Trial Outcomes & Findings for Study of Verinurad in Heart Failure With Preserved Ejection Fraction (NCT NCT04327024)
NCT ID: NCT04327024
Last Updated: 2023-06-29
Results Overview
Mean change from baseline in peak VO2 at Week 32 between the treatment groups was compared using change from baseline (i.e., week 32 value - baseline value) as the dependent variable, treatment as the independent variable and baseline peak VO2 included as covariate. H0: Difference in mean change from baseline in peak VO2 (verinurad + allopurinol vs placebo) = 0 Ha: Difference in mean change from baseline in peak VO2 (verinurad + allopurinol vs placebo) ≠ 0 A hierarchical test sequence was used for the confirmatory analysis of the primary and secondary objectives in order to address the issue of multiple testing and control the Type I error rate at an overall two-sided 0.05 level. Since this was the first test in the hierarchical test sequence and endpoint was not rejected at a two-sided 0.05 level, the testing sequence did not continue.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
159 participants
Primary outcome timeframe
From baseline to Week 32
Results posted on
2023-06-29
Participant Flow
475 subjects were screened between May 19, 2020, and July 16, 2021, at 59 sites in 12 different countries. Of those screened, 159 were randomized into the study and received treatment, 53 in each arm of the study.
Subjects who met all the of inclusion criteria and none of the exclusion criteria were randomized to a study treatment. Study treatment was titrated over 8 weeks. Colchicine prophylaxis was given during the titration period and during the first 4 weeks of treatment at target dose (12 weeks total) and was distributed as available, currently 500 μg within the European Union (EU) and 600 μg within the United States (US).
Participant milestones
| Measure |
Verinurad + Allopurinol
12 mg verinurad + 300 mg allopurinol
|
Allopurinol
300 mg Allopurinol
|
Placebo
0 mg placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
53
|
53
|
53
|
|
Overall Study
COMPLETED
|
51
|
49
|
50
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
3
|
Reasons for withdrawal
| Measure |
Verinurad + Allopurinol
12 mg verinurad + 300 mg allopurinol
|
Allopurinol
300 mg Allopurinol
|
Placebo
0 mg placebo
|
|---|---|---|---|
|
Overall Study
Death
|
1
|
2
|
1
|
|
Overall Study
Non-compliance with study drug
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
2
|
Baseline Characteristics
Study of Verinurad in Heart Failure With Preserved Ejection Fraction
Baseline characteristics by cohort
| Measure |
Verinurad + Allopurinol
n=53 Participants
12 mg verinurad + 300 mg allopurinol
|
Allopurinol
n=53 Participants
300 mg Allopurinol
|
Placebo
n=53 Participants
0 mg placebo
|
Total
n=159 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
69.6 Years
STANDARD_DEVIATION 9.04 • n=5 Participants
|
70.6 Years
STANDARD_DEVIATION 6.98 • n=7 Participants
|
67.5 Years
STANDARD_DEVIATION 9.77 • n=5 Participants
|
69.2 Years
STANDARD_DEVIATION 8.72 • n=4 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
103 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
146 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
46 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
140 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From baseline to Week 32Population: Full Analysis Set
Mean change from baseline in peak VO2 at Week 32 between the treatment groups was compared using change from baseline (i.e., week 32 value - baseline value) as the dependent variable, treatment as the independent variable and baseline peak VO2 included as covariate. H0: Difference in mean change from baseline in peak VO2 (verinurad + allopurinol vs placebo) = 0 Ha: Difference in mean change from baseline in peak VO2 (verinurad + allopurinol vs placebo) ≠ 0 A hierarchical test sequence was used for the confirmatory analysis of the primary and secondary objectives in order to address the issue of multiple testing and control the Type I error rate at an overall two-sided 0.05 level. Since this was the first test in the hierarchical test sequence and endpoint was not rejected at a two-sided 0.05 level, the testing sequence did not continue.
Outcome measures
| Measure |
Verinurad + Allopurinol
n=53 Participants
12 mg verinurad + 300 mg allopurinol
|
Placebo
n=53 Participants
0 mg placebo
|
|---|---|---|
|
Change From Baseline at Week 32 in Peak V02 Consumption in Verinurad + Allopurinol Compared to Placebo (ANCOVA Model)
|
0.27 mL/kg/min
Interval -0.56 to 1.1
|
0.37 mL/kg/min
Interval -0.45 to 1.19
|
SECONDARY outcome
Timeframe: From baseline to Week 32Population: Full Analysis Set
Mean change from baseline in peak VO2 at Week 32 between the treatment groups was compared using change from baseline (i.e., week 32 value - baseline value) as the dependent variable, treatment as the independent variable and baseline peak VO2 included as covariate. H0: Difference in mean change from baseline in peak VO2 (verinurad + allopurinol vs allopurinol) = 0 Ha: Difference in mean change from baseline in peak VO2 (verinurad + allopurinol vs allopurinol) ≠ 0 A hierarchical test sequence was used for the confirmatory analysis of the primary and secondary objectives in order to address the issue of multiple testing and control the Type I error rate at an overall two-sided 0.05 level.
Outcome measures
| Measure |
Verinurad + Allopurinol
n=53 Participants
12 mg verinurad + 300 mg allopurinol
|
Placebo
n=53 Participants
0 mg placebo
|
|---|---|---|
|
Change From Baseline at Week 32 in Peak V02 Consumption in Verinurad+ Allopurinol Compared to Allopurinol Monotherapy (ANCOVA Model)
|
0.27 mL/Kg/min
Interval -0.56 to 1.1
|
-0.17 mL/Kg/min
Interval -1.03 to 0.69
|
SECONDARY outcome
Timeframe: From baseline to Week 22 and Week 32Population: Full Analysis Set
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item assessment that measures the patient's perception of their health status, which includes heart failure-related symptoms (frequency, burden, recent change), impact on physical and social function, self-efficacy and knowledge, and how the patient's heart failure affects their quality of life. The Total Symptom Score (TSS) averages the frequency domain and the symptom burden domain subscales, which each range from 0 to 100. The TSS ranges from 0-100 (higher scores = better health status). Mean change from baseline in KCCQ-TSS at Week 32 between the treatment groups was compared using MMRM analysis, with change from baseline (i.e., week 32 value - baseline value) as the dependent variable, treatment as the independent variable and visit, visit by treatment, and baseline KCCQ-TSS included as covariates. The number analyzed at each timepoint represents the number of subjects with data at each visit.
Outcome measures
| Measure |
Verinurad + Allopurinol
n=53 Participants
12 mg verinurad + 300 mg allopurinol
|
Placebo
n=53 Participants
0 mg placebo
|
|---|---|---|
|
Change From Baseline at Week 32 in KCCQ-TSS in Verinurad+ Allopurinol Compared to Placebo (MMRM)
Week 22
|
0.50 Scores on a scale
Interval -4.08 to 5.08
|
3.55 Scores on a scale
Interval -1.29 to 8.39
|
|
Change From Baseline at Week 32 in KCCQ-TSS in Verinurad+ Allopurinol Compared to Placebo (MMRM)
Week 32
|
4.31 Scores on a scale
Interval 0.28 to 8.33
|
1.16 Scores on a scale
Interval -3.02 to 5.34
|
SECONDARY outcome
Timeframe: From baseline to Week 22 and Week 32Population: Full Analysis Set
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item assessment that measures the patient's perception of their health status, which includes heart failure-related symptoms (frequency, burden, recent change), impact on physical and social function, self-efficacy and knowledge, and how the patient's heart failure affects their quality of life. The Total Symptom Score (TSS) averages the frequency domain and the symptom burden domain subscales, which each range from 0 to 100. The TSS ranges from 0-100 (higher scores = better health status). Mean change from baseline in KCCQ-TSS at Week 32 between the treatment groups was compared using MMRM analysis, with change from baseline (i.e., week 32 value - baseline value) as the dependent variable, treatment as the independent variable and visit, visit by treatment, and baseline KCCQ-TSS included as covariates. The number analyzed at each timepoint represents the number of subjects with data at each visit.
Outcome measures
| Measure |
Verinurad + Allopurinol
n=53 Participants
12 mg verinurad + 300 mg allopurinol
|
Placebo
n=53 Participants
0 mg placebo
|
|---|---|---|
|
Change From Baseline at Week 32 in KCCQ-TSS in Verinurad+ Allopurinol Compared to Allopurinol Monotherapy (MMRM)
Week 22
|
0.50 Scores on a scale
Interval -4.08 to 5.08
|
2.85 Scores on a scale
Interval -1.91 to 7.62
|
|
Change From Baseline at Week 32 in KCCQ-TSS in Verinurad+ Allopurinol Compared to Allopurinol Monotherapy (MMRM)
Week 32
|
4.31 Scores on a scale
Interval 0.28 to 8.33
|
4.45 Scores on a scale
Interval 0.34 to 8.57
|
Adverse Events
Verinurad + Allopurinol
Serious events: 10 serious events
Other events: 24 other events
Deaths: 1 deaths
Allopurinol
Serious events: 10 serious events
Other events: 26 other events
Deaths: 2 deaths
Placebo
Serious events: 9 serious events
Other events: 20 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Verinurad + Allopurinol
n=53 participants at risk
12 mg verinurad + 300 mg allopurinol
|
Allopurinol
n=53 participants at risk
300 mg Allopurinol
|
Placebo
n=53 participants at risk
0 mg placebo
|
|---|---|---|---|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Nervous system disorders
Dizziness
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Gastrointestinal disorders
Abdominal hernia
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Gastrointestinal disorders
Anal fissure haemorrhage
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Gastrointestinal disorders
Duodenitis
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
3.8%
2/53 • Number of events 3 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Cardiac disorders
Angina pectoris
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
General disorders
Sudden cardiac death
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Infections and infestations
Appendicitis
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Infections and infestations
COVID-19
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Cardiac disorders
Atrial fibrillation
|
3.8%
2/53 • Number of events 2 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
3.8%
2/53 • Number of events 2 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
9.4%
5/53 • Number of events 8 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
Other adverse events
| Measure |
Verinurad + Allopurinol
n=53 participants at risk
12 mg verinurad + 300 mg allopurinol
|
Allopurinol
n=53 participants at risk
300 mg Allopurinol
|
Placebo
n=53 participants at risk
0 mg placebo
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.8%
2/53 • Number of events 2 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Metabolism and nutrition disorders
Gout
|
3.8%
2/53 • Number of events 2 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
3.8%
2/53 • Number of events 2 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
3.8%
2/53 • Number of events 3 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.8%
2/53 • Number of events 2 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
3.8%
2/53 • Number of events 2 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Nervous system disorders
Dizziness
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
3.8%
2/53 • Number of events 2 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Nervous system disorders
Headache
|
7.5%
4/53 • Number of events 4 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Psychiatric disorders
Depression
|
5.7%
3/53 • Number of events 3 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
3.8%
2/53 • Number of events 3 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
3.8%
2/53 • Number of events 2 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
3.8%
2/53 • Number of events 2 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
3.8%
2/53 • Number of events 2 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
3.8%
2/53 • Number of events 2 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.8%
2/53 • Number of events 2 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.8%
2/53 • Number of events 2 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Vascular disorders
Hypertension
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
3.8%
2/53 • Number of events 2 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
3.8%
2/53 • Number of events 2 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Vascular disorders
Hypotension
|
5.7%
3/53 • Number of events 4 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
3.8%
2/53 • Number of events 2 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Ear and labyrinth disorders
Vertigo
|
5.7%
3/53 • Number of events 3 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
3.8%
2/53 • Number of events 2 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Gastrointestinal disorders
Diarrhoea
|
9.4%
5/53 • Number of events 7 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
3.8%
2/53 • Number of events 2 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Gastrointestinal disorders
Dyspepsia
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
3.8%
2/53 • Number of events 2 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Cardiac disorders
Angina pectoris
|
3.8%
2/53 • Number of events 2 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
General disorders
Oedema peripheral
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
5.7%
3/53 • Number of events 3 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Infections and infestations
COVID-19
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
5.7%
3/53 • Number of events 3 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
3.8%
2/53 • Number of events 2 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
3.8%
2/53 • Number of events 2 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
3.8%
2/53 • Number of events 3 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Cardiac disorders
Cardiac failure
|
7.5%
4/53 • Number of events 7 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
7.5%
4/53 • Number of events 5 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Investigations
Blood creatinine increased
|
3.8%
2/53 • Number of events 2 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
9.4%
5/53 • Number of events 5 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
3.8%
2/53 • Number of events 2 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Investigations
Blood pressure increased
|
5.7%
3/53 • Number of events 3 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
3.8%
2/53 • Number of events 2 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
|
Investigations
Weight increased
|
1.9%
1/53 • Number of events 1 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
3.8%
2/53 • Number of events 2 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
0.00%
0/53 • Adverse events were collected with onset date on or after first dose and up to the end of the study (week 36). Serious adverse events were collected with onset date on or after the signing of the informed consent form and up to the end of the study (week 36).
All adverse events reported are treatment emergent with onset on or after the first dose and up to the end of the study (week 36).
|
Additional Information
Global Clinical Lead
AstraZeneca Clinical Study Information Center
Phone: 1-877-240-9479
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60