Trial Outcomes & Findings for Open-Label Extension Study for Patients Who Completed a Phase 3 Double-blind Study of PEG-uricase for Symptomatic Gout (NCT NCT01356498)
NCT ID: NCT01356498
Last Updated: 2011-12-02
Results Overview
Uric acid measured at 3 month-intervals
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
151 participants
Primary outcome timeframe
Week 13, Week 25, Week 53, Week 101
Results posted on
2011-12-02
Participant Flow
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.
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.
Participant milestones
| Measure |
q2 RCT, Responder
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
|
q4 RCT, Responder
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 in RCT, q2 in OLE
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
|
q2 RCT, Non-responder
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
|
q4 RCT Non-responder
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 in RCT, q4 in OLE
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
35
|
25
|
23
|
22
|
28
|
16
|
|
Overall Study
COMPLETED
|
24
|
17
|
11
|
8
|
8
|
2
|
|
Overall Study
NOT COMPLETED
|
11
|
8
|
12
|
14
|
20
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Open-Label Extension Study for Patients Who Completed a Phase 3 Double-blind Study of PEG-uricase for Symptomatic Gout
Baseline characteristics by cohort
| Measure |
q2 RCT, Responder
n=35 Participants
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
|
q4 RCT, Responder
n=25 Participants
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 in RCT, q2 in OLE
n=23 Participants
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
|
q2 RCT, Non-responder
n=22 Participants
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
|
q4 RCT Non-responder
n=28 Participants
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 in RCT, q4 in OLE
n=16 Participants
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
|
Total
n=149 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
105 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
44 Participants
n=8 Participants
|
|
Age Continuous
|
62.4 years
STANDARD_DEVIATION 13.66 • n=5 Participants
|
58.6 years
STANDARD_DEVIATION 13.59 • n=7 Participants
|
56.6 years
STANDARD_DEVIATION 10.53 • n=5 Participants
|
52.0 years
STANDARD_DEVIATION 13.12 • n=4 Participants
|
53.5 years
STANDARD_DEVIATION 12.25 • n=21 Participants
|
54.6 years
STANDARD_DEVIATION 13.62 • n=8 Participants
|
56.8 years
STANDARD_DEVIATION 13.19 • n=8 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
32 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
117 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
22 participants
n=7 Participants
|
22 participants
n=5 Participants
|
17 participants
n=4 Participants
|
27 participants
n=21 Participants
|
13 participants
n=8 Participants
|
133 participants
n=8 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
2 participants
n=8 Participants
|
|
Region of Enrollment
Mexico
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
5 participants
n=4 Participants
|
1 participants
n=21 Participants
|
3 participants
n=8 Participants
|
14 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Week 13, Week 25, Week 53, Week 101Population: ITT
Uric acid measured at 3 month-intervals
Outcome measures
| Measure |
q2 RCT, Responder
n=31 Participants
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
|
q4 RCT, Responder
n=24 Participants
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 in RCT, q2 in OLE
n=18 Participants
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
|
q2 RCT, Non-responder
n=17 Participants
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
|
q4 RCT Non-responder
n=22 Participants
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 in RCT, q4 in OLE
n=10 Participants
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
|
|---|---|---|---|---|---|---|
|
Uric Acid (mg/dL)
OLE Week 13
|
1.33 mg/dL
Standard Deviation 3.103
|
1.91 mg/dL
Standard Deviation 4.082
|
5.06 mg/dL
Standard Deviation 4.538
|
9.76 mg/dL
Standard Deviation 1.346
|
9.66 mg/dL
Standard Deviation 2.529
|
8.08 mg/dL
Standard Deviation 3.561
|
|
Uric Acid (mg/dL)
OLE Week 25
|
1.4 mg/dL
Standard Deviation 3.196
|
1.95 mg/dL
Standard Deviation 3.761
|
4.69 mg/dL
Standard Deviation 4.454
|
8.89 mg/dL
Standard Deviation 3.984
|
9.94 mg/dL
Standard Deviation 2.646
|
8.09 mg/dL
Standard Deviation 3.536
|
|
Uric Acid (mg/dL)
OLE Week 53
|
0.87 mg/dL
Standard Deviation 2.327
|
1.55 mg/dL
Standard Deviation 3.690
|
2.7 mg/dL
Standard Deviation 4.255
|
9.18 mg/dL
Standard Deviation 2.946
|
9.59 mg/dL
Standard Deviation 2.782
|
6.45 mg/dL
Standard Deviation 3.248
|
|
Uric Acid (mg/dL)
OLE Week 101
|
0.84 mg/dL
Standard Deviation 2.619
|
1.47 mg/dL
Standard Deviation 3.317
|
4.29 mg/dL
Standard Deviation 3.985
|
7.7 mg/dL
Standard Deviation 4.244
|
9.42 mg/dL
Standard Deviation 1.961
|
8.5 mg/dL
Standard Deviation NA
One subject only
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: ITT, Last observation(on drug) carried forward showing patients with an Overall Tophus Response of Complete or Partial Response.
