Trial Outcomes & Findings for Effect of Febuxostat on Renal Function in Patients With Gout and Moderate to Severe Renal Impairment (NCT NCT01082640)
NCT ID: NCT01082640
Last Updated: 2013-09-25
Results Overview
Renal function was assessed by measuring the change from Baseline in serum creatinine. Analyses were conducted by the Central Laboratory.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
96 participants
Primary outcome timeframe
Baseline and Month 12
Results posted on
2013-09-25
Participant Flow
Participants took part in the study at 46 investigative sites in the United States from 09 April 2010 to 31 May 2012.
Participants meeting the American Rheumatism Association (ARA) diagnostic criteria for gout (subjects with tophi were excluded). were randomized to 1 of 3 arms in a 1:1:1 ratio to receive either febuxostat 40 mg/80 mg once daily (QD) or febuxostat 30 mg twice daily (BID) or placebo for up to 12 months.
Participant milestones
| Measure |
Placebo
Placebo-matching capsules, orally, twice daily for up to 12 months.
|
Febuxostat 30 mg BID
Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
|
Febuxostat 40/80 mg QD
Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was \<6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
32
|
|
Overall Study
COMPLETED
|
15
|
17
|
24
|
|
Overall Study
NOT COMPLETED
|
17
|
15
|
8
|
Reasons for withdrawal
| Measure |
Placebo
Placebo-matching capsules, orally, twice daily for up to 12 months.
|
Febuxostat 30 mg BID
Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
|
Febuxostat 40/80 mg QD
Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was \<6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
9
|
5
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
2
|
|
Overall Study
Major protocol deviation
|
3
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
0
|
|
Overall Study
Other
|
2
|
1
|
3
|
Baseline Characteristics
Effect of Febuxostat on Renal Function in Patients With Gout and Moderate to Severe Renal Impairment
Baseline characteristics by cohort
| Measure |
Placebo
n=32 Participants
Placebo-matching capsules, orally, twice daily for up to 12 months.
|
Febuxostat 30 mg BID
n=32 Participants
Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
|
Febuxostat 40/80 mg QD
n=32 Participants
Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was \<6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study.
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
66.3 years
STANDARD_DEVIATION 12.05 • n=5 Participants
|
67.3 years
STANDARD_DEVIATION 11.11 • n=7 Participants
|
63.6 years
STANDARD_DEVIATION 8.15 • n=5 Participants
|
65.7 years
STANDARD_DEVIATION 10.57 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
29 participants
n=5 Participants
|
30 participants
n=7 Participants
|
29 participants
n=5 Participants
|
88 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
16 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
25 participants
n=5 Participants
|
24 participants
n=7 Participants
|
21 participants
n=5 Participants
|
70 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
32 participants
n=7 Participants
|
32 participants
n=5 Participants
|
96 participants
n=4 Participants
|
|
Height
|
172.6 cm
STANDARD_DEVIATION 11.55 • n=5 Participants
|
173.8 cm
STANDARD_DEVIATION 9.60 • n=7 Participants
|
172.8 cm
STANDARD_DEVIATION 9.48 • n=5 Participants
|
173.1 cm
STANDARD_DEVIATION 10.16 • n=4 Participants
|
|
Weight
|
100.7 kg
STANDARD_DEVIATION 27.54 • n=5 Participants
|
98.8 kg
STANDARD_DEVIATION 19.84 • n=7 Participants
|
102.6 kg
STANDARD_DEVIATION 25.85 • n=5 Participants
|
100.7 kg
STANDARD_DEVIATION 24.42 • n=4 Participants
|
|
Body Mass Index (BMI)
|
33.3 kg/m^2
STANDARD_DEVIATION 6.36 • n=5 Participants
|
32.8 kg/m^2
STANDARD_DEVIATION 6.45 • n=7 Participants
|
34.2 kg/m^2
STANDARD_DEVIATION 7.30 • n=5 Participants
|
33.4 kg/m^2
STANDARD_DEVIATION 6.67 • n=4 Participants
|
|
Prior Use of ARB or ACEi
Angiotensin receptor blocker (ARB)
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
24 participants
n=4 Participants
|
|
Prior Use of ARB or ACEi
Angiotensin converting enzyme inhibitors (ACEi)
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
13 participants
n=5 Participants
|
39 participants
n=4 Participants
|
|
Prior Use of ARB or ACEi
None
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
11 participants
n=5 Participants
|
33 participants
n=4 Participants
|
|
Renal History Based on Creatinine Clearance
Severely impaired
|
17 participants
n=5 Participants
|
9 participants
n=7 Participants
|
10 participants
n=5 Participants
|
36 participants
n=4 Participants
|
|
Renal History Based on Creatinine Clearance
Moderately impaired
|
15 participants
n=5 Participants
|
23 participants
n=7 Participants
|
22 participants
n=5 Participants
|
60 participants
n=4 Participants
|
|
Serum creatinine level
Less than 2.0 mg/dL
|
10 participants
n=5 Participants
|
13 participants
n=7 Participants
|
14 participants
n=5 Participants
|
37 participants
n=4 Participants
|
|
Serum creatinine level
2.0 to <2.5 mg/dL
|
7 participants
n=5 Participants
|
13 participants
n=7 Participants
|
9 participants
n=5 Participants
|
29 participants
n=4 Participants
|
|
Serum creatinine level
Greater than 2.5 mg/dL
|
15 participants
n=5 Participants
|
6 participants
n=7 Participants
|
9 participants
n=5 Participants
|
30 participants
n=4 Participants
|
|
Serum Urate
|
10.8 mg/dL
STANDARD_DEVIATION 1.96 • n=5 Participants
|
10.4 mg/dL
STANDARD_DEVIATION 1.43 • n=7 Participants
|
10.4 mg/dL
STANDARD_DEVIATION 1.70 • n=5 Participants
|
10.5 mg/dL
STANDARD_DEVIATION 1.70 • n=4 Participants
|
|
Serum Urate Categories
<9.0 mg/dL
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
16 participants
n=4 Participants
|
|
Serum Urate Categories
9.0 to <10.0 mg/dL
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
22 participants
n=4 Participants
|
|
Serum Urate Categories
≥10 mg/dL
|
19 participants
n=5 Participants
|
21 participants
n=7 Participants
|
18 participants
n=5 Participants
|
58 participants
n=4 Participants
|
|
Gout flares in the past year
1-3 flares
|
21 participnts
n=5 Participants
|
16 participnts
n=7 Participants
|
19 participnts
n=5 Participants
|
56 participnts
n=4 Participants
|
|
Gout flares in the past year
4-6 flares
|
4 participnts
n=5 Participants
|
8 participnts
n=7 Participants
|
3 participnts
n=5 Participants
|
15 participnts
n=4 Participants
|
|
Gout flares in the past year
More than 6
|
2 participnts
n=5 Participants
|
3 participnts
n=7 Participants
|
5 participnts
n=5 Participants
|
10 participnts
n=4 Participants
|
|
Time since last gout flare
Less than 1 month ago
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
15 participants
n=4 Participants
|
|
Time since last gout flare
1 to less than 4 months ago
|
2 participants
n=5 Participants
|
7 participants
n=7 Participants
|
5 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Time since last gout flare
4 to less than 6 months ago
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
2 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Time since last gout flare
6 to less than 12 months ago
|
14 participants
n=5 Participants
|
8 participants
n=7 Participants
|
11 participants
n=5 Participants
|
33 participants
n=4 Participants
|
|
Time since last gout flare
more than 1 year ago
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
9 participants
n=5 Participants
|
24 participants
n=4 Participants
|
|
Previous urate-lowering therapy
Febuxostat
|
0 participants
n=5 Participants
|
5 participants
n=7 Participants
|
2 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Previous urate-lowering therapy
Allopurinol
|
19 participants
n=5 Participants
|
22 participants
n=7 Participants
|
21 participants
n=5 Participants
|
62 participants
n=4 Participants
|
|
Previous urate-lowering therapy
Probenecid
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Previous urate-lowering therapy
None
|
11 participants
n=5 Participants
|
6 participants
n=7 Participants
|
9 participants
n=5 Participants
|
26 participants
n=4 Participants
|
|
Previous urate-lowering therapy
Other
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Number of Lifetime Kidney Stone Episodes
|
4.8 episodes
STANDARD_DEVIATION 3.90 • n=5 Participants
|
3.0 episodes
STANDARD_DEVIATION 1.67 • n=7 Participants
|
1.8 episodes
STANDARD_DEVIATION 1.78 • n=5 Participants
|
2.8 episodes
STANDARD_DEVIATION 2.56 • n=4 Participants
|
|
Kidney Stone Passage
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Composition of most recent passed stone
Calcium Oxalate
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Composition of most recent passed stone
Uric acid
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Composition of most recent passed stone
Calcium citrate
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Composition of most recent passed stone
Mixed
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 12Population: Full analysis set, including all patients who were randomized and received at least 1 dose of double-blind study medication. Only patients with both a baseline value and at least 1 value during the double-blind treatment period are included in the analysis. Missing data were imputed as carrying forward the last observed post-baseline value.
Renal function was assessed by measuring the change from Baseline in serum creatinine. Analyses were conducted by the Central Laboratory.
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo-matching capsules, orally, twice daily for up to 12 months.
|
Febuxostat 30 mg BID
n=32 Participants
Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
|
Febuxostat 40/80 mg QD
n=31 Participants
Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was \<6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study.
|
|---|---|---|---|
|
Change From Baseline to Month 12 in Serum Creatinine
Baseline
|
2.52 mg/dL
Standard Error 0.126
|
2.10 mg/dL
Standard Error 0.126
|
2.22 mg/dL
Standard Error 0.128
|
|
Change From Baseline to Month 12 in Serum Creatinine
Change from Baseline at Month 12
|
0.19 mg/dL
Standard Error 0.094
|
0.09 mg/dL
Standard Error 0.093
|
0.23 mg/dL
Standard Error 0.094
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Full analysis set with available data at Baseline. and at least 1 post-baseline value. Missing data was imputed as carrying forward the last post-baseline value.
Change from baseline to Month 12 in estimated Glomerular Filtration Rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula (as calculated by the central laboratory).
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo-matching capsules, orally, twice daily for up to 12 months.
|
Febuxostat 30 mg BID
n=32 Participants
Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
|
Febuxostat 40/80 mg QD
n=31 Participants
Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was \<6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study.
|
|---|---|---|---|
|
Change From Baseline to Month 12 in Estimated Glomerular Filtration Rate (eGFR)
Baseline
|
29.31 mL/min/1.73m²
Standard Error 1.461
|
34.14 mL/min/1.73m²
Standard Error 1.461
|
34.08 mL/min/1.73m²
Standard Error 1.484
|
|
Change From Baseline to Month 12 in Estimated Glomerular Filtration Rate (eGFR)
Change from Baseline at Month 12
|
-2.05 mL/min/1.73m²
Standard Error 1.198
|
0.33 mL/min/1.73m²
Standard Error 1.172
|
-0.86 mL/min/1.73m²
Standard Error 0.190
|
SECONDARY outcome
Timeframe: Month 12Population: Full analysis set, including all patients who were randomized and received at least 1 dose of double-blind study medication. A patient was included in the analysis only when there was at least 1 value during the double-blind treatment period. Missing data were imputed as carrying forward the last observed post-baseline value.
Serum urate concentrations were determined using the enzymatic method as performed by the Central Laboratory.
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo-matching capsules, orally, twice daily for up to 12 months.
|
Febuxostat 30 mg BID
n=32 Participants
Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
|
Febuxostat 40/80 mg QD
n=31 Participants
Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was \<6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study.
|
|---|---|---|---|
|
Percentage of Participants With Serum Urate (sUA) Less Than 6 mg/dL at Month 12
|
0 percentage of participants
|
68.8 percentage of participants
|
45.2 percentage of participants
|
SECONDARY outcome
Timeframe: The 2 pre-dose PK samples collected were collected at any 2 of the following visits: Months 3, 6, 9, and/or 12, at -0.25 to 0 hours. The 4 postdose PK samples were collected at Months 3, 6, and/or 9, at 0.25; 0.75 to 2.0; 2.5 to 4.0; and 5 to 12 hours.Population: Participants who received febuxostat and had available data for PK analysis.
Mean CL/F at steady state were estimated using a population pharmacokinetic (PK) approach, based on 2 PK samples collected prior to dosing, and 4 PK samples collected postdose.
Outcome measures
| Measure |
Placebo
n=25 Participants
Placebo-matching capsules, orally, twice daily for up to 12 months.
|
Febuxostat 30 mg BID
n=9 Participants
Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
|
Febuxostat 40/80 mg QD
n=20 Participants
Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was \<6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study.
|
|---|---|---|---|
|
Mean Clearance (CL/F) of Febuxostat at Steady State
|
8.16 liters/hour
Standard Deviation 2.31
|
8.71 liters/hour
Standard Deviation 2.21
|
10.9 liters/hour
Standard Deviation 4.70
|
SECONDARY outcome
Timeframe: The 2 pre-dose PK samples collected were collected at any 2 of the following visits: Months 3, 6, 9, and/or 12, at -0.25 to 0 hours. The 4 postdose PK samples were collected at Months 3, 6, and/or 9, at 0.25; 0.75 to 2.0; 2.5 to 4.0; and 5 to 12 hours.Population: Participants who received febuxostat and had available data for PK analysis.
Mean AUC during the dosing interval at steady state was estimated using a population pharmacokinetic (PK) approach, based on 2 PK samples collected prior to dosing, and 4 PK samples collected postdose.
Outcome measures
| Measure |
Placebo
n=25 Participants
Placebo-matching capsules, orally, twice daily for up to 12 months.
|
Febuxostat 30 mg BID
n=9 Participants
Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
|
Febuxostat 40/80 mg QD
n=20 Participants
Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was \<6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study.
|
|---|---|---|---|
|
Mean Area Under the Concentration-Time Curve During the Dosing Interval (AUC[0-τ]) of Febuxostat at Steady State
|
3.98 hr*µg/mL
Standard Deviation 1.21
|
4.91 hr*µg/mL
Standard Deviation 1.29
|
8.21 hr*µg/mL
Standard Deviation 2.30
|
Adverse Events
Placebo
Serious events: 7 serious events
Other events: 20 other events
Deaths: 0 deaths
Febuxostat 30 mg BID
Serious events: 5 serious events
Other events: 21 other events
Deaths: 0 deaths
Febuxostat 40/80 mg QD
Serious events: 8 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=32 participants at risk
Placebo-matching capsules, orally, twice daily for up to 12 months.
|
Febuxostat 30 mg BID
n=32 participants at risk
Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
|
Febuxostat 40/80 mg QD
n=32 participants at risk
Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was \<6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study.
|
|---|---|---|---|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Cardiogenic Shock
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
6.2%
2/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
2/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Cardiac Arrest
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Adverse Drug Reaction
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Urinary Tract Infection
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Fluid Overload
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Cerebrovascular Accident
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Renal Failure
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Renal Failure Acute
|
6.2%
2/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Renal Failure Chronic
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Renal Impairment
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Iliac Artery Occlusion
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Placebo
n=32 participants at risk
Placebo-matching capsules, orally, twice daily for up to 12 months.
|
Febuxostat 30 mg BID
n=32 participants at risk
Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
|
Febuxostat 40/80 mg QD
n=32 participants at risk
Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was \<6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
2/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
C-Reactive protein increased
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
2/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
2/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
2/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
2/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
2/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
2/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hypertension
|
6.2%
2/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood creatinine increased
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.6%
5/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
2/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
2/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
2/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
2/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.4%
3/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.4%
3/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Renal impairment
|
6.2%
2/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
4/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
2/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
4/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
9.4%
3/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
2/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
9.4%
3/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
2/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.2%
2/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
4/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.2%
2/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.4%
3/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.4%
3/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.4%
3/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
2/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Bronchitis
|
6.2%
2/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.4%
3/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Oedema peripheral
|
6.2%
2/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
2/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
2/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.4%
3/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
2/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
2/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
2/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
2/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
2/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
6.2%
2/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.2%
2/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
2/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
2/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
2/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • From first double-blind dose date and up to 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Sr. VP, Clinical Science
Takeda Global Research and Development Center, Inc.
Phone: 800-778-2860
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER