Trial Outcomes & Findings for A Phase 2, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of PF-00489791 In Patients With Type 2 Diabetes And Overt Nephropathy (NCT NCT01200394)
NCT ID: NCT01200394
Last Updated: 2019-03-12
Results Overview
UACR was ratio of albumin measured in urine (milligram) to creatinine measured in urine (millimole), reported in units milligram per millimole (mg/mmol). A decrease in UACR may be associated with improved renal and cardiovascular function. The mean values of the 3 consecutive first morning void urine samples (obtained 2 days prior to \[Day 5, 6 of Week 12\], and with last sample collected on the morning of scheduled clinic visit \[Day 7 of Week 12\]) were used to determine UACR at the scheduled clinic visit. The mean values of the 3 consecutive first morning void urine samples obtained at screening were used to determine baseline UACR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
256 participants
Primary outcome timeframe
Baseline, Week 12 (Day 5, 6, 7)
Results posted on
2019-03-12
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.
|
PF-00489791 20 mg
PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
192
|
|
Overall Study
COMPLETED
|
62
|
164
|
|
Overall Study
NOT COMPLETED
|
2
|
28
|
Reasons for withdrawal
| Measure |
Placebo
Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.
|
PF-00489791 20 mg
PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
14
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Did Not Meet Entrance Criteria
|
1
|
4
|
|
Overall Study
Protocol Violation
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
5
|
|
Overall Study
Other
|
0
|
1
|
Baseline Characteristics
A Phase 2, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of PF-00489791 In Patients With Type 2 Diabetes And Overt Nephropathy
Baseline characteristics by cohort
| Measure |
Placebo
n=64 Participants
Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.
|
PF-00489791 20 mg
n=192 Participants
PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.
|
Total
n=256 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.8 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
62.0 years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
61.5 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
27 participants
n=5 Participants
|
79 participants
n=7 Participants
|
106 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 participants
n=5 Participants
|
13 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
26 participants
n=5 Participants
|
83 participants
n=7 Participants
|
109 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 participants
n=5 Participants
|
17 participants
n=7 Participants
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12 (Day 5, 6, 7)Population: Full analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose efficacy measurement. Here, 'Number analyzed' = Participants evaluable at specified time points for each arm, respectively.
UACR was ratio of albumin measured in urine (milligram) to creatinine measured in urine (millimole), reported in units milligram per millimole (mg/mmol). A decrease in UACR may be associated with improved renal and cardiovascular function. The mean values of the 3 consecutive first morning void urine samples (obtained 2 days prior to \[Day 5, 6 of Week 12\], and with last sample collected on the morning of scheduled clinic visit \[Day 7 of Week 12\]) were used to determine UACR at the scheduled clinic visit. The mean values of the 3 consecutive first morning void urine samples obtained at screening were used to determine baseline UACR.
Outcome measures
| Measure |
Placebo
n=64 Participants
Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.
|
PF-00489791 20 mg
n=192 Participants
PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Week 12
Baseline
|
195.130 mg/mmol
Standard Deviation 171.8116
|
182.378 mg/mmol
Standard Deviation 156.5097
|
|
Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Week 12
Change at Week 12
|
9.072 mg/mmol
Standard Deviation 176.4360
|
-6.539 mg/mmol
Standard Deviation 128.4866
|
SECONDARY outcome
Timeframe: Baseline, Week 3 (Day 5, 6, 7), Week 6 (Day 5, 6, 7), Week 16 (Day 5, 6, 7)Population: Full analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose efficacy measurement. Here, 'Number analyzed' = Participants evaluable at specified time points for each arm, respectively.
UACR was ratio of albumin measured in urine (milligram) to creatinine measured in urine (millimole), reported in units mg/mmol. A decrease in UACR may be associated with improved renal and cardiovascular function. The mean values of the 3 consecutive first morning void urine samples (obtained 2 days prior to \[Day 5, 6 of specified Week\], and with last sample collected on the morning of scheduled clinic visit \[Day 7 of specified Week\]) were used to determine UACR at the scheduled clinic visit. The mean values of the 3 consecutive first morning void urine samples obtained at screening were used to determine baseline UACR.
