Study: NCT02841280

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 81 at risk

Adverse event: Cardiovascular Event
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 81 at risk

Adverse event: Renal Event
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 81 at risk

Adverse event: Event of Interest
Serious: yes
Organ System: General disorders
Notes: Event of Interest included orthostatic hypotension, acute kidney injury, hyperglycemia, and hypokalemia
Frequency: 3 affected / 81 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 81 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 81 at risk

Adverse event: Cardiovascular Event
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 81 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 42 affected / 81 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 81 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 19 affected / 81 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 81 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 81 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 81 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 13 affected / 81 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 16 affected / 81 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 81 at risk

Adverse event: Acute Gout
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 81 at risk

Adverse event: Syncope
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 81 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Notes: Orthostatic hypotension was defined as a decrease in the standing systolic blood pressure greater than 20 mm Hg, accompanied by a feeling of dizziness or light-headedness.
Frequency: 8 affected / 81 at risk

Adverse event: Dizziness
Serious: no
Organ System: Cardiac disorders
Notes: Dizziness was recorded when the patient felt dizzy when standing from a seated position but did not have a decrease in the systolic blood pressure greater than 20 mm Hg.
Frequency: 20 affected / 81 at risk

Adverse event: Asymptomatic Orthostatic Hypotension
Serious: no
Organ System: Vascular disorders
Notes: Asymptomatic orthostatic hypotension was defined as a decrease in the standing systolic blood pressure greater than 20 mm Hg that was not accompanied by a feeling of dizziness or light-headedness.
Frequency: 21 affected / 81 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 33 affected / 81 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 79 at risk

Adverse event: Cardiovascular Event
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 79 at risk

Adverse event: Renal Event
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 79 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 79 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 79 at risk

Adverse event: Cardiovascular Event
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 79 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 39 affected / 79 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 13 affected / 79 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 79 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 79 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 79 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 79 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 79 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 79 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 79 at risk

Adverse event: Acute Gout
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 79 at risk

Adverse event: Syncope
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 79 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Notes: Orthostatic hypotension was defined as a decrease in the standing systolic blood pressure greater than 20 mm Hg, accompanied by a feeling of dizziness or light-headedness.
Frequency: 5 affected / 79 at risk

Adverse event: Dizziness
Serious: no
Organ System: Cardiac disorders
Notes: Dizziness was recorded when the patient felt dizzy when standing from a seated position but did not have a decrease in the systolic blood pressure greater than 20 mm Hg.
Frequency: 13 affected / 79 at risk

Adverse event: Asymptomatic Orthostatic Hypotension
Serious: no
Organ System: Vascular disorders
Notes: Asymptomatic orthostatic hypotension was defined as a decrease in the standing systolic blood pressure greater than 20 mm Hg that was not accompanied by a feeling of dizziness or light-headedness.
Frequency: 18 affected / 79 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 79 at risk