Trial Outcomes & Findings for A Study to Evaluate Efficacy of Dotinurad and Febuxostat for the Treatment of Participants With Gout (NCT NCT05007392)
NCT ID: NCT05007392
Last Updated: 2025-07-30
Results Overview
Percentage of participants with SUA level less than or equal to (\<=) 6.0 milligrams per deciliter (mg/dL) at Week 24 was reported. In case the SUA level was missing, this data was compensated by the last observation carried forward (LOCF) method.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
451 participants
Primary outcome timeframe
At Week 24
Results posted on
2025-07-30
Participant Flow
Participants took part in the study at 30 investigative sites in China from 21 December 2021 to 14 June 2023.
A total of 604 participants were screened, of which 153 were screen failure. 451 participants were enrolled and randomized and 448 received study treatment.
Participant milestones
| Measure |
Febuxostat
Participants received febuxostat 20 milligrams (mg) tablet, orally, once daily for first 4 weeks; followed febuxostat 40 mg tablet, orally, once daily for 20 weeks. To maintain blinding, participants also received the dotinurad matching placebo up to Week 24.
|
Dotinurad
Participants received dotinurad 1 mg tablet, orally, once daily for first 4 weeks; followed by dotinurad 2 mg tablet, orally, once daily for 8 weeks; further followed by dotinurad 4 mg tablet, orally, once daily for 12 weeks. To maintain blinding, participants also received the febuxostat matching placebo up to Week 24.
|
|---|---|---|
|
Overall Study
STARTED
|
226
|
225
|
|
Overall Study
Safety Analysis Set
|
225
|
223
|
|
Overall Study
Full Analysis Set
|
220
|
221
|
|
Overall Study
COMPLETED
|
197
|
195
|
|
Overall Study
NOT COMPLETED
|
29
|
30
|
Reasons for withdrawal
| Measure |
Febuxostat
Participants received febuxostat 20 milligrams (mg) tablet, orally, once daily for first 4 weeks; followed febuxostat 40 mg tablet, orally, once daily for 20 weeks. To maintain blinding, participants also received the dotinurad matching placebo up to Week 24.
|
Dotinurad
Participants received dotinurad 1 mg tablet, orally, once daily for first 4 weeks; followed by dotinurad 2 mg tablet, orally, once daily for 8 weeks; further followed by dotinurad 4 mg tablet, orally, once daily for 12 weeks. To maintain blinding, participants also received the febuxostat matching placebo up to Week 24.
|
|---|---|---|
|
Overall Study
Randomized but not treated
|
1
|
2
|
|
Overall Study
Other
|
5
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Serum uric acid (SUA) level of <=2.0 milligram per deciliter (mg/dL) for 2 consecutive visits
|
0
|
1
|
|
Overall Study
Use of prohibited concomitant drug
|
1
|
1
|
|
Overall Study
Inadequate therapeutic effect or progression of disease
|
1
|
0
|
|
Overall Study
Adverse Event
|
10
|
6
|
|
Overall Study
Participant choice
|
5
|
10
|
|
Overall Study
Withdrawal of consent
|
5
|
4
|
Baseline Characteristics
A Study to Evaluate Efficacy of Dotinurad and Febuxostat for the Treatment of Participants With Gout
Baseline characteristics by cohort
| Measure |
Febuxostat
n=220 Participants
Participants received febuxostat 20 mg tablet, orally, once daily for first 4 weeks; followed febuxostat 40 mg tablet, orally, once daily for 20 weeks. To maintain blinding, participants also received the dotinurad matching placebo up to Week 24.
|
Dotinurad
n=221 Participants
Participants received dotinurad 1 mg tablet, orally, once daily for first 4 weeks; followed by dotinurad 2 mg tablet, orally, once daily for 8 weeks; further followed by dotinurad 4 mg tablet, orally, once daily for 12 weeks. To maintain blinding, participants also received the febuxostat matching placebo up to Week 24.
|
Total
n=441 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.2 years
STANDARD_DEVIATION 10.98 • n=99 Participants
|
38.9 years
STANDARD_DEVIATION 11.56 • n=107 Participants
|
39.1 years
STANDARD_DEVIATION 11.26 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
215 Participants
n=99 Participants
|
218 Participants
n=107 Participants
|
433 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
220 Participants
n=99 Participants
|
221 Participants
n=107 Participants
|
441 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
220 Participants
n=99 Participants
|
221 Participants
n=107 Participants
|
441 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: At Week 24Population: Full Analysis Set was the group of randomized participants who received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Percentage of participants with SUA level less than or equal to (\<=) 6.0 milligrams per deciliter (mg/dL) at Week 24 was reported. In case the SUA level was missing, this data was compensated by the last observation carried forward (LOCF) method.
