Trial Outcomes & Findings for Phase II Dose Finding Study of RDEA3170 Versus Placebo in Japanese Patients With Gout or Asymptomatic Hyperuricemia (NCT NCT02078219)
NCT ID: NCT02078219
Last Updated: 2019-09-24
Results Overview
The primary objective of the study is to compare percent changes of serum uric acid levels from baseline levels after 16 weeks of dosing between RDEA3170 treatment groups and the placebo treatment group.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
204 participants
Primary outcome timeframe
Baseline and Week 16
Results posted on
2019-09-24
Participant Flow
Of the 381 subjects who were screened in the study, 204 were randomized into one of the treatment groups. All 204 randomized subjects received at least 1 dose of randomized study medication. The first patient was enrolled on 11 March 2014 and the last enrolled patient completed the Last visit on 13 March 2015.
204 were randomized into one of the following treatment groups; allopurinol, placebo, RDEA3170 Group 1, Group 2 and Group 3. Of the enrolled subjects, 177 were withdrawn prior to randomization because of 'eligibility criteria not fulfill' (176 subjects) or 'patient decision' (1 subject).
Participant milestones
| Measure |
Allopurinol 200 mg Treatment Group
100 mg qd for 4 weeks and allopurinol 100 mg bid for 20 weeks
|
RDEA3170 Placebo Treatment Group
RDEA3170 matching placebo qd for 24 weeks
|
RDEA3170 Treatment Group 1
RDEA3170 2.5 mg once daily (qd) for 4 weeks followed by RDEA3170 5 mg qd for 12 weeks followed by RDEA3170 7.5 mg qd for 8 weeks
|
RDEA3170 Treatment Group 2
RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 10 mg qd for 8 weeks followed by RDEA3170 12.5 mg qd for 8 weeks
|
RDEA3170 Treatment Group 3
RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 12.5 mg qd for 8 weeks followed by RDEA3170 15 mg qd for 8 weeks
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
41
|
40
|
41
|
41
|
41
|
|
Overall Study
COMPLETED
|
38
|
36
|
35
|
37
|
39
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
6
|
4
|
2
|
Reasons for withdrawal
| Measure |
Allopurinol 200 mg Treatment Group
100 mg qd for 4 weeks and allopurinol 100 mg bid for 20 weeks
|
RDEA3170 Placebo Treatment Group
RDEA3170 matching placebo qd for 24 weeks
|
RDEA3170 Treatment Group 1
RDEA3170 2.5 mg once daily (qd) for 4 weeks followed by RDEA3170 5 mg qd for 12 weeks followed by RDEA3170 7.5 mg qd for 8 weeks
|
RDEA3170 Treatment Group 2
RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 10 mg qd for 8 weeks followed by RDEA3170 12.5 mg qd for 8 weeks
|
RDEA3170 Treatment Group 3
RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 12.5 mg qd for 8 weeks followed by RDEA3170 15 mg qd for 8 weeks
|
|---|---|---|---|---|---|
|
Overall Study
Other
|
2
|
2
|
3
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
1
|
3
|
1
|
0
|
Baseline Characteristics
Phase II Dose Finding Study of RDEA3170 Versus Placebo in Japanese Patients With Gout or Asymptomatic Hyperuricemia
Baseline characteristics by cohort
| Measure |
Allopurinol 200 mg Treatment Group
n=41 Participants
100 mg qd for 4 weeks and allopurinol 100 mg bid for 20 weeks
|
RDEA3170 Placebo Treatment Group
n=40 Participants
RDEA3170 matching placebo qd for 24 weeks
|
RDEA3170 Treatment Group 1
n=41 Participants
RDEA3170 2.5 mg once daily (qd) for 4 weeks followed by RDEA3170 5 mg qd for 12 weeks followed by RDEA3170 7.5 mg qd for 8 weeks
|
RDEA3170 Treatment Group 2
n=41 Participants
RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 10 mg qd for 8 weeks followed by RDEA3170 12.5 mg qd for 8 weeks
|
RDEA3170 Treatment Group 3
n=41 Participants
RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 12.5 mg qd for 8 weeks followed by RDEA3170 15 mg qd for 8 weeks
|
Total
n=204 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
51.0 Years
STANDARD_DEVIATION 10.6 • n=93 Participants
|
54.5 Years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
51.3 Years
STANDARD_DEVIATION 9.3 • n=27 Participants
|
52.7 Years
STANDARD_DEVIATION 10.0 • n=483 Participants
|
52.3 Years
STANDARD_DEVIATION 10.7 • n=36 Participants
|
52.3 Years
STANDARD_DEVIATION 10.2 • n=10 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=93 Participants
|
39 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
40 Participants
n=483 Participants
|
39 Participants
n=36 Participants
|
200 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 16Population: Efficacy analysis set
The primary objective of the study is to compare percent changes of serum uric acid levels from baseline levels after 16 weeks of dosing between RDEA3170 treatment groups and the placebo treatment group.
