Trial Outcomes & Findings for Safety and Efficacy Study of PEG-uricase in the Treatment of Hyperuricemic Patients With Symptomatic Gout (NCT NCT00325195)
NCT ID: NCT00325195
Last Updated: 2011-02-28
Results Overview
PUA Responder was defined as a participant who achieved and maintained plasma uric acid concentrations \< 6 mg/dL for at least 80% of the time during months 3 and 6 combined. Participants who withdrew from the study before month 6 were considered non-responders.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
225 participants
Primary outcome timeframe
Months 3 and 6
Results posted on
2011-02-28
Participant Flow
Rheumatology practices across the US, Canada and Mexico
13 subjects were randomized but withdrew before intervention. These subjects were not part of the modified Intent to Treat Population, which included only subjects who received at least one dose of study drug.
Participant milestones
| Measure |
q2 Wks
8 mg pegloticase every 2 weeks
|
q4 Wks
8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
|
Placebo
placebo infusion every 2 weeks
|
|---|---|---|---|
|
Randomized
STARTED
|
90
|
89
|
46
|
|
Randomized
COMPLETED
|
85
|
84
|
43
|
|
Randomized
NOT COMPLETED
|
5
|
5
|
3
|
|
Received Intervention: ITT Population
STARTED
|
85
|
84
|
43
|
|
Received Intervention: ITT Population
COMPLETED
|
59
|
59
|
39
|
|
Received Intervention: ITT Population
NOT COMPLETED
|
26
|
25
|
4
|
Reasons for withdrawal
| Measure |
q2 Wks
8 mg pegloticase every 2 weeks
|
q4 Wks
8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
|
Placebo
placebo infusion every 2 weeks
|
|---|---|---|---|
|
Randomized
Not dosed
|
5
|
5
|
3
|
|
Received Intervention: ITT Population
Adverse Event
|
15
|
17
|
1
|
|
Received Intervention: ITT Population
Death
|
3
|
1
|
0
|
|
Received Intervention: ITT Population
Withdrawal by Subject
|
7
|
6
|
1
|
|
Received Intervention: ITT Population
Lost to Follow-up
|
0
|
0
|
2
|
|
Received Intervention: ITT Population
Protocol violation/non-compliance
|
1
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy Study of PEG-uricase in the Treatment of Hyperuricemic Patients With Symptomatic Gout
Baseline characteristics by cohort
| Measure |
q2 Wks
n=85 Participants
8 mg pegloticase every 2 weeks
|
q4 Wks
n=84 Participants
8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
|
Placebo
n=43 Participants
placebo infusion every 2 weeks
|
Total
n=212 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
56 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
152 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
29 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Age Continuous
|
56.3 years
STANDARD_DEVIATION 15.53 • n=5 Participants
|
54.5 years
STANDARD_DEVIATION 13.34 • n=7 Participants
|
55.4 years
STANDARD_DEVIATION 12.21 • n=5 Participants
|
55.4 years
STANDARD_DEVIATION 14.01 • n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
173 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
73 participants
n=5 Participants
|
77 participants
n=7 Participants
|
39 participants
n=5 Participants
|
189 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Region of Enrollment
Mexico
|
11 participants
n=5 Participants
|
6 participants
n=7 Participants
|
3 participants
n=5 Participants
|
20 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Months 3 and 6Population: Modified ITT (all patients receiving at least one dose of study drug). Participants dropping out before Week 25 were imputed as Non-Responders
PUA Responder was defined as a participant who achieved and maintained plasma uric acid concentrations \< 6 mg/dL for at least 80% of the time during months 3 and 6 combined. Participants who withdrew from the study before month 6 were considered non-responders.
Outcome measures
| Measure |
q2 Wks
n=85 Participants
8 mg pegloticase every 2 weeks
|
q4 Wks
n=84 Participants
8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
|
Placebo
n=43 Participants
placebo infusion every 2 weeks
|
|---|---|---|---|
|
Plasma Uric Acid (PUA) Responder
|
36 Participants
|
29 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and Final Visit (6 months or LOCF)Population: Number of participants analyzed was based upon the number of patients who had one or more tophus at Baseline, as determined by the PI, AND who had at least one follow-up assessment, with the final visit for each subject included (last observation carried forward).
percentage of tophaceous subjects who demonstrated a complete resolution (100 % decrease in measured area or complete disappearance)of at least one tophus in the absence of other tophus progression or new tophi, as assessed by a blinded Central Reader using standardized digital photographs and image analysis software.
Outcome measures
| Measure |
q2 Wks
n=52 Participants
8 mg pegloticase every 2 weeks
|
q4 Wks
n=52 Participants
8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
|
Placebo
n=27 Participants
placebo infusion every 2 weeks
|
|---|---|---|---|
|
Reduction in Tophus Burden
|
40 Percent subjects with resolved tophus
|
21 Percent subjects with resolved tophus
|
7 Percent subjects with resolved tophus
|
SECONDARY outcome
Timeframe: Months 1-3 and Months 4-6Population: Number analyzed in each period was based upon number of participants remaining in study during the assessed treatment period: 85/84/43 in Months 1-3 and 69/69/43 in Months 4-6
Percent of participants reporting a gout flare during Months 1-3 and Months 4-6. Denominator during the respective period was based upon number of participants during that period.
Outcome measures
| Measure |
q2 Wks
n=85 Participants
8 mg pegloticase every 2 weeks
|
q4 Wks
n=84 Participants
8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
|
Placebo
n=43 Participants
placebo infusion every 2 weeks
|
|---|---|---|---|
|
Percentage of Subjects With Gout Flare Per 3-month Period
Months 1-3
|
75 Percent subjects reporting flares
|
81 Percent subjects reporting flares
|
54 Percent subjects reporting flares
|
|
Percentage of Subjects With Gout Flare Per 3-month Period
Months 4-6
|
41 Percent subjects reporting flares
|
56 Percent subjects reporting flares
|
67 Percent subjects reporting flares
|
SECONDARY outcome
Timeframe: Baseline and Final Visit (Month 6 or LOCF)Population: All ITT participants with baseline and at least one post-baseline assessment were included in analysis. LOCF was used for participants dropping out early.
Change from Baseline to Month 6 (or last observation carried forward)in number of swollen joints per subject. Values were inputed using last observation carried forward analysis for subjects who did not complete the studies.
Outcome measures
| Measure |
q2 Wks
n=78 Participants
8 mg pegloticase every 2 weeks
|
q4 Wks
n=77 Participants
8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
|
Placebo
n=43 Participants
placebo infusion every 2 weeks
|
|---|---|---|---|
|
Change in Number of Swollen Joints
|
-5.5 Swollen joints
Standard Deviation 10.47
|
-5.1 Swollen joints
Standard Deviation 7.83
|
-2.6 Swollen joints
Standard Deviation 11.64
|
SECONDARY outcome
Timeframe: Baseline and Final Visit (Month 6 or LOCF)Population: All ITT participants with baseline and at least one post-baseline assessment were included in analysis. LOCF was used for participants dropping out early.
Change from Baseline to Month 6 (or last observation carried forward) in number of tender joints per participant
Outcome measures
| Measure |
q2 Wks
n=78 Participants
8 mg pegloticase every 2 weeks
|
q4 Wks
n=77 Participants
8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
|
Placebo
n=43 Participants
placebo infusion every 2 weeks
|
|---|---|---|---|
|
Change in Number of Tender Joints
|
-7.4 Tender joints
Standard Deviation 11.95
|
-6.1 Tender joints
Standard Deviation 10.64
|
-1.2 Tender joints
Standard Deviation 12.30
|
SECONDARY outcome
Timeframe: Baseline to Final Visit (Month 6 or LOCF)Population: Number of participants analyzed was based upon the number who had baseline and at least one follow-up assessment, with the final visit for each subject included (LOCF).
Health Assessment Questionnaire(HAQ: VAS pain scale where 0 (no pain)-100 (severe pain); HAQ disability index (HAQ-DI) on a scale from 0(no disability) to 3 (completely disabled), and a unit change of \> or =0.22 is considerd a mimimal clinically important difference(MCID). SF-36 Physical Component Summary Score (SF36-PCS), a composite score where 0 is the worst score and 100 the best possible, and where a change of \> or =2.5 units in the PCS is considered a MCID.
Outcome measures
| Measure |
q2 Wks
n=77 Participants
8 mg pegloticase every 2 weeks
|
q4 Wks
n=77 Participants
8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
|
Placebo
n=43 Participants
placebo infusion every 2 weeks
|
|---|---|---|---|
|
Change in Patient Reported Outcomes of Pain, Physical Function and Quality of Life
HAQ-VAS Pain
|
-11.4 Units on a scale
Standard Deviation 33.8
|
-6.9 Units on a scale
Standard Deviation 27.0
|
1.4 Units on a scale
Standard Deviation 30.0
|
|
Change in Patient Reported Outcomes of Pain, Physical Function and Quality of Life
HAQ-DI
|
-0.22 Units on a scale
Standard Deviation 0.64
|
-0.20 Units on a scale
Standard Deviation 0.55
|
0.0 Units on a scale
Standard Deviation 0.41
|
|
Change in Patient Reported Outcomes of Pain, Physical Function and Quality of Life
SF-36 PCS
|
4.4 Units on a scale
Standard Deviation 9.4
|
4.9 Units on a scale
Standard Deviation 8.5
|
-0.3 Units on a scale
Standard Deviation 9.0
|
Adverse Events
q2 Wks
Serious events: 20 serious events
Other events: 69 other events
Deaths: 0 deaths
q4 Wks
Serious events: 19 serious events
Other events: 79 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
q2 Wks
n=85 participants at risk
8 mg pegloticase every 2 weeks
|
q4 Wks
n=84 participants at risk
8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
|
Placebo
n=43 participants at risk
placebo infusion every 2 weeks
|
|---|---|---|---|
|
General disorders
Infusion Related Reaction
|
4.7%
4/85 • Number of events 4 • 6 months
|
8.3%
7/84 • Number of events 7 • 6 months
|
0.00%
0/43 • 6 months
|
|
General disorders
Chest Pain
|
1.2%
1/85 • Number of events 1 • 6 months
|
0.00%
0/84 • 6 months
|
0.00%
0/43 • 6 months
|
|
General disorders
Oedoma Peripheral
|
1.2%
1/85 • Number of events 1 • 6 months
|
0.00%
0/84 • 6 months
|
0.00%
0/43 • 6 months
|
|
General disorders
Pyrexia
|
1.2%
1/85 • Number of events 1 • 6 months
|
0.00%
0/84 • 6 months
|
0.00%
0/43 • 6 months
|
|
Infections and infestations
Pneumonia
|
1.2%
1/85 • Number of events 1 • 6 months
|
1.2%
1/84 • Number of events 1 • 6 months
|
2.3%
1/43 • Number of events 1 • 6 months
|
|
Infections and infestations
Cellulitis
|
1.2%
1/85 • Number of events 2 • 6 months
|
1.2%
1/84 • Number of events 1 • 6 months
|
0.00%
0/43 • 6 months
|
|
Infections and infestations
Arthritis Bacterial
|
0.00%
0/85 • 6 months
|
0.00%
0/84 • 6 months
|
2.3%
1/43 • Number of events 1 • 6 months
|
|
Infections and infestations
Cellulitis Staphylococcal
|
0.00%
0/85 • 6 months
|
1.2%
1/84 • Number of events 1 • 6 months
|
0.00%
0/43 • 6 months
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/85 • 6 months
|
0.00%
0/84 • 6 months
|
2.3%
1/43 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Localised Infection
|
0.00%
0/85 • 6 months
|
1.2%
1/84 • Number of events 1 • 6 months
|
0.00%
0/43 • 6 months
|
|
Infections and infestations
Necrotising Fasciitis
|
0.00%
0/85 • 6 months
|
1.2%
1/84 • Number of events 1 • 6 months
|
0.00%
0/43 • 6 months
|
|
Infections and infestations
Perianal Abscess
|
0.00%
0/85 • 6 months
|
0.00%
0/84 • 6 months
|
2.3%
1/43 • Number of events 1 • 6 months
|
|
Infections and infestations
Pyelonephritis
|
1.2%
1/85 • Number of events 1 • 6 months
|
0.00%
0/84 • 6 months
|
0.00%
0/43 • 6 months
|
|
Infections and infestations
Sepsis
|
1.2%
1/85 • Number of events 1 • 6 months
|
0.00%
0/84 • 6 months
|
0.00%
0/43 • 6 months
|
|
Infections and infestations
Staphyloccal Sepsis
|
1.2%
1/85 • Number of events 1 • 6 months
|
0.00%
0/84 • 6 months
|
0.00%
0/43 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Gout
|
4.7%
4/85 • Number of events 4 • 6 months
|
1.2%
1/84 • Number of events 1 • 6 months
|
4.7%
2/43 • Number of events 2 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/85 • 6 months
|
1.2%
1/84 • Number of events 1 • 6 months
|
0.00%
0/43 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
1.2%
1/85 • Number of events 1 • 6 months
|
0.00%
0/84 • 6 months
|
0.00%
0/43 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Myopathy Steroid
|
1.2%
1/85 • Number of events 1 • 6 months
|
0.00%
0/84 • 6 months
|
0.00%
0/43 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.2%
1/85 • Number of events 1 • 6 months
|
0.00%
0/84 • 6 months
|
0.00%
0/43 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Synovial Cyst
|
1.2%
1/85 • Number of events 1 • 6 months
|
0.00%
0/84 • 6 months
|
0.00%
0/43 • 6 months
|
|
Cardiac disorders
Arrhythmia
|
2.4%
2/85 • Number of events 2 • 6 months
|
0.00%
0/84 • 6 months
|
0.00%
0/43 • 6 months
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/85 • 6 months
|
1.2%
1/84 • Number of events 1 • 6 months
|
0.00%
0/43 • 6 months
|
|
Cardiac disorders
Cardiac Arrest
|
1.2%
1/85 • Number of events 1 • 6 months
|
0.00%
0/84 • 6 months
|
0.00%
0/43 • 6 months
|
|
Cardiac disorders
Cardiac Failure Congestive
|
1.2%
1/85 • Number of events 1 • 6 months
|
0.00%
0/84 • 6 months
|
0.00%
0/43 • 6 months
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/85 • 6 months
|
1.2%
1/84 • Number of events 1 • 6 months
|
0.00%
0/43 • 6 months
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/85 • 6 months
|
1.2%
1/84 • Number of events 1 • 6 months
|
0.00%
0/43 • 6 months
|
|
Gastrointestinal disorders
Gatrooesophageal Reflux Disease
|
2.4%
2/85 • Number of events 2 • 6 months
|
0.00%
0/84 • 6 months
|
0.00%
0/43 • 6 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/85 • 6 months
|
1.2%
1/84 • Number of events 1 • 6 months
|
2.3%
1/43 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Barrett's Oesophagus
|
1.2%
1/85 • Number of events 1 • 6 months
|
0.00%
0/84 • 6 months
|
0.00%
0/43 • 6 months
|
|
Gastrointestinal disorders
Gastritis Erosive
|
1.2%
1/85 • Number of events 1 • 6 months
|
0.00%
0/84 • 6 months
|
0.00%
0/43 • 6 months
|
|
Gastrointestinal disorders
Inguinal Hernia, Obstructive
|
0.00%
0/85 • 6 months
|
0.00%
0/84 • 6 months
|
2.3%
1/43 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/85 • 6 months
|
1.2%
1/84 • Number of events 1 • 6 months
|
2.3%
1/43 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/85 • 6 months
|
0.00%
0/84 • 6 months
|
2.3%
1/43 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/85 • 6 months
|
1.2%
1/84 • Number of events 1 • 6 months
|
0.00%
0/43 • 6 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.2%
1/85 • Number of events 1 • 6 months
|
1.2%
1/84 • Number of events 2 • 6 months
|
0.00%
0/43 • 6 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/85 • 6 months
|
0.00%
0/84 • 6 months
|
2.3%
1/43 • Number of events 1 • 6 months
|
|
Nervous system disorders
Convulsion