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.
Outcome measures
| Measure |
q2 RCT, Responder
n=23 Participants
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
|
q4 RCT, Responder
n=14 Participants
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 in RCT, q2 in OLE
n=16 Participants
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
|
q2 RCT, Non-responder
n=16 Participants
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
|
q4 RCT Non-responder
n=20 Participants
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 in RCT, q4 in OLE
n=5 Participants
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
|
|---|---|---|---|---|---|---|
|
Tophus Response
Partial Response
|
4 participants
|
0 participants
|
3 participants
|
4 participants
|
2 participants
|
1 participants
|
|
Tophus Response
Complete Response
|
19 participants
|
13 participants
|
10 participants
|
4 participants
|
7 participants
|
3 participants
|
SECONDARY outcome
Timeframe: RCT Week 25; OLE Week 25; OLE Week 53, OLE Week 77, OLE Week 101Population: Number of participants was the subset of the ITT population with SF-36 baseline data
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.
Outcome measures
| Measure |
q2 RCT, Responder
n=34 Participants
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
|
q4 RCT, Responder
n=25 Participants
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 in RCT, q2 in OLE
n=23 Participants
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
|
q2 RCT, Non-responder
n=19 Participants
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
|
q4 RCT Non-responder
n=26 Participants
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 in RCT, q4 in OLE
n=15 Participants
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
|
|---|---|---|---|---|---|---|
|
Patient Reported Outcome: SF-36 Physical Component Summary Score
Baseline value (pre-pegloticase)
|
34.92 units on a scale
Standard Deviation 10.988
|
34.11 units on a scale
Standard Deviation 10.022
|
27.55 units on a scale
Standard Deviation 11.405
|
33.71 units on a scale
Standard Deviation 11.581
|
32.8 units on a scale
Standard Deviation 10.129
|
36.2 units on a scale
Standard Deviation 11.926
|
|
Patient Reported Outcome: SF-36 Physical Component Summary Score
Final Visit value (LOCF)
|
40.40 units on a scale
Standard Deviation 13.393
|
40.82 units on a scale
Standard Deviation 7.482
|
30.34 units on a scale
Standard Deviation 11.132
|
37.68 units on a scale
Standard Deviation 10.298
|
34.76 units on a scale
Standard Deviation 11.413
|
38.8 units on a scale
Standard Deviation 13.155
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Analysis is based on ITT population, and is presented by intervals of time on pegloticase
The the mean number of flares per subject (flare frequency)was assessed over 3-month periods for up to 2 years of treatment
Outcome measures
| Measure |
q2 RCT, Responder
n=35 Participants
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
|
q4 RCT, Responder
n=25 Participants
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 in RCT, q2 in OLE
n=23 Participants
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
|
q2 RCT, Non-responder
n=22 Participants
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
|
q4 RCT Non-responder
n=28 Participants
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 in RCT, q4 in OLE
n=16 Participants
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
|
|---|---|---|---|---|---|---|
|
Gout Flare Frequency
Months 1-3
|
0.4 Flares
Standard Deviation 0.69
|
0.8 Flares
Standard Deviation 0.90
|
2.3 Flares
Standard Deviation 2.91
|
0.6 Flares
Standard Deviation 0.90
|
1.3 Flares
Standard Deviation 1.49
|
1.5 Flares
Standard Deviation 1.41
|
|
Gout Flare Frequency
Months 4-6
|
0.4 Flares
Standard Deviation 0.96
|
0.7 Flares
Standard Deviation 0.95
|
1.3 Flares
Standard Deviation 2.17
|
1.0 Flares
Standard Deviation 1.73
|
0.8 Flares
Standard Deviation 0.94
|
0.8 Flares
Standard Deviation 1.18
|
|
Gout Flare Frequency
Months 7-9
|
0.0 Flares
Standard Deviation 0.17
|
0.3 Flares
Standard Deviation 0.54
|
1.2 Flares
Standard Deviation 1.80
|
0.6 Flares
Standard Deviation 1.20
|
0.6 Flares
Standard Deviation 0.97
|
0.4 Flares
Standard Deviation 1.01
|
|
Gout Flare Frequency
Months 10-12
|
0.1 Flares
Standard Deviation 0.30
|
0.2 Flares
Standard Deviation 0.51
|
0.6 Flares
Standard Deviation 1.18
|
0.9 Flares
Standard Deviation 1.34
|
0.9 Flares
Standard Deviation 1.46
|
0.4 Flares
Standard Deviation 0.63
|
|
Gout Flare Frequency
Months 16-18
|
0.1 Flares
Standard Deviation 0.25
|
.3 Flares
Standard Deviation 0.44
|
0.2 Flares
Standard Deviation 0.40
|
0.7 Flares
Standard Deviation 1.18
|
0.6 Flares
Standard Deviation 0.85
|
0.4 Flares
Standard Deviation 0.89
|
|
Gout Flare Frequency
Months 22-24
|
0.1 Flares
Standard Deviation 0.37
|
0.1 Flares
Standard Deviation 0.23
|
0.4 Flares
Standard Deviation 0.67
|
0.3 Flares
Standard Deviation 0.65
|
0.6 Flares
Standard Deviation 0.53
|
0.7 Flares
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: Assessed in 3-month intervals up to 2 yearsPopulation: The flare incidence is reported as the percentage of participants reporting flares during each 3-month interval.
Percentage of participants remaining in the study during the specified interval who experienced a gout flare during this interval.
Outcome measures
| Measure |
q2 RCT, Responder
n=35 Participants
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
|
q4 RCT, Responder
n=25 Participants
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 in RCT, q2 in OLE
n=23 Participants
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
|
q2 RCT, Non-responder
n=22 Participants
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
|
q4 RCT Non-responder
n=28 Participants
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 in RCT, q4 in OLE
n=16 Participants
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
|
|---|---|---|---|---|---|---|
|
Gout Flare Incidence
Months 7-9
|
3.0 Percentage of participants
|
24.0 Percentage of participants
|
43.8 Percentage of participants
|
27.8 Percentage of participants
|
42.9 Percentage of participants
|
22.2 Percentage of participants
|
|
Gout Flare Incidence
Months 22-24
|
3.4 Percentage of participants
|
5.3 Percentage of participants
|
27.3 Percentage of participants
|
25.0 Percentage of participants
|
55.6 Percentage of participants
|
33.3 Percentage of participants
|
|
Gout Flare Incidence
Months 1-3
|
25.7 Percentage of participants
|
56.0 Percentage of participants
|
65.2 Percentage of participants
|
45.5 Percentage of participants
|
67.9 Percentage of participants
|
68.8 Percentage of participants
|
|
Gout Flare Incidence
Months 4-6
|
23.5 Percentage of participants
|
40.0 Percentage of participants
|
45.0 Percentage of participants
|
35.0 Percentage of participants
|
50.0 Percentage of participants
|
38.5 Percentage of participants
|
|
Gout Flare Incidence
Months 10-12
|
9.4 Percentage of participants
|
16.7 Percentage of participants
|
28.6 Percentage of participants
|
47.1 Percentage of participants
|
45.0 Percentage of participants
|
28.6 Percentage of participants
|
|
Gout Flare Incidence
Months 16-18
|
6.5 Percentage of participants
|
25.0 Percentage of participants
|
18.2 Percentage of participants
|
33.3 Percentage of participants
|
38.9 Percentage of participants
|
20.0 Percentage of participants
|
Adverse Events
q2 RCT, Responder
Serious events: 9 serious events
Other events: 34 other events
Deaths: 0 deaths
q4 RCT, Responder
Serious events: 7 serious events
Other events: 25 other events
Deaths: 0 deaths
Placebo in RCT, q2 in OLE
Serious events: 8 serious events
Other events: 23 other events
Deaths: 0 deaths
q2 RCT, Non-responder
Serious events: 7 serious events
Other events: 21 other events
Deaths: 0 deaths
q4 RCT Non-responder
Serious events: 12 serious events
Other events: 28 other events
Deaths: 0 deaths
Placebo in RCT, q4 in OLE
Serious events: 8 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
q2 RCT, Responder
n=35 participants at risk
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
|
q4 RCT, Responder
n=25 participants at risk
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 in RCT, q2 in OLE
n=23 participants at risk
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
|
q2 RCT, Non-responder
n=22 participants at risk
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
|
q4 RCT Non-responder
n=28 participants at risk
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 in RCT, q4 in OLE
n=16 participants at risk
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
|
|---|---|---|---|---|---|---|
|
General disorders
Infusion related reaction
|
2.9%
1/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
17.4%
4/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.5%
1/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
10.7%
3/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
18.8%
3/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
General disorders
Chest pain
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.0%
1/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
7.1%
2/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
General disorders
Asthenia
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
3.6%
1/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.3%
1/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.5%
1/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
3.6%
1/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
6.2%
1/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Injury, poisoning and procedural complications
Arthritis Bacterial
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.5%
1/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
3.6%
1/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
3.6%
1/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.3%
1/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Infections and infestations
Sepsis
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
3.6%
1/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Infections and infestations
Staphylococcal Infection
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
3.6%
1/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Infections and infestations
Urinary Tract Infection Bacterial
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
3.6%
1/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.5%
1/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.0%
1/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
6.2%
1/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Musculoskeletal and connective tissue disorders
Gout
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.5%
1/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Musculoskeletal and connective tissue disorders
Gouty Arthritis
|
2.9%
1/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.0%
1/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.0%
1/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.5%
1/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
6.2%
1/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.0%
1/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.5%
1/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.5%
1/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Renal and urinary disorders
Renal Failure Acute
|
2.9%
1/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.5%
1/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
3.6%
1/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
6.2%
1/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.0%
1/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
3.6%
1/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Renal and urinary disorders
Renal Failure Chronic
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.3%
1/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
3.6%
1/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Renal and urinary disorders
Azotemia
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.3%
1/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
3.6%
1/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.0%
1/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
8.7%
2/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.0%
1/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.3%
1/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Gastrointestinal disorders
Constipation
|
2.9%
1/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Gastrointestinal disorders
Diverticular Performation
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.5%
1/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.3%
1/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
3.6%
1/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
8.7%
2/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
3.6%
1/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Vascular disorders
Femoral Artery Occlusion
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.0%
1/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Vascular disorders
Hypertension
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.0%
1/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Vascular disorders
Hypotension
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
3.6%
1/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
2.9%
1/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.3%
1/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
3.6%
1/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.0%
1/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.5%
1/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.3%
1/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
3.6%
1/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.0%
1/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
3.6%
1/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Injury, poisoning and procedural complications
Intentional Overdose
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.5%
1/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
3.6%
1/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Nervous system disorders
Hepatic Encephalopathy
|
2.9%
1/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Nervous system disorders
Lumbar Radiculopathy
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
6.2%
1/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Nervous system disorders
Syncope
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.0%
1/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
5.7%
2/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
2.9%
1/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Septum Deviation
|
2.9%
1/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.9%
1/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.5%
1/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Metabolism and nutrition disorders
Fluid Overload
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.0%
1/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.9%
1/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.0%
1/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
3.6%
1/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Psychiatric disorders
Depression
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.5%
1/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Psychiatric disorders
Stress
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
3.6%
1/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.5%
1/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Endocrine disorders
Goitre
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.0%
1/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Eye disorders
Glaucoma
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
6.2%
1/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloproliferative Disorder
|
2.9%
1/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.0%
1/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Skin and subcutaneous tissue disorders
Skin Necrosis
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.0%
1/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Surgical and medical procedures
Inguinal Hernia Repair
|
2.9%
1/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
Other adverse events
| Measure |
q2 RCT, Responder
n=35 participants at risk
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
|
q4 RCT, Responder
n=25 participants at risk
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 in RCT, q2 in OLE
n=23 participants at risk
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
|
q2 RCT, Non-responder
n=22 participants at risk
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
|
q4 RCT Non-responder
n=28 participants at risk
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 in RCT, q4 in OLE
n=16 participants at risk
Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
|
|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Gout
|
42.9%
15/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
76.0%
19/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
82.6%
19/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
72.7%
16/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
85.7%
24/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
81.2%
13/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
7/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
28.0%
7/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
26.1%
6/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.5%
1/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
28.6%
8/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
14.3%
5/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
32.0%
8/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
17.4%
4/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.5%
1/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
21.4%
6/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
12.5%
2/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
14.3%
5/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
16.0%
4/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
39.1%
9/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
13.6%
3/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
10.7%
3/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
6.2%
1/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
8.6%
3/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
8.0%
2/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.3%
1/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
10.7%
3/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
5.7%
2/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
16.0%
4/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.3%
1/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
7.1%
2/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.7%
2/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
8.0%
2/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.3%
1/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.5%
1/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
3.6%
1/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain
|
5.7%
2/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
8.0%
2/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.3%
1/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.5%
1/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
3.6%
1/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
5.7%
2/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.3%
1/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
9.1%
2/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
7.1%
2/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Infections and infestations
Upper Respiratory Tract Invection
|
22.9%
8/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
32.0%
8/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
17.4%
4/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
13.6%
3/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
14.3%
4/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Infections and infestations
Urinary Tract Infection
|
20.0%
7/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
20.0%
5/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
8.7%
2/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
9.1%
2/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
14.3%
4/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Infections and infestations
Nasopharyngitis
|
8.6%
3/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
20.0%
5/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.3%
1/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.5%
1/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
14.3%
4/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
6.2%
1/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Infections and infestations
Sinusitits
|
11.4%
4/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
8.0%
2/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.3%
1/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
22.7%
5/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
10.7%
3/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Infections and infestations
Cellulitis
|
5.7%
2/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.0%
1/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
8.7%
2/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
13.6%
3/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
10.7%
3/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
6.2%
1/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Infections and infestations
Bronchitis
|
17.1%
6/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
8.7%
2/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
7.1%
2/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
6.2%
1/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Infections and infestations
Gastroenteritis Viral
|
2.9%
1/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
8.0%
2/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
13.0%
3/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
13.6%
3/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
3.6%
1/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Infections and infestations
Influenza
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
12.0%
3/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.3%
1/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
13.6%
3/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
7.1%
2/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
6.2%
1/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Infections and infestations
Localised Infection
|
5.7%
2/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.0%
1/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
13.0%
3/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
3.6%
1/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
General disorders
Infusion Related Reaction
|
20.0%
7/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
24.0%
6/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
56.5%
13/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
36.4%
8/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
67.9%
19/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
75.0%
12/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
General disorders
Oedema Peripheral
|
20.0%
7/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
24.0%
6/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
21.7%
5/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.5%
1/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
7.1%
2/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
General disorders
Fatigue
|
20.0%
7/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
12.0%
3/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
21.7%
5/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
General disorders
Chest Pain
|
2.9%
1/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.0%
1/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
8.7%
2/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
9.1%
2/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
14.3%
4/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
7/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
24.0%
6/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
13.0%
3/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
9.1%
2/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
14.3%
4/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Gastrointestinal disorders
Nausea
|
8.6%
3/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
20.0%
5/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
8.7%
2/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
9.1%
2/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
17.9%
5/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Gastrointestinal disorders
Vomiting
|
8.6%
3/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
12.0%
3/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.3%
1/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
9.1%
2/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
10.7%
3/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Gastrointestinal disorders
Constipation
|
8.6%
3/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.0%
1/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
13.0%
3/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.5%
1/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
7.1%
2/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
6.2%
1/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.7%
2/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
8.0%
2/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
8.7%
2/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
3.6%
1/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.7%
2/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
16.0%
4/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
8.7%
2/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.5%
1/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
3.6%
1/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
6.2%
1/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.9%
1/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
12.0%
3/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
8.7%
2/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.5%
1/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
3.6%
1/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Injury, poisoning and procedural complications
Fall
|
8.6%
3/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
12.0%
3/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
8.7%
2/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
5.7%
2/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.3%
1/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
9.1%
2/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
10.7%
3/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.9%
8/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
8.0%
2/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
13.0%
3/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
6.2%
1/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.9%
1/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
8.0%
2/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.3%
1/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.5%
1/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
3.6%
1/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
6.2%
1/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Nervous system disorders
Headache
|
11.4%
4/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
20.0%
5/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
17.4%
4/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
9.1%
2/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
6.2%
1/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Nervous system disorders
Dizziness
|
2.9%
1/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
12.0%
3/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
9.1%
2/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
3.6%
1/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Vascular disorders
Hypertension
|
8.6%
3/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
8.0%
2/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
13.0%
3/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
13.6%
3/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
3.6%
1/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Vascular disorders
Flushing
|
2.9%
1/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
12.0%
3/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.3%
1/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
9.1%
2/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
3.6%
1/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Vascular disorders
Hypotension
|
2.9%
1/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
8.0%
2/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.3%
1/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
10.7%
3/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Eye disorders
Cataract
|
5.7%
2/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
12.0%
3/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.3%
1/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
7.1%
2/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
5.7%
2/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
8.7%
2/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.5%
1/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
12.5%
2/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Renal and urinary disorders
Haematuria
|
5.7%
2/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.0%
1/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.3%
1/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.5%
1/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
7.1%
2/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
0.00%
0/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.0%
1/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.3%
1/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.5%
1/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
10.7%
3/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
6.2%
1/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
|
Psychiatric disorders
Depression
|
2.9%
1/35 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.0%
1/25 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.3%
1/23 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
4.5%
1/22 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
7.1%
2/28 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
12.5%
2/16 • Up to 30 days post-treatment (maximum of 32 months)
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.
|
Additional Information
Chief Medical Officer
Savient Pharmaceuticals, Inc.
Phone: 732-418-9300
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60