Outcome measures
| Measure |
RDEA3170 Treatment Group 1
n=41 Participants
RDEA3170 2.5 mg once daily (qd) for 4 weeks followed by RDEA3170 5 mg qd for 12 weeks followed by RDEA3170 7.5 mg qd for 8 weeks
|
RDEA3170 Treatment Group 2
n=41 Participants
RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 10 mg qd for 8 weeks followed by RDEA3170 12.5 mg qd for 8 weeks
|
RDEA3170 Treatment Group 3
n=41 Participants
RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 12.5 mg qd for 8 weeks followed by RDEA3170 15 mg qd for 8 weeks
|
RDEA3170 Placebo Treatment Group
n=40 Participants
RDEA3170 matching placebo qd for 24 weeks
|
Allopurinol 200 mg Treatment Group
n=41 Participants
Allopurinol 100 mg qd for 4 weeks followed by allopurinol 100 mg twice daily (bid) for 20 weeks
|
|---|---|---|---|---|---|
|
Percent Changes of Serum Uric Acid Levels From Baseline Levels
|
-30.93 Percent change
Standard Deviation 17.80
|
-49.91 Percent change
Standard Deviation 18.38
|
-54.32 Percent change
Standard Deviation 13.40
|
-2.05 Percent change
Standard Deviation 9.29
|
-39.09 Percent change
Standard Deviation 11.54
|
SECONDARY outcome
Timeframe: Weeks 1,2,4,6,8,10,12,16,18,20,24Population: Efficacy analysis set
To compare the percentage of subjects whose serum uric acid levels are ≤ 6.0 mg/dL between RDEA3170 treatment groups and the placebo treatment group at each study visit
Outcome measures
| Measure |
RDEA3170 Treatment Group 1
n=41 Participants
RDEA3170 2.5 mg once daily (qd) for 4 weeks followed by RDEA3170 5 mg qd for 12 weeks followed by RDEA3170 7.5 mg qd for 8 weeks
|
RDEA3170 Treatment Group 2
n=41 Participants
RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 10 mg qd for 8 weeks followed by RDEA3170 12.5 mg qd for 8 weeks
|
RDEA3170 Treatment Group 3
n=41 Participants
RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 12.5 mg qd for 8 weeks followed by RDEA3170 15 mg qd for 8 weeks
|
RDEA3170 Placebo Treatment Group
n=40 Participants
RDEA3170 matching placebo qd for 24 weeks
|
Allopurinol 200 mg Treatment Group
n=41 Participants
Allopurinol 100 mg qd for 4 weeks followed by allopurinol 100 mg twice daily (bid) for 20 weeks
|
|---|---|---|---|---|---|
|
Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL
Week 1
|
26.8 % subjects
|
31.7 % subjects
|
39.0 % subjects
|
0 % subjects
|
19.5 % subjects
|
|
Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL
Week 2
|
29.3 % subjects
|
34.1 % subjects
|
34.1 % subjects
|
0 % subjects
|
19.5 % subjects
|
|
Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL
Week 4
|
26.8 % subjects
|
31.7 % subjects
|
39.0 % subjects
|
0 % subjects
|
17.1 % subjects
|
|
Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL
Week 6
|
70.7 % subjects
|
61.0 % subjects
|
82.9 % subjects
|
0 % subjects
|
73.2 % subjects
|
|
Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL
Week 8
|
53.7 % subjects
|
56.1 % subjects
|
78.0 % subjects
|
0 % subjects
|
65.9 % subjects
|
|
Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL
Week 10
|
46.3 % subjects
|
78.0 % subjects
|
92.7 % subjects
|
0 % subjects
|
61.0 % subjects
|
|
Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL
Week 12
|
53.7 % subjects
|
85.4 % subjects
|
92.7 % subjects
|
0 % subjects
|
75.6 % subjects
|
|
Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL
Week 16
|
51.2 % subjects
|
95.1 % subjects
|
97.6 % subjects
|
0 % subjects
|
78.0 % subjects
|
|
Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL
Week 18
|
63.4 % subjects
|
92.7 % subjects
|
95.1 % subjects
|
0 % subjects
|
73.2 % subjects
|
|
Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL
Week 20
|
61.0 % subjects
|
82.9 % subjects
|
92.7 % subjects
|
0 % subjects
|
78.0 % subjects
|
|
Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL
Week 24
|
68.3 % subjects
|
82.9 % subjects
|
87.8 % subjects
|
0 % subjects
|
75.6 % subjects
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1,2,4,6,8,10,12,16,18,20,24Population: Efficacy analysis set
To compare percent change in sUA at each study visit.
Outcome measures
| Measure |
RDEA3170 Treatment Group 1
n=41 Participants
RDEA3170 2.5 mg once daily (qd) for 4 weeks followed by RDEA3170 5 mg qd for 12 weeks followed by RDEA3170 7.5 mg qd for 8 weeks
|
RDEA3170 Treatment Group 2
n=41 Participants
RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 10 mg qd for 8 weeks followed by RDEA3170 12.5 mg qd for 8 weeks
|
RDEA3170 Treatment Group 3
n=41 Participants
RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 12.5 mg qd for 8 weeks followed by RDEA3170 15 mg qd for 8 weeks
|
RDEA3170 Placebo Treatment Group
n=40 Participants
RDEA3170 matching placebo qd for 24 weeks
|
Allopurinol 200 mg Treatment Group
n=41 Participants
Allopurinol 100 mg qd for 4 weeks followed by allopurinol 100 mg twice daily (bid) for 20 weeks
|
|---|---|---|---|---|---|
|
Percent Change in sUA
Week 6
|
-32.05 % Change
Standard Deviation 13.05
|
-31.26 % Change
Standard Deviation 19.83
|
-35.24 % Change
Standard Deviation 10.74
|
-0.01 % Change
Standard Deviation 9.86
|
-37.06 % Change
Standard Deviation 8.72
|
|
Percent Change in sUA
Week 8
|
-27.94 % Change
Standard Deviation 16.54
|
-30.19 % Change
Standard Deviation 19.22
|
-32.11 % Change
Standard Deviation 13.96
|
0.55 % Change
Standard Deviation 9.50
|
-36.51 % Change
Standard Deviation 11.14
|
|
Percent Change in sUA
Week 10
|
-24.69 % Change
Standard Deviation 18.81
|
-37.61 % Change
Standard Deviation 18.35
|
-44.38 % Change
Standard Deviation 12.33
|
-0.27 % Change
Standard Deviation 9.53
|
-33.42 % Change
Standard Deviation 11.28
|
|
Percent Change in sUA
Week 18
|
-32.94 % Change
Standard Deviation 18.11
|
-49.04 % Change
Standard Deviation 19.19
|
-54.70 % Change
Standard Deviation 13.32
|
-2.86 % Change
Standard Deviation 8.55
|
-38.59 % Change
Standard Deviation 10.32
|
|
Percent Change in sUA
Week 20
|
-32.96 % Change
Standard Deviation 18.69
|
-47.20 % Change
Standard Deviation 21.46
|
-53.60 % Change
Standard Deviation 12.92
|
-2.27 % Change
Standard Deviation 8.76
|
-38.00 % Change
Standard Deviation 11.11
|
|
Percent Change in sUA
Week 24
|
-35.73 % Change
Standard Deviation 19.49
|
-47.34 % Change
Standard Deviation 21.39
|
-54.46 % Change
Standard Deviation 18.97
|
-4.67 % Change
Standard Deviation 10.36
|
-37.77 % Change
Standard Deviation 11.47
|
|
Percent Change in sUA
Week 1
|
-19.72 % Change
Standard Deviation 10.93
|
-20.29 % Change
Standard Deviation 17.51
|
-19.93 % Change
Standard Deviation 22.98
|
-0.25 % Change
Standard Deviation 8.57
|
-20.74 % Change
Standard Deviation 7.72
|
|
Percent Change in sUA
Week 2
|
-21.03 % Change
Standard Deviation 11.87
|
-20.28 % Change
Standard Deviation 16.87
|
-20.93 % Change
Standard Deviation 10.68
|
-0.53 % Change
Standard Deviation 7.20
|
-20.80 % Change
Standard Deviation 9.37
|
|
Percent Change in sUA
Week 4
|
-22.95 % Change
Standard Deviation 10.86
|
-19.66 % Change
Standard Deviation 17.24
|
-24.21 % Change
Standard Deviation 10.69
|
0.97 % Change
Standard Deviation 8.70
|
-20.60 % Change
Standard Deviation 8.83
|
|
Percent Change in sUA
Week 12
|
-28.08 % Change
Standard Deviation 18.22
|
-45.77 % Change
Standard Deviation 17.94
|
-51.17 % Change
Standard Deviation 16.19
|
0.43 % Change
Standard Deviation 7.89
|
-37.96 % Change
Standard Deviation 10.65
|
|
Percent Change in sUA
Week 16
|
-30.93 % Change
Standard Deviation 17.80
|
-49.91 % Change
Standard Deviation 18.38
|
-54.32 % Change
Standard Deviation 13.40
|
-2.05 % Change
Standard Deviation 9.29
|
-39.09 % Change
Standard Deviation 11.54
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1,2,4,6,8,10,12,16,18,20,24Population: Efficacy analysis set
To compare the absolute change of serum uric acid levels from baseline levels
Outcome measures
| Measure |
RDEA3170 Treatment Group 1
n=41 Participants
RDEA3170 2.5 mg once daily (qd) for 4 weeks followed by RDEA3170 5 mg qd for 12 weeks followed by RDEA3170 7.5 mg qd for 8 weeks
|
RDEA3170 Treatment Group 2
n=41 Participants
RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 10 mg qd for 8 weeks followed by RDEA3170 12.5 mg qd for 8 weeks
|
RDEA3170 Treatment Group 3
n=41 Participants
RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 12.5 mg qd for 8 weeks followed by RDEA3170 15 mg qd for 8 weeks
|
RDEA3170 Placebo Treatment Group
n=40 Participants
RDEA3170 matching placebo qd for 24 weeks
|
Allopurinol 200 mg Treatment Group
n=41 Participants
Allopurinol 100 mg qd for 4 weeks followed by allopurinol 100 mg twice daily (bid) for 20 weeks
|
|---|---|---|---|---|---|
|
Absolute Change of Serum Uric Acid Levels From Baseline Levels
Week 8
|
-2.44 mg/dL
Standard Deviation 1.48
|
-2.61 mg/dL
Standard Deviation 1.75
|
-2.74 mg/dL
Standard Deviation 1.23
|
0.02 mg/dL
Standard Deviation 0.85
|
-3.22 mg/dL
Standard Deviation 1.09
|
|
Absolute Change of Serum Uric Acid Levels From Baseline Levels
Week 10
|
-2.19 mg/dL
Standard Deviation 1.65
|
-3.22 mg/dL
Standard Deviation 1.78
|
-3.75 mg/dL
Standard Deviation 1.19
|
-0.06 mg/dL
Standard Deviation 0.79
|
-2.96 mg/dL
Standard Deviation 1.13
|
|
Absolute Change of Serum Uric Acid Levels From Baseline Levels
Week 12
|
-2.44 mg/dL
Standard Deviation 1.56
|
-3.85 mg/dL
Standard Deviation 1.62
|
-4.33 mg/dL
Standard Deviation 1.45
|
0.02 mg/dL
Standard Deviation 0.70
|
-3.35 mg/dL
Standard Deviation 1.09
|
|
Absolute Change of Serum Uric Acid Levels From Baseline Levels
Week 16
|
-2.67 mg/dL
Standard Deviation 1.48
|
-4.24 mg/dL
Standard Deviation 1.82
|
-4.57 mg/dL
Standard Deviation 1.28
|
-0.22 mg/dL
Standard Deviation 0.81
|
-3.44 mg/dL
Standard Deviation 1.10
|
|
Absolute Change of Serum Uric Acid Levels From Baseline Levels
Week 24
|
-3.10 mg/dL
Standard Deviation 1.67
|
-3.99 mg/dL
Standard Deviation 1.96
|
-4.57 mg/dL
Standard Deviation 1.64
|
-0.42 mg/dL
Standard Deviation 0.90
|
-3.31 mg/dL
Standard Deviation 1.10
|
|
Absolute Change of Serum Uric Acid Levels From Baseline Levels
Week 1
|
-1.68 mg/dL
Standard Deviation 1.01
|
-1.74 mg/dL
Standard Deviation 1.48
|
-1.68 mg/dL
Standard Deviation 2.10
|
-0.05 mg/dL
Standard Deviation 0.77
|
-1.82 mg/dL
Standard Deviation 0.73
|
|
Absolute Change of Serum Uric Acid Levels From Baseline Levels
Week 2
|
-1.81 mg/dL
Standard Deviation 1.11
|
-1.75 mg/dL
Standard Deviation 1.45
|
-1.78 mg/dL
Standard Deviation 0.98
|
-0.07 mg/dL
Standard Deviation 0.64
|
-1.83 mg/dL
Standard Deviation 0.90
|
|
Absolute Change of Serum Uric Acid Levels From Baseline Levels
Week 4
|
-2.01 mg/dL
Standard Deviation 1.09
|
-1.72 mg/dL
Standard Deviation 1.48
|
-2.07 mg/dL
Standard Deviation 1.01
|
0.06 mg/dL
Standard Deviation 0.76
|
-1.83 mg/dL
Standard Deviation 0.89
|
|
Absolute Change of Serum Uric Acid Levels From Baseline Levels
Week 6
|
-2.78 mg/dL
Standard Deviation 1.34
|
-2.66 mg/dL
Standard Deviation 1.73
|
-3.00 mg/dL
Standard Deviation 1.09
|
-0.04 mg/dL
Standard Deviation 0.81
|
-3.26 mg/dL
Standard Deviation 0.93
|
|
Absolute Change of Serum Uric Acid Levels From Baseline Levels
Week 18
|
-2.86 mg/dL
Standard Deviation 1.54
|
-4.17 mg/dL
Standard Deviation 1.82
|
-4.62 mg/dL
Standard Deviation 1.27
|
-0.27 mg/dL
Standard Deviation 0.75
|
-3.40 mg/dL
Standard Deviation 1.06
|
|
Absolute Change of Serum Uric Acid Levels From Baseline Levels
Week 20
|
-2.87 mg/dL
Standard Deviation 1.61
|
-3.98 mg/dL
Standard Deviation 1.97
|
-4.52 mg/dL
Standard Deviation 1.15
|
-0.22 mg/dL
Standard Deviation 0.75
|
-3.35 mg/dL
Standard Deviation 1.15
|
Adverse Events
Allopurinol 200 mg Treatment Group
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
RDEA3170 Placebo Treatment Group
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
RDEA3170 Treatment Group 1
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
RDEA3170 Treatment Group 2
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
RDEA3170 Treatment Group 3
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Allopurinol 200 mg Treatment Group
n=41 participants at risk
allopurinol 100 mg qd for 4 weeks followed by allopurinol 100 mg twice daily (bid) for 20 weeks.
|
RDEA3170 Placebo Treatment Group
n=40 participants at risk
RDEA3170 matching placebo qd for 24 weeks
|
RDEA3170 Treatment Group 1
n=41 participants at risk
RDEA3170 2.5 mg once daily (qd) for 4 weeks followed by RDEA3170 5 mg qd for 12 weeks followed by RDEA3170 7.5 mg qd for 8 weeks
|
RDEA3170 Treatment Group 2
n=41 participants at risk
RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 10 mg qd for 8 weeks followed by RDEA3170 12.5 mg qd for 8 weeks
|
RDEA3170 Treatment Group 3
n=41 participants at risk
RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 12.5 mg qd for 8 weeks followed by RDEA3170 15 mg qd for 8 weeks
|
|---|---|---|---|---|---|
|
Cardiac disorders
Silent myocardial infarction
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Hepatobiliary disorders
Bile duct stone
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.5%
1/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
Other adverse events
| Measure |
Allopurinol 200 mg Treatment Group
n=41 participants at risk
allopurinol 100 mg qd for 4 weeks followed by allopurinol 100 mg twice daily (bid) for 20 weeks.
|
RDEA3170 Placebo Treatment Group
n=40 participants at risk
RDEA3170 matching placebo qd for 24 weeks
|
RDEA3170 Treatment Group 1
n=41 participants at risk
RDEA3170 2.5 mg once daily (qd) for 4 weeks followed by RDEA3170 5 mg qd for 12 weeks followed by RDEA3170 7.5 mg qd for 8 weeks
|
RDEA3170 Treatment Group 2
n=41 participants at risk
RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 10 mg qd for 8 weeks followed by RDEA3170 12.5 mg qd for 8 weeks
|
RDEA3170 Treatment Group 3
n=41 participants at risk
RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 12.5 mg qd for 8 weeks followed by RDEA3170 15 mg qd for 8 weeks
|
|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
17.1%
7/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
17.5%
7/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
22.0%
9/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
19.5%
8/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
14.6%
6/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Infections and infestations
Pharyngitis
|
4.9%
2/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
4.9%
2/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Infections and infestations
Bronchitis
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
4.9%
2/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.5%
1/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
9.8%
4/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
4.9%
2/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
5.0%
2/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
4.9%
2/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
4.9%
2/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
4.9%
2/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.5%
1/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Skin and subcutaneous tissue disorders
Chronic pigmented purpura
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.5%
1/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
5.0%
2/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
4.9%
2/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Vascular disorders
Hypertension
|
4.9%
2/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.5%
1/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Nervous system disorders
Headache
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
4.9%
2/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.9%
2/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
5.0%
2/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Gastrointestinal disorders
Nausea
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Gastrointestinal disorders
Contact stomatitis
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Gastrointestinal disorders
Chronic gastritis
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.5%
1/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Gastrointestinal disorders
Gastric polyps
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Infections and infestations
Gastroenteritis
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
4.9%
2/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Infections and infestations
Influenza
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Infections and infestations
Nasal vestibulitis
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Infections and infestations
Tonsillitis
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Infections and infestations
Urethritis
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Infections and infestations
Dermatitis infected
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.5%
1/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.5%
1/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Infections and infestations
Oral herpes
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Investigations
Weight increased
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Injury, poisoning and procedural complications
Muscle contusion
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.5%
1/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.5%
1/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.5%
1/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Injury, poisoning and procedural complications
Venomous sting
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.5%
1/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.5%
1/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Injury, poisoning and procedural complications
Foreign body
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Psychiatric disorders
Depression
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
7.5%
3/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Cardiac disorders
Silent myocardial infarction
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Cardiac disorders
Atrial fibrillation
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Eye disorders
Dry eye
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Eye disorders
Glaucoma
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
General disorders
Fatigue
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
General disorders
Local swelling
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
General disorders
Oedema peripheral
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.5%
1/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
General disorders
Pyrexia
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.5%
1/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.5%
1/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Hepatobiliary disorders
Bile duct stone
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Hepatobiliary disorders
Cholangitis acute
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
5.0%
2/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
2.5%
1/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
5.0%
2/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
2.4%
1/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/40 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
0.00%
0/41 • Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
|
Additional Information
Fredrik Erlandsson, MD
Study Information Center AstraZeneca
Phone: +1 877-240-9479
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place