Outcome measures
| Measure |
Febuxostat
n=218 Participants
Participants received febuxostat 20 mg tablet, orally, once daily for first 4 weeks; followed febuxostat 40 mg tablet, orally, once daily for 20 weeks. To maintain blinding, participants also received the dotinurad matching placebo up to Week 24.
|
Dotinurad
n=220 Participants
Participants received dotinurad 1 mg tablet, orally, once daily for first 4 weeks; followed by dotinurad 2 mg tablet, orally, once daily for 8 weeks; further followed by dotinurad 4 mg tablet, orally, once daily for 12 weeks. To maintain blinding, participants also received the febuxostat matching placebo up to Week 24.
|
|---|---|---|
|
Percentage of Participants With Serum Uric Acid (SUA) Level <=6.0 mg/dL at Week 24 (LOCF)
|
38.1 percentage of participants
Interval 31.6 to 44.5
|
73.6 percentage of participants
Interval 67.8 to 79.5
|
SECONDARY outcome
Timeframe: At Week 12Population: Full Analysis Set was the group of randomized participants who received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Percentage of participants with SUA level \<=6.0 mg/dL at Week 12 was reported. In case the SUA level was missing, this data was compensated by the LOCF method.
Outcome measures
| Measure |
Febuxostat
n=216 Participants
Participants received febuxostat 20 mg tablet, orally, once daily for first 4 weeks; followed febuxostat 40 mg tablet, orally, once daily for 20 weeks. To maintain blinding, participants also received the dotinurad matching placebo up to Week 24.
|
Dotinurad
n=220 Participants
Participants received dotinurad 1 mg tablet, orally, once daily for first 4 weeks; followed by dotinurad 2 mg tablet, orally, once daily for 8 weeks; further followed by dotinurad 4 mg tablet, orally, once daily for 12 weeks. To maintain blinding, participants also received the febuxostat matching placebo up to Week 24.
|
|---|---|---|
|
Percentage of Participants With SUA Level <=6.0 mg/dL at Week 12 (LOCF)
|
50.5 percentage of participants
Interval 43.8 to 57.1
|
55.5 percentage of participants
Interval 48.9 to 62.0
|
SECONDARY outcome
Timeframe: At Weeks 4, 8, 12, 16, 20 and 24Population: Full Analysis Set was the group of randomized participants who received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at specified timepoints.
Percentage of participants with SUA level \<=6.0 mg/dL at Weeks 4, 8, 12, 16, 20 and 24 was reported. Data was reported for observed participants at specified visits.
Outcome measures
| Measure |
Febuxostat
n=198 Participants
Participants received febuxostat 20 mg tablet, orally, once daily for first 4 weeks; followed febuxostat 40 mg tablet, orally, once daily for 20 weeks. To maintain blinding, participants also received the dotinurad matching placebo up to Week 24.
|
Dotinurad
n=202 Participants
Participants received dotinurad 1 mg tablet, orally, once daily for first 4 weeks; followed by dotinurad 2 mg tablet, orally, once daily for 8 weeks; further followed by dotinurad 4 mg tablet, orally, once daily for 12 weeks. To maintain blinding, participants also received the febuxostat matching placebo up to Week 24.
|
|---|---|---|
|
Percentage of Participants With SUA Level <=6.0 mg/dL at Weeks 4, 8, 12, 16, 20 and 24
Week 4
|
26.3 percentage of participants
|
27.6 percentage of participants
|
|
Percentage of Participants With SUA Level <=6.0 mg/dL at Weeks 4, 8, 12, 16, 20 and 24
Week 8
|
55.6 percentage of participants
|
62.7 percentage of participants
|
|
Percentage of Participants With SUA Level <=6.0 mg/dL at Weeks 4, 8, 12, 16, 20 and 24
Wee 12
|
52.8 percentage of participants
|
56.9 percentage of participants
|
|
Percentage of Participants With SUA Level <=6.0 mg/dL at Weeks 4, 8, 12, 16, 20 and 24
Week 16
|
48.7 percentage of participants
|
84.7 percentage of participants
|
|
Percentage of Participants With SUA Level <=6.0 mg/dL at Weeks 4, 8, 12, 16, 20 and 24
Week 20
|
53.7 percentage of participants
|
83.0 percentage of participants
|
|
Percentage of Participants With SUA Level <=6.0 mg/dL at Weeks 4, 8, 12, 16, 20 and 24
Week 24
|
40.2 percentage of participants
|
78.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20 and 24Population: Full Analysis Set was the group of randomized participants who received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at specified timepoints.
Mean percent reduction from baseline in SUA level at Weeks 4, 8, 12, 16, 20 and 24 was reported.
Outcome measures
| Measure |
Febuxostat
n=198 Participants
Participants received febuxostat 20 mg tablet, orally, once daily for first 4 weeks; followed febuxostat 40 mg tablet, orally, once daily for 20 weeks. To maintain blinding, participants also received the dotinurad matching placebo up to Week 24.
|
Dotinurad
n=202 Participants
Participants received dotinurad 1 mg tablet, orally, once daily for first 4 weeks; followed by dotinurad 2 mg tablet, orally, once daily for 8 weeks; further followed by dotinurad 4 mg tablet, orally, once daily for 12 weeks. To maintain blinding, participants also received the febuxostat matching placebo up to Week 24.
|
|---|---|---|
|
Mean Percent Reduction From Baseline in SUA Level at Weeks 4, 8, 12, 16, 20 and 24
Percent Reduction from Baseline at Week 4
|
26.43 Percent change in SUA level
Standard Deviation 13.200
|
27.43 Percent change in SUA level
Standard Deviation 14.754
|
|
Mean Percent Reduction From Baseline in SUA Level at Weeks 4, 8, 12, 16, 20 and 24
Percent Reduction from Baseline at Week 8
|
37.06 Percent change in SUA level
Standard Deviation 14.018
|
39.10 Percent change in SUA level
Standard Deviation 18.931
|
|
Mean Percent Reduction From Baseline in SUA Level at Weeks 4, 8, 12, 16, 20 and 24
Percent Reduction from Baseline at Week 12
|
36.06 Percent change in SUA level
Standard Deviation 15.383
|
38.62 Percent change in SUA level
Standard Deviation 17.305
|
|
Mean Percent Reduction From Baseline in SUA Level at Weeks 4, 8, 12, 16, 20 and 24
Percent Reduction from Baseline at Week 16
|
35.13 Percent change in SUA level
Standard Deviation 16.016
|
51.47 Percent change in SUA level
Standard Deviation 18.542
|
|
Mean Percent Reduction From Baseline in SUA Level at Weeks 4, 8, 12, 16, 20 and 24
Percent Reduction from Baseline at Week 20
|
35.71 Percent change in SUA level
Standard Deviation 15.728
|
50.22 Percent change in SUA level
Standard Deviation 20.714
|
|
Mean Percent Reduction From Baseline in SUA Level at Weeks 4, 8, 12, 16, 20 and 24
Percent Reduction from Baseline at Week 24
|
32.28 Percent change in SUA level
Standard Deviation 16.907
|
48.07 Percent change in SUA level
Standard Deviation 23.243
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20 and 24Population: Full Analysis Set was the group of randomized participants who received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at specified timepoints.
Mean change from baseline in SUA level at Weeks 4, 8, 12, 16, 20 and 24 was reported.
Outcome measures
| Measure |
Febuxostat
n=198 Participants
Participants received febuxostat 20 mg tablet, orally, once daily for first 4 weeks; followed febuxostat 40 mg tablet, orally, once daily for 20 weeks. To maintain blinding, participants also received the dotinurad matching placebo up to Week 24.
|
Dotinurad
n=202 Participants
Participants received dotinurad 1 mg tablet, orally, once daily for first 4 weeks; followed by dotinurad 2 mg tablet, orally, once daily for 8 weeks; further followed by dotinurad 4 mg tablet, orally, once daily for 12 weeks. To maintain blinding, participants also received the febuxostat matching placebo up to Week 24.
|
|---|---|---|
|
Mean Change From Baseline in SUA Level at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 4
|
-2.60 mg/dL
Standard Deviation 1.457
|
-2.70 mg/dL
Standard Deviation 1.508
|
|
Mean Change From Baseline in SUA Level at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 8
|
-3.62 mg/dL
Standard Deviation 1.597
|
-3.80 mg/dL
Standard Deviation 1.973
|
|
Mean Change From Baseline in SUA Level at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 12
|
-3.52 mg/dL
Standard Deviation 1.691
|
-3.78 mg/dL
Standard Deviation 1.817
|
|
Mean Change From Baseline in SUA Level at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 16
|
-3.44 mg/dL
Standard Deviation 1.731
|
-5.05 mg/dL
Standard Deviation 2.078
|
|
Mean Change From Baseline in SUA Level at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 20
|
-3.52 mg/dL
Standard Deviation 1.757
|
-4.92 mg/dL
Standard Deviation 2.201
|
|
Mean Change From Baseline in SUA Level at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 24
|
-3.20 mg/dL
Standard Deviation 1.800
|
-4.71 mg/dL
Standard Deviation 2.415
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20 and 24Population: Full Analysis Set was the group of randomized participants who received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. Here, "number analyzed" signifies those participants who were evaluable at specified timepoints.
Mean SUA level at Baseline, Weeks 4, 8, 12, 16, 20 and 24 was reported.
Outcome measures
| Measure |
Febuxostat
n=220 Participants
Participants received febuxostat 20 mg tablet, orally, once daily for first 4 weeks; followed febuxostat 40 mg tablet, orally, once daily for 20 weeks. To maintain blinding, participants also received the dotinurad matching placebo up to Week 24.
|
Dotinurad
n=221 Participants
Participants received dotinurad 1 mg tablet, orally, once daily for first 4 weeks; followed by dotinurad 2 mg tablet, orally, once daily for 8 weeks; further followed by dotinurad 4 mg tablet, orally, once daily for 12 weeks. To maintain blinding, participants also received the febuxostat matching placebo up to Week 24.
|
|---|---|---|
|
Mean SUA Level at Baseline, Weeks 4, 8, 12, 16, 20 and 24
Week 16
|
6.24 mg/dL
Standard Deviation 1.605
|
4.65 mg/dL
Standard Deviation 1.776
|
|
Mean SUA Level at Baseline, Weeks 4, 8, 12, 16, 20 and 24
Baseline
|
9.65 mg/dL
Standard Deviation 1.426
|
9.67 mg/dL
Standard Deviation 1.451
|
|
Mean SUA Level at Baseline, Weeks 4, 8, 12, 16, 20 and 24
Week 4
|
7.07 mg/dL
Standard Deviation 1.432
|
6.93 mg/dL
Standard Deviation 1.447
|
|
Mean SUA Level at Baseline, Weeks 4, 8, 12, 16, 20 and 24
Week 8
|
6.01 mg/dL
Standard Deviation 1.372
|
5.80 mg/dL
Standard Deviation 1.857
|
|
Mean SUA Level at Baseline, Weeks 4, 8, 12, 16, 20 and 24
Week 12
|
6.12 mg/dL
Standard Deviation 1.546
|
5.88 mg/dL
Standard Deviation 1.708
|
|
Mean SUA Level at Baseline, Weeks 4, 8, 12, 16, 20 and 24
Week 20
|
6.14 mg/dL
Standard Deviation 1.467
|
4.76 mg/dL
Standard Deviation 1.900
|
|
Mean SUA Level at Baseline, Weeks 4, 8, 12, 16, 20 and 24
Week 24
|
6.49 mg/dL
Standard Deviation 1.575
|
5.00 mg/dL
Standard Deviation 2.296
|
Adverse Events
Febuxostat
Serious events: 4 serious events
Other events: 203 other events
Deaths: 0 deaths
Dotinurad
Serious events: 3 serious events
Other events: 201 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Febuxostat
n=225 participants at risk
Participants received febuxostat 20 mg tablet, orally, once daily for first 4 weeks; followed febuxostat 40 mg tablet, orally, once daily for 20 weeks. To maintain blinding, participants also received the dotinurad matching placebo up to Week 24.
|
Dotinurad
n=223 participants at risk
Participants received dotinurad 1 mg tablet, orally, once daily for first 4 weeks; followed by dotinurad 2 mg tablet, orally, once daily for 8 weeks; further followed by dotinurad 4 mg tablet, orally, once daily for 12 weeks. To maintain blinding, participants also received the febuxostat matching placebo up to Week 24.
|
|---|---|---|
|
Eye disorders
Cataract
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Renal and urinary disorders
Glomerulonephritis membranous
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
Other adverse events
| Measure |
Febuxostat
n=225 participants at risk
Participants received febuxostat 20 mg tablet, orally, once daily for first 4 weeks; followed febuxostat 40 mg tablet, orally, once daily for 20 weeks. To maintain blinding, participants also received the dotinurad matching placebo up to Week 24.
|
Dotinurad
n=223 participants at risk
Participants received dotinurad 1 mg tablet, orally, once daily for first 4 weeks; followed by dotinurad 2 mg tablet, orally, once daily for 8 weeks; further followed by dotinurad 4 mg tablet, orally, once daily for 12 weeks. To maintain blinding, participants also received the febuxostat matching placebo up to Week 24.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.89%
2/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.90%
2/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Blood and lymphatic system disorders
Monocytopenia
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Blood and lymphatic system disorders
Monocytosis
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Cardiac disorders
Sinus bradycardia
|
1.3%
3/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.90%
2/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Cardiac disorders
Bundle branch block right
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Cardiac disorders
Sinus tachycardia
|
1.3%
3/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Cardiac disorders
Ventricular extrasystoles
|
1.3%
3/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Cardiac disorders
Arrhythmia
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Cardiac disorders
Cardiac discomfort
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.89%
2/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Cardiac disorders
Palpitations
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Cardiac disorders
Right ventricular hypertrophy
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Cardiac disorders
Sinus arrhythmia
|
0.89%
2/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Eye disorders
Dry eye
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Eye disorders
Keratitis
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Eye disorders
Xerophthalmia
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
3/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
4.9%
11/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Toothache
|
0.89%
2/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
1.8%
4/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
1.3%
3/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.90%
2/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Gingival swelling
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.90%
2/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.90%
2/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Anal eczema
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Duodenogastric reflux
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Ileal ulcer
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Vomiting
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Gastritis
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Tooth disorder
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
General disorders
Pyrexia
|
4.9%
11/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
3.1%
7/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
General disorders
Fatigue
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
General disorders
Influenza like illness
|
1.8%
4/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
General disorders
Chest discomfort
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
General disorders
Chest pain
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
General disorders
Hyperthermia
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
8.0%
18/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
10.8%
24/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
1.8%
4/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
1.3%
3/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Hepatobiliary disorders
Liver injury
|
1.8%
4/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
1.3%
3/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Hepatobiliary disorders
Gallbladder enlargement
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.89%
2/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Infections and infestations
COVID-19
|
25.3%
57/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
25.6%
57/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.8%
22/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
5.8%
13/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Infections and infestations
Coronavirus infection
|
1.3%
3/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
2.2%
5/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Infections and infestations
Influenza
|
0.89%
2/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
1.8%
4/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Infections and infestations
Nasopharyngitis
|
1.3%
3/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
1.3%
3/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Infections and infestations
Urinary tract infection
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
1.3%
3/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.90%
2/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.90%
2/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Infections and infestations
Pharyngitis
|
0.89%
2/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.90%
2/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Infections and infestations
Carbuncle
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Infections and infestations
Clonorchiasis
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Infections and infestations
Gastroenteritis
|
1.3%
3/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Infections and infestations
Helicobacter infection
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Infections and infestations
Otitis media
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Infections and infestations
Paronychia
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Infections and infestations
Tinea cruris
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Infections and infestations
Conjunctivitis
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Infections and infestations
Gastroenteritis viral
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Infections and infestations
Hordeolum
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Infections and infestations
Onychomycosis
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Infections and infestations
Periodontitis
|
0.89%
2/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.90%
2/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.89%
2/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Injury, poisoning and procedural complications
Injury corneal
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.89%
2/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Alanine aminotransferase increased
|
12.4%
28/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
8.1%
18/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
SARS-CoV-2 test positive
|
3.6%
8/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
7.6%
17/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Alpha 1 microglobulin increased
|
8.4%
19/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
5.4%
12/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Blood uric acid decreased
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
4.5%
10/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.3%
12/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
4.5%
10/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Blood creatine phosphokinase increased
|
6.7%
15/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
3.6%
8/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Blood creatinine increased
|
3.6%
8/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
3.1%
7/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Low density lipoprotein increased
|
1.3%
3/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
3.1%
7/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Aspartate aminotransferase increased
|
5.3%
12/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
2.7%
6/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Eosinophil count increased
|
1.3%
3/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
2.7%
6/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
High density lipoprotein decreased
|
1.3%
3/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
2.7%
6/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Beta 2 microglobulin urine increased
|
3.1%
7/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
2.2%
5/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Amylase increased
|
0.89%
2/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
1.8%
4/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Beta 2 microglobulin increased
|
1.8%
4/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
1.8%
4/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Urine osmolarity decreased
|
2.2%
5/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
1.8%
4/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Blood cholesterol increased
|
0.89%
2/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
1.3%
3/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Protein urine present
|
0.89%
2/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
1.3%
3/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Urinary occult blood positive
|
1.3%
3/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
1.3%
3/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
White blood cell count decreased
|
0.89%
2/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
1.3%
3/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Beta-N-acetyl-D-glucosaminidase increased
|
3.1%
7/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.90%
2/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.90%
2/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Blood glucose increased
|
1.8%
4/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.90%
2/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.90%
2/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.90%
2/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Weight increased
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.90%
2/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Alanine aminotransferase
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Albumin urine present
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Blood glucose
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.89%
2/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Blood pressure increased
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Blood triglycerides
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Blood triglycerides increased
|
1.3%
3/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Blood urea increased
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Bone density increased
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Coronavirus test positive
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Globulins increased
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Monocyte count decreased
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Monocyte count increased
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Renal scan abnormal
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Urine albumin/creatinine ratio increased
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Urine leukocyte esterase positive
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Weight decreased
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
White blood cells urine positive
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.89%
2/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Blood creatine phosphokinase MB increased
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Blood glucose abnormal
|
0.89%
2/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Creatinine urine increased
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Electrocardiogram P wave abnormal
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Electrocardiogram Q waves
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Electrocardiogram ST segment abnormal
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Electrocardiogram T wave abnormal
|
1.3%
3/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Electrocardiogram repolarisation abnormality
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Globulins decreased
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Platelet count increased
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Transaminases increased
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
Urinary occult blood
|
0.89%
2/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Investigations
White blood cell count increased
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
5.8%
13/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
7.2%
16/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Metabolism and nutrition disorders
Gout
|
5.8%
13/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
4.0%
9/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.2%
5/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
4.0%
9/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
2.7%
6/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
2.2%
5/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
2.2%
5/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
1.8%
4/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Metabolism and nutrition disorders
Hypouricaemia
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
1.8%
4/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.90%
2/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.8%
4/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.90%
2/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.90%
2/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.90%
2/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Metabolism and nutrition disorders
Hyperhomocysteinaemia
|
0.89%
2/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.3%
3/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
34.7%
78/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
43.5%
97/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
2.2%
5/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.89%
2/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
1.3%
3/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.89%
2/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.90%
2/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.90%
2/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.90%
2/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.90%
2/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.90%
2/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Bone hypertrophy
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Gouty tophus
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Nervous system disorders
Dizziness
|
0.89%
2/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Nervous system disorders
Headache
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Nervous system disorders
Hypoaesthesia
|
0.89%
2/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Nervous system disorders
Dreamy state
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Nervous system disorders
Somnolence
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.90%
2/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Psychiatric disorders
Cardiovascular somatic symptom disorder
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
7.6%
17/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
6.3%
14/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Renal and urinary disorders
Microalbuminuria
|
1.8%
4/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
2.7%
6/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Renal and urinary disorders
Haematuria
|
1.8%
4/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
2.2%
5/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Renal and urinary disorders
Renal cyst
|
2.2%
5/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
1.8%
4/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Renal and urinary disorders
Renal impairment
|
1.8%
4/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
1.3%
3/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Renal and urinary disorders
Proteinuria
|
2.2%
5/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.90%
2/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Renal and urinary disorders
Albuminuria
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Renal and urinary disorders
Renal injury
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Renal and urinary disorders
Calculus bladder
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Renal and urinary disorders
Calculus urinary
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Renal and urinary disorders
Glomerulonephritis
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Renal and urinary disorders
Leukocyturia
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Renal and urinary disorders
Renal milk of calcium cyst
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Renal and urinary disorders
Urate nephropathy
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Reproductive system and breast disorders
Prostatic calcification
|
1.8%
4/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.90%
2/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.8%
4/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
1.3%
3/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.90%
2/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.3%
3/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Reflux laryngitis
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.89%
2/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.8%
4/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Skin and subcutaneous tissue disorders
Urticaria papular
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Vascular disorders
Hypertension
|
3.1%
7/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
2.2%
5/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Vascular disorders
Phlebolith
|
0.44%
1/225 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.45%
1/223 • From first dose of study drug up to Week 24
Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place