|
0.00%
0/85 • 6 months
|
1.2%
1/84 • Number of events 1 • 6 months
|
0.00%
0/43 • 6 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/85 • 6 months
|
0.00%
0/84 • 6 months
|
2.3%
1/43 • Number of events 1 • 6 months
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/85 • 6 months
|
1.2%
1/84 • Number of events 1 • 6 months
|
0.00%
0/43 • 6 months
|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
1.2%
1/85 • Number of events 1 • 6 months
|
0.00%
0/84 • 6 months
|
0.00%
0/43 • 6 months
|
|
Injury, poisoning and procedural complications
Injury
|
1.2%
1/85 • Number of events 1 • 6 months
|
0.00%
0/84 • 6 months
|
0.00%
0/43 • 6 months
|
|
Injury, poisoning and procedural complications
Muscle Rupture
|
1.2%
1/85 • Number of events 2 • 6 months
|
0.00%
0/84 • 6 months
|
0.00%
0/43 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic Lymphocytic Leukaemia Recurrent
|
0.00%
0/85 • 6 months
|
0.00%
0/84 • 6 months
|
2.3%
1/43 • Number of events 1 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.00%
0/85 • 6 months
|
1.2%
1/84 • Number of events 1 • 6 months
|
0.00%
0/43 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
1/85 • Number of events 1 • 6 months
|
0.00%
0/84 • 6 months
|
0.00%
0/43 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exacerbated
|
0.00%
0/85 • 6 months
|
1.2%
1/84 • Number of events 1 • 6 months
|
0.00%
0/43 • 6 months
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/85 • 6 months
|
0.00%
0/84 • 6 months
|
2.3%
1/43 • Number of events 1 • 6 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/85 • 6 months
|
1.2%
1/84 • Number of events 1 • 6 months
|
0.00%
0/43 • 6 months
|
|
Skin and subcutaneous tissue disorders
Angioneurotic Oedema
|
0.00%
0/85 • 6 months
|
1.2%
1/84 • Number of events 1 • 6 months
|
0.00%
0/43 • 6 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/85 • 6 months
|
1.2%
1/84 • Number of events 1 • 6 months
|
0.00%
0/43 • 6 months
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/85 • 6 months
|
1.2%
1/84 • Number of events 1 • 6 months
|
0.00%
0/43 • 6 months
|
Other adverse events
| Measure |
q2 Wks
n=85 participants at risk
8 mg pegloticase every 2 weeks
|
q4 Wks
n=84 participants at risk
8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
|
Placebo
n=43 participants at risk
placebo infusion every 2 weeks
|
|---|---|---|---|
|
Vascular disorders
Hypertension
|
2.4%
2/85 • 6 months
|
6.0%
5/84 • 6 months
|
7.0%
3/43 • 6 months
|
|
Blood and lymphatic system disorders
Anaemia
|
8.2%
7/85 • 6 months
|
4.8%
4/84 • 6 months
|
9.3%
4/43 • 6 months
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.7%
4/85 • 6 months
|
4.8%
4/84 • 6 months
|
20.9%
9/43 • 6 months
|
|
Infections and infestations
Urinary Tract Infection
|
7.1%
6/85 • 6 months
|
6.0%
5/84 • 6 months
|
7.0%
3/43 • 6 months
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
6/85 • 6 months
|
4.8%
4/84 • 6 months
|
2.3%
1/43 • 6 months
|
|
Infections and infestations
Localised Infection
|
2.4%
2/85 • 6 months
|
4.8%
4/84 • 6 months
|
7.0%
3/43 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
6/85 • 6 months
|
17.9%
15/84 • 6 months
|
18.6%
8/43 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.5%
3/85 • 6 months
|
8.3%
7/84 • 6 months
|
4.7%
2/43 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
3.5%
3/85 • 6 months
|
6.0%
5/84 • 6 months
|
9.3%
4/43 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
4.7%
4/85 • 6 months
|
0.00%
0/84 • 6 months
|
0.00%
0/43 • 6 months
|
|
Gastrointestinal disorders
Diarrhoea
|
10.6%
9/85 • 6 months
|
16.7%
14/84 • 6 months
|
18.6%
8/43 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
11.8%
10/85 • 6 months
|
7.1%
6/84 • 6 months
|
2.3%
1/43 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
4.7%
4/85 • 6 months
|
4.8%
4/84 • 6 months
|
7.0%
3/43 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
1.2%
1/85 • 6 months
|
4.8%
4/84 • 6 months
|
0.00%
0/43 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
4.7%
4/85 • 6 months
|
6.0%
5/84 • 6 months
|
2.3%
1/43 • 6 months
|
|
Gastrointestinal disorders
Constipation
|
5.9%
5/85 • 6 months
|
2.4%
2/84 • 6 months
|
4.7%
2/43 • 6 months
|
|
General disorders
Oedema Peripheral
|
10.6%
9/85 • 6 months
|
13.1%
11/84 • 6 months
|
14.0%
6/43 • 6 months
|
|
General disorders
Fatigue
|
5.9%
5/85 • 6 months
|
7.1%
6/84 • 6 months
|
9.3%
4/43 • 6 months
|
|
General disorders
Chest Pain
|
4.7%
4/85 • 6 months
|
4.8%
4/84 • 6 months
|
2.3%
1/43 • 6 months
|
|
General disorders
Pain
|
4.7%
4/85 • 6 months
|
4.8%
4/84 • 6 months
|
4.7%
2/43 • 6 months
|
|
General disorders
Pyrexia
|
1.2%
1/85 • 6 months
|
6.0%
5/84 • 6 months
|
2.3%
1/43 • 6 months
|
|
General disorders
Asthenia
|
2.4%
2/85 • 6 months
|
4.8%
4/84 • 6 months
|
0.00%
0/43 • 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.5%
3/85 • 6 months
|
6.0%
5/84 • 6 months
|
0.00%
0/43 • 6 months
|
|
Nervous system disorders
Headache
|
9.4%
8/85 • 6 months
|
10.7%
9/84 • 6 months
|
9.3%
4/43 • 6 months
|
|
Nervous system disorders
Dizziness
|
3.5%
3/85 • 6 months
|
8.3%
7/84 • 6 months
|
9.3%
4/43 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.5%
3/85 • 6 months
|
6.0%
5/84 • 6 months
|
4.7%
2/43 • 6 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.7%
4/85 • 6 months
|
1.2%
1/84 • 6 months
|
2.3%
1/43 • 6 months
|
|
Injury, poisoning and procedural complications
Contusion
|
8.2%
7/85 • 6 months
|
0.00%
0/84 • 6 months
|
2.3%
1/43 • 6 months
|
|
Investigations
Blood Glucose Increased
|
4.7%
4/85 • 6 months
|
2.4%
2/84 • 6 months
|
2.3%
1/43 • 6 months
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/85 • 6 months
|
7.1%
6/84 • 6 months
|
0.00%
0/43 • 6 months
|
|
Psychiatric disorders
Insomnia
|
5.9%
5/85 • 6 months
|
9.5%
8/84 • 6 months
|
9.3%
4/43 • 6 months
|
|
Psychiatric disorders
Depression
|
3.5%
3/85 • 6 months
|
4.8%
4/84 • 6 months
|
9.3%
4/43 • 6 months
|
|
Cardiac disorders
Tachycardia
|
1.2%
1/85 • 6 months
|
4.8%
4/84 • 6 months
|
0.00%
0/43 • 6 months
|
Additional Information
Medical Director
Savient Pharmaceuticals, Inc.
Phone: 732-418-9300
Results disclosure agreements
- Principal investigator is a sponsor employee Multicenter publication is to be generated before any individual PI publishes on the results. If multicenter publication is not completed within 18 months from the date of completion, then PI can publish individual results from the Study. Sponsor can review results prior to public release and embargo for no more than 90 days. Sponsor can request removal of Confidential Information only.
- Publication restrictions are in place
Restriction type: OTHER