Trial Outcomes & Findings for Open-Label, Multicenter Extension Study for Patients Completing Treatment Phase of a Rigel-Sponsored R935788 Studies (NCT NCT00805467)
NCT ID: NCT00805467
Last Updated: 2014-06-25
Results Overview
AE = adverse event, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
624 participants
Primary outcome timeframe
Entry in extension to end of study, up to a maximum of 5 years. (Variable by subject - median duration of 3 years)
Results posted on
2014-06-25
Participant Flow
A total of 624 patients were enrolled: 1, 59, 183 \& 381 were allocated to the 50mg twice daily (bid), 100 mg once daily (qd), 150 mg qd and 100 mg bid groups, respectively. As this was a long-term extension study no specific end date was given. Patients who were ongoing when the study was terminated are shown as completers.
Treatments were assigned according to those given in the qualifying studies. All patients received investigational product.
Participant milestones
| Measure |
Fostamatinib 50 mg Bid
Oral treatment
|
Fostamatinib 100 mg qd
Oral treatment
|
Fostamatinib 150 mg qd
Oral treatment
|
Fostamatinib 100 mg Bid
Oral treatment
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
59
|
183
|
381
|
|
Overall Study
Enrolled But Did Not Receive Treatment
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
1
|
25
|
80
|
144
|
|
Overall Study
NOT COMPLETED
|
0
|
34
|
103
|
237
|
Reasons for withdrawal
| Measure |
Fostamatinib 50 mg Bid
Oral treatment
|
Fostamatinib 100 mg qd
Oral treatment
|
Fostamatinib 150 mg qd
Oral treatment
|
Fostamatinib 100 mg Bid
Oral treatment
|
|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
8
|
13
|
86
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
7
|
21
|
|
Overall Study
Withdrawal by Subject
|
0
|
6
|
45
|
50
|
|
Overall Study
Protocol Violation
|
0
|
3
|
0
|
5
|
|
Overall Study
Adverse Event
|
0
|
13
|
26
|
57
|
|
Overall Study
Death
|
0
|
2
|
7
|
5
|
|
Overall Study
Physician Decision
|
0
|
1
|
2
|
6
|
|
Overall Study
Not reported
|
0
|
0
|
3
|
7
|
Baseline Characteristics
Open-Label, Multicenter Extension Study for Patients Completing Treatment Phase of a Rigel-Sponsored R935788 Studies
Baseline characteristics by cohort
| Measure |
Fostamatinib 50 mg Bid
n=1 Participants
Oral treatment
|
Fostamatinib 100 mg qd
n=59 Participants
Oral treatment
|
Fostamatinib 150 mg qd
n=183 Participants
Oral treatment
|
Fostamatinib 100 mg Bid
n=381 Participants
Oral treatment
|
Total
n=624 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
70 years
STANDARD_DEVIATION NA • n=5 Participants
|
51.4 years
STANDARD_DEVIATION 11.15 • n=7 Participants
|
51.7 years
STANDARD_DEVIATION 13.32 • n=5 Participants
|
53.8 years
STANDARD_DEVIATION 12.36 • n=4 Participants
|
53.0 years
STANDARD_DEVIATION 12.58 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
324 Participants
n=4 Participants
|
535 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
89 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
0 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
184 Participants
n=4 Participants
|
290 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
179 Participants
n=4 Participants
|
307 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Entry in extension to end of study, up to a maximum of 5 years. (Variable by subject - median duration of 3 years)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 50 mg Bid
n=1 Participants
Oral treatment
|
Fostamatinib 100 mg qd
n=59 Participants
Oral treatment
|
Fostamatinib 150 mg qd
n=183 Participants
Oral treatment
|
Fostamatinib 100 mg Bid
n=381 Participants
Oral treatment
|
|---|---|---|---|---|
|
Percentage of Patients Who Had at Least 1 Treatment Emergent Adverse Event in Any Category
Any AE
|
100 % of patients
|
91.5 % of patients
|
90.7 % of patients
|
88.7 % of patients
|
|
Percentage of Patients Who Had at Least 1 Treatment Emergent Adverse Event in Any Category
Any fatal AE
|
0 % of patients
|
1.7 % of patients
|
3.8 % of patients
|
1.6 % of patients
|
|
Percentage of Patients Who Had at Least 1 Treatment Emergent Adverse Event in Any Category
Any SAE (including fatal AEs)
|
100 % of patients
|
3.4 % of patients
|
18.6 % of patients
|
20.2 % of patients
|
|
Percentage of Patients Who Had at Least 1 Treatment Emergent Adverse Event in Any Category
Any AE leading to termination of study therapy
|
0 % of patients
|
22.0 % of patients
|
16.4 % of patients
|
15.2 % of patients
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Number of participants are those with baseline data. Baseline defined at entry into qualifying study or at entry into this study if more than 14 days since last dose in qualifying study. As no imputation was applied, the numbers at subsequent visits are lower.
The Disease Activity Score 28 using C-Reactive Protein (DAS28-CRP) is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). These measures are then fed into a complex mathematical formula to produce the overall DAS on a scale from 1 to 10, where scores greater than 5.1 are considered to indicate active disease, scores less than 3.2 are considered to indicate with well controlled disease, and scores less than 2.6 are considered to indicate remission. bid = twice daily, CRP = C-reactive protein, DAS28 = Disease Activity Score based on a 28 joint count, n/a = not applicable, qd = once daily
Outcome measures
| Measure |
Fostamatinib 50 mg Bid
n=1 Participants
Oral treatment
|
Fostamatinib 100 mg qd
n=55 Participants
Oral treatment
|
Fostamatinib 150 mg qd
n=181 Participants
Oral treatment
|
Fostamatinib 100 mg Bid
n=374 Participants
Oral treatment
|
|---|---|---|---|---|
|
DAS28-CRP Score
Baseline (n=1, 55, 181, 374)
|
5.27 scores on a scale
Standard Deviation NA
Standard deviation cannot be defined for a single patient.
|
5.34 scores on a scale
Standard Deviation 1.123
|
5.31 scores on a scale
Standard Deviation 1.162
|
5.36 scores on a scale
Standard Deviation 1.259
|
|
DAS28-CRP Score
Quarter 4 (n=1, 41, 136, 254)
|
2.00 scores on a scale
Standard Deviation NA
Standard deviation cannot be defined for a single patient.
|
3.57 scores on a scale
Standard Deviation 1.408
|
3.46 scores on a scale
Standard Deviation 1.282
|
3.44 scores on a scale
Standard Deviation 1.453
|
|
DAS28-CRP Score
Quarter 8 (n=1, 33, 114, 201)
|
2.92 scores on a scale
Standard Deviation NA
Standard deviation cannot be defined for a single patient.
|
3.43 scores on a scale
Standard Deviation 1.412
|
3.25 scores on a scale
Standard Deviation 1.290
|
3.35 scores on a scale
Standard Deviation 1.484
|
|
DAS28-CRP Score
Quarter 12 (n=1, 30, 94, 174)
|
2.31 scores on a scale
Standard Deviation NA
Standard deviation cannot be defined for a single patient.
|
3.36 scores on a scale
Standard Deviation 1.376
|
3.07 scores on a scale
Standard Deviation 1.055
|
3.27 scores on a scale
Standard Deviation 1.373
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Number of participants are those with baseline data. Baseline defined at entry into qualifying study or at entry into this study if more than 14 days since last dose in qualifying study. As no imputation was applied, the numbers at subsequent visits are lower.
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 |
Fostamatinib 50 mg Bid
n=1 Participants
Oral treatment
|
Fostamatinib 100 mg qd
n=56 Participants
Oral treatment
|
Fostamatinib 150 mg qd
n=181 Participants
Oral treatment
|
Fostamatinib 100 mg Bid
n=376 Participants
Oral treatment
|
|---|---|---|---|---|
|
HAQ-DI Score
Quarter 4 (n=1, 41, 138, 254)
|
0.57 Scores on a Scale
Standard Deviation NA
Standard deviation cannot be defined for a single patient
|
1.00 Scores on a Scale
Standard Deviation 0.677
|
1.07 Scores on a Scale
Standard Deviation 0.726
|
0.99 Scores on a Scale
Standard Deviation 0.722
|
|
HAQ-DI Score
Quarter 8 (n=1, 33, 107, 201)
|
0.43 Scores on a Scale
Standard Deviation NA
Standard deviation cannot be defined for a single patient
|
1.00 Scores on a Scale
Standard Deviation 0.657
|
1.02 Scores on a Scale
Standard Deviation 0.720
|
0.95 Scores on a Scale
Standard Deviation 0.703
|
|
HAQ-DI Score
Quarter 12 (n=1, 30, 94, 176)
|
0.38 Scores on a Scale
Standard Deviation NA
Standard deviation cannot be defined for a single patient
|
1.01 Scores on a Scale
Standard Deviation 0.651
|
0.98 Scores on a Scale
Standard Deviation 0.718
|
0.96 Scores on a Scale
Standard Deviation 0.687
|
|
HAQ-DI Score
Baseline (n=1, 56, 181, 376)
|
1.25 Scores on a Scale
Standard Deviation NA
Standard deviation cannot be defined for a single patient
|
1.50 Scores on a Scale
Standard Deviation 0.735
|
1.46 Scores on a Scale
Standard Deviation 0.707
|
1.46 Scores on a Scale
Standard Deviation 0.715
|
Adverse Events
100 MG BID
Serious events: 77 serious events
Other events: 306 other events
Deaths: 0 deaths
100 MG QD
Serious events: 2 serious events
Other events: 49 other events
Deaths: 0 deaths
150 MG QD
Serious events: 34 serious events
Other events: 141 other events
Deaths: 0 deaths
50 MG BID
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
100 MG BID
n=381 participants at risk
|
100 MG QD
n=59 participants at risk
|
150 MG QD
n=183 participants at risk
|
50 MG BID
n=1 participants at risk
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
THYROID CANCER
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE LEIOMYOMA
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Nervous system disorders
ACUTE POLYNEUROPATHY
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.00%
0/381
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Nervous system disorders
LUMBAR RADICULOPATHY
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Nervous system disorders
PRESYNCOPE
|
0.00%
0/381
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Nervous system disorders
RADICULOPATHY
|
0.00%
0/381
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/381
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS
|
0.52%
2/381 • Number of events 2
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS INCOMPLETE
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Psychiatric disorders
ANXIETY
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Reproductive system and breast disorders
ENDOMETRIAL HYPERTROPHY
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Reproductive system and breast disorders
OVARIAN CYST
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Reproductive system and breast disorders
POSTMENOPAUSAL HAEMORRHAGE
|
0.00%
0/381
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Reproductive system and breast disorders
VAGINAL PROLAPSE
|
0.00%
0/381
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/381
|
0.00%
0/59
|
0.00%
0/183
|
100.0%
1/1 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.00%
0/381
|
0.00%
0/59
|
0.55%
1/183 • Number of events 3
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
LUNG INFILTRATION
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY FIBROSIS
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Surgical and medical procedures
HIP ARTHROPLASTY
|
0.26%
1/381 • Number of events 2
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Surgical and medical procedures
IMPLANTABLE DEFIBRILLATOR INSERTION
|
0.00%
0/381
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Surgical and medical procedures
KNEE ARTHROPLASTY
|
0.00%
0/381
|
1.7%
1/59 • Number of events 1
|
0.00%
0/183
|
0.00%
0/1
|
|
Vascular disorders
AORTIC ANEURYSM
|
0.52%
2/381 • Number of events 2
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Vascular disorders
ARTERIOSCLEROSIS
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/381
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Vascular disorders
HYPERTENSIVE CRISIS
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Vascular disorders
HYPOTENSION
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
SPINAL FRACTURE
|
0.00%
0/381
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS
|
0.52%
2/381 • Number of events 2
|
0.00%
0/59
|
1.1%
2/183 • Number of events 2
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
SPINAL OSTEOARTHRITIS
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ANAL CANCER
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASOSQUAMOUS CARCINOMA OF SKIN
|
0.00%
0/381
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BRAIN NEOPLASM MALIGNANT
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
1.1%
2/183 • Number of events 2
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CERVIX CARCINOMA
|
0.00%
0/381
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER STAGE IV
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
DIFFUSE LARGE B-CELL LYMPHOMA
|
0.00%
0/381
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LARGE INTESTINE CARCINOMA
|
0.00%
0/381
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED
|
0.00%
0/381
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PARATHYROID TUMOUR BENIGN
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.00%
0/381
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Blood and lymphatic system disorders
THROMBOTIC THROMBOCYTOPENIC PURPURA
|
0.00%
0/381
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Cardiac disorders
ARTERIOSPASM CORONARY
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Cardiac disorders
CARDIAC ARREST
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/381
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.52%
2/381 • Number of events 3
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.00%
0/381
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Cardiac disorders
CARDIOPULMONARY FAILURE
|
0.00%
0/381
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Cardiac disorders
INTRACARDIAC THROMBUS
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Cardiac disorders
VENTRICULAR DYSFUNCTION
|
0.00%
0/381
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Endocrine disorders
GOITRE
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Eye disorders
PANOPHTHALMITIS
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.79%
3/381 • Number of events 3
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Gastrointestinal disorders
COLITIS
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Gastrointestinal disorders
COLITIS MICROSCOPIC
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Gastrointestinal disorders
COLONIC POLYP
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.52%
2/381 • Number of events 2
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Gastrointestinal disorders
DIVERTICULUM
|
0.00%
0/381
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Gastrointestinal disorders
FAECALOMA
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Gastrointestinal disorders
GASTRIC PERFORATION
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/381
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Gastrointestinal disorders
GASTROINTESTINAL PERFORATION
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Gastrointestinal disorders
HIATUS HERNIA
|
0.00%
0/381
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Gastrointestinal disorders
ILEUS
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.00%
0/381
|
0.00%
0/59
|
1.1%
2/183 • Number of events 2
|
0.00%
0/1
|
|
Gastrointestinal disorders
PANCREATITIS HAEMORRHAGIC
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Gastrointestinal disorders
RECTAL PROLAPSE
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.00%
0/381
|
0.00%
0/59
|
0.00%
0/183
|
100.0%
1/1 • Number of events 1
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Gastrointestinal disorders
VOMITING
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
General disorders
CHEST PAIN
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
General disorders
DEVICE DISLOCATION
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
General disorders
PYREXIA
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
General disorders
SUDDEN DEATH
|
0.00%
0/381
|
1.7%
1/59 • Number of events 1
|
0.00%
0/183
|
0.00%
0/1
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.52%
2/381 • Number of events 2
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.52%
2/381 • Number of events 2
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Hepatobiliary disorders
HEPATIC CIRRHOSIS
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Hepatobiliary disorders
HEPATIC STEATOSIS
|
0.00%
0/381
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Infections and infestations
ABSCESS SOFT TISSUE
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Infections and infestations
APPENDICITIS
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Infections and infestations
BRONCHITIS
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Infections and infestations
BURSITIS INFECTIVE
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Infections and infestations
CELLULITIS
|
1.0%
4/381 • Number of events 4
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Infections and infestations
CYTOMEGALOVIRUS HEPATITIS
|
0.00%
0/381
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Infections and infestations
CYTOMEGALOVIRUS INFECTION
|
0.00%
0/381
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Infections and infestations
DIVERTICULITIS
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Infections and infestations
DYSENTERY
|
0.00%
0/381
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Infections and infestations
EPIGLOTTITIS
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Infections and infestations
ERYTHEMA MIGRANS
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Infections and infestations
ESCHERICHIA SEPSIS
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Infections and infestations
GASTROENTERITIS
|
0.52%
2/381 • Number of events 2
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Infections and infestations
GIARDIASIS
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Infections and infestations
INFECTED BITES
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Infections and infestations
LOBAR PNEUMONIA
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Infections and infestations
MENINGITIS BACTERIAL
|
0.00%
0/381
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Infections and infestations
NECROTISING FASCIITIS
|
0.00%
0/381
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Infections and infestations
OSTEOMYELITIS
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Infections and infestations
PERITONITIS
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Infections and infestations
PNEUMONIA
|
1.6%
6/381 • Number of events 7
|
0.00%
0/59
|
1.6%
3/183 • Number of events 3
|
0.00%
0/1
|
|
Infections and infestations
PNEUMONIA STAPHYLOCOCCAL
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Infections and infestations
PYELONEPHRITIS
|
0.52%
2/381 • Number of events 2
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Infections and infestations
SEPSIS
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
1.1%
2/183 • Number of events 2
|
0.00%
0/1
|
|
Infections and infestations
SEPTIC SHOCK
|
0.00%
0/381
|
0.00%
0/59
|
1.1%
2/183 • Number of events 2
|
0.00%
0/1
|
|
Infections and infestations
SINUSITIS
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/381
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
100.0%
1/1 • Number of events 1
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.52%
2/381 • Number of events 2
|
0.00%
0/59
|
1.1%
2/183 • Number of events 2
|
0.00%
0/1
|
|
Infections and infestations
UROSEPSIS
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Infections and infestations
VARICELLA
|
0.00%
0/381
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Infections and infestations
VIRAL INFECTION
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Infections and infestations
WOUND INFECTION STAPHYLOCOCCAL
|
0.00%
0/381
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
DISLOCATION OF VERTEBRA
|
0.00%
0/381
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
JOINT DISLOCATION
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
MUSCLE RUPTURE
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
PUBIS FRACTURE
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
0.00%
0/381
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.79%
3/381 • Number of events 3
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
CERVICAL SPINAL STENOSIS
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.52%
2/381 • Number of events 2
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
LUMBAR SPINAL STENOSIS
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
MYOSITIS
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.26%
1/381 • Number of events 1
|
0.00%
0/59
|
0.00%
0/183
|
0.00%
0/1
|
Other adverse events
| Measure |
100 MG BID
n=381 participants at risk
|
100 MG QD
n=59 participants at risk
|
150 MG QD
n=183 participants at risk
|
50 MG BID
n=1 participants at risk
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
6.3%
24/381 • Number of events 28
|
1.7%
1/59 • Number of events 1
|
7.1%
13/183 • Number of events 17
|
0.00%
0/1
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
7.9%
30/381 • Number of events 34
|
8.5%
5/59 • Number of events 5
|
5.5%
10/183 • Number of events 13
|
0.00%
0/1
|
|
Eye disorders
CONJUNCTIVITIS
|
2.9%
11/381 • Number of events 11
|
5.1%
3/59 • Number of events 3
|
2.7%
5/183 • Number of events 5
|
0.00%
0/1
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
2.6%
10/381 • Number of events 10
|
5.1%
3/59 • Number of events 3
|
1.6%
3/183 • Number of events 4
|
0.00%
0/1
|
|
Gastrointestinal disorders
DIARRHOEA
|
25.2%
96/381 • Number of events 151
|
33.9%
20/59 • Number of events 36
|
32.8%
60/183 • Number of events 93
|
0.00%
0/1
|
|
Gastrointestinal disorders
DYSPEPSIA
|
2.1%
8/381 • Number of events 8
|
5.1%
3/59 • Number of events 4
|
1.6%
3/183 • Number of events 4
|
100.0%
1/1 • Number of events 1
|
|
Gastrointestinal disorders
GASTRITIS
|
3.7%
14/381 • Number of events 15
|
8.5%
5/59 • Number of events 5
|
4.4%
8/183 • Number of events 8
|
0.00%
0/1
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.26%
1/381 • Number of events 1
|
6.8%
4/59 • Number of events 4
|
0.00%
0/183
|
0.00%
0/1
|
|
Gastrointestinal disorders
NAUSEA
|
7.1%
27/381 • Number of events 31
|
5.1%
3/59 • Number of events 4
|
6.0%
11/183 • Number of events 12
|
0.00%
0/1
|
|
Gastrointestinal disorders
VOMITING
|
6.0%
23/381 • Number of events 27
|
8.5%
5/59 • Number of events 9
|
5.5%
10/183 • Number of events 11
|
0.00%
0/1
|
|
General disorders
CHEST PAIN
|
1.6%
6/381 • Number of events 6
|
5.1%
3/59 • Number of events 3
|
0.00%
0/183
|
0.00%
0/1
|
|
General disorders
OEDEMA PERIPHERAL
|
6.3%
24/381 • Number of events 34
|
5.1%
3/59 • Number of events 3
|
3.8%
7/183 • Number of events 8
|
0.00%
0/1
|
|
Infections and infestations
BRONCHITIS
|
6.8%
26/381 • Number of events 38
|
5.1%
3/59 • Number of events 4
|
7.7%
14/183 • Number of events 20
|
0.00%
0/1
|
|
Infections and infestations
INFLUENZA
|
9.4%
36/381 • Number of events 54
|
13.6%
8/59 • Number of events 15
|
9.8%
18/183 • Number of events 20
|
0.00%
0/1
|
|
Infections and infestations
NASOPHARYNGITIS
|
7.1%
27/381 • Number of events 31
|
5.1%
3/59 • Number of events 3
|
5.5%
10/183 • Number of events 12
|
0.00%
0/1
|
|
Infections and infestations
PHARYNGITIS
|
4.2%
16/381 • Number of events 19
|
8.5%
5/59 • Number of events 6
|
2.7%
5/183 • Number of events 6
|
0.00%
0/1
|
|
Infections and infestations
SINUSITIS
|
6.8%
26/381 • Number of events 37
|
5.1%
3/59 • Number of events 3
|
2.2%
4/183 • Number of events 4
|
0.00%
0/1
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
13.4%
51/381 • Number of events 76
|
11.9%
7/59 • Number of events 8
|
10.9%
20/183 • Number of events 29
|
100.0%
1/1 • Number of events 1
|
|
Infections and infestations
URINARY TRACT INFECTION
|
18.9%
72/381 • Number of events 125
|
20.3%
12/59 • Number of events 32
|
15.3%
28/183 • Number of events 45
|
0.00%
0/1
|
|
Investigations
BLOOD PRESSURE INCREASED
|
7.1%
27/381 • Number of events 35
|
1.7%
1/59 • Number of events 1
|
6.0%
11/183 • Number of events 11
|
0.00%
0/1
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
1.6%
6/381 • Number of events 10
|
0.00%
0/59
|
1.1%
2/183 • Number of events 5
|
100.0%
1/1 • Number of events 1
|
|
Investigations
TRANSAMINASES INCREASED
|
9.2%
35/381 • Number of events 45
|
11.9%
7/59 • Number of events 8
|
8.2%
15/183 • Number of events 16
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
HYPERLIPIDAEMIA
|
0.79%
3/381 • Number of events 3
|
5.1%
3/59 • Number of events 3
|
0.55%
1/183 • Number of events 1
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
2.4%
9/381 • Number of events 16
|
5.1%
3/59 • Number of events 3
|
1.1%
2/183 • Number of events 2
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
4.5%
17/381 • Number of events 25
|
1.7%
1/59 • Number of events 2
|
5.5%
10/183 • Number of events 16
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
7.9%
30/381 • Number of events 35
|
5.1%
3/59 • Number of events 3
|
4.9%
9/183 • Number of events 11
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
BURSITIS
|
4.2%
16/381 • Number of events 20
|
6.8%
4/59 • Number of events 5
|
2.7%
5/183 • Number of events 5
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
2.6%
10/381 • Number of events 10
|
5.1%
3/59 • Number of events 3
|
1.1%
2/183 • Number of events 2
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS
|
10.0%
38/381 • Number of events 69
|
5.1%
3/59 • Number of events 6
|
5.5%
10/183 • Number of events 16
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
TENDONITIS
|
0.52%
2/381 • Number of events 3
|
6.8%
4/59 • Number of events 4
|
1.1%
2/183 • Number of events 2
|
0.00%
0/1
|
|
Nervous system disorders
HEADACHE
|
8.7%
33/381 • Number of events 49
|
6.8%
4/59 • Number of events 7
|
12.6%
23/183 • Number of events 35
|
0.00%
0/1
|
|
Renal and urinary disorders
HYPERTONIC BLADDER
|
0.52%
2/381 • Number of events 2
|
0.00%
0/59
|
0.00%
0/183
|
100.0%
1/1 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
1.0%
4/381 • Number of events 6
|
0.00%
0/59
|
0.55%
1/183 • Number of events 1
|
100.0%
1/1 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
3.9%
15/381 • Number of events 18
|
3.4%
2/59 • Number of events 2
|
4.4%
8/183 • Number of events 9
|
100.0%
1/1 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
RASH
|
2.4%
9/381 • Number of events 10
|
5.1%
3/59 • Number of events 3
|
4.4%
8/183 • Number of events 9
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
SKIN LESION
|
1.0%
4/381 • Number of events 4
|
5.1%
3/59 • Number of events 3
|
1.1%
2/183 • Number of events 2
|
0.00%
0/1
|
|
Vascular disorders
HYPERTENSION
|
16.3%
62/381 • Number of events 82
|
16.9%
10/59 • Number of events 13
|
14.2%
26/183 • Number of events 31
|
0.00%
0/1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER