Trial Outcomes & Findings for A Trial of Bardoxolone Methyl in Patients With CKD at Risk of Rapid Progression (MERLIN) (NCT NCT04702997)

NCT ID: NCT04702997

Last Updated: 2025-06-03

Results Overview

To assess the change in eGFR from baseline to week 12. eGFR is a measure of kidney function assessed through blood/serum. Higher eGFRs represent better/improved kidney function. Lower eGFRs represent poorer/decreased kidney function.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 81 participants
• Primary outcome timeframe: Baseline through 12 weeks after participant receives the first dose
• Results posted on: 2025-06-03

Participant Flow

Participant milestones

Measure	Bardoxolone Methyl Bardoxolone methyl capsules administered orally once daily for 12 weeks 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)	Placebo Placebo capsules administered orally once-daily for 12 weeks, with sham titration to maintain the blind.
Overall Study STARTED	39	42
Overall Study COMPLETED	38	41
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Bardoxolone Methyl Bardoxolone methyl capsules administered orally once daily for 12 weeks 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)	Placebo Placebo capsules administered orally once-daily for 12 weeks, with sham titration to maintain the blind.
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

A Trial of Bardoxolone Methyl in Patients With CKD at Risk of Rapid Progression (MERLIN)

Baseline characteristics by cohort

Measure	Bardoxolone Methyl n=39 Participants Bardoxolone methyl capsules administered orally once daily for 12 weeks 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)	Placebo n=42 Participants Placebo capsules administered orally once daily for 12 weeks, with sham titration to maintain the blind	Total n=81 Participants Total of all reporting groups
Age, Continuous	56.4 years STANDARD_DEVIATION 13.5 • n=5 Participants	59.8 years STANDARD_DEVIATION 12.66 • n=7 Participants	58.2 years STANDARD_DEVIATION 13.11 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	26 Participants n=7 Participants	49 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants n=5 Participants	10 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants	31 Participants n=7 Participants	53 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants	39 Participants n=7 Participants	71 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants	42 participants n=7 Participants	81 participants n=5 Participants
Baseline estimated glomerular filtration rate (eGFR)	36.563 mL/min/1.73 m^2 STANDARD_DEVIATION 9.8465 • n=5 Participants	34.883 mL/min/1.73 m^2 STANDARD_DEVIATION 10.1765 • n=7 Participants	35.692 mL/min/1.73 m^2 STANDARD_DEVIATION 9.9921 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline through 12 weeks after participant receives the first dose

Population: Intent-to-treat population (all enrolled patients whether or not they received the study drug)

To assess the change in eGFR from baseline to week 12. eGFR is a measure of kidney function assessed through blood/serum. Higher eGFRs represent better/improved kidney function. Lower eGFRs represent poorer/decreased kidney function.

Outcome measures

Measure	Bardoxolone Methyl n=39 Participants Bardoxolone methyl capsules administered orally once daily for 12 weeks 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)	Placebo n=42 Participants Placebo capsules administered orally once daily for 12 weeks, with sham titration to maintain the blind
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12	6.79 mL/min/1.73 m^2 Standard Error 0.925	-0.92 mL/min/1.73 m^2 Standard Error 0.868

Adverse Events

Bardoxolone Methyl

Serious events: 3 serious events

Other events: 31 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Measure	Bardoxolone Methyl n=39 participants at risk Bardoxolone methyl capsules administered orally once daily for 12 weeks 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)	Placebo n=42 participants at risk Placebo capsules administered orally once daily for 12 weeks, with sham titration to maintain the blind
Gastrointestinal disorders Gastrooesophageal reflux disease	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/39 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Hepatobiliary disorders Biliary dyskinesia	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Renal and urinary disorders Acute kidney injury	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.

Other adverse events

Measure	Bardoxolone Methyl n=39 participants at risk Bardoxolone methyl capsules administered orally once daily for 12 weeks 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)	Placebo n=42 participants at risk Placebo capsules administered orally once daily for 12 weeks, with sham titration to maintain the blind
Blood and lymphatic system disorders Anaemia	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Cardiac disorders Cardiac septal hypertrophy	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Cardiac disorders Diastolic dysfunction	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Cardiac disorders Left ventricular hypertrophy	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Cardiac disorders Mitral valve incompetence	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Cardiac disorders Pulmonary valve incompetence	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Cardiac disorders Sinus bradycardia	0.00% 0/39 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Cardiac disorders Tachycardia	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Cardiac disorders Tricuspid valve incompetence	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Ear and labyrinth disorders Ear pain	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Ear and labyrinth disorders Vertigo	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Eye disorders Cataract	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Eye disorders Diabetic retinal oedema	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Eye disorders Diabetic retinopathy	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Eye disorders Glaucoma	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Eye disorders Macular detachment	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Eye disorders Non-proliferative retinopathy	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Gastrointestinal disorders Abdominal mass	0.00% 0/39 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Gastrointestinal disorders Abdominal pain	10.3% 4/39 • Number of events 4 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Gastrointestinal disorders Abdominal pain upper	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Gastrointestinal disorders Constipation	7.7% 3/39 • Number of events 3 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Gastrointestinal disorders Diarrhoea	12.8% 5/39 • Number of events 6 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	4.8% 2/42 • Number of events 2 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Gastrointestinal disorders Dry mouth	0.00% 0/39 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Gastrointestinal disorders Flatulence	2.6% 1/39 • Number of events 2 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Gastrointestinal disorders Gastrooesophageal reflux disease	5.1% 2/39 • Number of events 2 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Gastrointestinal disorders Haematochezia	0.00% 0/39 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 2 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Gastrointestinal disorders Nausea	15.4% 6/39 • Number of events 8 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	7.1% 3/42 • Number of events 4 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Gastrointestinal disorders Stomatitis	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Gastrointestinal disorders Vomiting	12.8% 5/39 • Number of events 5 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	4.8% 2/42 • Number of events 2 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
General disorders Asthenia	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
General disorders Chest pain	0.00% 0/39 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 2 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
General disorders Fatigue	5.1% 2/39 • Number of events 2 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
General disorders Oedema peripheral	5.1% 2/39 • Number of events 3 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	9.5% 4/42 • Number of events 4 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
General disorders Pyrexia	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Hepatobiliary disorders Hepatic steatosis	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Immune system disorders Seasonal allergy	0.00% 0/39 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 2 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Infections and infestations Bronchitis	5.1% 2/39 • Number of events 2 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Infections and infestations Cellulitis	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Infections and infestations Conjunctivitis	0.00% 0/39 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Infections and infestations Corona virus infection	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Infections and infestations Furuncle	0.00% 0/39 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	4.8% 2/42 • Number of events 2 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Infections and infestations Nasopharyngitis	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Infections and infestations Oral candidiasis	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Infections and infestations Orchitis	0.00% 0/39 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Infections and infestations Otitis media	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Infections and infestations Pharyngitis	0.00% 0/39 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Infections and infestations Sinusitis	5.1% 2/39 • Number of events 2 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Infections and infestations Skin infection	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Infections and infestations Tooth abscess	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Infections and infestations Upper respiratory tract infection	0.00% 0/39 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Infections and infestations Urinary tract infection	5.1% 2/39 • Number of events 2 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/39 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/39 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Injury, poisoning and procedural complications Ligament sprain	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/39 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Injury, poisoning and procedural complications Tendon rupture	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Investigations Alanine aminotransferase increased	7.7% 3/39 • Number of events 3 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Investigations Aspartate aminotransferase increased	5.1% 2/39 • Number of events 2 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Investigations Blood alkaline phosphatase increased	5.1% 2/39 • Number of events 2 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Investigations Blood magnesium decreased	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Investigations Blood potassium decreased	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Investigations Blood pressure increased	0.00% 0/39 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Investigations Brain natriuretic peptide increased	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Investigations Cardiac murmur	0.00% 0/39 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Investigations Gamma-glutamyltransferase increased	7.7% 3/39 • Number of events 3 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Investigations Hepatic enzyme increased	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Investigations Liver function test increased	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Investigations N-terminal prohormone brain natriuretic peptide increased	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Investigations Weight decreased	15.4% 6/39 • Number of events 6 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Investigations Weight increased	0.00% 0/39 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Metabolism and nutrition disorders Decreased appetite	7.7% 3/39 • Number of events 3 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Metabolism and nutrition disorders Dehydration	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/39 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Metabolism and nutrition disorders Fluid overload	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	4.8% 2/42 • Number of events 2 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Metabolism and nutrition disorders Gout	7.7% 3/39 • Number of events 3 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Metabolism and nutrition disorders Hyperkalaemia	7.7% 3/39 • Number of events 3 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	11.9% 5/42 • Number of events 5 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/39 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Metabolism and nutrition disorders Hypomagnesaemia	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Metabolism and nutrition disorders Increased appetite	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Metabolism and nutrition disorders Magnesium deficiency	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Metabolism and nutrition disorders Metabolic acidosis	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Metabolism and nutrition disorders Type 2 diabetes mellitus	10.3% 4/39 • Number of events 4 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/39 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Musculoskeletal and connective tissue disorders Arthritis	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/39 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Musculoskeletal and connective tissue disorders Bursitis	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Musculoskeletal and connective tissue disorders Flank pain	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Musculoskeletal and connective tissue disorders Muscle spasms	23.1% 9/39 • Number of events 9 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	19.0% 8/42 • Number of events 8 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Musculoskeletal and connective tissue disorders Muscular weakness	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Musculoskeletal and connective tissue disorders Myalgia	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Musculoskeletal and connective tissue disorders Pain in extremity	2.6% 1/39 • Number of events 2 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/39 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Monoclonal gammopathy	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Nervous system disorders Dizziness	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Nervous system disorders Dysgeusia	5.1% 2/39 • Number of events 2 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Nervous system disorders Headache	5.1% 2/39 • Number of events 2 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	9.5% 4/42 • Number of events 6 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Nervous system disorders Paraesthesia	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Nervous system disorders Tremor	0.00% 0/39 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Psychiatric disorders Confusional state	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Psychiatric disorders Insomnia	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Renal and urinary disorders Acute kidney injury	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Renal and urinary disorders Dysuria	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Renal and urinary disorders Haematuria	5.1% 2/39 • Number of events 2 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Renal and urinary disorders Micturition urgency	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Renal and urinary disorders Pollakiuria	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Renal and urinary disorders Renal pain	0.00% 0/39 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	4.8% 2/42 • Number of events 2 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Respiratory, thoracic and mediastinal disorders Atelectasis	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/39 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Respiratory, thoracic and mediastinal disorders Cough	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/39 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Skin and subcutaneous tissue disorders Acne	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Skin and subcutaneous tissue disorders Dermal cyst	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Skin and subcutaneous tissue disorders Hyperhidrosis	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Skin and subcutaneous tissue disorders Ingrowing nail	2.6% 1/39 • Number of events 2 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Skin and subcutaneous tissue disorders Rash macular	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Skin and subcutaneous tissue disorders Skin ulcer	2.6% 1/39 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	0.00% 0/42 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Surgical and medical procedures Meniscus operation	0.00% 0/39 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	2.4% 1/42 • Number of events 1 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
Vascular disorders Hypertension	0.00% 0/39 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.	4.8% 2/42 • Number of events 2 • 17 weeks All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.

Additional Information

US Biogen Clinical Trial Center

Biogen

Phone: 866-633-4636

Email: clinicaltrials@biogen.com

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