OSKIRA-X: Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA)

Sponsor
AstraZeneca (Industry)
Overall Status
Terminated
CT.gov ID
NCT01242514
Collaborator
(none)
1,917
310
3
48
6.2
0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the long term safety and tolerability of fostamatinib in patients with rheumatoid arthritis (RA).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1917 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
(OSKIRA-X): A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis
Study Start Date :
Jan 1, 2011
Anticipated Primary Completion Date :
Jan 1, 2015
Anticipated Study Completion Date :
Jan 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

Oral treatment

Drug: Fostamatinib
Fostamatinib 100mg twice daily

Experimental: B

Oral treatment

Drug: Fostamatinib
Fostamatinib 150mg once daily

Experimental: C

Oral treatment

Drug: Fostamatinib
Fostamatinib 100mg once daily

Outcome Measures

Primary Outcome Measures

  1. Percentage of Patients Who Had at Least 1 Adverse Event in Any Category [Entry in extension to end of study (variable duration; maximum 109 weeks)]

    AE = adverse event, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event

Secondary Outcome Measures

  1. Mean DAS28-CRP Score [Weeks 0, 12, 24, 36 and 52]

    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

  2. Mean mTSS Score [Weeks 0 and 52]

    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

  3. Mean HAQ-DI Score [Weeks 0, 12, 24, 36 and 52]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients who have successfully completed a qualifying study (D4300C00001, D4300C00002, D4300C00003 or D4300C00004) with fostamatinib

  • Patients who have participated in a qualifying study and who have been classified as non-responders due to pre-defined lack of efficacy at Week 12 (D4300C00001, D4300C00002, D4300C00003).

Exclusion Criteria:
  • Premature withdrawal from the qualifying study (D4300C00001, D4300C00002, D4300C00003 and D4300C00004)

  • Females who are pregnant or breast feeding

  • Poorly controlled hypertension

  • Significant liver function test abnormalities or physical symptoms of hepatotoxicity

  • Significant infection

  • Gastrointestinal intolerance

  • Cancer

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Sponsors and Collaborators

  • AstraZeneca

Investigators

  • Study Director: Chris O'Brien, MD PhD, AstraZeneca

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01242514
Other Study ID Numbers:
  • D4300C00005
  • 2010-020892-22
First Posted:
Nov 17, 2010
Last Update Posted:
Apr 4, 2014
Last Verified:
Feb 1, 2014
Keywords provided by AstraZeneca
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details 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.
Pre-assignment Detail A total of 5 patients did not receive treatment.
Arm/Group Title Fostamatinib 100 mg Bid Fostamatinib 150 mg qd Fostamatinib 100 mg qd
Arm/Group Description Oral treatment Oral treatment Oral treatment
Period Title: Overall Study
STARTED 1343 357 212
Enrolled But Did Not Receive Treatment 3 0 2
COMPLETED 0 0 0
NOT COMPLETED 1343 357 212

Baseline Characteristics

Arm/Group Title Fostamatinib 100 mg Bid Fostamatinib 150 mg qd Fostamatinib 100 mg qd Total
Arm/Group Description Oral treatment Oral treatment Oral treatment Total of all reporting groups
Overall Participants 1343 357 212 1912
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
53
(12.0)
53
(11.6)
53
(11.3)
53
(11.8)
Sex: Female, Male (Count of Participants)
Female
1086
80.9%
297
83.2%
193
91%
1576
82.4%
Male
257
19.1%
60
16.8%
19
9%
336
17.6%
Race/Ethnicity, Customized (Number) [Number]
White
1092
81.3%
278
77.9%
141
66.5%
1511
79%
Black or African American
63
4.7%
11
3.1%
6
2.8%
80
4.2%
Asian
40
3%
12
3.4%
7
3.3%
59
3.1%
American Indian or Alaska Native
20
1.5%
11
3.1%
6
2.8%
37
1.9%
Indian or Pakistani
54
4%
15
4.2%
22
10.4%
91
4.8%
Other
74
5.5%
30
8.4%
30
14.2%
134
7%

Outcome Measures

1. Secondary Outcome
Title Mean DAS28-CRP Score
Description 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
Time Frame Weeks 0, 12, 24, 36 and 52

Outcome Measure Data

Analysis Population Description
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).
Arm/Group Title Fostamatinib 100 mg Bid Fostamatinib 150 mg qd Fostamatinib 100 mg qd
Arm/Group Description Oral treatment Oral treatment Oral treatment
Measure Participants 1247 336 198
Week 0 (n=1247, 336, 198)
4.5
(1.58)
3.8
(1.24)
3.9
(1.27)
Week 12 (n=1018, 288, 160)
3.8
(1.34)
3.6
(1.19)
3.7
(1.21)
Week 24 (n=800, 230 126)
3.8
(1.30)
3.7
(1.24)
3.6
(1.19)
Week 36 (n=581, 148, 68)
3.9
(1.32)
3.7
(1.24)
3.9
(1.07)
Week 52 (n=290, 28, 14)
4.0
(1.25)
3.8
(1.37)
3.6
(1.22)
2. Primary Outcome
Title Percentage of Patients Who Had at Least 1 Adverse Event in Any Category
Description AE = adverse event, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event
Time Frame Entry in extension to end of study (variable duration; maximum 109 weeks)

Outcome Measure Data

Analysis Population Description
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).
Arm/Group Title Fostamatinib 100 mg Bid Fostamatinib 150 mg qd Fostamatinib 100 mg qd
Arm/Group Description Oral treatment Oral treatment Oral treatment
Measure Participants 1343 357 212
Any AE
74.4
70.3
69.8
Any AE with outcome of death
0.7
0.3
0.5
Any SAE (including events with outcome of death)
11.4
8.7
5.7
Any AE leading to discontinuation of IP
10.5
5.9
9.9
3. Secondary Outcome
Title Mean mTSS Score
Description 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
Time Frame Weeks 0 and 52

Outcome Measure Data

Analysis Population Description
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).
Arm/Group Title Fostamatinib 100 mg Bid Fostamatinib 150 mg qd Fostamatinib 100 mg qd
Arm/Group Description Oral treatment Oral treatment Oral treatment
Measure Participants 480 73 37
Week 0 (n=480, 73, 37)
30.5
(47.73)
22.2
(32.89)
20.8
(46.60)
Week 52 (n=223, 1, 6)
30.1
(46.83)
0.5
(NA)
37.3
(67.70)
4. Secondary Outcome
Title Mean HAQ-DI Score
Description 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
Time Frame Weeks 0, 12, 24, 36 and 52

Outcome Measure Data

Analysis Population Description
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).
Arm/Group Title Fostamatinib 100 mg Bid Fostamatinib 150 mg qd Fostamatinib 100 mg qd
Arm/Group Description Oral treatment Oral treatment Oral treatment
Measure Participants 1271 342 201
Week 0 (n=1271, 342, 201)
1.2
(0.69)
1.0
(0.64)
1.0
(0.62)
Week 12 (n=1061, 298, 166)
1.1
(0.68)
1.0
(0.63)
1.0
(0.63)
Week 24 (n=817, 238, 132)
1.1
(0.68)
1.0
(0.67)
0.9
(0.55)
Week 36 (n=587, 149, 71)
1.1
(0.67)
1.0
(0.65)
1.1
(0.62)
Week 52 (n=296, 28, 14)
1.2
(0.68)
1.1
(0.64)
1.0
(0.73)

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group Title FOSTA 100 MG BID FOSTA 100 MG QD FOSTA 150 MG QD
Arm/Group Description
All Cause Mortality
FOSTA 100 MG BID FOSTA 100 MG QD FOSTA 150 MG QD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN) / (NaN)
Serious Adverse Events
FOSTA 100 MG BID FOSTA 100 MG QD FOSTA 150 MG QD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 153/1343 (11.4%) 12/212 (5.7%) 31/357 (8.7%)
Blood and lymphatic system disorders
SPLENIC INFARCTION 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION 0/1343 (0%) 0 0/212 (0%) 0 1/357 (0.3%) 1
ANGINA UNSTABLE 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
ATRIAL FIBRILLATION 2/1343 (0.1%) 2 0/212 (0%) 0 0/357 (0%) 0
BRADYCARDIA 0/1343 (0%) 0 1/212 (0.5%) 1 0/357 (0%) 0
CARDIAC FAILURE CHRONIC 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
CARDIAC FAILURE CONGESTIVE 2/1343 (0.1%) 2 0/212 (0%) 0 0/357 (0%) 0
CARDIO-RESPIRATORY ARREST 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
CARDIOMYOPATHY 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
MYOCARDIAL INFARCTION 2/1343 (0.1%) 2 0/212 (0%) 0 0/357 (0%) 0
MYOCARDIAL ISCHAEMIA 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
Endocrine disorders
GOITRE 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
Eye disorders
RETINAL DETACHMENT 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
Gastrointestinal disorders
ABDOMINAL PAIN 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
ABDOMINAL PAIN UPPER 0/1343 (0%) 0 1/212 (0.5%) 1 0/357 (0%) 0
ACUTE ABDOMEN 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
BARRETT'S OESOPHAGUS 0/1343 (0%) 0 0/212 (0%) 0 1/357 (0.3%) 1
COLITIS 2/1343 (0.1%) 2 0/212 (0%) 0 0/357 (0%) 0
COLITIS MICROSCOPIC 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
COLONIC STENOSIS 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
DIARRHOEA 4/1343 (0.3%) 4 1/212 (0.5%) 1 0/357 (0%) 0
DYSPEPSIA 0/1343 (0%) 0 0/212 (0%) 0 1/357 (0.3%) 1
GASTRIC ULCER 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
GASTRITIS 2/1343 (0.1%) 2 0/212 (0%) 0 1/357 (0.3%) 1
GASTRITIS EROSIVE 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
GASTROINTESTINAL HAEMORRHAGE 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
HAEMATEMESIS 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
ILEITIS 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
ILEUS 2/1343 (0.1%) 2 0/212 (0%) 0 0/357 (0%) 0
INGUINAL HERNIA 2/1343 (0.1%) 2 0/212 (0%) 0 1/357 (0.3%) 1
INTESTINAL HAEMORRHAGE 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
INTESTINAL ISCHAEMIA 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
INTESTINAL OBSTRUCTION 0/1343 (0%) 0 0/212 (0%) 0 1/357 (0.3%) 1
OESOPHAGEAL ACHALASIA 1/1343 (0.1%) 2 0/212 (0%) 0 0/357 (0%) 0
PANCREATIC PSEUDOCYST 0/1343 (0%) 0 1/212 (0.5%) 1 0/357 (0%) 0
PANCREATITIS 3/1343 (0.2%) 3 0/212 (0%) 0 0/357 (0%) 0
PANCREATITIS ACUTE 3/1343 (0.2%) 3 1/212 (0.5%) 1 0/357 (0%) 0
General disorders
DEVICE DISLOCATION 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
GENERAL PHYSICAL HEALTH DETERIORATION 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
NON-CARDIAC CHEST PAIN 3/1343 (0.2%) 3 1/212 (0.5%) 1 0/357 (0%) 0
Hepatobiliary disorders
BILE DUCT OBSTRUCTION 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
BILIARY COLIC 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
CHOLECYSTITIS 2/1343 (0.1%) 2 0/212 (0%) 0 0/357 (0%) 0
CHOLECYSTITIS ACUTE 0/1343 (0%) 0 0/212 (0%) 0 1/357 (0.3%) 1
CHOLECYSTITIS CHRONIC 0/1343 (0%) 0 0/212 (0%) 0 1/357 (0.3%) 1
CHOLELITHIASIS 4/1343 (0.3%) 4 0/212 (0%) 0 0/357 (0%) 0
GALLBLADDER POLYP 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
POST CHOLECYSTECTOMY SYNDROME 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
Immune system disorders
ANAPHYLACTIC SHOCK 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
FOOD ALLERGY 0/1343 (0%) 0 0/212 (0%) 0 1/357 (0.3%) 1
HYPERSENSITIVITY 2/1343 (0.1%) 2 0/212 (0%) 0 0/357 (0%) 0
Infections and infestations
ABSCESS LIMB 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
APPENDICITIS 4/1343 (0.3%) 4 0/212 (0%) 0 0/357 (0%) 0
ARTHRITIS BACTERIAL 0/1343 (0%) 0 1/212 (0.5%) 1 0/357 (0%) 0
BACTERAEMIA 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
BACTERIAL PYELONEPHRITIS 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
BACTERIAL SEPSIS 2/1343 (0.1%) 2 0/212 (0%) 0 0/357 (0%) 0
BRONCHITIS 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
BRONCHOPNEUMONIA 0/1343 (0%) 0 0/212 (0%) 0 1/357 (0.3%) 1
CELLULITIS 6/1343 (0.4%) 7 1/212 (0.5%) 1 0/357 (0%) 0
CYTOMEGALOVIRUS INFECTION 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
DIVERTICULITIS 0/1343 (0%) 0 0/212 (0%) 0 1/357 (0.3%) 1
ENTEROCOLITIS BACTERIAL 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
ENTEROCOLITIS VIRAL 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
ERYSIPELAS 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
ESCHERICHIA URINARY TRACT INFECTION 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
GANGRENE 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
GASTROENTERITIS 1/1343 (0.1%) 1 1/212 (0.5%) 1 0/357 (0%) 0
GASTROENTERITIS BACTERIAL 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
GASTROENTERITIS VIRAL 1/1343 (0.1%) 1 0/212 (0%) 0 1/357 (0.3%) 1
HERPES ZOSTER 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
INTERVERTEBRAL DISCITIS 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
LIVER ABSCESS 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
LUNG ABSCESS 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
OSTEOMYELITIS 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
OTITIS EXTERNA 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
PANCREATITIS VIRAL 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
PERITONITIS 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
PNEUMONIA 5/1343 (0.4%) 5 1/212 (0.5%) 1 1/357 (0.3%) 1
PNEUMONIA BACTERIAL 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
PNEUMONIA VIRAL 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
PULMONARY TUBERCULOSIS 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
STAPHYLOCOCCAL SEPSIS 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
SUBCUTANEOUS ABSCESS 0/1343 (0%) 0 0/212 (0%) 0 1/357 (0.3%) 1
URINARY TRACT INFECTION 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
URINARY TRACT INFECTION BACTERIAL 2/1343 (0.1%) 2 0/212 (0%) 0 0/357 (0%) 0
UROSEPSIS 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
VIRAL UPPER RESPIRATORY TRACT INFECTION 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
WOUND INFECTION BACTERIAL 0/1343 (0%) 0 0/212 (0%) 0 1/357 (0.3%) 1
WOUND SEPSIS 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
Injury, poisoning and procedural complications
ACCIDENTAL OVERDOSE 0/1343 (0%) 0 0/212 (0%) 0 2/357 (0.6%) 2
FACIAL BONES FRACTURE 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
FEMORAL NECK FRACTURE 1/1343 (0.1%) 1 1/212 (0.5%) 1 0/357 (0%) 0
FEMUR FRACTURE 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
FIBULA FRACTURE 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
HUMERUS FRACTURE 2/1343 (0.1%) 2 0/212 (0%) 0 1/357 (0.3%) 1
JOINT DISLOCATION 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
JOINT INJURY 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
PATELLA FRACTURE 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
TENDON RUPTURE 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
TIBIA FRACTURE 0/1343 (0%) 0 1/212 (0.5%) 1 0/357 (0%) 0
ULNA FRACTURE 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
UPPER LIMB FRACTURE 0/1343 (0%) 0 0/212 (0%) 0 1/357 (0.3%) 1
WOUND DEHISCENCE 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
WRIST FRACTURE 0/1343 (0%) 0 0/212 (0%) 0 1/357 (0.3%) 1
Investigations
LIVER FUNCTION TEST ABNORMAL 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
Metabolism and nutrition disorders
DEHYDRATION 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
HYPOKALAEMIA 1/1343 (0.1%) 1 1/212 (0.5%) 1 1/357 (0.3%) 1
HYPONATRAEMIA 1/1343 (0.1%) 1 0/212 (0%) 0 1/357 (0.3%) 1
TYPE 2 DIABETES MELLITUS 0/1343 (0%) 0 1/212 (0.5%) 1 0/357 (0%) 0
Musculoskeletal and connective tissue disorders
ARTHRITIS 2/1343 (0.1%) 2 0/212 (0%) 0 0/357 (0%) 0
BACK PAIN 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
HIP DEFORMITY 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
INTERVERTEBRAL DISC DISORDER 0/1343 (0%) 0 0/212 (0%) 0 1/357 (0.3%) 1
INTERVERTEBRAL DISC DISPLACEMENT 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
INTERVERTEBRAL DISC PROTRUSION 4/1343 (0.3%) 4 1/212 (0.5%) 1 0/357 (0%) 0
LUMBAR SPINAL STENOSIS 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
MUSCULOSKELETAL CHEST PAIN 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
OSTEITIS 0/1343 (0%) 0 1/212 (0.5%) 1 0/357 (0%) 0
OSTEOARTHRITIS 6/1343 (0.4%) 8 0/212 (0%) 0 2/357 (0.6%) 2
OSTEONECROSIS 0/1343 (0%) 0 0/212 (0%) 0 1/357 (0.3%) 1
PATHOLOGICAL FRACTURE 2/1343 (0.1%) 2 0/212 (0%) 0 0/357 (0%) 0
RHEUMATOID ARTHRITIS 9/1343 (0.7%) 11 0/212 (0%) 0 0/357 (0%) 0
SJOGREN'S SYNDROME 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
SPONDYLOLISTHESIS 0/1343 (0%) 0 0/212 (0%) 0 1/357 (0.3%) 1
SYNOVITIS 0/1343 (0%) 0 0/212 (0%) 0 1/357 (0.3%) 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA 2/1343 (0.1%) 2 0/212 (0%) 0 0/357 (0%) 0
BENIGN NEOPLASM OF PROSTATE 0/1343 (0%) 0 0/212 (0%) 0 1/357 (0.3%) 1
BENIGN SOFT TISSUE NEOPLASM 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
BREAST CANCER 2/1343 (0.1%) 2 0/212 (0%) 0 0/357 (0%) 0
CERVIX CARCINOMA 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
COLORECTAL CANCER 0/1343 (0%) 0 0/212 (0%) 0 1/357 (0.3%) 1
GASTRIC CANCER 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
LIPOMA 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
MALIGNANT MELANOMA 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
PANCREATIC NEUROENDOCRINE TUMOUR 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
PROSTATE CANCER 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
RECTAL CANCER 0/1343 (0%) 0 0/212 (0%) 0 1/357 (0.3%) 1
RENAL CANCER METASTATIC 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
RENAL CELL CARCINOMA 0/1343 (0%) 0 0/212 (0%) 0 1/357 (0.3%) 1
UTERINE LEIOMYOMA 2/1343 (0.1%) 2 0/212 (0%) 0 1/357 (0.3%) 1
VAGINAL CANCER 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
Nervous system disorders
APHASIA 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
CAROTID ARTERY STENOSIS 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
CONVULSION 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
DYSARTHRIA 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
HAEMORRHAGIC STROKE 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
HYPERTENSIVE ENCEPHALOPATHY 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
HYPOGLYCAEMIC COMA 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
ISCHAEMIC STROKE 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
LUMBAR RADICULOPATHY 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
RADICULITIS LUMBOSACRAL 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
SCIATICA 0/1343 (0%) 0 1/212 (0.5%) 1 0/357 (0%) 0
SYNCOPE 3/1343 (0.2%) 3 0/212 (0%) 0 2/357 (0.6%) 2
TENSION HEADACHE 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
TRANSIENT ISCHAEMIC ATTACK 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
VITH NERVE PARALYSIS 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
Psychiatric disorders
ADJUSTMENT DISORDER 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
ALCOHOL ABUSE 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
DEPRESSION 2/1343 (0.1%) 2 0/212 (0%) 0 0/357 (0%) 0
Renal and urinary disorders
CALCULUS URETERIC 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
CALCULUS URINARY 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
NEPHROLITHIASIS 1/1343 (0.1%) 1 1/212 (0.5%) 1 0/357 (0%) 0
RENAL FAILURE ACUTE 3/1343 (0.2%) 3 0/212 (0%) 0 0/357 (0%) 0
RENAL IMPAIRMENT 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
URINARY BLADDER POLYP 0/1343 (0%) 0 0/212 (0%) 0 1/357 (0.3%) 1
Reproductive system and breast disorders
ADENOMYOSIS 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
BENIGN PROSTATIC HYPERPLASIA 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
OVARIAN CYST 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
UTERINE POLYP 0/1343 (0%) 0 0/212 (0%) 0 1/357 (0.3%) 1
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE 2/1343 (0.1%) 2 0/212 (0%) 0 0/357 (0%) 0
CHRONIC OBSTRUCTIVE PULMONARY DISEASE 1/1343 (0.1%) 1 0/212 (0%) 0 1/357 (0.3%) 1
HYPERVENTILATION 0/1343 (0%) 0 0/212 (0%) 0 1/357 (0.3%) 1
PNEUMONIA ASPIRATION 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
PULMONARY EMBOLISM 4/1343 (0.3%) 4 0/212 (0%) 0 0/357 (0%) 0
RESPIRATORY FAILURE 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
Skin and subcutaneous tissue disorders
DIGITAL ULCER 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
ERYTHEMA MULTIFORME 0/1343 (0%) 0 0/212 (0%) 0 1/357 (0.3%) 1
TOXIC EPIDERMAL NECROLYSIS 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
Vascular disorders
AORTIC ANEURYSM RUPTURE 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
AORTIC STENOSIS 0/1343 (0%) 0 1/212 (0.5%) 1 0/357 (0%) 0
AORTIC THROMBOSIS 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
ARTERIAL THROMBOSIS 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
FEMORAL ARTERY OCCLUSION 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
PERIPHERAL ISCHAEMIA 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
THROMBOPHLEBITIS SUPERFICIAL 1/1343 (0.1%) 1 0/212 (0%) 0 0/357 (0%) 0
Other (Not Including Serious) Adverse Events
FOSTA 100 MG BID FOSTA 100 MG QD FOSTA 150 MG QD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 466/1343 (34.7%) 68/212 (32.1%) 98/357 (27.5%)
Gastrointestinal disorders
DIARRHOEA 202/1343 (15%) 268 28/212 (13.2%) 40 43/357 (12%) 61
Infections and infestations
NASOPHARYNGITIS 86/1343 (6.4%) 102 15/212 (7.1%) 16 28/357 (7.8%) 31
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS 116/1343 (8.6%) 155 19/212 (9%) 22 30/357 (8.4%) 35
Vascular disorders
HYPERTENSION 166/1343 (12.4%) 197 14/212 (6.6%) 15 20/357 (5.6%) 23

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.

Results Point of Contact

Name/Title Dave Goldstraw
Organization AstraZeneca Pharmaceuticals
Phone +44 (0)1625 512415
Email dave.goldstraw@astrazeneca.com
Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01242514
Other Study ID Numbers:
  • D4300C00005
  • 2010-020892-22
First Posted:
Nov 17, 2010
Last Update Posted:
Apr 4, 2014
Last Verified:
Feb 1, 2014