Open-Label Extension Study for Patients Who Completed a Phase 3 Double-blind Study of PEG-uricase for Symptomatic Gout
Sponsor
Savient Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01356498
Collaborator
(none)
151
22
3
37
6.9
0.2
Study Details
Study Description
Brief Summary
This is an open-label extension phase of two double-blind, placebo-controled Phase 3 protocols evaluating PEG-uricase in the treatment of hyperuricemic subjects with symptomatic gout. The purpose of this study is to provide a continuation of treatment to subjects completing the double-blind studies and obtain long-term safety and efficacy data.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
151 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Multicenter, Open Label Extension Study of 8 mg PEG-uricase in Subjects Who Completed Protocols C0405 or C0406 for Symptomatic Gout
Study Start Date
:
Dec 1, 2006
Actual Primary Completion Date
:
Jan 1, 2010
Actual Study Completion Date
:
Jan 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: q2 RCT Pegloticase every 2 wk arm of Randomized Controlled Trial(RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extention (OLE) study |
Biological: pegloticase
8 mg intravenous infusion
|
| Experimental: q4 RCT Pegloticase every 4 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extention (OLE) study |
Biological: pegloticase
8 mg intravenous infusion
|
| Experimental: Placebo in RCT Placebo arm in Randomized Controlled Trial (RCT), received pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in OLE |
Biological: pegloticase
8 mg intravenous infusion
|
Outcome Measures
Primary Outcome Measures
- Uric Acid (mg/dL) [Week 13, Week 25, Week 53, Week 101]
Uric acid measured at 3 month-intervals
Secondary Outcome Measures
- Tophus Response [Up to 2 years]
Target tophi evaluated during the randomized, controlled study were followed for response at 3, 6, 12, 18 and 24 months in this open-label extention study. Results from each participant's final assessment on drug are reported (as last observation carried forward). Complete response=complete disappearance of at least one tophus with no new or worsening tophus. Partial Response=a 50% or more decrease in at least one tophus with no new or worsening tophus.
- Patient Reported Outcome: SF-36 Physical Component Summary Score [RCT Week 25; OLE Week 25; OLE Week 53, OLE Week 77, OLE Week 101]
SF-36 is the Medical Outcomes Survey Short Form-36, a 36-item self-reported questionnaire which assesses health-related limitations in 8 dimensions. The Physical Component Summary Score (PCS) is a composite summary score derived from the dimensions related to physical functioning outcomes: Physical Function, Role Physical, General Health and Bodily Pain (each with a 0 to 100 scale where 0=worst, 100=best). The Summary Score is constructed as a T-score with a mean of 50 and standard deviation of 10, where higher scores indicate a better health status.
- Gout Flare Frequency [Up to 2 years]
The the mean number of flares per subject (flare frequency)was assessed over 3-month periods for up to 2 years of treatment
- Gout Flare Incidence [Assessed in 3-month intervals up to 2 years]
Percentage of participants remaining in the study during the specified interval who experienced a gout flare during this interval.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Completed treatment in one of two double-blind, placebo controlled studies of PEG-uricase in subjects with hyperuricemia and symptomatic gout
Exclusion Criteria:
-
unstable angina
-
uncontrolled arrhythmia
-
uncontrolled hypertension
-
end stage renal disease requiring dialysis
-
anemia
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kaiser Permanente Medical Center, Clinical Trials Unit | San Francisco | California | United States | 94118 |
| 2 | Pacific Arthritis Center Medical Group | Santa Maria | California | United States | 93454 |
| 3 | Agilence Arthritis & Osteoporosis Medical Center | Whittier | California | United States | 90606 |
| 4 | Veterans Affairs Medical Center | Washington | District of Columbia | United States | 20422 |
| 5 | Arthritis & Rheumatic Disease Specialties | Aventura | Florida | United States | 33180 |
| 6 | Ocala Rheumatology Research Center | Ocala | Florida | United States | 34474 |
| 7 | St. Petersburg Arthritis Center | St. Petersburg | Florida | United States | 33703 |
| 8 | The University of Chicago | Chicago | Illinois | United States | 60637 |
| 9 | Graves Gilbert Clinic | Bowling Green | Kentucky | United States | 42101 |
| 10 | Peter A. Holt, M.D. | Baltimore | Maryland | United States | 21239 |
| 11 | Center for Rheumatology and Bone Research | Wheaton | Maryland | United States | 20902 |
| 12 | Justus J. Fiechtner, MD, PC | Lansing | Michigan | United States | 48910 |
| 13 | CentraCare Clinic | St. Cloud | Minnesota | United States | 56377 |
| 14 | Rheumatology Associates of North Jersey | Teaneck | New Jersey | United States | 07666 |
| 15 | Duke University Medical Center | Durham | North Carolina | United States | 27302 |
| 16 | New Horizons Clinical Research | Cincinnati | Ohio | United States | 45242 |
| 17 | The Ohio State University | Columbus | Ohio | United States | 43210 |
| 18 | STAT Research, Inc. | Dayton | Ohio | United States | 45402 |
| 19 | David R. Mandel, MD, Inc. | Mayfield Village | Ohio | United States | 44143 |
| 20 | Altoona Center for Clinical Research | Duncansville | Pennsylvania | United States | 16635 |
| 21 | Mid Atlantic Research Assoc. | Philadelphia | Pennsylvania | United States | 19154 |
| 22 | Arthritis Northwest, PLLC | Spokane | Washington | United States | 99204 |
Sponsors and Collaborators
- Savient Pharmaceuticals
Investigators
- Study Director: Medical Director, M.D., Savient Pharmaceuticals, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Savient Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01356498
Other Study ID Numbers:
- C0407
First Posted:
May 19, 2011
Last Update Posted:
Dec 2, 2011
Last Verified:
Oct 1, 2011
Study Results
Participant Flow
| Recruitment Details | Subjects completing one of the randomized, controlled Phase 3 clinical trials (RCTs) of pegloticase [C0405 and C0406 (NCT00325195)] were invited to participate in this open-label extension study. |
|---|---|
| Pre-assignment Detail | Participants made the decision, along with the treating investigator, of which dose to receive in this study while remaining blinded to treatment received and results during the RCT. Cohort designations are based on participants' initial RCT treatment and whether uric acid remained <6 mg/dL for 80% of the time during months 3 and 6 in the RCT. |
| Arm/Group Title | q2 RCT, Responder | q4 RCT, Responder | Placebo in RCT, q2 in OLE | q2 RCT, Non-responder | q4 RCT Non-responder | Placebo in RCT, q4 in OLE |
|---|---|---|---|---|---|---|
| Arm/Group Description | Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study | Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study | Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study | Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study | Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study | Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study |
| Period Title: Overall Study | ||||||
| STARTED | 35 | 25 | 23 | 22 | 28 | 16 |
| COMPLETED | 24 | 17 | 11 | 8 | 8 | 2 |
| NOT COMPLETED | 11 | 8 | 12 | 14 | 20 | 14 |
Baseline Characteristics
| Arm/Group Title | q2 RCT, Responder | q4 RCT, Responder | Placebo in RCT, q2 in OLE | q2 RCT, Non-responder | q4 RCT Non-responder | Placebo in RCT, q4 in OLE | Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study | Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study | Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study | Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study | Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study | Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study | Total of all reporting groups |
| Overall Participants | 35 | 25 | 23 | 22 | 28 | 16 | 149 |
| Age (Count of Participants) | |||||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
20
57.1%
|
17
68%
|
18
78.3%
|
16
72.7%
|
23
82.1%
|
11
68.8%
|
105
70.5%
|
| >=65 years |
15
42.9%
|
8
32%
|
5
21.7%
|
6
27.3%
|
5
17.9%
|
5
31.3%
|
44
29.5%
|
| Age (years) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [years] |
62.4
(13.66)
|
58.6
(13.59)
|
56.6
(10.53)
|
52.0
(13.12)
|
53.5
(12.25)
|
54.6
(13.62)
|
56.8
(13.19)
|
| Sex: Female, Male (Count of Participants) | |||||||
| Female |
10
28.6%
|
7
28%
|
4
17.4%
|
4
18.2%
|
4
14.3%
|
3
18.8%
|
32
21.5%
|
| Male |
25
71.4%
|
18
72%
|
19
82.6%
|
18
81.8%
|
24
85.7%
|
13
81.3%
|
117
78.5%
|
| Region of Enrollment (participants) [Number] | |||||||
| United States |
32
91.4%
|
22
88%
|
22
95.7%
|
17
77.3%
|
27
96.4%
|
13
81.3%
|
133
89.3%
|
| Canada |
0
0%
|
1
4%
|
1
4.3%
|
0
0%
|
0
0%
|
0
0%
|
2
1.3%
|
| Mexico |
3
8.6%
|
2
8%
|
0
0%
|
5
22.7%
|
1
3.6%
|
3
18.8%
|
14
9.4%
|
Outcome Measures
| Title | Uric Acid (mg/dL) |
|---|---|
| Description | Uric acid measured at 3 month-intervals |
| Time Frame | Week 13, Week 25, Week 53, Week 101 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT |
| Arm/Group Title | q2 RCT, Responder | q4 RCT, Responder | Placebo in RCT, q2 in OLE | q2 RCT, Non-responder | q4 RCT Non-responder | Placebo in RCT, q4 in OLE |
|---|---|---|---|---|---|---|
| Arm/Group Description | Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study | Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study | Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study | Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study | Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study | Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study |
| Measure Participants | 31 | 24 | 18 | 17 | 22 | 10 |
| OLE Week 13 |
1.33
(3.103)
|
1.91
(4.082)
|
5.06
(4.538)
|
9.76
(1.346)
|
9.66
(2.529)
|
8.08
(3.561)
|
| OLE Week 25 |
1.4
(3.196)
|
1.95
(3.761)
|
4.69
(4.454)
|
8.89
(3.984)
|
9.94
(2.646)
|
8.09
(3.536)
|
| OLE Week 53 |
0.87
(2.327)
|
1.55
(3.690)
|
2.7
(4.255)
|
9.18
(2.946)
|
9.59
(2.782)
|
6.45
(3.248)
|
| OLE Week 101 |
0.84
(2.619)
|
1.47
(3.317)
|
4.29
(3.985)
|
7.7
(4.244)
|
9.42
(1.961)
|
8.5
(NA)
|
| Title | Tophus Response |
|---|---|
| Description | Target tophi evaluated during the randomized, controlled study were followed for response at 3, 6, 12, 18 and 24 months in this open-label extention study. Results from each participant's final assessment on drug are reported (as last observation carried forward). Complete response=complete disappearance of at least one tophus with no new or worsening tophus. Partial Response=a 50% or more decrease in at least one tophus with no new or worsening tophus. |
| Time Frame | Up to 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT, Last observation(on drug) carried forward showing patients with an Overall Tophus Response of Complete or Partial Response. |
| Arm/Group Title | q2 RCT, Responder | q4 RCT, Responder | Placebo in RCT, q2 in OLE | q2 RCT, Non-responder | q4 RCT Non-responder | Placebo in RCT, q4 in OLE |
|---|---|---|---|---|---|---|
| Arm/Group Description | Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study | Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study | Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study | Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study | Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study | Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study |
| Measure Participants | 23 | 14 | 16 | 16 | 20 | 5 |
| Complete Response |
19
54.3%
|
13
52%
|
10
43.5%
|
4
18.2%
|
7
25%
|
3
18.8%
|
| Partial Response |
4
11.4%
|
0
0%
|
3
13%
|
4
18.2%
|
2
7.1%
|
1
6.3%
|
| Title | Patient Reported Outcome: SF-36 Physical Component Summary Score |
|---|---|
| Description | SF-36 is the Medical Outcomes Survey Short Form-36, a 36-item self-reported questionnaire which assesses health-related limitations in 8 dimensions. The Physical Component Summary Score (PCS) is a composite summary score derived from the dimensions related to physical functioning outcomes: Physical Function, Role Physical, General Health and Bodily Pain (each with a 0 to 100 scale where 0=worst, 100=best). The Summary Score is constructed as a T-score with a mean of 50 and standard deviation of 10, where higher scores indicate a better health status. |
| Time Frame | RCT Week 25; OLE Week 25; OLE Week 53, OLE Week 77, OLE Week 101 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants was the subset of the ITT population with SF-36 baseline data |
| Arm/Group Title | q2 RCT, Responder | q4 RCT Responder | Placebo in RCT, q2 in OLE | q2 RCT, Non-responder | q4 RCT, Non-responder | Placebo in RCT, q4 in OLE |
|---|---|---|---|---|---|---|
| Arm/Group Description | Responder in Pegloticase every 2 wk arm of RCT, continued to received pegloticase (q2 wk or q4 wk) in OLE | REsponder in Pegloticase every 4 wk arm of RCT, contuned to received pegloticase (q2 wk or q4 wk) in OLE | Placebo arm in RCT, initiated pegloticase treatment q2 wk in OLE | Non-responder in pegloticase every 2 wk arm of RCT, continued to received pegloticase (q2 wk or q4 wk) in OLE | Non-responder in Pegloticase every 4 wk arm of RCT, continued to received pegloticase (q2 wk or q4 wk) in OLE | Placebo arm in RCT, initiated pegloticase treatment q4 wk in OLE |
| Measure Participants | 34 | 25 | 23 | 19 | 26 | 15 |
| Baseline value (pre-pegloticase) |
34.92
(10.988)
|
34.11
(10.022)
|
27.55
(11.405)
|
33.71
(11.581)
|
32.8
(10.129)
|
36.2
(11.926)
|
| Final Visit value (LOCF) |
40.40
(13.393)
|
40.82
(7.482)
|
30.34
(11.132)
|
37.68
(10.298)
|
34.76
(11.413)
|
38.8
(13.155)
|
| Title | Gout Flare Frequency |
|---|---|
| Description | The the mean number of flares per subject (flare frequency)was assessed over 3-month periods for up to 2 years of treatment |
| Time Frame | Up to 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis is based on ITT population, and is presented by intervals of time on pegloticase |
| Arm/Group Title | q2 RCT, Responder | q4 RCT, Responder | Placebo in RCT, q2 in OLE | q2 RCT, Non-responder | q4 RCT Non-responder | Placebo in RCT, q4 in OLE |
|---|---|---|---|---|---|---|
| Arm/Group Description | Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study | Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study | Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study | Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study | Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study | Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study |
| Measure Participants | 35 | 25 | 23 | 22 | 28 | 16 |
| Months 1-3 |
0.4
(0.69)
|
0.8
(0.90)
|
2.3
(2.91)
|
0.6
(0.90)
|
1.3
(1.49)
|
1.5
(1.41)
|
| Months 4-6 |
0.4
(0.96)
|
0.7
(0.95)
|
1.3
(2.17)
|
1.0
(1.73)
|
0.8
(0.94)
|
0.8
(1.18)
|
| Months 7-9 |
0.0
(0.17)
|
0.3
(0.54)
|
1.2
(1.80)
|
0.6
(1.20)
|
0.6
(0.97)
|
0.4
(1.01)
|
| Months 10-12 |
0.1
(0.30)
|
0.2
(0.51)
|
0.6
(1.18)
|
0.9
(1.34)
|
0.9
(1.46)
|
0.4
(0.63)
|
| Months 16-18 |
0.1
(0.25)
|
.3
(0.44)
|
0.2
(0.40)
|
0.7
(1.18)
|
0.6
(0.85)
|
0.4
(0.89)
|
| Months 22-24 |
0.1
(0.37)
|
0.1
(0.23)
|
0.4
(0.67)
|
0.3
(0.65)
|
0.6
(0.53)
|
0.7
(1.15)
|
| Title | Gout Flare Incidence |
|---|---|
| Description | Percentage of participants remaining in the study during the specified interval who experienced a gout flare during this interval. |
| Time Frame | Assessed in 3-month intervals up to 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| The flare incidence is reported as the percentage of participants reporting flares during each 3-month interval. |
| Arm/Group Title | q2 RCT, Responder | q4 RCT, Responder | Placebo in RCT, q2 in OLE | q2 RCT, Non-responder | q4 RCT Non-responder | Placebo in RCT, q4 in OLE |
|---|---|---|---|---|---|---|
| Arm/Group Description | Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study | Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study | Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study | Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study | Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study | Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study |
| Measure Participants | 35 | 25 | 23 | 22 | 28 | 16 |
| Months 1-3 |
25.7
73.4%
|
56.0
224%
|
65.2
283.5%
|
45.5
206.8%
|
67.9
242.5%
|
68.8
430%
|
| Months 4-6 |
23.5
67.1%
|
40.0
160%
|
45.0
195.7%
|
35.0
159.1%
|
50.0
178.6%
|
38.5
240.6%
|
| Months 7-9 |
3.0
8.6%
|
24.0
96%
|
43.8
190.4%
|
27.8
126.4%
|
42.9
153.2%
|
22.2
138.8%
|
| Months 10-12 |
9.4
26.9%
|
16.7
66.8%
|
28.6
124.3%
|
47.1
214.1%
|
45.0
160.7%
|
28.6
178.8%
|
| Months 16-18 |
6.5
18.6%
|
25.0
100%
|
18.2
79.1%
|
33.3
151.4%
|
38.9
138.9%
|
20.0
125%
|
| Months 22-24 |
3.4
9.7%
|
5.3
21.2%
|
27.3
118.7%
|
25.0
113.6%
|
55.6
198.6%
|
33.3
208.1%
|
Adverse Events
| Time Frame | Up to 30 days post-treatment (maximum of 32 months) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Serious Adverse Events are reported for subjects during the On-pegloticase period, and includes events reported through 30 days after the last exposure to pegloticase. | |||||||||||
| Arm/Group Title | q2 RCT, Responder | q4 RCT, Responder | Placebo in RCT, q2 in OLE | q2 RCT, Non-responder | q4 RCT Non-responder | Placebo in RCT, q4 in OLE | ||||||
| Arm/Group Description | Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study | Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study | Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study | Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study | Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study | Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study | ||||||
All Cause Mortality |
||||||||||||
| q2 RCT, Responder | q4 RCT, Responder | Placebo in RCT, q2 in OLE | q2 RCT, Non-responder | q4 RCT Non-responder | Placebo in RCT, q4 in OLE | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||
Serious Adverse Events |
||||||||||||
| q2 RCT, Responder | q4 RCT, Responder | Placebo in RCT, q2 in OLE | q2 RCT, Non-responder | q4 RCT Non-responder | Placebo in RCT, q4 in OLE | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 9/35 (25.7%) | 7/25 (28%) | 8/23 (34.8%) | 7/22 (31.8%) | 12/28 (42.9%) | 8/16 (50%) | ||||||
| Blood and lymphatic system disorders | ||||||||||||
| Anaemia | 0/35 (0%) | 1/25 (4%) | 0/23 (0%) | 0/22 (0%) | 1/28 (3.6%) | 0/16 (0%) | ||||||
| Cardiac disorders | ||||||||||||
| Cardiac Failure Congestive | 1/35 (2.9%) | 0/25 (0%) | 1/23 (4.3%) | 0/22 (0%) | 1/28 (3.6%) | 0/16 (0%) | ||||||
| Myocardial Infarction | 0/35 (0%) | 1/25 (4%) | 0/23 (0%) | 1/22 (4.5%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Endocrine disorders | ||||||||||||
| Goitre | 0/35 (0%) | 1/25 (4%) | 0/23 (0%) | 0/22 (0%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Eye disorders | ||||||||||||
| Glaucoma | 0/35 (0%) | 0/25 (0%) | 0/23 (0%) | 0/22 (0%) | 0/28 (0%) | 1/16 (6.3%) | ||||||
| Gastrointestinal disorders | ||||||||||||
| Diarrhoea | 0/35 (0%) | 1/25 (4%) | 2/23 (8.7%) | 0/22 (0%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Vomiting | 0/35 (0%) | 1/25 (4%) | 1/23 (4.3%) | 0/22 (0%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Constipation | 1/35 (2.9%) | 0/25 (0%) | 0/23 (0%) | 0/22 (0%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Diverticular Performation | 0/35 (0%) | 0/25 (0%) | 0/23 (0%) | 1/22 (4.5%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Gastrointestinal Haemorrhage | 0/35 (0%) | 0/25 (0%) | 1/23 (4.3%) | 0/22 (0%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Peritonitis | 0/35 (0%) | 0/25 (0%) | 0/23 (0%) | 0/22 (0%) | 1/28 (3.6%) | 0/16 (0%) | ||||||
| General disorders | ||||||||||||
| Infusion related reaction | 1/35 (2.9%) | 0/25 (0%) | 4/23 (17.4%) | 1/22 (4.5%) | 3/28 (10.7%) | 3/16 (18.8%) | ||||||
| Chest pain | 0/35 (0%) | 1/25 (4%) | 0/23 (0%) | 0/22 (0%) | 2/28 (7.1%) | 0/16 (0%) | ||||||
| Asthenia | 0/35 (0%) | 0/25 (0%) | 0/23 (0%) | 0/22 (0%) | 1/28 (3.6%) | 0/16 (0%) | ||||||
| Infections and infestations | ||||||||||||
| Osteomyelitis | 0/35 (0%) | 0/25 (0%) | 1/23 (4.3%) | 1/22 (4.5%) | 1/28 (3.6%) | 0/16 (0%) | ||||||
| Appendicitis | 0/35 (0%) | 0/25 (0%) | 0/23 (0%) | 0/22 (0%) | 0/28 (0%) | 1/16 (6.3%) | ||||||
| Bronchitis | 0/35 (0%) | 0/25 (0%) | 0/23 (0%) | 0/22 (0%) | 1/28 (3.6%) | 0/16 (0%) | ||||||
| Cellulitis | 0/35 (0%) | 0/25 (0%) | 0/23 (0%) | 0/22 (0%) | 1/28 (3.6%) | 0/16 (0%) | ||||||
| Gastroenteritis Viral | 0/35 (0%) | 0/25 (0%) | 1/23 (4.3%) | 0/22 (0%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Sepsis | 0/35 (0%) | 0/25 (0%) | 0/23 (0%) | 0/22 (0%) | 1/28 (3.6%) | 0/16 (0%) | ||||||
| Staphylococcal Infection | 0/35 (0%) | 0/25 (0%) | 0/23 (0%) | 0/22 (0%) | 1/28 (3.6%) | 0/16 (0%) | ||||||
| Urinary Tract Infection Bacterial | 0/35 (0%) | 0/25 (0%) | 0/23 (0%) | 0/22 (0%) | 1/28 (3.6%) | 0/16 (0%) | ||||||
| Urosepsis | 0/35 (0%) | 0/25 (0%) | 0/23 (0%) | 1/22 (4.5%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Injury, poisoning and procedural complications | ||||||||||||
| Arthritis Bacterial | 0/35 (0%) | 0/25 (0%) | 0/23 (0%) | 1/22 (4.5%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Hip Fracture | 0/35 (0%) | 0/25 (0%) | 1/23 (4.3%) | 0/22 (0%) | 1/28 (3.6%) | 0/16 (0%) | ||||||
| Ankle Fracture | 0/35 (0%) | 1/25 (4%) | 0/23 (0%) | 0/22 (0%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Humerus Fracture | 0/35 (0%) | 0/25 (0%) | 0/23 (0%) | 0/22 (0%) | 1/28 (3.6%) | 0/16 (0%) | ||||||
| Intentional Overdose | 0/35 (0%) | 0/25 (0%) | 0/23 (0%) | 1/22 (4.5%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Metabolism and nutrition disorders | ||||||||||||
| Hypoglycaemia | 1/35 (2.9%) | 0/25 (0%) | 0/23 (0%) | 1/22 (4.5%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Fluid Overload | 0/35 (0%) | 1/25 (4%) | 0/23 (0%) | 0/22 (0%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Hyperkalaemia | 1/35 (2.9%) | 0/25 (0%) | 0/23 (0%) | 0/22 (0%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||
| Arthralgia | 0/35 (0%) | 1/25 (4%) | 0/23 (0%) | 0/22 (0%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Fasciitis | 0/35 (0%) | 0/25 (0%) | 0/23 (0%) | 0/22 (0%) | 0/28 (0%) | 1/16 (6.3%) | ||||||
| Gout | 0/35 (0%) | 0/25 (0%) | 0/23 (0%) | 1/22 (4.5%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Gouty Arthritis | 1/35 (2.9%) | 0/25 (0%) | 0/23 (0%) | 0/22 (0%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Lumbar Spinal Stenosis | 0/35 (0%) | 1/25 (4%) | 0/23 (0%) | 0/22 (0%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Muscular Weakness | 0/35 (0%) | 1/25 (4%) | 0/23 (0%) | 0/22 (0%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Musculoskeletal Pain | 0/35 (0%) | 0/25 (0%) | 0/23 (0%) | 1/22 (4.5%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Myositis | 0/35 (0%) | 0/25 (0%) | 0/23 (0%) | 0/22 (0%) | 0/28 (0%) | 1/16 (6.3%) | ||||||
| Pain in Extremity | 0/35 (0%) | 1/25 (4%) | 0/23 (0%) | 0/22 (0%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Rheumatoid Arthritis | 0/35 (0%) | 0/25 (0%) | 0/23 (0%) | 1/22 (4.5%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Rotator Cuff Syndrome | 0/35 (0%) | 0/25 (0%) | 0/23 (0%) | 1/22 (4.5%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||
| Myeloproliferative Disorder | 1/35 (2.9%) | 0/25 (0%) | 0/23 (0%) | 0/22 (0%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Nervous system disorders | ||||||||||||
| Carotid Artery Stenosis | 0/35 (0%) | 0/25 (0%) | 0/23 (0%) | 0/22 (0%) | 1/28 (3.6%) | 0/16 (0%) | ||||||
| Hepatic Encephalopathy | 1/35 (2.9%) | 0/25 (0%) | 0/23 (0%) | 0/22 (0%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Lumbar Radiculopathy | 0/35 (0%) | 0/25 (0%) | 0/23 (0%) | 0/22 (0%) | 0/28 (0%) | 1/16 (6.3%) | ||||||
| Syncope | 0/35 (0%) | 1/25 (4%) | 0/23 (0%) | 0/22 (0%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Psychiatric disorders | ||||||||||||
| Depression | 0/35 (0%) | 0/25 (0%) | 0/23 (0%) | 1/22 (4.5%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Stress | 0/35 (0%) | 0/25 (0%) | 0/23 (0%) | 0/22 (0%) | 1/28 (3.6%) | 0/16 (0%) | ||||||
| Suicide Attempt | 0/35 (0%) | 0/25 (0%) | 0/23 (0%) | 1/22 (4.5%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Renal and urinary disorders | ||||||||||||
| Renal Failure Acute | 1/35 (2.9%) | 0/25 (0%) | 0/23 (0%) | 1/22 (4.5%) | 1/28 (3.6%) | 1/16 (6.3%) | ||||||
| Renal Failure | 0/35 (0%) | 1/25 (4%) | 0/23 (0%) | 0/22 (0%) | 1/28 (3.6%) | 0/16 (0%) | ||||||
| Renal Failure Chronic | 0/35 (0%) | 0/25 (0%) | 1/23 (4.3%) | 0/22 (0%) | 1/28 (3.6%) | 0/16 (0%) | ||||||
| Azotemia | 0/35 (0%) | 0/25 (0%) | 1/23 (4.3%) | 0/22 (0%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Nephrolithiasis | 0/35 (0%) | 0/25 (0%) | 0/23 (0%) | 0/22 (0%) | 1/28 (3.6%) | 0/16 (0%) | ||||||
| Reproductive system and breast disorders | ||||||||||||
| Breast pain | 0/35 (0%) | 1/25 (4%) | 0/23 (0%) | 0/22 (0%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| Pulmonary Embolism | 2/35 (5.7%) | 0/25 (0%) | 0/23 (0%) | 0/22 (0%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Chronic Obstructive Pulmonary Disease | 1/35 (2.9%) | 0/25 (0%) | 0/23 (0%) | 0/22 (0%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Nasal Septum Deviation | 1/35 (2.9%) | 0/25 (0%) | 0/23 (0%) | 0/22 (0%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Skin and subcutaneous tissue disorders | ||||||||||||
| Skin Necrosis | 0/35 (0%) | 1/25 (4%) | 0/23 (0%) | 0/22 (0%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Surgical and medical procedures | ||||||||||||
| Inguinal Hernia Repair | 1/35 (2.9%) | 0/25 (0%) | 0/23 (0%) | 0/22 (0%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Vascular disorders | ||||||||||||
| Deep Vein Thrombosis | 0/35 (0%) | 0/25 (0%) | 2/23 (8.7%) | 0/22 (0%) | 1/28 (3.6%) | 0/16 (0%) | ||||||
| Femoral Artery Occlusion | 0/35 (0%) | 1/25 (4%) | 0/23 (0%) | 0/22 (0%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Hypertension | 0/35 (0%) | 1/25 (4%) | 0/23 (0%) | 0/22 (0%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Hypotension | 0/35 (0%) | 0/25 (0%) | 0/23 (0%) | 0/22 (0%) | 1/28 (3.6%) | 0/16 (0%) | ||||||
Other (Not Including Serious) Adverse Events |
||||||||||||
| q2 RCT, Responder | q4 RCT, Responder | Placebo in RCT, q2 in OLE | q2 RCT, Non-responder | q4 RCT Non-responder | Placebo in RCT, q4 in OLE | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 34/35 (97.1%) | 25/25 (100%) | 23/23 (100%) | 21/22 (95.5%) | 28/28 (100%) | 15/16 (93.8%) | ||||||
| Eye disorders | ||||||||||||
| Cataract | 2/35 (5.7%) | 3/25 (12%) | 1/23 (4.3%) | 0/22 (0%) | 2/28 (7.1%) | 0/16 (0%) | ||||||
| Gastrointestinal disorders | ||||||||||||
| Diarrhoea | 7/35 (20%) | 6/25 (24%) | 3/23 (13%) | 2/22 (9.1%) | 4/28 (14.3%) | 0/16 (0%) | ||||||
| Nausea | 3/35 (8.6%) | 5/25 (20%) | 2/23 (8.7%) | 2/22 (9.1%) | 5/28 (17.9%) | 0/16 (0%) | ||||||
| Vomiting | 3/35 (8.6%) | 3/25 (12%) | 1/23 (4.3%) | 2/22 (9.1%) | 3/28 (10.7%) | 0/16 (0%) | ||||||
| Constipation | 3/35 (8.6%) | 1/25 (4%) | 3/23 (13%) | 1/22 (4.5%) | 2/28 (7.1%) | 1/16 (6.3%) | ||||||
| Abdominal Pain | 2/35 (5.7%) | 2/25 (8%) | 2/23 (8.7%) | 0/22 (0%) | 1/28 (3.6%) | 0/16 (0%) | ||||||
| General disorders | ||||||||||||
| Infusion Related Reaction | 7/35 (20%) | 6/25 (24%) | 13/23 (56.5%) | 8/22 (36.4%) | 19/28 (67.9%) | 12/16 (75%) | ||||||
| Oedema Peripheral | 7/35 (20%) | 6/25 (24%) | 5/23 (21.7%) | 1/22 (4.5%) | 2/28 (7.1%) | 0/16 (0%) | ||||||
| Fatigue | 7/35 (20%) | 3/25 (12%) | 5/23 (21.7%) | 0/22 (0%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Chest Pain | 1/35 (2.9%) | 1/25 (4%) | 2/23 (8.7%) | 2/22 (9.1%) | 4/28 (14.3%) | 0/16 (0%) | ||||||
| Infections and infestations | ||||||||||||
| Upper Respiratory Tract Invection | 8/35 (22.9%) | 8/25 (32%) | 4/23 (17.4%) | 3/22 (13.6%) | 4/28 (14.3%) | 0/16 (0%) | ||||||
| Urinary Tract Infection | 7/35 (20%) | 5/25 (20%) | 2/23 (8.7%) | 2/22 (9.1%) | 4/28 (14.3%) | 0/16 (0%) | ||||||
| Nasopharyngitis | 3/35 (8.6%) | 5/25 (20%) | 1/23 (4.3%) | 1/22 (4.5%) | 4/28 (14.3%) | 1/16 (6.3%) | ||||||
| Sinusitits | 4/35 (11.4%) | 2/25 (8%) | 1/23 (4.3%) | 5/22 (22.7%) | 3/28 (10.7%) | 0/16 (0%) | ||||||
| Cellulitis | 2/35 (5.7%) | 1/25 (4%) | 2/23 (8.7%) | 3/22 (13.6%) | 3/28 (10.7%) | 1/16 (6.3%) | ||||||
| Bronchitis | 6/35 (17.1%) | 0/25 (0%) | 2/23 (8.7%) | 0/22 (0%) | 2/28 (7.1%) | 1/16 (6.3%) | ||||||
| Gastroenteritis Viral | 1/35 (2.9%) | 2/25 (8%) | 3/23 (13%) | 3/22 (13.6%) | 1/28 (3.6%) | 0/16 (0%) | ||||||
| Influenza | 0/35 (0%) | 3/25 (12%) | 1/23 (4.3%) | 3/22 (13.6%) | 2/28 (7.1%) | 1/16 (6.3%) | ||||||
| Localised Infection | 2/35 (5.7%) | 1/25 (4%) | 3/23 (13%) | 0/22 (0%) | 1/28 (3.6%) | 0/16 (0%) | ||||||
| Injury, poisoning and procedural complications | ||||||||||||
| Fall | 3/35 (8.6%) | 3/25 (12%) | 2/23 (8.7%) | 0/22 (0%) | 0/28 (0%) | 0/16 (0%) | ||||||
| Skin Laceration | 2/35 (5.7%) | 0/25 (0%) | 1/23 (4.3%) | 2/22 (9.1%) | 3/28 (10.7%) | 0/16 (0%) | ||||||
| Metabolism and nutrition disorders | ||||||||||||
| Diabetes Mellitus | 2/35 (5.7%) | 0/25 (0%) | 2/23 (8.7%) | 1/22 (4.5%) | 0/28 (0%) | 2/16 (12.5%) | ||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||
| Gout | 15/35 (42.9%) | 19/25 (76%) | 19/23 (82.6%) | 16/22 (72.7%) | 24/28 (85.7%) | 13/16 (81.3%) | ||||||
| Arthralgia | 7/35 (20%) | 7/25 (28%) | 6/23 (26.1%) | 1/22 (4.5%) | 8/28 (28.6%) | 0/16 (0%) | ||||||
| Pain in Extremity | 5/35 (14.3%) | 8/25 (32%) | 4/23 (17.4%) | 1/22 (4.5%) | 6/28 (21.4%) | 2/16 (12.5%) | ||||||
| Back Pain | 5/35 (14.3%) | 4/25 (16%) | 9/23 (39.1%) | 3/22 (13.6%) | 3/28 (10.7%) | 1/16 (6.3%) | ||||||
| Bursitis | 3/35 (8.6%) | 2/25 (8%) | 1/23 (4.3%) | 0/22 (0%) | 3/28 (10.7%) | 0/16 (0%) | ||||||
| Osteoarthritis | 2/35 (5.7%) | 4/25 (16%) | 1/23 (4.3%) | 0/22 (0%) | 2/28 (7.1%) | 0/16 (0%) | ||||||
| Musculoskeletal pain | 2/35 (5.7%) | 2/25 (8%) | 1/23 (4.3%) | 1/22 (4.5%) | 1/28 (3.6%) | 0/16 (0%) | ||||||
| Shoulder Pain | 2/35 (5.7%) | 2/25 (8%) | 1/23 (4.3%) | 1/22 (4.5%) | 1/28 (3.6%) | 0/16 (0%) | ||||||
| Tendonitis | 2/35 (5.7%) | 0/25 (0%) | 1/23 (4.3%) | 2/22 (9.1%) | 2/28 (7.1%) | 0/16 (0%) | ||||||
| Nervous system disorders | ||||||||||||
| Headache | 4/35 (11.4%) | 5/25 (20%) | 4/23 (17.4%) | 2/22 (9.1%) | 0/28 (0%) | 1/16 (6.3%) | ||||||
| Dizziness | 1/35 (2.9%) | 3/25 (12%) | 0/23 (0%) | 2/22 (9.1%) | 1/28 (3.6%) | 0/16 (0%) | ||||||
| Psychiatric disorders | ||||||||||||
| Depression | 1/35 (2.9%) | 1/25 (4%) | 1/23 (4.3%) | 1/22 (4.5%) | 2/28 (7.1%) | 2/16 (12.5%) | ||||||
| Renal and urinary disorders | ||||||||||||
| Haematuria | 2/35 (5.7%) | 1/25 (4%) | 1/23 (4.3%) | 1/22 (4.5%) | 2/28 (7.1%) | 0/16 (0%) | ||||||
| Nephrolithiasis | 0/35 (0%) | 1/25 (4%) | 1/23 (4.3%) | 1/22 (4.5%) | 3/28 (10.7%) | 1/16 (6.3%) | ||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| Cough | 8/35 (22.9%) | 2/25 (8%) | 3/23 (13%) | 0/22 (0%) | 0/28 (0%) | 1/16 (6.3%) | ||||||
| Dyspnoea | 1/35 (2.9%) | 2/25 (8%) | 1/23 (4.3%) | 1/22 (4.5%) | 1/28 (3.6%) | 1/16 (6.3%) | ||||||
| Skin and subcutaneous tissue disorders | ||||||||||||
| Rash | 2/35 (5.7%) | 4/25 (16%) | 2/23 (8.7%) | 1/22 (4.5%) | 1/28 (3.6%) | 1/16 (6.3%) | ||||||
| Pruritus | 1/35 (2.9%) | 3/25 (12%) | 2/23 (8.7%) | 1/22 (4.5%) | 1/28 (3.6%) | 0/16 (0%) | ||||||
| Vascular disorders | ||||||||||||
| Hypertension | 3/35 (8.6%) | 2/25 (8%) | 3/23 (13%) | 3/22 (13.6%) | 1/28 (3.6%) | 0/16 (0%) | ||||||
| Flushing | 1/35 (2.9%) | 3/25 (12%) | 1/23 (4.3%) | 2/22 (9.1%) | 1/28 (3.6%) | 0/16 (0%) | ||||||
| Hypotension | 1/35 (2.9%) | 2/25 (8%) | 1/23 (4.3%) | 0/22 (0%) | 3/28 (10.7%) | 0/16 (0%) | ||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Chief Medical Officer |
|---|---|
| Organization | Savient Pharmaceuticals, Inc. |
| Phone | 732-418-9300 |
Responsible Party:
Savient Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01356498
Other Study ID Numbers:
- C0407
First Posted:
May 19, 2011
Last Update Posted:
Dec 2, 2011
Last Verified:
Oct 1, 2011