Trial Outcomes & Findings for Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) (NCT NCT01242514)
NCT ID: NCT01242514
Last Updated: 2014-04-04
Results Overview
AE = adverse event, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
1917 participants
Primary outcome timeframe
Entry in extension to end of study (variable duration; maximum 109 weeks)
Results posted on
2014-04-04
Participant Flow
Total of 1917 enrolled patients: 1346, 357 \& 214 were allocated to the 100 mg twice daily (bid), 150 mg once daily (qd) and 100 mg qd groups, respectively (1343, 357 \& 212 received at least 1 dose of investigational product). As this was a long-term extension study no specific end date was given. As such no patients were recorded as completers.
A total of 5 patients did not receive treatment.
Participant milestones
| Measure |
Fostamatinib 100 mg Bid
Oral treatment
|
Fostamatinib 150 mg qd
Oral treatment
|
Fostamatinib 100 mg qd
Oral treatment
|
|---|---|---|---|
|
Overall Study
STARTED
|
1343
|
357
|
212
|
|
Overall Study
Enrolled But Did Not Receive Treatment
|
3
|
0
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1343
|
357
|
212
|
Reasons for withdrawal
| Measure |
Fostamatinib 100 mg Bid
Oral treatment
|
Fostamatinib 150 mg qd
Oral treatment
|
Fostamatinib 100 mg qd
Oral treatment
|
|---|---|---|---|
|
Overall Study
e.g., project closure
|
1042
|
305
|
171
|
|
Overall Study
Subject decision
|
33
|
8
|
2
|
|
Overall Study
Severe non-compliance to protocol
|
5
|
2
|
1
|
|
Overall Study
Lack of therapeutic response
|
99
|
16
|
10
|
|
Overall Study
Dev. of study specific discont. criteria
|
21
|
3
|
5
|
|
Overall Study
Lost to Follow-up
|
14
|
5
|
4
|
|
Overall Study
Adverse Event
|
129
|
18
|
19
|
Baseline Characteristics
Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA)
Baseline characteristics by cohort
| Measure |
Fostamatinib 100 mg Bid
n=1343 Participants
Oral treatment
|
Fostamatinib 150 mg qd
n=357 Participants
Oral treatment
|
Fostamatinib 100 mg qd
n=212 Participants
Oral treatment
|
Total
n=1912 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
53 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
53 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
53 years
STANDARD_DEVIATION 11.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1086 Participants
n=5 Participants
|
297 Participants
n=7 Participants
|
193 Participants
n=5 Participants
|
1576 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
257 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
336 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
1092 Participants
n=5 Participants
|
278 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
1511 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
63 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
40 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
20 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Indian or Pakistani
|
54 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
74 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
134 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Entry in extension to end of study (variable duration; maximum 109 weeks)Population: The full analysis set includes those patients who received at least 1 dose of investigational product, and were summarised according to treatment first received in this study (intention-to-treat principle).
AE = adverse event, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event
Outcome measures
| Measure |
Fostamatinib 100 mg Bid
n=1343 Participants
Oral treatment
|
Fostamatinib 150 mg qd
n=357 Participants
Oral treatment
|
Fostamatinib 100 mg qd
n=212 Participants
Oral treatment
|
|---|---|---|---|
|
Percentage of Patients Who Had at Least 1 Adverse Event in Any Category
Any AE
|
74.4 Percentage of patients
|
70.3 Percentage of patients
|
69.8 Percentage of patients
|
|
Percentage of Patients Who Had at Least 1 Adverse Event in Any Category
Any AE with outcome of death
|
0.7 Percentage of patients
|
0.3 Percentage of patients
|
0.5 Percentage of patients
|
|
Percentage of Patients Who Had at Least 1 Adverse Event in Any Category
Any SAE (including events with outcome of death)
|
11.4 Percentage of patients
|
8.7 Percentage of patients
|
5.7 Percentage of patients
|
|
Percentage of Patients Who Had at Least 1 Adverse Event in Any Category
Any AE leading to discontinuation of IP
|
10.5 Percentage of patients
|
5.9 Percentage of patients
|
9.9 Percentage of patients
|
SECONDARY outcome
Timeframe: Weeks 0, 12, 24, 36 and 52Population: The full analysis set includes those patients who received at least 1 dose of investigational product, and were summarised according to treatment first received in this study (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 patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, CRP = C-reactive protein, qd = once daily
Outcome measures
| Measure |
Fostamatinib 100 mg Bid
n=1247 Participants
Oral treatment
|
Fostamatinib 150 mg qd
n=336 Participants
Oral treatment
|
Fostamatinib 100 mg qd
n=198 Participants
Oral treatment
|
|---|---|---|---|
|
Mean DAS28-CRP Score
Week 0 (n=1247, 336, 198)
|
4.5 Units on a scale
Standard Deviation 1.58 • Interval 0.23 to 0.9
|
3.8 Units on a scale
Standard Deviation 1.24 • Interval 0.14 to 0.84
|
3.9 Units on a scale
Standard Deviation 1.27 • Interval -0.12 to 0.56
|
|
Mean DAS28-CRP Score
Week 12 (n=1018, 288, 160)
|
3.8 Units on a scale
Standard Deviation 1.34
|
3.6 Units on a scale
Standard Deviation 1.19
|
3.7 Units on a scale
Standard Deviation 1.21
|
|
Mean DAS28-CRP Score
Week 24 (n=800, 230 126)
|
3.8 Units on a scale
Standard Deviation 1.30
|
3.7 Units on a scale
Standard Deviation 1.24
|
3.6 Units on a scale
Standard Deviation 1.19
|
|
Mean DAS28-CRP Score
Week 36 (n=581, 148, 68)
|
3.9 Units on a scale
Standard Deviation 1.32
|
3.7 Units on a scale
Standard Deviation 1.24
|
3.9 Units on a scale
Standard Deviation 1.07
|
|
Mean DAS28-CRP Score
Week 52 (n=290, 28, 14)
|
4.0 Units on a scale
Standard Deviation 1.25
|
3.8 Units on a scale
Standard Deviation 1.37
|
3.6 Units on a scale
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: Weeks 0 and 52Population: The full analysis set includes those patients who received at least 1 dose of investigational product, and were summarised according to treatment first received in this study (intention-to-treat principle).
mTSS: modified total sharp score, a measure of structural progression based upon X-rays. Hand and foot joints are scored for erosions and joint space narrowing and the results summed to give a value between 0 and 488. A higher value represents more serious progression of the disease. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, N/A = not applicable, qd = once daily
Outcome measures
| Measure |
Fostamatinib 100 mg Bid
n=480 Participants
Oral treatment
|
Fostamatinib 150 mg qd
n=73 Participants
Oral treatment
|
Fostamatinib 100 mg qd
n=37 Participants
Oral treatment
|
|---|---|---|---|
|
Mean mTSS Score
Week 0 (n=480, 73, 37)
|
30.5 Units on a scale
Standard Deviation 47.73
|
22.2 Units on a scale
Standard Deviation 32.89
|
20.8 Units on a scale
Standard Deviation 46.60
|
|
Mean mTSS Score
Week 52 (n=223, 1, 6)
|
30.1 Units on a scale
Standard Deviation 46.83
|
0.5 Units on a scale
Standard Deviation NA
Measures of spread are not defined for treatment groups containing a single patient.
|
37.3 Units on a scale
Standard Deviation 67.70
|
SECONDARY outcome
Timeframe: Weeks 0, 12, 24, 36 and 52Population: The full analysis set includes those patients who received at least 1 dose of investigational product, and were summarised according to treatment first received in this study (intention-to-treat principle).
HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is then calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, qd = once daily
Outcome measures
| Measure |
Fostamatinib 100 mg Bid
n=1271 Participants
Oral treatment
|
Fostamatinib 150 mg qd
n=342 Participants
Oral treatment
|
Fostamatinib 100 mg qd
n=201 Participants
Oral treatment
|
|---|---|---|---|
|
Mean HAQ-DI Score
Week 12 (n=1061, 298, 166)
|
1.1 Units on a scale
Standard Deviation 0.68
|
1.0 Units on a scale
Standard Deviation 0.63
|
1.0 Units on a scale
Standard Deviation 0.63
|
|
Mean HAQ-DI Score
Week 24 (n=817, 238, 132)
|
1.1 Units on a scale
Standard Deviation 0.68
|
1.0 Units on a scale
Standard Deviation 0.67
|
0.9 Units on a scale
Standard Deviation 0.55
|
|
Mean HAQ-DI Score
Week 0 (n=1271, 342, 201)
|
1.2 Units on a scale
Standard Deviation 0.69
|
1.0 Units on a scale
Standard Deviation 0.64
|
1.0 Units on a scale
Standard Deviation 0.62
|
|
Mean HAQ-DI Score
Week 36 (n=587, 149, 71)
|
1.1 Units on a scale
Standard Deviation 0.67
|
1.0 Units on a scale
Standard Deviation 0.65
|
1.1 Units on a scale
Standard Deviation 0.62
|
|
Mean HAQ-DI Score
Week 52 (n=296, 28, 14)
|
1.2 Units on a scale
Standard Deviation 0.68
|
1.1 Units on a scale
Standard Deviation 0.64
|
1.0 Units on a scale
Standard Deviation 0.73
|
Adverse Events
FOSTA 100 MG BID
Serious events: 153 serious events
Other events: 466 other events
Deaths: 0 deaths
FOSTA 100 MG QD
Serious events: 12 serious events
Other events: 68 other events
Deaths: 0 deaths
FOSTA 150 MG QD
Serious events: 31 serious events
Other events: 98 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FOSTA 100 MG BID
n=1343 participants at risk
|
FOSTA 100 MG QD
n=212 participants at risk
|
FOSTA 150 MG QD
n=357 participants at risk
|
|---|---|---|---|
|
Blood and lymphatic system disorders
SPLENIC INFARCTION
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.00%
0/1343
|
0.00%
0/212
|
0.28%
1/357 • Number of events 1
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.15%
2/1343 • Number of events 2
|
0.00%
0/212
|
0.00%
0/357
|
|
Cardiac disorders
BRADYCARDIA
|
0.00%
0/1343
|
0.47%
1/212 • Number of events 1
|
0.00%
0/357
|
|
Cardiac disorders
CARDIAC FAILURE CHRONIC
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.15%
2/1343 • Number of events 2
|
0.00%
0/212
|
0.00%
0/357
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Cardiac disorders
CARDIOMYOPATHY
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.15%
2/1343 • Number of events 2
|
0.00%
0/212
|
0.00%
0/357
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Endocrine disorders
GOITRE
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Eye disorders
RETINAL DETACHMENT
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/1343
|
0.47%
1/212 • Number of events 1
|
0.00%
0/357
|
|
Gastrointestinal disorders
ACUTE ABDOMEN
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Gastrointestinal disorders
BARRETT'S OESOPHAGUS
|
0.00%
0/1343
|
0.00%
0/212
|
0.28%
1/357 • Number of events 1
|
|
Gastrointestinal disorders
COLITIS
|
0.15%
2/1343 • Number of events 2
|
0.00%
0/212
|
0.00%
0/357
|
|
Gastrointestinal disorders
COLITIS MICROSCOPIC
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Gastrointestinal disorders
COLONIC STENOSIS
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.30%
4/1343 • Number of events 4
|
0.47%
1/212 • Number of events 1
|
0.00%
0/357
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/1343
|
0.00%
0/212
|
0.28%
1/357 • Number of events 1
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Gastrointestinal disorders
GASTRITIS
|
0.15%
2/1343 • Number of events 2
|
0.00%
0/212
|
0.28%
1/357 • Number of events 1
|
|
Gastrointestinal disorders
GASTRITIS EROSIVE
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Gastrointestinal disorders
ILEITIS
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Gastrointestinal disorders
ILEUS
|
0.15%
2/1343 • Number of events 2
|
0.00%
0/212
|
0.00%
0/357
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.15%
2/1343 • Number of events 2
|
0.00%
0/212
|
0.28%
1/357 • Number of events 1
|
|
Gastrointestinal disorders
INTESTINAL HAEMORRHAGE
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Gastrointestinal disorders
INTESTINAL ISCHAEMIA
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.00%
0/1343
|
0.00%
0/212
|
0.28%
1/357 • Number of events 1
|
|
Gastrointestinal disorders
OESOPHAGEAL ACHALASIA
|
0.07%
1/1343 • Number of events 2
|
0.00%
0/212
|
0.00%
0/357
|
|
Gastrointestinal disorders
PANCREATIC PSEUDOCYST
|
0.00%
0/1343
|
0.47%
1/212 • Number of events 1
|
0.00%
0/357
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.22%
3/1343 • Number of events 3
|
0.00%
0/212
|
0.00%
0/357
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.22%
3/1343 • Number of events 3
|
0.47%
1/212 • Number of events 1
|
0.00%
0/357
|
|
General disorders
DEVICE DISLOCATION
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.22%
3/1343 • Number of events 3
|
0.47%
1/212 • Number of events 1
|
0.00%
0/357
|
|
Hepatobiliary disorders
BILE DUCT OBSTRUCTION
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Hepatobiliary disorders
BILIARY COLIC
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.15%
2/1343 • Number of events 2
|
0.00%
0/212
|
0.00%
0/357
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.00%
0/1343
|
0.00%
0/212
|
0.28%
1/357 • Number of events 1
|
|
Hepatobiliary disorders
CHOLECYSTITIS CHRONIC
|
0.00%
0/1343
|
0.00%
0/212
|
0.28%
1/357 • Number of events 1
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.30%
4/1343 • Number of events 4
|
0.00%
0/212
|
0.00%
0/357
|
|
Hepatobiliary disorders
GALLBLADDER POLYP
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Hepatobiliary disorders
POST CHOLECYSTECTOMY SYNDROME
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Immune system disorders
ANAPHYLACTIC SHOCK
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Immune system disorders
FOOD ALLERGY
|
0.00%
0/1343
|
0.00%
0/212
|
0.28%
1/357 • Number of events 1
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.15%
2/1343 • Number of events 2
|
0.00%
0/212
|
0.00%
0/357
|
|
Infections and infestations
ABSCESS LIMB
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Infections and infestations
APPENDICITIS
|
0.30%
4/1343 • Number of events 4
|
0.00%
0/212
|
0.00%
0/357
|
|
Infections and infestations
ARTHRITIS BACTERIAL
|
0.00%
0/1343
|
0.47%
1/212 • Number of events 1
|
0.00%
0/357
|
|
Infections and infestations
BACTERAEMIA
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Infections and infestations
BACTERIAL PYELONEPHRITIS
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Infections and infestations
BACTERIAL SEPSIS
|
0.15%
2/1343 • Number of events 2
|
0.00%
0/212
|
0.00%
0/357
|
|
Infections and infestations
BRONCHITIS
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Infections and infestations
BRONCHOPNEUMONIA
|
0.00%
0/1343
|
0.00%
0/212
|
0.28%
1/357 • Number of events 1
|
|
Infections and infestations
CELLULITIS
|
0.45%
6/1343 • Number of events 7
|
0.47%
1/212 • Number of events 1
|
0.00%
0/357
|
|
Infections and infestations
CYTOMEGALOVIRUS INFECTION
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/1343
|
0.00%
0/212
|
0.28%
1/357 • Number of events 1
|
|
Infections and infestations
ENTEROCOLITIS BACTERIAL
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Infections and infestations
ENTEROCOLITIS VIRAL
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Infections and infestations
ERYSIPELAS
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Infections and infestations
ESCHERICHIA URINARY TRACT INFECTION
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Infections and infestations
GANGRENE
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Infections and infestations
GASTROENTERITIS
|
0.07%
1/1343 • Number of events 1
|
0.47%
1/212 • Number of events 1
|
0.00%
0/357
|
|
Infections and infestations
GASTROENTERITIS BACTERIAL
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.28%
1/357 • Number of events 1
|
|
Infections and infestations
HERPES ZOSTER
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Infections and infestations
INTERVERTEBRAL DISCITIS
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Infections and infestations
LIVER ABSCESS
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Infections and infestations
LUNG ABSCESS
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Infections and infestations
OSTEOMYELITIS
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Infections and infestations
OTITIS EXTERNA
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Infections and infestations
PANCREATITIS VIRAL
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Infections and infestations
PERITONITIS
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Infections and infestations
PNEUMONIA
|
0.37%
5/1343 • Number of events 5
|
0.47%
1/212 • Number of events 1
|
0.28%
1/357 • Number of events 1
|
|
Infections and infestations
PNEUMONIA BACTERIAL
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Infections and infestations
PNEUMONIA VIRAL
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Infections and infestations
PULMONARY TUBERCULOSIS
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Infections and infestations
STAPHYLOCOCCAL SEPSIS
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Infections and infestations
SUBCUTANEOUS ABSCESS
|
0.00%
0/1343
|
0.00%
0/212
|
0.28%
1/357 • Number of events 1
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Infections and infestations
URINARY TRACT INFECTION BACTERIAL
|
0.15%
2/1343 • Number of events 2
|
0.00%
0/212
|
0.00%
0/357
|
|
Infections and infestations
UROSEPSIS
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Infections and infestations
WOUND INFECTION BACTERIAL
|
0.00%
0/1343
|
0.00%
0/212
|
0.28%
1/357 • Number of events 1
|
|
Infections and infestations
WOUND SEPSIS
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Injury, poisoning and procedural complications
ACCIDENTAL OVERDOSE
|
0.00%
0/1343
|
0.00%
0/212
|
0.56%
2/357 • Number of events 2
|
|
Injury, poisoning and procedural complications
FACIAL BONES FRACTURE
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE
|
0.07%
1/1343 • Number of events 1
|
0.47%
1/212 • Number of events 1
|
0.00%
0/357
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Injury, poisoning and procedural complications
FIBULA FRACTURE
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.15%
2/1343 • Number of events 2
|
0.00%
0/212
|
0.28%
1/357 • Number of events 1
|
|
Injury, poisoning and procedural complications
JOINT DISLOCATION
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Injury, poisoning and procedural complications
JOINT INJURY
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Injury, poisoning and procedural complications
PATELLA FRACTURE
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Injury, poisoning and procedural complications
TENDON RUPTURE
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Injury, poisoning and procedural complications
TIBIA FRACTURE
|
0.00%
0/1343
|
0.47%
1/212 • Number of events 1
|
0.00%
0/357
|
|
Injury, poisoning and procedural complications
ULNA FRACTURE
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.00%
0/1343
|
0.00%
0/212
|
0.28%
1/357 • Number of events 1
|
|
Injury, poisoning and procedural complications
WOUND DEHISCENCE
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Injury, poisoning and procedural complications
WRIST FRACTURE
|
0.00%
0/1343
|
0.00%
0/212
|
0.28%
1/357 • Number of events 1
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.07%
1/1343 • Number of events 1
|
0.47%
1/212 • Number of events 1
|
0.28%
1/357 • Number of events 1
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.28%
1/357 • Number of events 1
|
|
Metabolism and nutrition disorders
TYPE 2 DIABETES MELLITUS
|
0.00%
0/1343
|
0.47%
1/212 • Number of events 1
|
0.00%
0/357
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.15%
2/1343 • Number of events 2
|
0.00%
0/212
|
0.00%
0/357
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Musculoskeletal and connective tissue disorders
HIP DEFORMITY
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC DISORDER
|
0.00%
0/1343
|
0.00%
0/212
|
0.28%
1/357 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC DISPLACEMENT
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.30%
4/1343 • Number of events 4
|
0.47%
1/212 • Number of events 1
|
0.00%
0/357
|
|
Musculoskeletal and connective tissue disorders
LUMBAR SPINAL STENOSIS
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Musculoskeletal and connective tissue disorders
OSTEITIS
|
0.00%
0/1343
|
0.47%
1/212 • Number of events 1
|
0.00%
0/357
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.45%
6/1343 • Number of events 8
|
0.00%
0/212
|
0.56%
2/357 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS
|
0.00%
0/1343
|
0.00%
0/212
|
0.28%
1/357 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
PATHOLOGICAL FRACTURE
|
0.15%
2/1343 • Number of events 2
|
0.00%
0/212
|
0.00%
0/357
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS
|
0.67%
9/1343 • Number of events 11
|
0.00%
0/212
|
0.00%
0/357
|
|
Musculoskeletal and connective tissue disorders
SJOGREN'S SYNDROME
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Musculoskeletal and connective tissue disorders
SPONDYLOLISTHESIS
|
0.00%
0/1343
|
0.00%
0/212
|
0.28%
1/357 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
SYNOVITIS
|
0.00%
0/1343
|
0.00%
0/212
|
0.28%
1/357 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.15%
2/1343 • Number of events 2
|
0.00%
0/212
|
0.00%
0/357
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN NEOPLASM OF PROSTATE
|
0.00%
0/1343
|
0.00%
0/212
|
0.28%
1/357 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN SOFT TISSUE NEOPLASM
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.15%
2/1343 • Number of events 2
|
0.00%
0/212
|
0.00%
0/357
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CERVIX CARCINOMA
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLORECTAL CANCER
|
0.00%
0/1343
|
0.00%
0/212
|
0.28%
1/357 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTRIC CANCER
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LIPOMA
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PANCREATIC NEUROENDOCRINE TUMOUR
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECTAL CANCER
|
0.00%
0/1343
|
0.00%
0/212
|
0.28%
1/357 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CANCER METASTATIC
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CELL CARCINOMA
|
0.00%
0/1343
|
0.00%
0/212
|
0.28%
1/357 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE LEIOMYOMA
|
0.15%
2/1343 • Number of events 2
|
0.00%
0/212
|
0.28%
1/357 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
VAGINAL CANCER
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Nervous system disorders
APHASIA
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Nervous system disorders
CAROTID ARTERY STENOSIS
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Nervous system disorders
CONVULSION
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Nervous system disorders
DYSARTHRIA
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Nervous system disorders
HAEMORRHAGIC STROKE
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Nervous system disorders
HYPERTENSIVE ENCEPHALOPATHY
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Nervous system disorders
HYPOGLYCAEMIC COMA
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Nervous system disorders
LUMBAR RADICULOPATHY
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Nervous system disorders
POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Nervous system disorders
RADICULITIS LUMBOSACRAL
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Nervous system disorders
SCIATICA
|
0.00%
0/1343
|
0.47%
1/212 • Number of events 1
|
0.00%
0/357
|
|
Nervous system disorders
SYNCOPE
|
0.22%
3/1343 • Number of events 3
|
0.00%
0/212
|
0.56%
2/357 • Number of events 2
|
|
Nervous system disorders
TENSION HEADACHE
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Nervous system disorders
VITH NERVE PARALYSIS
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Psychiatric disorders
ADJUSTMENT DISORDER
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Psychiatric disorders
ALCOHOL ABUSE
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Psychiatric disorders
DEPRESSION
|
0.15%
2/1343 • Number of events 2
|
0.00%
0/212
|
0.00%
0/357
|
|
Renal and urinary disorders
CALCULUS URETERIC
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Renal and urinary disorders
CALCULUS URINARY
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.07%
1/1343 • Number of events 1
|
0.47%
1/212 • Number of events 1
|
0.00%
0/357
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.22%
3/1343 • Number of events 3
|
0.00%
0/212
|
0.00%
0/357
|
|
Renal and urinary disorders
RENAL IMPAIRMENT
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Renal and urinary disorders
URINARY BLADDER POLYP
|
0.00%
0/1343
|
0.00%
0/212
|
0.28%
1/357 • Number of events 1
|
|
Reproductive system and breast disorders
ADENOMYOSIS
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Reproductive system and breast disorders
OVARIAN CYST
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Reproductive system and breast disorders
UTERINE POLYP
|
0.00%
0/1343
|
0.00%
0/212
|
0.28%
1/357 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.15%
2/1343 • Number of events 2
|
0.00%
0/212
|
0.00%
0/357
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.28%
1/357 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
HYPERVENTILATION
|
0.00%
0/1343
|
0.00%
0/212
|
0.28%
1/357 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.30%
4/1343 • Number of events 4
|
0.00%
0/212
|
0.00%
0/357
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Skin and subcutaneous tissue disorders
DIGITAL ULCER
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA MULTIFORME
|
0.00%
0/1343
|
0.00%
0/212
|
0.28%
1/357 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
TOXIC EPIDERMAL NECROLYSIS
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Vascular disorders
AORTIC ANEURYSM RUPTURE
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Vascular disorders
AORTIC STENOSIS
|
0.00%
0/1343
|
0.47%
1/212 • Number of events 1
|
0.00%
0/357
|
|
Vascular disorders
AORTIC THROMBOSIS
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Vascular disorders
ARTERIAL THROMBOSIS
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Vascular disorders
FEMORAL ARTERY OCCLUSION
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Vascular disorders
PERIPHERAL ISCHAEMIA
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
|
Vascular disorders
THROMBOPHLEBITIS SUPERFICIAL
|
0.07%
1/1343 • Number of events 1
|
0.00%
0/212
|
0.00%
0/357
|
Other adverse events
| Measure |
FOSTA 100 MG BID
n=1343 participants at risk
|
FOSTA 100 MG QD
n=212 participants at risk
|
FOSTA 150 MG QD
n=357 participants at risk
|
|---|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
15.0%
202/1343 • Number of events 268
|
13.2%
28/212 • Number of events 40
|
12.0%
43/357 • Number of events 61
|
|
Infections and infestations
NASOPHARYNGITIS
|
6.4%
86/1343 • Number of events 102
|
7.1%
15/212 • Number of events 16
|
7.8%
28/357 • Number of events 31
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS
|
8.6%
116/1343 • Number of events 155
|
9.0%
19/212 • Number of events 22
|
8.4%
30/357 • Number of events 35
|
|
Vascular disorders
HYPERTENSION
|
12.4%
166/1343 • Number of events 197
|
6.6%
14/212 • Number of events 15
|
5.6%
20/357 • Number of events 23
|
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