Outcome measures
| Measure |
Placebo
n=64 Participants
Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.
|
PF-00489791 20 mg
n=192 Participants
PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Week 3, 6 and 16
Change at Week 3
|
-11.805 mg/mmol
Standard Deviation 161.7282
|
-14.268 mg/mmol
Standard Deviation 94.8469
|
|
Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Week 3, 6 and 16
Change at Week 6
|
-7.772 mg/mmol
Standard Deviation 162.0838
|
-2.546 mg/mmol
Standard Deviation 179.5896
|
|
Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Week 3, 6 and 16
Change at Week 16
|
16.500 mg/mmol
Standard Deviation 202.7600
|
2.802 mg/mmol
Standard Deviation 107.9582
|
SECONDARY outcome
Timeframe: Baseline, Week 3 (Day 5, 6, 7), Week 6 (Day 5, 6, 7), Week 12 (Day 5, 6, 7), Week 16 (Day 5, 6, 7)Population: Full analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose efficacy measurement. Here, 'Number analyzed' = Participants evaluable at specified time points for each arm, respectively.
UPCR is a ratio between two measured substances in urine: milligram of protein per millimole (mmol) of creatinine, reported in units mg/mmol. A decrease in UPCR may be associated with improved renal and cardiovascular function. The mean values of the 3 consecutive first morning void urine samples (obtained 2 days prior to \[Day 5, 6 of Week 3, 6, 12, 16\], and with last sample collected on the morning of scheduled clinic visit \[Day 7 of Week 3, 6, 12, 16\]) were used to determine UPCR at the scheduled clinic visit. The mean values of the 3 consecutive first morning void urine samples obtained at screening were used to determine baseline UPCR.
Outcome measures
| Measure |
Placebo
n=64 Participants
Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.
|
PF-00489791 20 mg
n=192 Participants
PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Urinary Protein Creatinine Ratio (UPCR) at Week 3, 6, 12, and 16
Baseline
|
282.208 mg/mmol
Standard Deviation 259.8496
|
261.015 mg/mmol
Standard Deviation 220.5260
|
|
Change From Baseline in Urinary Protein Creatinine Ratio (UPCR) at Week 3, 6, 12, and 16
Change at Week 3
|
-20.302 mg/mmol
Standard Deviation 247.4490
|
-26.883 mg/mmol
Standard Deviation 161.0038
|
|
Change From Baseline in Urinary Protein Creatinine Ratio (UPCR) at Week 3, 6, 12, and 16
Change at Week 6
|
-10.278 mg/mmol
Standard Deviation 256.7216
|
10.699 mg/mmol
Standard Deviation 290.5749
|
|
Change From Baseline in Urinary Protein Creatinine Ratio (UPCR) at Week 3, 6, 12, and 16
Change at Week 12
|
14.632 mg/mmol
Standard Deviation 283.9874
|
-5.371 mg/mmol
Standard Deviation 207.3333
|
|
Change From Baseline in Urinary Protein Creatinine Ratio (UPCR) at Week 3, 6, 12, and 16
Change at Week 16
|
30.880 mg/mmol
Standard Deviation 332.0766
|
20.299 mg/mmol
Standard Deviation 190.3546
|
SECONDARY outcome
Timeframe: Baseline, Week 3, 6, 12, 16 (follow-up)Population: Full analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose efficacy measurement. Here, 'Number analyzed' = Participants evaluable at specified time points for each arm, respectively.
The eGFR was calculated using 4 variable formula developed by the modification of diet in renal disease (MDRD) study group. The 4 variables needed to estimate glomerular filtration rate (GFR) using this formula were serum creatinine concentration (sCr), age, sex (for females, eGFR was multiplied by 0.742) and ethnic origin (for African-Caribbean people only, eGFR was multiplied by 1.212). Thus eGFR in milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2) = 175\*(sCr/88.4)\^-1.154\*(Age)\^-0.203\*(0.742 if female)\*(1.212 if African-Caribbean). Baseline eGFR was determined predose at Week 0 (Day 1).
Outcome measures
| Measure |
Placebo
n=64 Participants
Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.
|
PF-00489791 20 mg
n=192 Participants
PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 3, 6, 12, and 16
Baseline
|
38.575 mL/min/1.73 m^2
Standard Deviation 11.9122
|
37.740 mL/min/1.73 m^2
Standard Deviation 9.8834
|
|
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 3, 6, 12, and 16
Change at Week 3
|
0.069 mL/min/1.73 m^2
Standard Deviation 6.2868
|
-0.156 mL/min/1.73 m^2
Standard Deviation 4.6044
|
|
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 3, 6, 12, and 16
Change at Week 6
|
-0.930 mL/min/1.73 m^2
Standard Deviation 5.3513
|
-0.755 mL/min/1.73 m^2
Standard Deviation 5.2701
|
|
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 3, 6, 12, and 16
Change at Week 12
|
-1.435 mL/min/1.73 m^2
Standard Deviation 5.3757
|
-1.463 mL/min/1.73 m^2
Standard Deviation 5.1074
|
|
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 3, 6, 12, and 16
Change at Week 16
|
-1.915 mL/min/1.73 m^2
Standard Deviation 5.9005
|
-1.659 mL/min/1.73 m^2
Standard Deviation 6.0659
|
SECONDARY outcome
Timeframe: Week 0, 3, 6, 12, 16 (follow-up)Population: Full analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose efficacy measurement.
Systolic blood pressure (SBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. diastolic blood pressure (DBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. Mean blood pressure (MBP) = diastolic blood pressure + (\[systolic blood pressure - diastolic blood pressure\]/3). After a minimum of 5 minutes of rest, supine BP was measured with the participant's arm supported at the level of the heart.
Outcome measures
| Measure |
Placebo
n=64 Participants
Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.
|
PF-00489791 20 mg
n=192 Participants
PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.
|
|---|---|---|
|
Systolic, Diastolic and Mean Blood Pressure at Week 0, 3, 6, 12, and 16
Supine Systolic BP, Week 0
|
137.20 millimeter of mercury (mmHg)
Interval 135.01 to 139.4
|
131.81 millimeter of mercury (mmHg)
Interval 130.53 to 133.1
|
|
Systolic, Diastolic and Mean Blood Pressure at Week 0, 3, 6, 12, and 16
Supine Diastolic BP, Week 0
|
76.98 millimeter of mercury (mmHg)
Interval 75.53 to 78.42
|
73.27 millimeter of mercury (mmHg)
Interval 72.43 to 74.11
|
|
Systolic, Diastolic and Mean Blood Pressure at Week 0, 3, 6, 12, and 16
Supine Mean BP, Week 0
|
107.27 millimeter of mercury (mmHg)
Interval 105.66 to 108.88
|
102.68 millimeter of mercury (mmHg)
Interval 101.74 to 103.62
|
|
Systolic, Diastolic and Mean Blood Pressure at Week 0, 3, 6, 12, and 16
Supine Systolic BP, Week 3
|
136.68 millimeter of mercury (mmHg)
Interval 134.3 to 139.05
|
136.15 millimeter of mercury (mmHg)
Interval 134.74 to 137.56
|
|
Systolic, Diastolic and Mean Blood Pressure at Week 0, 3, 6, 12, and 16
Supine Diastolic BP, Week 3
|
76.78 millimeter of mercury (mmHg)
Interval 75.25 to 78.31
|
77.18 millimeter of mercury (mmHg)
Interval 76.27 to 78.1
|
|
Systolic, Diastolic and Mean Blood Pressure at Week 0, 3, 6, 12, and 16
Supine Mean BP, Week 3
|
107.06 millimeter of mercury (mmHg)
Interval 105.32 to 108.8
|
106.90 millimeter of mercury (mmHg)
Interval 105.86 to 107.94
|
|
Systolic, Diastolic and Mean Blood Pressure at Week 0, 3, 6, 12, and 16
Supine Systolic BP, Week 6
|
137.41 millimeter of mercury (mmHg)
Interval 134.9 to 139.93
|
136.94 millimeter of mercury (mmHg)
Interval 135.42 to 138.45
|
|
Systolic, Diastolic and Mean Blood Pressure at Week 0, 3, 6, 12, and 16
Supine Diastolic BP, Week 6
|
76.88 millimeter of mercury (mmHg)
Interval 75.32 to 78.43
|
76.41 millimeter of mercury (mmHg)
Interval 75.48 to 77.35
|
|
Systolic, Diastolic and Mean Blood Pressure at Week 0, 3, 6, 12, and 16
Supine Mean BP, Week 6
|
107.37 millimeter of mercury (mmHg)
Interval 105.58 to 109.15
|
106.70 millimeter of mercury (mmHg)
Interval 105.62 to 107.77
|
|
Systolic, Diastolic and Mean Blood Pressure at Week 0, 3, 6, 12, and 16
Supine Systolic BP, Week 12
|
136.89 millimeter of mercury (mmHg)
Interval 133.73 to 140.06
|
137.70 millimeter of mercury (mmHg)
Interval 135.79 to 139.6
|
|
Systolic, Diastolic and Mean Blood Pressure at Week 0, 3, 6, 12, and 16
Supine Diastolic BP, Week 12
|
77.32 millimeter of mercury (mmHg)
Interval 75.51 to 79.13
|
76.69 millimeter of mercury (mmHg)
Interval 75.61 to 77.78
|
|
Systolic, Diastolic and Mean Blood Pressure at Week 0, 3, 6, 12, and 16
Supine Mean BP, Week 12
|
107.41 millimeter of mercury (mmHg)
Interval 105.27 to 109.55
|
107.14 millimeter of mercury (mmHg)
Interval 105.85 to 108.42
|
|
Systolic, Diastolic and Mean Blood Pressure at Week 0, 3, 6, 12, and 16
Supine Systolic BP, Week 16
|
138.38 millimeter of mercury (mmHg)
Interval 135.51 to 141.25
|
138.89 millimeter of mercury (mmHg)
Interval 137.15 to 140.63
|
|
Systolic, Diastolic and Mean Blood Pressure at Week 0, 3, 6, 12, and 16
Supine Diastolic BP, Week 16
|
77.25 millimeter of mercury (mmHg)
Interval 75.59 to 78.92
|
77.90 millimeter of mercury (mmHg)
Interval 76.9 to 78.91
|
|
Systolic, Diastolic and Mean Blood Pressure at Week 0, 3, 6, 12, and 16
Supine Mean BP, Week 16
|
108.00 millimeter of mercury (mmHg)
Interval 106.1 to 109.91
|
108.47 millimeter of mercury (mmHg)
Interval 107.31 to 109.62
|
SECONDARY outcome
Timeframe: Baseline, Week 3, 6, 12, 16 (follow-up)Population: Full analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose efficacy measurement. Here, 'Number analyzed' = Participants evaluable at specified time points for each arm, respectively.
Serum creatinine concentration was used as a marker of renal function. Baseline serum creatinine concentration was determined predose at Week 0 (Day 1).
Outcome measures
| Measure |
Placebo
n=64 Participants
Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.
|
PF-00489791 20 mg
n=192 Participants
PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Serum Creatinine Concentration at Week 3, 6, 12, and 16
Change at Week 16
|
11.527 micromole per liter (mcmol/L)
Standard Deviation 28.5175
|
9.269 micromole per liter (mcmol/L)
Standard Deviation 26.6470
|
|
Change From Baseline in Serum Creatinine Concentration at Week 3, 6, 12, and 16
Baseline
|
164.929 micromole per liter (mcmol/L)
Standard Deviation 42.0837
|
163.637 micromole per liter (mcmol/L)
Standard Deviation 42.9529
|
|
Change From Baseline in Serum Creatinine Concentration at Week 3, 6, 12, and 16
Change at Week 3
|
1.232 micromole per liter (mcmol/L)
Standard Deviation 23.9961
|
2.691 micromole per liter (mcmol/L)
Standard Deviation 20.6884
|
|
Change From Baseline in Serum Creatinine Concentration at Week 3, 6, 12, and 16
Change at Week 6
|
3.158 micromole per liter (mcmol/L)
Standard Deviation 18.0835
|
4.974 micromole per liter (mcmol/L)
Standard Deviation 21.7977
|
|
Change From Baseline in Serum Creatinine Concentration at Week 3, 6, 12, and 16
Change at Week 12
|
6.139 micromole per liter (mcmol/L)
Standard Deviation 20.7198
|
8.110 micromole per liter (mcmol/L)
Standard Deviation 22.3709
|
SECONDARY outcome
Timeframe: Baseline, Week 3, 6, 12, 16 (follow-up)Population: Full analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose efficacy measurement. Here, 'Number analyzed' = Participants evaluable at specified time points for each arm, respectively.
TGF Beta-1 is a major fibrogenic growth factor implicated in the pathogenesis of renal scarring. It is overexpressed in the diabetic kidney where it may promote matrix accumulation. Baseline TGF Beta-1 concentration was determined predose at Week 0 (Day 1).
Outcome measures
| Measure |
Placebo
n=64 Participants
Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.
|
PF-00489791 20 mg
n=192 Participants
PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Urine Transforming Growth Factor (TGF) Beta-1 Concentration at Week 3, 6, 12, and 16
Baseline
|
177.88 picogram per milliliter (pg/mL)
Standard Deviation 231.154
|
213.37 picogram per milliliter (pg/mL)
Standard Deviation 274.409
|
|
Change From Baseline in Urine Transforming Growth Factor (TGF) Beta-1 Concentration at Week 3, 6, 12, and 16
Change at Week 3
|
-22.81 picogram per milliliter (pg/mL)
Standard Deviation 260.140
|
-54.06 picogram per milliliter (pg/mL)
Standard Deviation 349.817
|
|
Change From Baseline in Urine Transforming Growth Factor (TGF) Beta-1 Concentration at Week 3, 6, 12, and 16
Change at Week 6
|
23.33 picogram per milliliter (pg/mL)
Standard Deviation 345.304
|
-68.59 picogram per milliliter (pg/mL)
Standard Deviation 333.378
|
|
Change From Baseline in Urine Transforming Growth Factor (TGF) Beta-1 Concentration at Week 3, 6, 12, and 16
Change at Week 12
|
-36.20 picogram per milliliter (pg/mL)
Standard Deviation 281.523
|
-11.87 picogram per milliliter (pg/mL)
Standard Deviation 328.482
|
|
Change From Baseline in Urine Transforming Growth Factor (TGF) Beta-1 Concentration at Week 3, 6, 12, and 16
Change at Week 16
|
-23.54 picogram per milliliter (pg/mL)
Standard Deviation 134.752
|
-31.32 picogram per milliliter (pg/mL)
Standard Deviation 299.546
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 16 (follow-up)Population: Full analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose efficacy measurement. Here, 'Number analyzed' = Participants evaluable at specified time points for each arm, respectively.
The CRP is an acute phase reactant which is virtually absent from the blood serum of healthy persons but rapidly appears in blood and body fluids in response to injurious stimuli. Baseline hs-CRP was determined predose at Week 0 (Day 1).
Outcome measures
| Measure |
Placebo
n=64 Participants
Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.
|
PF-00489791 20 mg
n=192 Participants
PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Serum High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 12 and 16
Baseline
|
3.019 milligram per liter (mg/L)
Standard Deviation 3.4924
|
4.330 milligram per liter (mg/L)
Standard Deviation 8.6809
|
|
Change From Baseline in Serum High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 12 and 16
Change at Week 12
|
1.183 milligram per liter (mg/L)
Standard Deviation 3.4600
|
0.106 milligram per liter (mg/L)
Standard Deviation 7.4909
|
|
Change From Baseline in Serum High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 12 and 16
Change at Week 16
|
0.317 milligram per liter (mg/L)
Standard Deviation 2.9508
|
-0.102 milligram per liter (mg/L)
Standard Deviation 6.3317
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 16 (follow-up)Population: Full analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose efficacy measurement. Here, 'Number analyzed' = Participants evaluable at specified time points for each arm, respectively.
Cystatin C is produced by all nucleated cells at a constant rate and is freely filtered at the glomerulus. The blood concentration of cystatin C depends almost entirely on the GFR and is not substantially affected by diet, nutritional status or inflammatory disease. Serum cystatin C had been proposed as an endogenous marker of GFR in participant with chronic kidney disease (CKD) than sCr. Baseline serum cystatin C was determined predose at Week 0 (Day 1).
Outcome measures
| Measure |
Placebo
n=64 Participants
Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.
|
PF-00489791 20 mg
n=192 Participants
PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Serum Cystatin-C Concentration at Week 12 and 16
Baseline
|
1.659 mg/L
Standard Deviation 0.4122
|
1.695 mg/L
Standard Deviation 0.4497
|
|
Change From Baseline in Serum Cystatin-C Concentration at Week 12 and 16
Change at Week 12
|
0.096 mg/L
Standard Deviation 0.1844
|
0.070 mg/L
Standard Deviation 0.2890
|
|
Change From Baseline in Serum Cystatin-C Concentration at Week 12 and 16
Change at Week 16
|
0.104 mg/L
Standard Deviation 0.3234
|
0.075 mg/L
Standard Deviation 0.3176
|
SECONDARY outcome
Timeframe: Pre-dose at Day 1 of Week 0, 3, 6 and 12; 4 hours post-dose on Day 1 of Week 0, 3 and 6Population: Pharmacokinetic analysis set included all randomized and treated participants with at least 1 measured PF-00489791 concentration. Here, "Number analyzed" signifies number of participants evaluable for specified categories. This outcome measure was planned not to be analyzed for Placebo reporting arm.
Outcome measures
| Measure |
Placebo
n=191 Participants
Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.
|
PF-00489791 20 mg
PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.
|
|---|---|---|
|
Plasma Concentration Versus Time Summary of PF-00489791
4 hours post-dose at Day 1 of Week 0
|
0.6540 microgram per millilitre (microgram/mL)
Standard Deviation 0.33644
|
—
|
|
Plasma Concentration Versus Time Summary of PF-00489791
Pre-dose at Day 1 of Week 3
|
0.4156 microgram per millilitre (microgram/mL)
Standard Deviation 0.44674
|
—
|
|
Plasma Concentration Versus Time Summary of PF-00489791
4 hours post-dose at Day 1 of Week 3
|
0.9772 microgram per millilitre (microgram/mL)
Standard Deviation 0.59610
|
—
|
|
Plasma Concentration Versus Time Summary of PF-00489791
Pre-dose at Day 1 of Week 6
|
0.3514 microgram per millilitre (microgram/mL)
Standard Deviation 0.40417
|
—
|
|
Plasma Concentration Versus Time Summary of PF-00489791
4 hours post-dose at Day 1 of Week 6
|
0.9274 microgram per millilitre (microgram/mL)
Standard Deviation 0.52405
|
—
|
|
Plasma Concentration Versus Time Summary of PF-00489791
Pre-dose at Day 1 of Week 12
|
0.3930 microgram per millilitre (microgram/mL)
Standard Deviation 0.41593
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12, 16 (follow-up)Population: Safety analysis set consists of all participants who received at least 1 dose of study medication. Here, 'Number analyzed' = Participants evaluable at specified time points for each arm, respectively.
Level of HbA1c is an indicator for the average level of blood glucose over the previous 3 months. Baseline HbA1c level was determined predose at Week 0 (Day 1).
Outcome measures
| Measure |
Placebo
n=64 Participants
Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.
|
PF-00489791 20 mg
n=192 Participants
PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Plasma Glycosylated Hemoglobin (HbA1c) Level at Week 12 and 16
Change at Week 12
|
0.12 percentage of hemoglobin
Standard Deviation 0.856
|
-0.28 percentage of hemoglobin
Standard Deviation 0.975
|
|
Change From Baseline in Plasma Glycosylated Hemoglobin (HbA1c) Level at Week 12 and 16
Baseline
|
7.13 percentage of hemoglobin
Standard Deviation 1.023
|
7.39 percentage of hemoglobin
Standard Deviation 1.135
|
|
Change From Baseline in Plasma Glycosylated Hemoglobin (HbA1c) Level at Week 12 and 16
Change at Week 16
|
0.14 percentage of hemoglobin
Standard Deviation 1.009
|
-0.09 percentage of hemoglobin
Standard Deviation 0.986
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 16 (follow-up)Population: Safety analysis set consists of all participants who received at least 1 dose of study medication. Here, 'Number analyzed' = Participants evaluable at specified time points for each arm, respectively.
Criteria for determining vital signs abnormalities: supine or standing systolic BP (SBP) (less than \[\<\] 90 mmHg and increase or decrease of greater than or equal to \[\>=\] 30 mmHg compared to baseline value), supine or standing diastolic BP (DBP) (\<50 mmHg and increase or decrease of \>=20 mmHg compared to baseline value), supine pulse rate (\>120 beats per minute \[bpm\] or \<40 bpm), standing pulse rate (\>140 bpm or \<40 bpm). For supine, baseline was the average of the triplicate predose readings at Week 0 (Day 1). For standing, baseline is the predose reading at Week 0 (Day 1). Only categories who had at least 1 participant are reported.
Outcome measures
| Measure |
Placebo
n=64 Participants
Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.
|
PF-00489791 20 mg
n=192 Participants
PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.
|
|---|---|---|
|
Number of Participants With Vital Signs Abnormalities
Supine SBP <90 mmHg
|
0 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs Abnormalities
Standing SBP <90 mmHg
|
0 Participants
|
2 Participants
|
|
Number of Participants With Vital Signs Abnormalities
Supine DBP <50 mmHg
|
0 Participants
|
3 Participants
|
|
Number of Participants With Vital Signs Abnormalities
Standing DBP <50 mmHg
|
0 Participants
|
3 Participants
|
|
Number of Participants With Vital Signs Abnormalities
Supine Pulse Rate <40 bpm
|
0 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs Abnormalities
Increase in Supine SBP >=30 mmHg
|
0 Participants
|
14 Participants
|
|
Number of Participants With Vital Signs Abnormalities
Increase in Standing SBP >=30 mmHg
|
1 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs Abnormalities
Increase in Supine DBP >=20 mmHg
|
0 Participants
|
7 Participants
|
|
Number of Participants With Vital Signs Abnormalities
Increase in Standing DBP >=20 mmHg
|
1 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Abnormalities
Decrease in Supine SBP >=30 mmHg
|
0 Participants
|
9 Participants
|
|
Number of Participants With Vital Signs Abnormalities
Decrease in Standing SBP >=30 mmHg
|
2 Participants
|
11 Participants
|
|
Number of Participants With Vital Signs Abnormalities
Decrease in Supine DBP >=20 mmHg
|
0 Participants
|
5 Participants
|
|
Number of Participants With Vital Signs Abnormalities
Decrease in Standing DBP >=20 mmHg
|
1 Participants
|
11 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 0, 3, 6, 12, 16 (follow-up)Population: Safety analysis set consists of all participants who received at least 1 dose of study medication.
Participants were assessed for signs of edema and fluid overload.
Outcome measures
| Measure |
Placebo
n=64 Participants
Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.
|
PF-00489791 20 mg
n=192 Participants
PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.
|
|---|---|---|
|
Number of Participants With Edema and Fluid Overload
Week 0
|
0 Participants
|
4 Participants
|
|
Number of Participants With Edema and Fluid Overload
Week 3
|
1 Participants
|
8 Participants
|
|
Number of Participants With Edema and Fluid Overload
Week 6
|
1 Participants
|
11 Participants
|
|
Number of Participants With Edema and Fluid Overload
Week 12
|
4 Participants
|
9 Participants
|
|
Number of Participants With Edema and Fluid Overload
Week 16
|
5 Participants
|
6 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 16 (follow-up)Population: Safety analysis set consists of all participants who received at least 1 dose of study medication.
Outcome measures
| Measure |
Placebo
n=64 Participants
Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.
|
PF-00489791 20 mg
n=192 Participants
PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.
|
|---|---|---|
|
Number of Participants With Increased Use of Diuretics
|
3 Participants
|
10 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 16 (follow-up)Population: Safety analysis set consists of all participants who received at least 1 dose of study medication. Here 'N' (Overall Number of Participants Analyzed) signifies participants evaluable for this measure.
Criteria for laboratory test abnormalities: Hematology (hemoglobin \[\<0.8\*lower limit of normal{LLN}\], hematocrit \[\<0.8\*LLN\], red blood cells \[\<0.8\*LLN\], platelet \[\<0.5\*LLN/\>1.75\*upper limit of normal{ULN}\], white blood cells \[\<0.6\*LLN/\>1.5\*ULN\], lymphocytes \[\<0.8\*LLN/\>1.2\*ULN\], neutrophils \[\<0.8\*LLN/\>1.2\*ULN\], basophils \[\>1.2\*ULN\], eosinophils \[\>1.2\*ULN\], monocytes \[\>1.2\*ULN\]); Liver Function (total/direct/indirect bilirubin \[\>1.5\*ULN\], aspartate aminotransferase/ alanine aminotransferase/ gamma glutamyl transpeptidase/ lactate dehydrogenase/ alkaline phosphatase \[\>3.0\*ULN\]); Renal Function (blood urea nitrogen/ creatinine \[\>1.3\*ULN\], uric acid \[\>1.2\*ULN\]); Electrolytes (sodium \[\<0.95\*LLN/\>1.05\*ULN\], potassium, chloride, calcium, bicarbonate \[\<0.9\*LLN/\>1.1\*ULN\]); Clinical Chemistry (glucose \[\<0.6\*LLN/\>1.5\*ULN\], glycosylated hemoglobin \[\>1.3\*ULN\], Creatine Kinase \[\>2.0\*ULN\], Amylase, Lipase\[\>1.5\*ULN\]).
Outcome measures
| Measure |
Placebo
n=63 Participants
Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.
|
PF-00489791 20 mg
n=190 Participants
PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.
|
|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities
|
62 Participants
|
190 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 16 (follow-up)Population: Safety analysis set consists of all participants who received at least 1 dose of study medication.
An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication and up to Week 16 (follow-up) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both non-serious (AEs) and serious adverse events (SAEs)
Outcome measures
| Measure |
Placebo
n=64 Participants
Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.
|
PF-00489791 20 mg
n=192 Participants
PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
36 Participants
|
105 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
6 Participants
|
13 Participants
|
Adverse Events
Placebo
Serious events: 6 serious events
Other events: 35 other events
Deaths: 1 deaths
PF-00489791 20 mg
Serious events: 13 serious events
Other events: 104 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=64 participants at risk
Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.
|
PF-00489791 20 mg
n=192 participants at risk
PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
1.6%
3/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Cardiac disorders
Acute myocardial infarction
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
1.0%
2/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
General disorders
Chest discomfort
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Infections and infestations
Cellulitis
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Infections and infestations
Localised infection
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
1.0%
2/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Renal and urinary disorders
Renal failure acute
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Reproductive system and breast disorders
Prostatitis
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Surgical and medical procedures
Prostatectomy
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Vascular disorders
Accelerated hypertension
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
Other adverse events
| Measure |
Placebo
n=64 participants at risk
Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.
|
PF-00489791 20 mg
n=192 participants at risk
PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
2.1%
4/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
1.0%
2/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Cardiac disorders
Cardiac failure
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Cardiac disorders
Coronary artery disease
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Cardiac disorders
Palpitations
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
1.0%
2/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Eye disorders
Eye irritation
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
1.0%
2/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Eye disorders
Visual impairment
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
1.0%
2/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Colitis
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Constipation
|
3.1%
2/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
1.0%
2/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Diarrhoea
|
3.1%
2/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
8.9%
17/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Dry mouth
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Dyspepsia
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
6.2%
12/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
1.0%
2/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
1.6%
3/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
2.1%
4/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Nausea
|
3.1%
2/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
2.1%
4/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
2/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
3.6%
7/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
General disorders
Chest discomfort
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
General disorders
Chest pain
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
1.0%
2/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
General disorders
Chills
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
General disorders
Face oedema
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
General disorders
Fatigue
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
1.0%
2/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
General disorders
Feeling hot
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
General disorders
Oedema
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
1.6%
3/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
General disorders
Oedema peripheral
|
9.4%
6/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
5.2%
10/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
General disorders
Pyrexia
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
2.1%
4/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Infections and infestations
Abscess limb
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Infections and infestations
Bronchitis
|
3.1%
2/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Infections and infestations
Eye infection bacterial
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Infections and infestations
Influenza
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
1.6%
3/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Infections and infestations
Laryngitis
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Infections and infestations
Mastitis fungal
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Infections and infestations
Nasopharyngitis
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
4.7%
9/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Infections and infestations
Onychomycosis
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
1.0%
2/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Infections and infestations
Rhinitis
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Infections and infestations
Tooth infection
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Infections and infestations
Upper respiratory tract infection
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
3.1%
6/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Infections and infestations
Urinary tract infection
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Injury, poisoning and procedural complications
Contusion
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Injury, poisoning and procedural complications
Lip injury
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Investigations
Amylase increased
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Investigations
Blood calcium decreased
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Investigations
Blood creatine phosphokinase increased
|
4.7%
3/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
3.1%
6/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Investigations
Blood creatinine increased
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Investigations
Blood glucose abnormal
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Investigations
Blood glucose increased
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Investigations
Blood lactate dehydrogenase increased
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Investigations
Blood potassium increased
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
1.6%
3/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Investigations
Blood pressure abnormal
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Investigations
Blood pressure increased
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Investigations
Blood urea increased
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
1.0%
2/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Investigations
Blood uric acid increased
|
3.1%
2/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Investigations
Electrocardiogram ST segment depression
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Investigations
Haemoglobin decreased
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Investigations
International normalised ratio increased
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Investigations
Lipase increased
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
1.0%
2/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Investigations
Liver function test normal
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Investigations
Weight decreased
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Investigations
Weight increased
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
1.0%
2/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
2.1%
4/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
1.0%
2/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
1.6%
3/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
1.6%
3/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.1%
2/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
2.6%
5/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
1.0%
2/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.1%
2/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
1.0%
2/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
1.6%
3/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Monoclonal gammopathy
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Nervous system disorders
Dizziness
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
3.6%
7/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Nervous system disorders
Drooling
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Nervous system disorders
Headache
|
9.4%
6/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
6.2%
12/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Nervous system disorders
Memory impairment
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Nervous system disorders
Somnolence
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
1.0%
2/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Nervous system disorders
Tremor
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Psychiatric disorders
Nervousness
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Renal and urinary disorders
Nocturia
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
1.0%
2/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Renal and urinary disorders
Polyuria
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Renal and urinary disorders
Renal impairment
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Renal and urinary disorders
Urinary incontinence
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Reproductive system and breast disorders
Prostatitis
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Reproductive system and breast disorders
Spontaneous penile erection
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
1.0%
2/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
1.0%
2/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.1%
2/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Skin and subcutaneous tissue disorders
Neuropathic ulcer
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
1.6%
3/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Social circumstances
Immobile
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Vascular disorders
Flushing
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Vascular disorders
Hot flush
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Vascular disorders
Hypertension
|
3.1%
2/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
4.7%
9/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Vascular disorders
Hypotension
|
3.1%
2/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Vascular disorders
Peripheral venous disease
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.00%
0/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
General disorders
Peripheral swelling
|
0.00%
0/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
1.0%
2/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
1.6%
1/64 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
0.52%
1/192 • Baseline up to Week 16 (follow-up)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER