants
Dosing Group B
|
PLACEBO PO
n=109 Participants
Dosing Group C
|
|---|---|---|---|
|
ACRn - Comparison Between Fostamatinib and Placebo at Week 24
|
16.25 Percentage improvement from baseline
Standard Deviation 36.994
|
13.00 Percentage improvement from baseline
Standard Deviation 24.718
|
5.87 Percentage improvement from baseline
Standard Deviation 26.726
|
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.
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 patients' own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. A DAS28-CRP score of \<2.6 is indicative of remission of RA symptoms. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once daily.
Outcome measures
| Measure |
FOSTA 100 MG BID PO
n=105 Participants
Dosing Group A
|
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
n=108 Participants
Dosing Group B
|
PLACEBO PO
n=109 Participants
Dosing Group C
|
|---|---|---|---|
|
Proportion of Patients Achieving DAS28-CRP <2.6 at Week 24, Comparison Between Fostamatinib and Placebo
|
11.4 Percentage of responders
|
7.4 Percentage of responders
|
3.7 Percentage of responders
|
SECONDARY outcome
Timeframe: 12 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.
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 patients' own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. A DAS28-CRP score of \<=3.2 indicates low disease activity. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once daily.
Outcome measures
| Measure |
FOSTA 100 MG BID PO
n=105 Participants
Dosing Group A
|
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
n=108 Participants
Dosing Group B
|
PLACEBO PO
n=109 Participants
Dosing Group C
|
|---|---|---|---|
|
Proportion of Patients Achieving DAS28-CRP <=3.2 at Week 12, Comparison Between Fostamatinib and Placebo
|
18.1 Percentage of responders
|
20.4 Percentage of responders
|
5.5 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.
Change from baseline in DAS28-CRP at Week 24 was categorised using the European League Against Rheumatism (EULAR) response criteria. BID = twice daily, CRP = C-reactive protein, DAS28 = Disease Activity Score based on a 28-joint count, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.
Outcome measures
| Measure |
FOSTA 100 MG BID PO
n=105 Participants
Dosing Group A
|
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
n=108 Participants
Dosing Group B
|
PLACEBO PO
n=109 Participants
Dosing Group C
|
|---|---|---|---|
|
Proportion of Patients Achieving DAS28-CRP EULAR Response at Week 24, Comparison Between Fostamatinib and Placebo
No response
|
46.7 Percentage of responders
1.46 • Interval 0.2 to 0.68
|
54.6 Percentage of responders
1.34 • Interval 0.26 to 0.89
|
67.9 Percentage of responders
1.30 • Interval 0.2 to 0.65
|
|
Proportion of Patients Achieving DAS28-CRP EULAR Response at Week 24, Comparison Between Fostamatinib and Placebo
Moderate response
|
29.5 Percentage of responders
|
34.3 Percentage of responders
|
26.6 Percentage of responders
|
|
Proportion of Patients Achieving DAS28-CRP EULAR Response at Week 24, Comparison Between Fostamatinib and Placebo
Good response
|
23.8 Percentage of responders
|
11.1 Percentage of responders
|
5.5 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.
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, hygeine, 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. A HAQ-DI response is a reduction from baseline in HAQ-DI greater than or equal to the minimally important difference (0.22). BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.
Outcome measures
| Measure |
FOSTA 100 MG BID PO
n=105 Participants
Dosing Group A
|
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
n=108 Participants
Dosing Group B
|
PLACEBO PO
n=109 Participants
Dosing Group C
|
|---|---|---|---|
|
Proportion of Patients With a HAQ-DI Response at Week 24 - Comparison Between Fostamatinib and Placebo
|
41.9 Percentage of responders
|
31.5 Percentage of responders
|
23.9 Percentage of responders
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksPopulation: The full analysis set includes patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle. Measurements at 2 timepoints are required for a patient to be included in the analysis; therefore patients with only 1 result have been excluded from the analysis population.
mTSS: modified total sharp score, a measure of structural progression based upon X-rays. Hand and foot joints are scored for eroisions and joint space narrowing and the results summed to give a value between 0 and 488. A higher value represents more serious progression of the disease. After disregarding ineligible records, patients with 2 or more non-missing values had missing data imputed via linear extrapolation/interpolation methods. Patients with only 1 result were excluded from the analysis. ANCOVA = Analysis of covariance, BID = twice daily, IP = investigational product, PO = orally, QD = once a day.
Outcome measures
| Measure |
FOSTA 100 MG BID PO
n=81 Participants
Dosing Group A
|
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
n=87 Participants
Dosing Group B
|
PLACEBO PO
n=88 Participants
Dosing Group C
|
|---|---|---|---|
|
Change From Baseline to Week 24 in mTSS Score, Comparison Between Fostamatinib and Placebo
|
0.80 Units on a scale
Standard Deviation 2.636
|
0.18 Units on a scale
Standard Deviation 3.455
|
0.84 Units on a scale
Standard Deviation 1.989
|
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.
SF-36: 36 item short form health survey, as a measure of health-related quality of life. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0 to 100. The physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with a mean of 50, standard deviation of 10. A higher score represents a better quality of life. Mean changes from baseline score are presented as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. Mean refers to change in scores at Week 24. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease modifying antirheumatic drugs, PO = orally, QD = once daily
Outcome measures
| Measure |
FOSTA 100 MG BID PO
n=104 Participants
Dosing Group A
|
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
n=108 Participants
Dosing Group B
|
PLACEBO PO
n=109 Participants
Dosing Group C
|
|---|---|---|---|
|
SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 24
|
5 Units on a scale
Standard Deviation 8.3
|
4 Units on a scale
Standard Deviation 7.4
|
2 Units on a scale
Standard Deviation 6.2
|
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.
SF-36: 36 item short form health survey, as a measure of health-related quality of life. The SF-36 scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0 to 100. The physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with a mean of 50, standard deviation of 10. A higher score represents a better quality of life. Mean changes from baseline score are presented as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. Mean refers to change in score at Week 24. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease modifying antirheumatic drugs, PO = orally, QD = once daily.
Outcome measures
| Measure |
FOSTA 100 MG BID PO
n=104 Participants
Dosing Group A
|
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
n=108 Participants
Dosing Group B
|
PLACEBO PO
n=109 Participants
Dosing Group C
|
|---|---|---|---|
|
SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 24
|
2 Units on a scale
Standard Deviation 8.6
|
2 Units on a scale
Standard Deviation 7.0
|
2 Units on a scale
Standard Deviation 7.3
|
Adverse Events
FOSTA 100 MG BID PO
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
PLACEBO PO
Serious adverse events
| Measure |
FOSTA 100 MG BID PO
n=105 participants at risk
Dosing Group A
|
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
n=108 participants at risk
Dosing Group B
|
PLACEBO PO
n=109 participants at risk
Dosing Group C
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/105
|
0.00%
0/108
|
0.92%
1/109 • Number of events 1
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.00%
0/105
|
0.00%
0/108
|
0.92%
1/109 • Number of events 1
|
|
Cardiac disorders
ARTERIOSCLEROSIS CORONARY ARTERY
|
0.95%
1/105 • Number of events 1
|
0.00%
0/108
|
0.00%
0/109
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.00%
0/105
|
0.93%
1/108 • Number of events 1
|
0.00%
0/109
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.00%
0/105
|
0.93%
1/108 • Number of events 1
|
0.00%
0/109
|
|
Cardiac disorders
CORONARY ARTERY OCCLUSION
|
0.00%
0/105
|
0.93%
1/108 • Number of events 1
|
0.00%
0/109
|
|
Gastrointestinal disorders
CROHN'S DISEASE
|
0.00%
0/105
|
0.00%
0/108
|
0.92%
1/109 • Number of events 1
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/105
|
0.00%
0/108
|
0.92%
1/109 • Number of events 1
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.95%
1/105 • Number of events 1
|
0.00%
0/108
|
0.00%
0/109
|
|
Gastrointestinal disorders
GASTRITIS
|
0.95%
1/105 • Number of events 1
|
0.00%
0/108
|
0.00%
0/109
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/105
|
0.00%
0/108
|
0.92%
1/109 • Number of events 1
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.95%
1/105 • Number of events 1
|
0.93%
1/108 • Number of events 1
|
0.00%
0/109
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.95%
1/105 • Number of events 1
|
0.00%
0/108
|
0.00%
0/109
|
|
Infections and infestations
DIVERTICULITIS
|
0.95%
1/105 • Number of events 1
|
0.00%
0/108
|
0.00%
0/109
|
|
Infections and infestations
ESCHERICHIA URINARY TRACT INFECTION
|
0.00%
0/105
|
0.00%
0/108
|
0.92%
1/109 • Number of events 1
|
|
Infections and infestations
GASTROENTERITIS
|
0.95%
1/105 • Number of events 1
|
1.9%
2/108 • Number of events 2
|
0.00%
0/109
|
|
Infections and infestations
GASTROENTERITIS BACTERIAL
|
0.95%
1/105 • Number of events 1
|
0.00%
0/108
|
0.00%
0/109
|
|
Infections and infestations
HERPES PHARYNGITIS
|
0.00%
0/105
|
0.00%
0/108
|
0.92%
1/109 • Number of events 2
|
|
Infections and infestations
OROPHARYNGEAL CANDIDIASIS
|
0.00%
0/105
|
0.00%
0/108
|
0.92%
1/109 • Number of events 1
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.00%
0/105
|
0.00%
0/108
|
0.92%
1/109 • Number of events 1
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.95%
1/105 • Number of events 1
|
0.00%
0/108
|
0.00%
0/109
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.95%
1/105 • Number of events 1
|
0.00%
0/108
|
0.00%
0/109
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CELL CARCINOMA
|
0.00%
0/105
|
0.93%
1/108 • Number of events 1
|
0.00%
0/109
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/105
|
0.93%
1/108 • Number of events 1
|
0.00%
0/109
|
|
Nervous system disorders
TRANSIENT GLOBAL AMNESIA
|
0.95%
1/105 • Number of events 1
|
0.00%
0/108
|
0.00%
0/109
|
Other adverse events
| Measure |
FOSTA 100 MG BID PO
n=105 participants at risk
Dosing Group A
|
FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
n=108 participants at risk
Dosing Group B
|
PLACEBO PO
n=109 participants at risk
Dosing Group C
|
|---|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
20.0%
21/105 • Number of events 23
|
26.9%
29/108 • Number of events 31
|
6.4%
7/109 • Number of events 8
|
|
Gastrointestinal disorders
FLATULENCE
|
5.7%
6/105 • Number of events 7
|
1.9%
2/108 • Number of events 2
|
3.7%
4/109 • Number of events 4
|
|
Gastrointestinal disorders
NAUSEA
|
3.8%
4/105 • Number of events 5
|
6.5%
7/108 • Number of events 8
|
8.3%
9/109 • Number of events 9
|
|
Gastrointestinal disorders
VOMITING
|
0.95%
1/105 • Number of events 1
|
5.6%
6/108 • Number of events 6
|
3.7%
4/109 • Number of events 4
|
|
General disorders
FATIGUE
|
0.00%
0/105
|
0.00%
0/108
|
5.5%
6/109 • Number of events 6
|
|
Infections and infestations
NASOPHARYNGITIS
|
5.7%
6/105 • Number of events 6
|
3.7%
4/108 • Number of events 5
|
3.7%
4/109 • Number of events 4
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
5.7%
6/105 • Number of events 7
|
1.9%
2/108 • Number of events 2
|
0.92%
1/109 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
5.7%
6/105 • Number of events 6
|
0.00%
0/108
|
4.6%
5/109 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS
|
3.8%
4/105 • Number of events 5
|
5.6%
6/108 • Number of events 9
|
10.1%
11/109 • Number of events 11
|
|
Nervous system disorders
DIZZINESS
|
6.7%
7/105 • Number of events 9
|
5.6%
6/108 • Number of events 6
|
1.8%
2/109 • Number of events 2
|
|
Nervous system disorders
HEADACHE
|
7.6%
8/105 • Number of events 8
|
8.3%
9/108 • Number of events 9
|
10.1%
11/109 • Number of events 12
|
|
Vascular disorders
HYPERTENSION
|
13.3%
14/105 • Number of events 15
|
13.9%
15/108 • Number of events 15
|
8.3%
9/109 • Number of events 11
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place