Trial Outcomes & Findings for A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome - CARDINAL (NCT NCT03019185)
NCT ID: NCT03019185
Last Updated: 2025-06-11
Results Overview
To assess the change in eGFR from baseline to week 12 (Phase 2). Estimated Glomerular filtration rate (eGFR) indicates how well the kidneys are filtering waste from the blood. The higher the eGFR number, the better the kidney function.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
187 participants
Primary outcome timeframe
Baseline through 12 weeks after participant receives the first dose in the Phase 2 study
Results posted on
2025-06-11
Participant Flow
CARDINAL Phase 2 and Phase 3 were conducted under the same protocol. Participants enrolled in Phase 2 were not allowed to enroll in Phase 3.
Participant milestones
| Measure |
Phase 2 Bardoxolone Methyl
Participants who received bardoxolone methyl capsules at a starting dose of 5 mg and titrated up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily in the Cardinal Phase 2 Study
|
Phase 3 Placebo
Participants who received placebo (with sham titration) in the Cardinal Phase 3 Study
|
Phase 3 Bardoxolone Methyl
Participants who received bardoxolone methyl capsules at a starting dose of 5 mg and titrated up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily in the Cardinal Phase 3 Study
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
80
|
77
|
|
Overall Study
COMPLETED
|
24
|
79
|
75
|
|
Overall Study
NOT COMPLETED
|
6
|
1
|
2
|
Reasons for withdrawal
| Measure |
Phase 2 Bardoxolone Methyl
Participants who received bardoxolone methyl capsules at a starting dose of 5 mg and titrated up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily in the Cardinal Phase 2 Study
|
Phase 3 Placebo
Participants who received placebo (with sham titration) in the Cardinal Phase 3 Study
|
Phase 3 Bardoxolone Methyl
Participants who received bardoxolone methyl capsules at a starting dose of 5 mg and titrated up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily in the Cardinal Phase 3 Study
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
|
Overall Study
Inability to continue due to increased serum creatinine
|
1
|
0
|
0
|
|
Overall Study
ESKD Resulting in Kidney Transplant
|
1
|
0
|
0
|
Baseline Characteristics
A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome - CARDINAL
Baseline characteristics by cohort
| Measure |
Phase 2 Bardoxolone Methyl
n=30 Participants
Participants who received bardoxolone methyl capsules at a starting dose of 5 mg and titrated up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily in the Cardinal Phase 2 Study
|
Phase 3 Placebo
n=80 Participants
Participants who received placebo (with sham titration) in the Cardinal Phase 3 Study
|
Phase 3 Bardoxolone Methyl
n=77 Participants
Participants who received bardoxolone methyl capsules at a starting dose of 5 mg and titrated up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily in the Cardinal Phase 3 Study
|
Total
n=187 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.63 years
STANDARD_DEVIATION 12.557 • n=5 Participants
|
39.6 years
STANDARD_DEVIATION 16.03 • n=7 Participants
|
38.8 years
STANDARD_DEVIATION 14.55 • n=5 Participants
|
39.9 years
STANDARD_DEVIATION 14.94 • n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
109 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
165 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
144 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
57 participants
n=7 Participants
|
54 participants
n=5 Participants
|
141 participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
0 participants
n=5 Participants
|
9 participants
n=7 Participants
|
12 participants
n=5 Participants
|
21 participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Region of Enrollment
France
|
0 participants
n=5 Participants
|
5 participants
n=7 Participants
|
2 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
0 participants
n=5 Participants
|
5 participants
n=7 Participants
|
3 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Baseline estimated glomerular filtration rate (eGFR)
|
54.17 mL/min/1.73 m^2
STANDARD_DEVIATION 24.075 • n=5 Participants
|
62.63 mL/min/1.73 m^2
STANDARD_DEVIATION 18.234 • n=7 Participants
|
62.74 mL/min/1.73 m^2
STANDARD_DEVIATION 17.719 • n=5 Participants
|
61.32 mL/min/1.73 m^2
STANDARD_DEVIATION 19.227 • n=4 Participants
|
|
Baseline urine albumin-to-creatinine ratio (UACR)
|
147.83 mg/g
n=5 Participants
|
134.45 mg/g
n=7 Participants
|
148.09 mg/g
n=5 Participants
|
142.05 mg/g
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline through 12 weeks after participant receives the first dose in the Phase 2 studyPopulation: Intent-to-treat population (all enrolled patients)
To assess the change in eGFR from baseline to week 12 (Phase 2). Estimated Glomerular filtration rate (eGFR) indicates how well the kidneys are filtering waste from the blood. The higher the eGFR number, the better the kidney function.
Outcome measures
| Measure |
Phase 2 Bardoxolone Methyl
n=30 Participants
Participants who received bardoxolone methyl capsules at a starting dose of 5 mg and titrated up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily in the Cardinal Phase 2 Study
|
Phase 3 Bardoxolone Methyl
Participants who received bardoxolone methyl capsules at a starting dose of 5 mg and titrated up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily in the Cardinal Phase 3 Study
|
|---|---|---|
|
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) After 12 Weeks of Treatment (Phase 2)
|
13.37 mL/min/1.73 m^2
Standard Error 1.4111
|
—
|
PRIMARY outcome
Timeframe: Baseline through 48 weeks after participant receives the first dose in the Phase 3 studyPopulation: Intent-to-treat population (all randomized patients)
To assess the change in eGFR from baseline to week 48 (Phase 3). Estimated Glomerular filtration rate (eGFR) indicates how well the kidneys are filtering waste from the blood. The higher the eGFR number, the better the kidney function.
Outcome measures
| Measure |
Phase 2 Bardoxolone Methyl
n=80 Participants
Participants who received bardoxolone methyl capsules at a starting dose of 5 mg and titrated up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily in the Cardinal Phase 2 Study
|
Phase 3 Bardoxolone Methyl
n=77 Participants
Participants who received bardoxolone methyl capsules at a starting dose of 5 mg and titrated up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily in the Cardinal Phase 3 Study
|
|---|---|---|
|
Change From Baseline in eGFR After 48 Weeks of Treatment (Phase 3)
|
-4.77 mL/min/1.73 m^2
Standard Error 1.248
|
4.71 mL/min/1.73 m^2
Standard Error 1.307
|
PRIMARY outcome
Timeframe: Baseline through 100 weeks after participant receives the first dose in the Phase 3 studyPopulation: Intent-to-treat population (all randomized patients)
To assess the change in eGFR from baseline to week 100 (Phase 3). Estimated Glomerular filtration rate (eGFR) indicates how well the kidneys are filtering waste from the blood. The higher the eGFR number, the better the kidney function.
Outcome measures
| Measure |
Phase 2 Bardoxolone Methyl
n=80 Participants
Participants who received bardoxolone methyl capsules at a starting dose of 5 mg and titrated up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily in the Cardinal Phase 2 Study
|
Phase 3 Bardoxolone Methyl
n=77 Participants
Participants who received bardoxolone methyl capsules at a starting dose of 5 mg and titrated up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily in the Cardinal Phase 3 Study
|
|---|---|---|
|
Change From Baseline in eGFR After 100 Weeks of Treatment (Phase 3)
|
-8.45 mL/min/1.73 m^2
Standard Error 1.478
|
-0.81 mL/min/1.73 m^2
Standard Error 1.556
|
SECONDARY outcome
Timeframe: Baseline through 48 weeks after participant receives the first dose in the Phase 2 studyPopulation: Intent-to-treat population (all enrolled patients)
To assess the change from baseline in eGFR in bardoxolone methyl-treated patients at Week 48. Estimated Glomerular filtration rate (eGFR) indicates how well the kidneys are filtering waste from the blood. The higher the eGFR number, the better the kidney function.
Outcome measures
| Measure |
Phase 2 Bardoxolone Methyl
n=30 Participants
Participants who received bardoxolone methyl capsules at a starting dose of 5 mg and titrated up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily in the Cardinal Phase 2 Study
|
Phase 3 Bardoxolone Methyl
Participants who received bardoxolone methyl capsules at a starting dose of 5 mg and titrated up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily in the Cardinal Phase 3 Study
|
|---|---|---|
|
Change From Baseline in eGFR After 48 Weeks of Treatment (Phase 2)
|
7.4 mL/min/1.73 m^2
Standard Error 1.9451
|
—
|
SECONDARY outcome
Timeframe: Baseline through 100 weeks after participant receives the first dose in the Phase 2 studyPopulation: Intent-to-treat population (all enrolled patients)
To assess the change from baseline in eGFR in bardoxolone methyl-treated patients at Week 100. Estimated Glomerular filtration rate (eGFR) indicates how well the kidneys are filtering waste from the blood. The higher the eGFR number, the better the kidney function.
Outcome measures
| Measure |
Phase 2 Bardoxolone Methyl
n=30 Participants
Participants who received bardoxolone methyl capsules at a starting dose of 5 mg and titrated up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily in the Cardinal Phase 2 Study
|
Phase 3 Bardoxolone Methyl
Participants who received bardoxolone methyl capsules at a starting dose of 5 mg and titrated up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily in the Cardinal Phase 3 Study
|
|---|---|---|
|
Change From Baseline in eGFR After 100 Weeks of Treatment (Phase 2)
|
4.28 mL/min/1.73 m^2
Standard Error 1.7484
|
—
|
SECONDARY outcome
Timeframe: Baseline through 52 weeks after participant receives the first dose in the Phase 3 study (or 4 weeks after last dose for patients who discontinued early in the first year)Population: Intent-to-treat population (all randomized patients)
To assess the change in eGFR from baseline to week 52 following a 4-week drug treatment withdrawal period (Phase 3). Estimated Glomerular filtration rate (eGFR) indicates how well the kidneys are filtering waste from the blood. The higher the eGFR number, the better the kidney function.
Outcome measures
| Measure |
Phase 2 Bardoxolone Methyl
n=80 Participants
Participants who received bardoxolone methyl capsules at a starting dose of 5 mg and titrated up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily in the Cardinal Phase 2 Study
|
Phase 3 Bardoxolone Methyl
n=77 Participants
Participants who received bardoxolone methyl capsules at a starting dose of 5 mg and titrated up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily in the Cardinal Phase 3 Study
|
|---|---|---|
|
Change From Baseline in eGFR at Week 52 Following a 4-week Drug Treatment Withdrawal Period (Phase 3)
|
-6.08 mL/min/1.73 m^2
Standard Error 1.243
|
-0.99 mL/min/1.73 m^2
Standard Error 1.253
|
SECONDARY outcome
Timeframe: Baseline through 104 weeks after participant receives the first dose in the Phase 3 study (or 4 weeks after last dose for patients who discontinued early in the second year)Population: Intent-to-treat population (all randomized patients)
To assess the change in eGFR from baseline to week 104 following a 4-week drug treatment withdrawal period (Phase 3). Estimated Glomerular filtration rate (eGFR) indicates how well the kidneys are filtering waste from the blood. The higher the eGFR number, the better the kidney function.
Outcome measures
| Measure |
Phase 2 Bardoxolone Methyl
n=80 Participants
Participants who received bardoxolone methyl capsules at a starting dose of 5 mg and titrated up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily in the Cardinal Phase 2 Study
|
Phase 3 Bardoxolone Methyl
n=77 Participants
Participants who received bardoxolone methyl capsules at a starting dose of 5 mg and titrated up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily in the Cardinal Phase 3 Study
|
|---|---|---|
|
Change From Baseline in eGFR at Week 104 Following a 4-week Drug Treatment Withdrawal Period (Phase 3)
|
-8.84 mL/min/1.73 m^2
Standard Error 1.353
|
-4.52 mL/min/1.73 m^2
Standard Error 1.395
|
Adverse Events
Phase 2 Bardoxolone Methyl
Serious events: 6 serious events
Other events: 29 other events
Deaths: 0 deaths
Phase 3 Placebo
Serious events: 15 serious events
Other events: 76 other events
Deaths: 0 deaths
Phase 3 Bardoxolone Methyl
Serious events: 8 serious events
Other events: 75 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 2 Bardoxolone Methyl
n=30 participants at risk
Participants who received bardoxolone methyl capsules at a starting dose of 5 mg and titrated up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily in the Cardinal Phase 2 Study
|
Phase 3 Placebo
n=80 participants at risk
Participants who received placebo (with sham titration) in the Cardinal Phase 3 Study
|
Phase 3 Bardoxolone Methyl
n=77 participants at risk
Participants who received bardoxolone methyl capsules at a starting dose of 5 mg and titrated up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily in the Cardinal Phase 3 Study
|
|---|---|---|---|
|
Gastrointestinal disorders
Ileus
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
General disorders
Asthenia
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/30 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
General disorders
Oedema peripheral
|
0.00%
0/30 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/30 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Infections and infestations
Empyema
|
0.00%
0/30 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/30 • 104 weeks
|
2.5%
2/80 • Number of events 2 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Infections and infestations
Pyelonephritis
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/30 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/30 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/30 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/30 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.00%
0/30 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/30 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/30 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour
|
0.00%
0/30 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour pulmonary
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.00%
0/30 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/30 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/30 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Nervous system disorders
Status migrainosus
|
0.00%
0/30 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/30 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
Renal and urinary disorders
End stage renal disease
|
10.0%
3/30 • Number of events 3 • 104 weeks
|
2.5%
2/80 • Number of events 2 • 104 weeks
|
2.6%
2/77 • Number of events 2 • 104 weeks
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/30 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
Reproductive system and breast disorders
Ovarian mass
|
0.00%
0/30 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/30 • 104 weeks
|
1.2%
1/80 • Number of events 2 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/30 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/30 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/30 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
Other adverse events
| Measure |
Phase 2 Bardoxolone Methyl
n=30 participants at risk
Participants who received bardoxolone methyl capsules at a starting dose of 5 mg and titrated up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily in the Cardinal Phase 2 Study
|
Phase 3 Placebo
n=80 participants at risk
Participants who received placebo (with sham titration) in the Cardinal Phase 3 Study
|
Phase 3 Bardoxolone Methyl
n=77 participants at risk
Participants who received bardoxolone methyl capsules at a starting dose of 5 mg and titrated up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) daily in the Cardinal Phase 3 Study
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.7%
2/30 • Number of events 2 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
5.2%
4/77 • Number of events 4 • 104 weeks
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
6.7%
2/30 • Number of events 2 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Cardiac disorders
Left ventricular hypertrophy
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Cardiac disorders
Mitral valve incompetence
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Cardiac disorders
Palpitations
|
0.00%
0/30 • 104 weeks
|
3.8%
3/80 • Number of events 3 • 104 weeks
|
2.6%
2/77 • Number of events 4 • 104 weeks
|
|
Ear and labyrinth disorders
Deafness
|
6.7%
2/30 • Number of events 2 • 104 weeks
|
2.5%
2/80 • Number of events 2 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/30 • 104 weeks
|
2.5%
2/80 • Number of events 2 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
2.5%
2/80 • Number of events 2 • 104 weeks
|
2.6%
2/77 • Number of events 2 • 104 weeks
|
|
Endocrine disorders
Hyperparathyroidism secondary
|
6.7%
2/30 • Number of events 2 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
Eye disorders
Blepharospasm
|
0.00%
0/30 • 104 weeks
|
3.8%
3/80 • Number of events 3 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Eye disorders
Dry eye
|
0.00%
0/30 • 104 weeks
|
2.5%
2/80 • Number of events 2 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.7%
2/30 • Number of events 2 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
2.6%
2/77 • Number of events 3 • 104 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
2/30 • Number of events 2 • 104 weeks
|
16.2%
13/80 • Number of events 16 • 104 weeks
|
10.4%
8/77 • Number of events 9 • 104 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
5.0%
4/80 • Number of events 4 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/30 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
2.6%
2/77 • Number of events 2 • 104 weeks
|
|
Gastrointestinal disorders
Constipation
|
13.3%
4/30 • Number of events 5 • 104 weeks
|
5.0%
4/80 • Number of events 4 • 104 weeks
|
9.1%
7/77 • Number of events 7 • 104 weeks
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/30 • 104 weeks
|
2.5%
2/80 • Number of events 4 • 104 weeks
|
3.9%
3/77 • Number of events 3 • 104 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
13.3%
4/30 • Number of events 6 • 104 weeks
|
7.5%
6/80 • Number of events 7 • 104 weeks
|
15.6%
12/77 • Number of events 14 • 104 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
10.0%
3/30 • Number of events 4 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
3.9%
3/77 • Number of events 3 • 104 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
3/30 • Number of events 3 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
Gastrointestinal disorders
Flatulence
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
2.5%
2/80 • Number of events 3 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/30 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
2.6%
2/77 • Number of events 2 • 104 weeks
|
|
Gastrointestinal disorders
Functional gastrointestinal disorder
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/30 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
2.6%
2/77 • Number of events 2 • 104 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/30 • 104 weeks
|
3.8%
3/80 • Number of events 3 • 104 weeks
|
6.5%
5/77 • Number of events 7 • 104 weeks
|
|
Gastrointestinal disorders
Lip dry
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Gastrointestinal disorders
Nausea
|
20.0%
6/30 • Number of events 10 • 104 weeks
|
13.8%
11/80 • Number of events 15 • 104 weeks
|
16.9%
13/77 • Number of events 19 • 104 weeks
|
|
Gastrointestinal disorders
Oral mucosal exfoliation
|
0.00%
0/30 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
2.6%
2/77 • Number of events 2 • 104 weeks
|
|
Gastrointestinal disorders
Paraesthesia oral
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Gastrointestinal disorders
Tongue discolouration
|
0.00%
0/30 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
2.6%
2/77 • Number of events 3 • 104 weeks
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
3/30 • Number of events 5 • 104 weeks
|
3.8%
3/80 • Number of events 4 • 104 weeks
|
9.1%
7/77 • Number of events 9 • 104 weeks
|
|
General disorders
Asthenia
|
0.00%
0/30 • 104 weeks
|
3.8%
3/80 • Number of events 3 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
General disorders
Chills
|
0.00%
0/30 • 104 weeks
|
2.5%
2/80 • Number of events 2 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
General disorders
Fatigue
|
20.0%
6/30 • Number of events 7 • 104 weeks
|
15.0%
12/80 • Number of events 16 • 104 weeks
|
18.2%
14/77 • Number of events 18 • 104 weeks
|
|
General disorders
Malaise
|
10.0%
3/30 • Number of events 3 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
5.2%
4/77 • Number of events 4 • 104 weeks
|
|
General disorders
Non-cardiac chest pain
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
2.5%
2/80 • Number of events 2 • 104 weeks
|
7.8%
6/77 • Number of events 6 • 104 weeks
|
|
General disorders
Oedema peripheral
|
23.3%
7/30 • Number of events 8 • 104 weeks
|
12.5%
10/80 • Number of events 15 • 104 weeks
|
15.6%
12/77 • Number of events 18 • 104 weeks
|
|
General disorders
Pain
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
2.5%
2/80 • Number of events 2 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
General disorders
Peripheral swelling
|
0.00%
0/30 • 104 weeks
|
2.5%
2/80 • Number of events 2 • 104 weeks
|
2.6%
2/77 • Number of events 2 • 104 weeks
|
|
General disorders
Pyrexia
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
5.0%
4/80 • Number of events 4 • 104 weeks
|
3.9%
3/77 • Number of events 3 • 104 weeks
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/30 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
3.9%
3/77 • Number of events 3 • 104 weeks
|
|
Hepatobiliary disorders
Hepatic steatosis
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/30 • 104 weeks
|
2.5%
2/80 • Number of events 2 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/30 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
2.6%
2/77 • Number of events 2 • 104 weeks
|
|
Infections and infestations
Bronchitis
|
13.3%
4/30 • Number of events 4 • 104 weeks
|
2.5%
2/80 • Number of events 2 • 104 weeks
|
3.9%
3/77 • Number of events 3 • 104 weeks
|
|
Infections and infestations
Conjunctivitis
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
Infections and infestations
Cystitis
|
0.00%
0/30 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
3.9%
3/77 • Number of events 3 • 104 weeks
|
|
Infections and infestations
Ear infection
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
1.2%
1/80 • Number of events 2 • 104 weeks
|
2.6%
2/77 • Number of events 2 • 104 weeks
|
|
Infections and infestations
Fungal infection
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
Infections and infestations
Fungal skin infection
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Infections and infestations
Gastroenteritis
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Infections and infestations
Gastrointestinal infection
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
3.8%
3/80 • Number of events 3 • 104 weeks
|
2.6%
2/77 • Number of events 2 • 104 weeks
|
|
Infections and infestations
Herpes zoster
|
6.7%
2/30 • Number of events 2 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Infections and infestations
Influenza
|
10.0%
3/30 • Number of events 3 • 104 weeks
|
8.8%
7/80 • Number of events 7 • 104 weeks
|
7.8%
6/77 • Number of events 6 • 104 weeks
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/30 • 104 weeks
|
2.5%
2/80 • Number of events 2 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
3/30 • Number of events 4 • 104 weeks
|
30.0%
24/80 • Number of events 29 • 104 weeks
|
23.4%
18/77 • Number of events 27 • 104 weeks
|
|
Infections and infestations
Oral herpes
|
0.00%
0/30 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
2.6%
2/77 • Number of events 2 • 104 weeks
|
|
Infections and infestations
Otitis externa
|
0.00%
0/30 • 104 weeks
|
2.5%
2/80 • Number of events 2 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Infections and infestations
Peritonitis
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Infections and infestations
Pharyngitis
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
3.8%
3/80 • Number of events 4 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
Infections and infestations
Pneumonia
|
6.7%
2/30 • Number of events 2 • 104 weeks
|
1.2%
1/80 • Number of events 2 • 104 weeks
|
2.6%
2/77 • Number of events 2 • 104 weeks
|
|
Infections and infestations
Rhinitis
|
0.00%
0/30 • 104 weeks
|
3.8%
3/80 • Number of events 3 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
Infections and infestations
Sinusitis
|
6.7%
2/30 • Number of events 3 • 104 weeks
|
8.8%
7/80 • Number of events 8 • 104 weeks
|
7.8%
6/77 • Number of events 7 • 104 weeks
|
|
Infections and infestations
Skin candida
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Infections and infestations
Tooth abscess
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
6/30 • Number of events 6 • 104 weeks
|
10.0%
8/80 • Number of events 10 • 104 weeks
|
15.6%
12/77 • Number of events 15 • 104 weeks
|
|
Infections and infestations
Urinary tract infection
|
6.7%
2/30 • Number of events 5 • 104 weeks
|
6.2%
5/80 • Number of events 9 • 104 weeks
|
3.9%
3/77 • Number of events 8 • 104 weeks
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/30 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
2.6%
2/77 • Number of events 3 • 104 weeks
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
5.2%
4/77 • Number of events 5 • 104 weeks
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/30 • 104 weeks
|
2.5%
2/80 • Number of events 2 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Injury, poisoning and procedural complications
Laceration
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/30 • 104 weeks
|
1.2%
1/80 • Number of events 3 • 104 weeks
|
3.9%
3/77 • Number of events 3 • 104 weeks
|
|
Injury, poisoning and procedural complications
Limb injury
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Injury, poisoning and procedural complications
Tendon injury
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Investigations
Alanine aminotransferase increased
|
43.3%
13/30 • Number of events 17 • 104 weeks
|
2.5%
2/80 • Number of events 2 • 104 weeks
|
46.8%
36/77 • Number of events 41 • 104 weeks
|
|
Investigations
Albumin urine present
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
6/30 • Number of events 6 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
24.7%
19/77 • Number of events 22 • 104 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
6.7%
2/30 • Number of events 2 • 104 weeks
|
11.2%
9/80 • Number of events 11 • 104 weeks
|
6.5%
5/77 • Number of events 7 • 104 weeks
|
|
Investigations
Blood creatinine increased
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
10.0%
8/80 • Number of events 8 • 104 weeks
|
3.9%
3/77 • Number of events 3 • 104 weeks
|
|
Investigations
Blood lactate dehydrogenase increased
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/30 • 104 weeks
|
3.8%
3/80 • Number of events 3 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
Investigations
Blood potassium increased
|
0.00%
0/30 • 104 weeks
|
2.5%
2/80 • Number of events 2 • 104 weeks
|
5.2%
4/77 • Number of events 4 • 104 weeks
|
|
Investigations
Brain natriuretic peptide abnormal
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Investigations
Brain natriuretic peptide increased
|
10.0%
3/30 • Number of events 4 • 104 weeks
|
3.8%
3/80 • Number of events 3 • 104 weeks
|
14.3%
11/77 • Number of events 23 • 104 weeks
|
|
Investigations
Eosinophil count increased
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.7%
2/30 • Number of events 2 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
5.2%
4/77 • Number of events 4 • 104 weeks
|
|
Investigations
Glomerular filtration rate decreased
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
2.6%
2/77 • Number of events 2 • 104 weeks
|
|
Investigations
Low density lipoprotein increased
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Investigations
N-terminal prohormone brain natriuretic peptide increased
|
0.00%
0/30 • 104 weeks
|
2.5%
2/80 • Number of events 2 • 104 weeks
|
6.5%
5/77 • Number of events 5 • 104 weeks
|
|
Investigations
Urine albumin/creatinine ratio increased
|
6.7%
2/30 • Number of events 2 • 104 weeks
|
8.8%
7/80 • Number of events 8 • 104 weeks
|
10.4%
8/77 • Number of events 9 • 104 weeks
|
|
Investigations
Vitamin D decreased
|
0.00%
0/30 • 104 weeks
|
2.5%
2/80 • Number of events 2 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
Investigations
Weight decreased
|
10.0%
3/30 • Number of events 3 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
13.0%
10/77 • Number of events 12 • 104 weeks
|
|
Investigations
Weight increased
|
0.00%
0/30 • 104 weeks
|
7.5%
6/80 • Number of events 7 • 104 weeks
|
2.6%
2/77 • Number of events 2 • 104 weeks
|
|
Investigations
White blood cell count decreased
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/30 • 104 weeks
|
2.5%
2/80 • Number of events 4 • 104 weeks
|
2.6%
2/77 • Number of events 2 • 104 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/30 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
3.9%
3/77 • Number of events 3 • 104 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/30 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
3.9%
3/77 • Number of events 3 • 104 weeks
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/30 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
2.6%
2/77 • Number of events 2 • 104 weeks
|
|
Metabolism and nutrition disorders
Gout
|
10.0%
3/30 • Number of events 3 • 104 weeks
|
7.5%
6/80 • Number of events 8 • 104 weeks
|
2.6%
2/77 • Number of events 2 • 104 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
30.0%
9/30 • Number of events 12 • 104 weeks
|
6.2%
5/80 • Number of events 9 • 104 weeks
|
14.3%
11/77 • Number of events 19 • 104 weeks
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
2.6%
2/77 • Number of events 2 • 104 weeks
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
6.7%
2/30 • Number of events 2 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
2.6%
2/77 • Number of events 2 • 104 weeks
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/30 • 104 weeks
|
5.0%
4/80 • Number of events 4 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.7%
2/30 • Number of events 2 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
13.3%
4/30 • Number of events 5 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
3.9%
3/77 • Number of events 3 • 104 weeks
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
13.3%
4/30 • Number of events 4 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
3.9%
3/77 • Number of events 3 • 104 weeks
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
13.3%
4/30 • Number of events 4 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
2/30 • Number of events 2 • 104 weeks
|
7.5%
6/80 • Number of events 7 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.3%
1/30 • Number of events 2 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
1.3%
1/77 • Number of events 2 • 104 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
23.3%
7/30 • Number of events 8 • 104 weeks
|
16.2%
13/80 • Number of events 16 • 104 weeks
|
11.7%
9/77 • Number of events 9 • 104 weeks
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/30 • 104 weeks
|
2.5%
2/80 • Number of events 2 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/30 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
2.6%
2/77 • Number of events 2 • 104 weeks
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.7%
2/30 • Number of events 2 • 104 weeks
|
3.8%
3/80 • Number of events 3 • 104 weeks
|
2.6%
2/77 • Number of events 2 • 104 weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/30 • 104 weeks
|
2.5%
2/80 • Number of events 2 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
73.3%
22/30 • Number of events 43 • 104 weeks
|
33.8%
27/80 • Number of events 45 • 104 weeks
|
49.4%
38/77 • Number of events 72 • 104 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/30 • 104 weeks
|
2.5%
2/80 • Number of events 2 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/30 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
2.6%
2/77 • Number of events 2 • 104 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/30 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
3.9%
3/77 • Number of events 3 • 104 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
2/30 • Number of events 4 • 104 weeks
|
3.8%
3/80 • Number of events 6 • 104 weeks
|
5.2%
4/77 • Number of events 4 • 104 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/30 • 104 weeks
|
2.5%
2/80 • Number of events 2 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
2/30 • Number of events 2 • 104 weeks
|
2.5%
2/80 • Number of events 2 • 104 weeks
|
9.1%
7/77 • Number of events 8 • 104 weeks
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
6.7%
2/30 • Number of events 2 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/30 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
2.6%
2/77 • Number of events 2 • 104 weeks
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basosquamous carcinoma
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
6.7%
2/30 • Number of events 2 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
Nervous system disorders
Ageusia
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Nervous system disorders
Dizziness
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
15.0%
12/80 • Number of events 13 • 104 weeks
|
3.9%
3/77 • Number of events 3 • 104 weeks
|
|
Nervous system disorders
Dysgeusia
|
13.3%
4/30 • Number of events 4 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
5.2%
4/77 • Number of events 5 • 104 weeks
|
|
Nervous system disorders
Headache
|
20.0%
6/30 • Number of events 9 • 104 weeks
|
20.0%
16/80 • Number of events 31 • 104 weeks
|
20.8%
16/77 • Number of events 28 • 104 weeks
|
|
Nervous system disorders
Migraine
|
6.7%
2/30 • Number of events 2 • 104 weeks
|
2.5%
2/80 • Number of events 3 • 104 weeks
|
1.3%
1/77 • Number of events 4 • 104 weeks
|
|
Nervous system disorders
Migraine without aura
|
3.3%
1/30 • Number of events 2 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Nervous system disorders
Neuropathy peripheral
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
2.5%
2/80 • Number of events 2 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Nervous system disorders
Periodic limb movement disorder
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Nervous system disorders
Presyncope
|
6.7%
2/30 • Number of events 2 • 104 weeks
|
2.5%
2/80 • Number of events 3 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Nervous system disorders
Sinus headache
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Nervous system disorders
Syncope
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/30 • 104 weeks
|
2.5%
2/80 • Number of events 2 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Psychiatric disorders
Anxiety
|
6.7%
2/30 • Number of events 2 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
0.00%
0/30 • 104 weeks
|
2.5%
2/80 • Number of events 2 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Psychiatric disorders
Confusional state
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Psychiatric disorders
Depression
|
6.7%
2/30 • Number of events 2 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
Psychiatric disorders
Insomnia
|
10.0%
3/30 • Number of events 3 • 104 weeks
|
3.8%
3/80 • Number of events 3 • 104 weeks
|
2.6%
2/77 • Number of events 2 • 104 weeks
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/30 • 104 weeks
|
2.5%
2/80 • Number of events 2 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
Renal and urinary disorders
Albuminuria
|
0.00%
0/30 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
2.6%
2/77 • Number of events 2 • 104 weeks
|
|
Renal and urinary disorders
Chronic kidney disease
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
2.5%
2/80 • Number of events 2 • 104 weeks
|
2.6%
2/77 • Number of events 2 • 104 weeks
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/30 • 104 weeks
|
2.5%
2/80 • Number of events 2 • 104 weeks
|
2.6%
2/77 • Number of events 3 • 104 weeks
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/30 • 104 weeks
|
3.8%
3/80 • Number of events 3 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/30 • 104 weeks
|
3.8%
3/80 • Number of events 3 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
Renal and urinary disorders
Proteinuria
|
16.7%
5/30 • Number of events 5 • 104 weeks
|
7.5%
6/80 • Number of events 6 • 104 weeks
|
9.1%
7/77 • Number of events 7 • 104 weeks
|
|
Reproductive system and breast disorders
Bartholin's cyst
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Reproductive system and breast disorders
Cervical discharge
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/30 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
3.9%
3/77 • Number of events 3 • 104 weeks
|
|
Reproductive system and breast disorders
Menorrhagia
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
2.6%
2/77 • Number of events 2 • 104 weeks
|
|
Reproductive system and breast disorders
Oligomenorrhoea
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
5.0%
4/80 • Number of events 4 • 104 weeks
|
2.6%
2/77 • Number of events 2 • 104 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
3/30 • Number of events 4 • 104 weeks
|
3.8%
3/80 • Number of events 4 • 104 weeks
|
10.4%
8/77 • Number of events 10 • 104 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/30 • 104 weeks
|
1.2%
1/80 • Number of events 1 • 104 weeks
|
2.6%
2/77 • Number of events 2 • 104 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
3/30 • Number of events 6 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
9.1%
7/77 • Number of events 14 • 104 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/30 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
2.6%
2/77 • Number of events 2 • 104 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.0%
3/30 • Number of events 3 • 104 weeks
|
7.5%
6/80 • Number of events 6 • 104 weeks
|
5.2%
4/77 • Number of events 4 • 104 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
1.2%
1/80 • Number of events 2 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/30 • 104 weeks
|
2.5%
2/80 • Number of events 3 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
20.0%
6/30 • Number of events 6 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
2.6%
2/77 • Number of events 2 • 104 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.7%
2/30 • Number of events 2 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
1.3%
1/77 • Number of events 1 • 104 weeks
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
2/30 • Number of events 3 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
1.2%
1/80 • Number of events 2 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.7%
2/30 • Number of events 2 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/30 • 104 weeks
|
2.5%
2/80 • Number of events 2 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Vascular disorders
Haematoma
|
3.3%
1/30 • Number of events 1 • 104 weeks
|
0.00%
0/80 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
|
Vascular disorders
Hypertension
|
16.7%
5/30 • Number of events 8 • 104 weeks
|
10.0%
8/80 • Number of events 9 • 104 weeks
|
9.1%
7/77 • Number of events 7 • 104 weeks
|
|
Vascular disorders
Hypotension
|
6.7%
2/30 • Number of events 2 • 104 weeks
|
2.5%
2/80 • Number of events 2 • 104 weeks
|
0.00%
0/77 • 104 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER