Trial Outcomes & Findings for Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy (NCT NCT01874431)
NCT ID: NCT01874431
Last Updated: 2021-07-01
Results Overview
Albumin-to-creatinine ratio (UACR) is defined as gram of albumin per kilogram of creatinine. UACR was calculating the average of 3 first morning void samples taken on 3 consecutive days.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
823 participants
Primary outcome timeframe
Baseline and Day 90±2
Results posted on
2021-07-01
Participant Flow
The study was conducted at 148 study centers in 23 countries, from 12 June 2013 (first participant, first visit) to 07 August 2014 (last participant, last visit). The randomization was stratified by region (Europe, North America, Asia, others \[Australia, Israel, and South Africa\]), and type of albuminuria at screening (very high or high albuminuria).
Of 1501 participants screened, 823 were randomized at 128 study centers and 678 were screening failures. The reasons were not fulfilled inclusion-/exclusion criteria's (635 participants), withdrawal by participants (37 participants), adverse event (3 participants), physician decision (2 participants), logistical difficulties (1 participant) and lost to follow-up (1 participant).
Participant milestones
| Measure |
Finerenone (BAY94-8862) (1.25 mg)
1.25 milligram (mg) BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (2.5 mg)
2.5 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (5 mg)
5 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (7.5 mg)
7.5 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (10 mg)
10 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (15 mg)
15 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (20 mg)
20 mg BAY94-8862 tablet once daily in the morning for 90 days
|
Placebo
Placebo tablet once daily in the morning for 90 days.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
96
|
92
|
100
|
98
|
98
|
125
|
120
|
94
|
|
Overall Study
Participants Received Treatment
|
96
|
92
|
100
|
97
|
98
|
125
|
119
|
94
|
|
Overall Study
COMPLETED
|
90
|
87
|
90
|
91
|
90
|
114
|
112
|
90
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
10
|
7
|
8
|
11
|
8
|
4
|
Reasons for withdrawal
| Measure |
Finerenone (BAY94-8862) (1.25 mg)
1.25 milligram (mg) BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (2.5 mg)
2.5 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (5 mg)
5 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (7.5 mg)
7.5 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (10 mg)
10 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (15 mg)
15 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (20 mg)
20 mg BAY94-8862 tablet once daily in the morning for 90 days
|
Placebo
Placebo tablet once daily in the morning for 90 days.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
5
|
4
|
6
|
5
|
2
|
8
|
2
|
3
|
|
Overall Study
Protocol Violation
|
1
|
1
|
1
|
0
|
3
|
2
|
1
|
1
|
|
Overall Study
Non-compliance
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Logistical difficulties
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
2
|
1
|
1
|
3
|
0
|
|
Overall Study
Sponsor decision
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Participants with valid data for this baseline characteristic
Baseline characteristics by cohort
| Measure |
Finerenone (BAY94-8862) (1.25 mg)
n=96 Participants
1.25 milligram (mg) BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (2.5 mg)
n=92 Participants
2.5 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (5 mg)
n=100 Participants
5 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (7.5 mg)
n=97 Participants
7.5 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (10 mg)
n=98 Participants
10 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (15 mg)
n=125 Participants
15 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (20 mg)
n=119 Participants
20 mg BAY94-8862 tablet once daily in the morning for 90 days
|
Placebo
n=94 Participants
Placebo tablet once daily in the morning for 90 days.
|
Total
n=821 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
64.91 years
STANDARD_DEVIATION 9.57 • n=96 Participants
|
64.86 years
STANDARD_DEVIATION 9.09 • n=92 Participants
|
63.31 years
STANDARD_DEVIATION 8.79 • n=100 Participants
|
63.73 years
STANDARD_DEVIATION 10.04 • n=97 Participants
|
64.94 years
STANDARD_DEVIATION 9.62 • n=98 Participants
|
63.95 years
STANDARD_DEVIATION 8.34 • n=125 Participants
|
64.70 years
STANDARD_DEVIATION 9.26 • n=119 Participants
|
63.26 years
STANDARD_DEVIATION 8.68 • n=94 Participants
|
64.21 years
STANDARD_DEVIATION 9.15 • n=821 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=96 Participants
|
14 Participants
n=92 Participants
|
29 Participants
n=100 Participants
|
18 Participants
n=97 Participants
|
21 Participants
n=98 Participants
|
27 Participants
n=125 Participants
|
30 Participants
n=119 Participants
|
25 Participants
n=94 Participants
|
182 Participants
n=821 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=96 Participants
|
78 Participants
n=92 Participants
|
71 Participants
n=100 Participants
|
79 Participants
n=97 Participants
|
77 Participants
n=98 Participants
|
98 Participants
n=125 Participants
|
89 Participants
n=119 Participants
|
69 Participants
n=94 Participants
|
639 Participants
n=821 Participants
|
|
Baseline UACR
|
412.02 g/kg
STANDARD_DEVIATION 507.51 • n=96 Participants
|
471.01 g/kg
STANDARD_DEVIATION 784.84 • n=92 Participants
|
402.04 g/kg
STANDARD_DEVIATION 535.44 • n=100 Participants
|
405.14 g/kg
STANDARD_DEVIATION 702.63 • n=97 Participants
|
441.16 g/kg
STANDARD_DEVIATION 571.27 • n=98 Participants
|
450.12 g/kg
STANDARD_DEVIATION 657.04 • n=125 Participants
|
379.28 g/kg
STANDARD_DEVIATION 457.33 • n=119 Participants
|
377.28 g/kg
STANDARD_DEVIATION 542.27 • n=94 Participants
|
417.16 g/kg
STANDARD_DEVIATION 599.12 • n=821 Participants
|
|
Baseline potassium
|
4.323 mmol/L
STANDARD_DEVIATION 0.425 • n=96 Participants
|
4.297 mmol/L
STANDARD_DEVIATION 0.426 • n=92 Participants
|
4.314 mmol/L
STANDARD_DEVIATION 0.325 • n=100 Participants
|
4.311 mmol/L
STANDARD_DEVIATION 0.435 • n=97 Participants
|
4.297 mmol/L
STANDARD_DEVIATION 0.420 • n=98 Participants
|
4.288 mmol/L
STANDARD_DEVIATION 0.459 • n=125 Participants
|
4.294 mmol/L
STANDARD_DEVIATION 0.439 • n=119 Participants
|
4.254 mmol/L
STANDARD_DEVIATION 0.479 • n=94 Participants
|
4.297 mmol/L
STANDARD_DEVIATION 0.427 • n=821 Participants
|
|
Baseline eGFR
|
66.113 mL/min/1.73m^2
STANDARD_DEVIATION 21.923 • n=96 Participants
|
67.425 mL/min/1.73m^2
STANDARD_DEVIATION 20.164 • n=92 Participants
|
67.080 mL/min/1.73m^2
STANDARD_DEVIATION 22.205 • n=100 Participants
|
67.497 mL/min/1.73m^2
STANDARD_DEVIATION 21.917 • n=97 Participants
|
67.042 mL/min/1.73m^2
STANDARD_DEVIATION 20.857 • n=98 Participants
|
67.455 mL/min/1.73m^2
STANDARD_DEVIATION 23.646 • n=125 Participants
|
66.039 mL/min/1.73m^2
STANDARD_DEVIATION 22.205 • n=119 Participants
|
72.213 mL/min/1.73m^2
STANDARD_DEVIATION 20.434 • n=94 Participants
|
67.544 mL/min/1.73m^2
STANDARD_DEVIATION 21.772 • n=821 Participants
|
|
Baseline KDQOL-36 domain score (Effects of Kidney Disease)
|
90.78 Scores on a scale
STANDARD_DEVIATION 10.28 • n=95 Participants • Participants with valid data for this baseline characteristic
|
92.53 Scores on a scale
STANDARD_DEVIATION 9.57 • n=90 Participants • Participants with valid data for this baseline characteristic
|
91.78 Scores on a scale
STANDARD_DEVIATION 12.55 • n=97 Participants • Participants with valid data for this baseline characteristic
|
92.99 Scores on a scale
STANDARD_DEVIATION 11.04 • n=96 Participants • Participants with valid data for this baseline characteristic
|
88.71 Scores on a scale
STANDARD_DEVIATION 16.50 • n=96 Participants • Participants with valid data for this baseline characteristic
|
90.45 Scores on a scale
STANDARD_DEVIATION 14.39 • n=122 Participants • Participants with valid data for this baseline characteristic
|
89.10 Scores on a scale
STANDARD_DEVIATION 17.45 • n=116 Participants • Participants with valid data for this baseline characteristic
|
81.45 Scores on a scale
STANDARD_DEVIATION 20.42 • n=93 Participants • Participants with valid data for this baseline characteristic
|
90.57 Scores on a scale
STANDARD_DEVIATION 13.69 • n=805 Participants • Participants with valid data for this baseline characteristic
|
|
Baseline EQ-5D scores (EQ5D - Visual Analog Scale)
|
71.76 Score on a scale
STANDARD_DEVIATION 16.39 • n=96 Participants • Participants with valid data for this baseline characteristic
|
72.79 Score on a scale
STANDARD_DEVIATION 14.81 • n=89 Participants • Participants with valid data for this baseline characteristic
|
73.01 Score on a scale
STANDARD_DEVIATION 16.21 • n=95 Participants • Participants with valid data for this baseline characteristic
|
74.49 Score on a scale
STANDARD_DEVIATION 15.92 • n=96 Participants • Participants with valid data for this baseline characteristic
|
73.89 Score on a scale
STANDARD_DEVIATION 16.47 • n=95 Participants • Participants with valid data for this baseline characteristic
|
73.19 Score on a scale
STANDARD_DEVIATION 16.11 • n=121 Participants • Participants with valid data for this baseline characteristic
|
71.36 Score on a scale
STANDARD_DEVIATION 17.49 • n=117 Participants • Participants with valid data for this baseline characteristic
|
70.05 Score on a scale
STANDARD_DEVIATION 17.69 • n=92 Participants • Participants with valid data for this baseline characteristic
|
72.56 Score on a scale
STANDARD_DEVIATION 16.42 • n=801 Participants • Participants with valid data for this baseline characteristic
|
PRIMARY outcome
Timeframe: Baseline and Day 90±2Population: Full analysis set (FAS): included all participants of the SAF who had baseline and at least one post-baseline UACR value.
Albumin-to-creatinine ratio (UACR) is defined as gram of albumin per kilogram of creatinine. UACR was calculating the average of 3 first morning void samples taken on 3 consecutive days.
Outcome measures
| Measure |
Finerenone (BAY94-8862) (1.25 mg)
n=96 Participants
1.25 milligram (mg) BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (2.5 mg)
n=92 Participants
2.5 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (5 mg)
n=98 Participants
5 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (7.5 mg)
n=96 Participants
7.5 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (10 mg)
n=96 Participants
10 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (15 mg)
n=123 Participants
15 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (20 mg)
n=117 Participants
20 mg BAY94-8862 tablet once daily in the morning for 90 days
|
Placebo
n=94 Participants
Placebo tablet once daily in the morning for 90 days.
|
|---|---|---|---|---|---|---|---|---|
|
Ratio of UACR at Day 90 to UACR at Baseline
|
0.869 Ratio
90% Confidence Interval 0.772 • Interval 0.772 to 0.979
|
0.89 Ratio
90% Confidence Interval 0.786 • Interval 0.786 to 1.009
|
0.824 Ratio
90% Confidence Interval 0.73 • Interval 0.73 to 0.929
|
0.739 Ratio
90% Confidence Interval 0.653 • Interval 0.653 to 0.835
|
0.708 Ratio
90% Confidence Interval 0.627 • Interval 0.627 to 0.8
|
0.63 Ratio
90% Confidence Interval 0.563 • Interval 0.563 to 0.705
|
0.585 Ratio
90% Confidence Interval 0.523 • Interval 0.523 to 0.654
|
0.938 Ratio
90% Confidence Interval 0.829 • Interval 0.829 to 1.061
|
SECONDARY outcome
Timeframe: Baseline and Day 90±2Population: Participants in SAF with valid data for this endpoint
Outcome measures
| Measure |
Finerenone (BAY94-8862) (1.25 mg)
n=90 Participants
1.25 milligram (mg) BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (2.5 mg)
n=87 Participants
2.5 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (5 mg)
n=85 Participants
5 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (7.5 mg)
n=88 Participants
7.5 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (10 mg)
n=87 Participants
10 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (15 mg)
n=109 Participants
15 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (20 mg)
n=112 Participants
20 mg BAY94-8862 tablet once daily in the morning for 90 days
|
Placebo
n=90 Participants
Placebo tablet once daily in the morning for 90 days.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Day 90 in Serum Potassium
|
0.109 millimole per liter
Interval 0.03 to 0.187
|
0.123 millimole per liter
Interval 0.043 to 0.203
|
0.202 millimole per liter
Interval 0.122 to 0.282
|
0.127 millimole per liter
Interval 0.047 to 0.207
|
0.167 millimole per liter
Interval 0.087 to 0.248
|
0.238 millimole per liter
Interval 0.165 to 0.31
|
0.188 millimole per liter
Interval 0.116 to 0.259
|
0.002 millimole per liter
Interval -0.077 to 0.081
|
SECONDARY outcome
Timeframe: Baseline and Day 90±2Population: Participants in SAF with valid data for this endpoint
An estimated glomerular filtration rate (eGFR) indicates the renal function. An eGFR was calculated based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
Outcome measures
| Measure |
Finerenone (BAY94-8862) (1.25 mg)
n=90 Participants
1.25 milligram (mg) BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (2.5 mg)
n=87 Participants
2.5 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (5 mg)
n=85 Participants
5 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (7.5 mg)
n=88 Participants
7.5 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (10 mg)
n=87 Participants
10 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (15 mg)
n=113 Participants
15 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (20 mg)
n=112 Participants
20 mg BAY94-8862 tablet once daily in the morning for 90 days
|
Placebo
n=90 Participants
Placebo tablet once daily in the morning for 90 days.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Day 90 in eGFR
|
-2.364 mL/min/1.73m^2
95% Confidence Interval -4.311 • Interval -4.311 to -0.418
|
-3.189 mL/min/1.73m^2
95% Confidence Interval -5.164 • Interval -5.164 to -1.213
|
-2.497 mL/min/1.73m^2
95% Confidence Interval -4.475 • Interval -4.475 to -0.518
|
-3.378 mL/min/1.73m^2
95% Confidence Interval -5.341 • Interval -5.341 to -1.415
|
-4.192 mL/min/1.73m^2
95% Confidence Interval -6.181 • Interval -6.181 to -2.202
|
-3.806 mL/min/1.73m^2
95% Confidence Interval -5.563 • Interval -5.563 to -2.05
|
-4.024 mL/min/1.73m^2
95% Confidence Interval -5.792 • Interval -5.792 to -2.256
|
-1.578 mL/min/1.73m^2
95% Confidence Interval -3.53 • Interval -3.53 to 0.373
|
SECONDARY outcome
Timeframe: Baseline and Day 90±2Population: Participants in FAS with valid data for this endpoint
The Kidney Disease QOL \[KDQOL\]-36 questionnaire is a specific measure of Health-Related Quality of Life (HRQoL) for chronic kidney disease (CKD) that includes effects and burden of kidney disease as well as physical and mental health scores. Index score ranges from 0 (severe problems in all items) to 100 (no problem in all items). "Effects of Kidney disease" subscore was analyzed.
Outcome measures
| Measure |
Finerenone (BAY94-8862) (1.25 mg)
n=89 Participants
1.25 milligram (mg) BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (2.5 mg)
n=84 Participants
2.5 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (5 mg)
n=87 Participants
5 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (7.5 mg)
n=89 Participants
7.5 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (10 mg)
n=88 Participants
10 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (15 mg)
n=113 Participants
15 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (20 mg)
n=109 Participants
20 mg BAY94-8862 tablet once daily in the morning for 90 days
|
Placebo
n=89 Participants
Placebo tablet once daily in the morning for 90 days.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Day 90 in KDQOL-36 Domain Score (Effects of Kidney Disease)
|
-2.116 scores on a scale
95% Confidence Interval -4.521 • Interval -4.521 to 0.289
|
0.104 scores on a scale
95% Confidence Interval -2.369 • Interval -2.369 to 2.577
|
-1.229 scores on a scale
95% Confidence Interval -3.643 • Interval -3.643 to 1.185
|
-1.185 scores on a scale
95% Confidence Interval -3.597 • Interval -3.597 to 1.226
|
-2.596 scores on a scale
95% Confidence Interval -5.049 • Interval -5.049 to -0.142
|
0.112 scores on a scale
95% Confidence Interval -2.054 • Interval -2.054 to 2.278
|
0.058 scores on a scale
95% Confidence Interval -2.146 • Interval -2.146 to 2.263
|
0.747 scores on a scale
95% Confidence Interval -1.684 • Interval -1.684 to 3.178
|
SECONDARY outcome
Timeframe: Baseline and Day 90±2Population: Participants in FAS with valid data for this endpoint
EuroQol Group 5-Dimension, 3-Level (EQ-5D-3L) questionnaires consist of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. EQ VAS was analyzed for this endpoint and it ranges from 0 (worst possible health state) to 100 (best possible health state).
Outcome measures
| Measure |
Finerenone (BAY94-8862) (1.25 mg)
n=89 Participants
1.25 milligram (mg) BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (2.5 mg)
n=83 Participants
2.5 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (5 mg)
n=86 Participants
5 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (7.5 mg)
n=89 Participants
7.5 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (10 mg)
n=86 Participants
10 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (15 mg)
n=112 Participants
15 mg BAY94-8862 tablet once daily in the morning for 90 days.
|
Finerenone (BAY94-8862) (20 mg)
n=109 Participants
20 mg BAY94-8862 tablet once daily in the morning for 90 days
|
Placebo
n=88 Participants
Placebo tablet once daily in the morning for 90 days.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Day 90 in EQ-5D Scores (EQ5D - Visual Analog Scale)
|
1.381 scores on a scale
95% Confidence Interval -1.22 • Interval -1.22 to 3.982
|
3.888 scores on a scale
95% Confidence Interval 1.208 • Interval 1.208 to 6.568
|
3.124 scores on a scale
95% Confidence Interval 0.494 • Interval 0.494 to 5.754
|
2.851 scores on a scale
95% Confidence Interval 0.241 • Interval 0.241 to 5.461
|
2.698 scores on a scale
95% Confidence Interval 0.026 • Interval 0.026 to 5.37
|
2.743 scores on a scale
95% Confidence Interval 0.394 • Interval 0.394 to 5.092
|
1.914 scores on a scale
95% Confidence Interval -0.465 • Interval -0.465 to 4.292
|
4.425 scores on a scale
95% Confidence Interval 1.794 • Interval 1.794 to 7.057
|
Adverse Events
Finerenone (BAY94-8862) (1.25 mg)
Serious events: 5 serious events
Other events: 14 other events
Deaths: 0 deaths
Finerenone (BAY94-8862)(2.5 mg)
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Finerenone (BAY94-8862)(5 mg)
Serious events: 7 serious events
Other events: 13 other events
Deaths: 0 deaths
Finerenone (BAY94-8862)(7.5 mg)
Serious events: 8 serious events
Other events: 11 other events
Deaths: 0 deaths
Finerenone (BAY94-8862)(10 mg)
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Finerenone (BAY94-8862)(15 mg)
Serious events: 6 serious events
Other events: 11 other events
Deaths: 1 deaths
Finerenone (BAY94-8862)(20 mg)
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 8 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Finerenone (BAY94-8862) (1.25 mg)
n=96 participants at risk
1.25 milligram (mg) BAY94-8862 tablet once daily in the morning for 90 days
|
Finerenone (BAY94-8862)(2.5 mg)
n=92 participants at risk
2.5 mg BAY94-8862 tablet once daily in the morning for 90 days
|
Finerenone (BAY94-8862)(5 mg)
n=100 participants at risk
5 mg BAY94-8862 tablet once daily in the morning for 90 days
|
Finerenone (BAY94-8862)(7.5 mg)
n=97 participants at risk
7.5 mg BAY94-8862 tablet once daily in the morning for 90 days
|
Finerenone (BAY94-8862)(10 mg)
n=98 participants at risk
10 mg BAY94-8862 tablet once daily in the morning for 90 days
|
Finerenone (BAY94-8862)(15 mg)
n=125 participants at risk
15 mg BAY94-8862 tablet once daily in the morning for 90 days
|
Finerenone (BAY94-8862)(20 mg)
n=119 participants at risk
20 mg BAY94-8862 tablet once daily in the morning for 90 days
|
Placebo
n=94 participants at risk
Placebo tablet once daily in the morning for 90 days
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/96 • Up to approximately 93 days after the start of study drug
|
0.00%
0/92 • Up to approximately 93 days after the start of study drug
|
0.00%
0/100 • Up to approximately 93 days after the start of study drug
|
0.00%
0/97 • Up to approximately 93 days after the start of study drug
|
1.0%
1/98 • Number of events 1 • Up to approximately 93 days after the start of study drug
|
0.00%
0/125 • Up to approximately 93 days after the start of study drug
|
0.00%
0/119 • Up to approximately 93 days after the start of study drug
|
0.00%
0/94 • Up to approximately 93 days after the start of study drug
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/96 • Up to approximately 93 days after the start of study drug
|
0.00%
0/92 • Up to approximately 93 days after the start of study drug
|
0.00%
0/100 • Up to approximately 93 days after the start of study drug
|
0.00%
0/97 • Up to approximately 93 days after the start of study drug
|
0.00%
0/98 • Up to approximately 93 days after the start of study drug
|
0.00%
0/125 • Up to approximately 93 days after the start of study drug
|
0.84%
1/119 • Number of events 1 • Up to approximately 93 days after the start of study drug
|
0.00%
0/94 • Up to approximately 93 days after the start of study drug
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/96 • Up to approximately 93 days after the start of study drug
|
0.00%
0/92 • Up to approximately 93 days after the start of study drug
|
1.0%
1/100 • Number of events 1 • Up to approximately 93 days after the start of study drug
|
0.00%
0/97 • Up to approximately 93 days after the start of study drug
|
0.00%
0/98 • Up to approximately 93 days after the start of study drug
|
0.00%
0/125 • Up to approximately 93 days after the start of study drug
|
0.00%
0/119 • Up to approximately 93 days after the start of study drug
|
0.00%
0/94 • Up to approximately 93 days after the start of study drug
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/96 • Up to approximately 93 days after the start of study drug
|
0.00%
0/92 • Up to approximately 93 days after the start of study drug
|
0.00%
0/100 • Up to approximately 93 days after the start of study drug
|
1.0%
1/97 • Number of events 1 • Up to approximately 93 days after the start of study drug
|
1.0%
1/98 • Number of events 1 • Up to approximately 93 days after the start of study drug
|
0.00%
0/125 • Up to approximately 93 days after the start of study drug
|
0.00%
0/119 • Up to approximately 93 days after the start of study drug
|
0.00%
0/94 • Up to approximately 93 days after the start of study drug
|
|
Eye disorders
Angle closure glaucoma
|
0.00%
0/96 • Up to approximately 93 days after the start of study drug
|
0.00%
0/92 • Up to approximately 93 days after the start of study drug
|
1.0%
1/100 • Number of events 2 • Up to approximately 93 days after the start of study drug
|
0.00%
0/97 • Up to approximately 93 days after the start of study drug
|
0.00%
0/98 • Up to approximately 93 days after the start of study drug
|
0.00%
0/125 • Up to approximately 93 days after the start of study drug
|
0.00%
0/119 • Up to approximately 93 days after the start of study drug
|
0.00%
0/94 • Up to approximately 93 days after the start of study drug
|
|
General disorders
Local swelling
|
0.00%
0/96 • Up to approximately 93 days after the start of study drug
|
0.00%
0/92 • Up to approximately 93 days after the start of study drug
|
0.00%
0/100 • Up to approximately 93 days after the start of study drug
|
0.00%
0/97 • Up to approximately 93 days after the start of study drug
|
0.00%
0/98 • Up to approximately 93 days after the start of study drug
|
0.00%
0/125 • Up to approximately 93 days after the start of study drug
|
0.00%
0/119 • Up to approximately 93 days after the start of study drug
|
1.1%
1/94 • Number of events 1 • Up to approximately 93 days after the start of study drug
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/96 • Up to approximately 93 days after the start of study drug
|
1.1%
1/92 • Number of events 1 • Up to approximately 93 days after the start of study drug
|
0.00%
0/100 • Up to approximately 93 days after the start of study drug
|
0.00%
0/97 • Up to approximately 93 days after the start of study drug
|
0.00%
0/98 • Up to approximately 93 days after the start of study drug
|
0.00%
0/125 • Up to approximately 93 days after the start of study drug
|
0.00%
0/119 • Up to approximately 93 days after the start of study drug
|
0.00%
0/94 • Up to approximately 93 days after the start of study drug
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/96 • Up to approximately 93 days after the start of study drug
|
0.00%
0/92 • Up to approximately 93 days after the start of study drug
|
1.0%
1/100 • Number of events 1 • Up to approximately 93 days after the start of study drug
|
0.00%
0/97 • Up to approximately 93 days after the start of study drug
|
0.00%
0/98 • Up to approximately 93 days after the start of study drug
|
0.00%
0/125 • Up to approximately 93 days after the start of study drug
|
0.00%
0/119 • Up to approximately 93 days after the start of study drug
|
0.00%
0/94 • Up to approximately 93 days after the start of study drug
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/96 • Up to approximately 93 days after the start of study drug
|
0.00%
0/92 • Up to approximately 93 days after the start of study drug
|
0.00%
0/100 • Up to approximately 93 days after the start of study drug
|
1.0%
1/97 • Number of events 1 • Up to approximately 93 days after the start of study drug
|
0.00%
0/98 • Up to approximately 93 days after the start of study drug
|
0.00%
0/125 • Up to approximately 93 days after the start of study drug
|
0.00%
0/119 • Up to approximately 93 days after the start of study drug
|
0.00%
0/94 • Up to approximately 93 days after the start of study drug
|
|
Infections and infestations
Urosepsis
|
0.00%
0/96 • Up to approximately 93 days after the start of study drug
|
0.00%
0/92 • Up to approximately 93 days after the start of study drug
|
0.00%
0/100 • Up to approximately 93 days after the start of study drug
|
1.0%
1/97 • Number of events 1 • Up to approximately 93 days after the start of study drug
|
0.00%
0/98 • Up to approximately 93 days after the start of study drug
|
0.00%
0/125 • Up to approximately 93 days after the start of study drug
|
0.00%
0/119 • Up to approximately 93 days after the start of study drug
|
0.00%
0/94 • Up to approximately 93 days after the start of study drug
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/96 • Up to approximately 93 days after the start of study drug
|
0.00%
0/92 • Up to approximately 93 days after the start of study drug
|
1.0%
1/100 • Number of events 1 • Up to approximately 93 days after the start of study drug
|
0.00%
0/97 • Up to approximately 93 days after the start of study drug
|
0.00%
0/98 • Up to approximately 93 days after the start of study drug
|
0.00%
0/125 • Up to approximately 93 days after the start of study drug
|
0.00%
0/119 • Up to approximately 93 days after the start of study drug
|
0.00%
0/94 • Up to approximately 93 days after the start of study drug
|
|
Investigations
Blood potassium increased
|
0.00%
0/96 • Up to approximately 93 days after the start of study drug
|
1.1%
1/92 • Number of events 1 • Up to approximately 93 days after the start of study drug
|
0.00%
0/100 • Up to approximately 93 days after the start of study drug
|
1.0%
1/97 • Number of events 1 • Up to approximately 93 days after the start of study drug
|
0.00%
0/98 • Up to approximately 93 days after the start of study drug
|
1.6%
2/125 • Number of events 2 • Up to approximately 93 days after the start of study drug
|
0.84%
1/119 • Number of events 1 • Up to approximately 93 days after the start of study drug
|
0.00%
0/94 • Up to approximately 93 days after the start of study drug
|
|
Investigations
Pancreatic enzymes increased
|
0.00%
0/96 • Up to approximately 93 days after the start of study drug
|
1.1%
1/92 • Number of events 1 • Up to approximately 93 days after the start of study drug
|
0.00%
0/100 • Up to approximately 93 days after the start of study drug
|
0.00%
0/97 • Up to approximately 93 days after the start of study drug
|
0.00%
0/98 • Up to approximately 93 days after the start of study drug
|
0.00%
0/125 • Up to approximately 93 days after the start of study drug
|
0.00%
0/119 • Up to approximately 93 days after the start of study drug
|
0.00%
0/94 • Up to approximately 93 days after the start of study drug
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/96 • Up to approximately 93 days after the start of study drug
|
0.00%
0/92 • Up to approximately 93 days after the start of study drug
|
0.00%
0/100 • Up to approximately 93 days after the start of study drug
|
0.00%
0/97 • Up to approximately 93 days after the start of study drug
|
1.0%
1/98 • Number of events 1 • Up to approximately 93 days after the start of study drug
|
0.00%
0/125 • Up to approximately 93 days after the start of study drug
|
0.00%
0/119 • Up to approximately 93 days after the start of study drug
|
0.00%
0/94 • Up to approximately 93 days after the start of study drug
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.1%
2/96 • Number of events 2 • Up to approximately 93 days after the start of study drug
|
0.00%
0/92 • Up to approximately 93 days after the start of study drug
|
1.0%
1/100 • Number of events 1 • Up to approximately 93 days after the start of study drug
|
1.0%
1/97 • Number of events 1 • Up to approximately 93 days after the start of study drug
|
0.00%
0/98 • Up to approximately 93 days after the start of study drug
|
1.6%
2/125 • Number of events 2 • Up to approximately 93 days after the start of study drug
|
1.7%
2/119 • Number of events 2 • Up to approximately 93 days after the start of study drug
|
0.00%
0/94 • Up to approximately 93 days after the start of study drug
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.0%
1/96 • Number of events 1 • Up to approximately 93 days after the start of study drug
|
0.00%
0/92 • Up to approximately 93 days after the start of study drug
|
0.00%
0/100 • Up to approximately 93 days after the start of study drug
|
0.00%
0/97 • Up to approximately 93 days after the start of study drug
|
0.00%
0/98 • Up to approximately 93 days after the start of study drug
|
0.00%
0/125 • Up to approximately 93 days after the start of study drug
|
0.00%
0/119 • Up to approximately 93 days after the start of study drug
|
0.00%
0/94 • Up to approximately 93 days after the start of study drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/96 • Up to approximately 93 days after the start of study drug
|
0.00%
0/92 • Up to approximately 93 days after the start of study drug
|
1.0%
1/100 • Number of events 1 • Up to approximately 93 days after the start of study drug
|
0.00%
0/97 • Up to approximately 93 days after the start of study drug
|
0.00%
0/98 • Up to approximately 93 days after the start of study drug
|
0.00%
0/125 • Up to approximately 93 days after the start of study drug
|
0.00%
0/119 • Up to approximately 93 days after the start of study drug
|
0.00%
0/94 • Up to approximately 93 days after the start of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/96 • Up to approximately 93 days after the start of study drug
|
0.00%
0/92 • Up to approximately 93 days after the start of study drug
|
0.00%
0/100 • Up to approximately 93 days after the start of study drug
|
0.00%
0/97 • Up to approximately 93 days after the start of study drug
|
0.00%
0/98 • Up to approximately 93 days after the start of study drug
|
0.80%
1/125 • Number of events 1 • Up to approximately 93 days after the start of study drug
|
0.00%
0/119 • Up to approximately 93 days after the start of study drug
|
0.00%
0/94 • Up to approximately 93 days after the start of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.0%
1/96 • Number of events 1 • Up to approximately 93 days after the start of study drug
|
0.00%
0/92 • Up to approximately 93 days after the start of study drug
|
0.00%
0/100 • Up to approximately 93 days after the start of study drug
|
1.0%
1/97 • Number of events 1 • Up to approximately 93 days after the start of study drug
|
0.00%
0/98 • Up to approximately 93 days after the start of study drug
|
0.00%
0/125 • Up to approximately 93 days after the start of study drug
|
0.00%
0/119 • Up to approximately 93 days after the start of study drug
|
0.00%
0/94 • Up to approximately 93 days after the start of study drug
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/96 • Up to approximately 93 days after the start of study drug
|
0.00%
0/92 • Up to approximately 93 days after the start of study drug
|
0.00%
0/100 • Up to approximately 93 days after the start of study drug
|
1.0%
1/97 • Number of events 1 • Up to approximately 93 days after the start of study drug
|
0.00%
0/98 • Up to approximately 93 days after the start of study drug
|
0.00%
0/125 • Up to approximately 93 days after the start of study drug
|
0.00%
0/119 • Up to approximately 93 days after the start of study drug
|
1.1%
1/94 • Number of events 1 • Up to approximately 93 days after the start of study drug
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.00%
0/96 • Up to approximately 93 days after the start of study drug
|
0.00%
0/92 • Up to approximately 93 days after the start of study drug
|
1.0%
1/100 • Number of events 1 • Up to approximately 93 days after the start of study drug
|
0.00%
0/97 • Up to approximately 93 days after the start of study drug
|
0.00%
0/98 • Up to approximately 93 days after the start of study drug
|
0.00%
0/125 • Up to approximately 93 days after the start of study drug
|
0.00%
0/119 • Up to approximately 93 days after the start of study drug
|
0.00%
0/94 • Up to approximately 93 days after the start of study drug
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/96 • Up to approximately 93 days after the start of study drug
|
0.00%
0/92 • Up to approximately 93 days after the start of study drug
|
1.0%
1/100 • Number of events 1 • Up to approximately 93 days after the start of study drug
|
0.00%
0/97 • Up to approximately 93 days after the start of study drug
|
0.00%
0/98 • Up to approximately 93 days after the start of study drug
|
0.00%
0/125 • Up to approximately 93 days after the start of study drug
|
0.00%
0/119 • Up to approximately 93 days after the start of study drug
|
0.00%
0/94 • Up to approximately 93 days after the start of study drug
|
|
Nervous system disorders
Syncope
|
0.00%
0/96 • Up to approximately 93 days after the start of study drug
|
0.00%
0/92 • Up to approximately 93 days after the start of study drug
|
0.00%
0/100 • Up to approximately 93 days after the start of study drug
|
1.0%
1/97 • Number of events 1 • Up to approximately 93 days after the start of study drug
|
0.00%
0/98 • Up to approximately 93 days after the start of study drug
|
0.00%
0/125 • Up to approximately 93 days after the start of study drug
|
0.00%
0/119 • Up to approximately 93 days after the start of study drug
|
0.00%
0/94 • Up to approximately 93 days after the start of study drug
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/96 • Up to approximately 93 days after the start of study drug
|
0.00%
0/92 • Up to approximately 93 days after the start of study drug
|
0.00%
0/100 • Up to approximately 93 days after the start of study drug
|
0.00%
0/97 • Up to approximately 93 days after the start of study drug
|
0.00%
0/98 • Up to approximately 93 days after the start of study drug
|
0.00%
0/125 • Up to approximately 93 days after the start of study drug
|
0.00%
0/119 • Up to approximately 93 days after the start of study drug
|
1.1%
1/94 • Number of events 1 • Up to approximately 93 days after the start of study drug
|
|
Renal and urinary disorders
Renal impairment
|
1.0%
1/96 • Number of events 1 • Up to approximately 93 days after the start of study drug
|
0.00%
0/92 • Up to approximately 93 days after the start of study drug
|
0.00%
0/100 • Up to approximately 93 days after the start of study drug
|
0.00%
0/97 • Up to approximately 93 days after the start of study drug
|
0.00%
0/98 • Up to approximately 93 days after the start of study drug
|
0.00%
0/125 • Up to approximately 93 days after the start of study drug
|
0.00%
0/119 • Up to approximately 93 days after the start of study drug
|
0.00%
0/94 • Up to approximately 93 days after the start of study drug
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.00%
0/96 • Up to approximately 93 days after the start of study drug
|
0.00%
0/92 • Up to approximately 93 days after the start of study drug
|
0.00%
0/100 • Up to approximately 93 days after the start of study drug
|
1.0%
1/97 • Number of events 1 • Up to approximately 93 days after the start of study drug
|
0.00%
0/98 • Up to approximately 93 days after the start of study drug
|
0.00%
0/125 • Up to approximately 93 days after the start of study drug
|
0.00%
0/119 • Up to approximately 93 days after the start of study drug
|
0.00%
0/94 • Up to approximately 93 days after the start of study drug
|
|
Surgical and medical procedures
Toe amputation
|
1.0%
1/96 • Number of events 1 • Up to approximately 93 days after the start of study drug
|
0.00%
0/92 • Up to approximately 93 days after the start of study drug
|
0.00%
0/100 • Up to approximately 93 days after the start of study drug
|
0.00%
0/97 • Up to approximately 93 days after the start of study drug
|
0.00%
0/98 • Up to approximately 93 days after the start of study drug
|
0.00%
0/125 • Up to approximately 93 days after the start of study drug
|
0.00%
0/119 • Up to approximately 93 days after the start of study drug
|
0.00%
0/94 • Up to approximately 93 days after the start of study drug
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/96 • Up to approximately 93 days after the start of study drug
|
0.00%
0/92 • Up to approximately 93 days after the start of study drug
|
0.00%
0/100 • Up to approximately 93 days after the start of study drug
|
0.00%
0/97 • Up to approximately 93 days after the start of study drug
|
0.00%
0/98 • Up to approximately 93 days after the start of study drug
|
0.00%
0/125 • Up to approximately 93 days after the start of study drug
|
0.00%
0/119 • Up to approximately 93 days after the start of study drug
|
1.1%
1/94 • Number of events 1 • Up to approximately 93 days after the start of study drug
|
|
Vascular disorders
Peripheral artery stenosis
|
0.00%
0/96 • Up to approximately 93 days after the start of study drug
|
0.00%
0/92 • Up to approximately 93 days after the start of study drug
|
0.00%
0/100 • Up to approximately 93 days after the start of study drug
|
0.00%
0/97 • Up to approximately 93 days after the start of study drug
|
0.00%
0/98 • Up to approximately 93 days after the start of study drug
|
0.80%
1/125 • Number of events 1 • Up to approximately 93 days after the start of study drug
|
0.00%
0/119 • Up to approximately 93 days after the start of study drug
|
0.00%
0/94 • Up to approximately 93 days after the start of study drug
|
Other adverse events
| Measure |
Finerenone (BAY94-8862) (1.25 mg)
n=96 participants at risk
1.25 milligram (mg) BAY94-8862 tablet once daily in the morning for 90 days
|
Finerenone (BAY94-8862)(2.5 mg)
n=92 participants at risk
2.5 mg BAY94-8862 tablet once daily in the morning for 90 days
|
Finerenone (BAY94-8862)(5 mg)
n=100 participants at risk
5 mg BAY94-8862 tablet once daily in the morning for 90 days
|
Finerenone (BAY94-8862)(7.5 mg)
n=97 participants at risk
7.5 mg BAY94-8862 tablet once daily in the morning for 90 days
|
Finerenone (BAY94-8862)(10 mg)
n=98 participants at risk
10 mg BAY94-8862 tablet once daily in the morning for 90 days
|
Finerenone (BAY94-8862)(15 mg)
n=125 participants at risk
15 mg BAY94-8862 tablet once daily in the morning for 90 days
|
Finerenone (BAY94-8862)(20 mg)
n=119 participants at risk
20 mg BAY94-8862 tablet once daily in the morning for 90 days
|
Placebo
n=94 participants at risk
Placebo tablet once daily in the morning for 90 days
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.2%
5/96 • Number of events 5 • Up to approximately 93 days after the start of study drug
|
2.2%
2/92 • Number of events 2 • Up to approximately 93 days after the start of study drug
|
4.0%
4/100 • Number of events 4 • Up to approximately 93 days after the start of study drug
|
2.1%
2/97 • Number of events 2 • Up to approximately 93 days after the start of study drug
|
2.0%
2/98 • Number of events 2 • Up to approximately 93 days after the start of study drug
|
2.4%
3/125 • Number of events 4 • Up to approximately 93 days after the start of study drug
|
4.2%
5/119 • Number of events 5 • Up to approximately 93 days after the start of study drug
|
2.1%
2/94 • Number of events 2 • Up to approximately 93 days after the start of study drug
|
|
Infections and infestations
Nasopharyngitis
|
7.3%
7/96 • Number of events 7 • Up to approximately 93 days after the start of study drug
|
4.3%
4/92 • Number of events 4 • Up to approximately 93 days after the start of study drug
|
8.0%
8/100 • Number of events 8 • Up to approximately 93 days after the start of study drug
|
9.3%
9/97 • Number of events 9 • Up to approximately 93 days after the start of study drug
|
5.1%
5/98 • Number of events 5 • Up to approximately 93 days after the start of study drug
|
3.2%
4/125 • Number of events 4 • Up to approximately 93 days after the start of study drug
|
6.7%
8/119 • Number of events 9 • Up to approximately 93 days after the start of study drug
|
5.3%
5/94 • Number of events 6 • Up to approximately 93 days after the start of study drug
|
|
Nervous system disorders
Dizziness
|
6.2%
6/96 • Number of events 6 • Up to approximately 93 days after the start of study drug
|
1.1%
1/92 • Number of events 1 • Up to approximately 93 days after the start of study drug
|
3.0%
3/100 • Number of events 3 • Up to approximately 93 days after the start of study drug
|
1.0%
1/97 • Number of events 1 • Up to approximately 93 days after the start of study drug
|
3.1%
3/98 • Number of events 3 • Up to approximately 93 days after the start of study drug
|
4.0%
5/125 • Number of events 5 • Up to approximately 93 days after the start of study drug
|
0.84%
1/119 • Number of events 1 • Up to approximately 93 days after the start of study drug
|
2.1%
2/94 • Number of events 2 • Up to approximately 93 days after the start of study drug
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER