Study: NCT01973335

Adverse event: Hospital readmission due to heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 9 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Renal and urinary disorders
Notes: Serum bicarbonate level \<22.0 mEq/L during the 72 h treatment interval
Frequency: 2 affected / 9 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Renal and urinary disorders
Notes: Serum potassium level \<3.5 mmol/L during the 72 h treatment interval
Frequency: 1 affected / 9 at risk

Adverse event: Worsening renal function
Serious: no
Organ System: Renal and urinary disorders
Notes: Increase of the serum creatinine level \>0.3 mg/dL during the 72 h treatment interval
Frequency: 2 affected / 9 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Notes: Mean arterial blood pressure \<65 mmHg or systolic blood pressure \<100 mmHg during the 72 h treatment interval
Frequency: 2 affected / 9 at risk

Adverse event: Hospital readmission due to heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 7 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Renal and urinary disorders
Notes: Serum bicarbonate level \<22.0 mEq/L during the 72 h treatment interval
Frequency: 3 affected / 7 at risk

Adverse event: Moderate hyperkalemia
Serious: no
Organ System: Renal and urinary disorders
Notes: Serum potassium level 5.1-6.5 mmol/L during the 72 h treatment interval
Frequency: 1 affected / 7 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Renal and urinary disorders
Notes: Serum potassium level \<3.5 mmol/L during the 72 h treatment interval
Frequency: 1 affected / 7 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Notes: Mean arterial blood pressure \<65 mmHg or systolic blood pressure \<100 mmHg during the 72 h treatment interval
Frequency: 1 affected / 7 at risk

Adverse event: Hospital readmission due to heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 9 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Renal and urinary disorders
Notes: Serum bicarbonate level \<22.0 mEq/L during the 72 h treatment interval
Frequency: 2 affected / 9 at risk

Adverse event: Moderate hyperkalemia
Serious: no
Organ System: Renal and urinary disorders
Notes: Serum potassium level 5.1-6.5 mmol/L during the 72 h treatment interval
Frequency: 2 affected / 9 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Renal and urinary disorders
Notes: Serum potassium level \<3.5 mmol/L during the 72 h treatment interval
Frequency: 3 affected / 9 at risk

Adverse event: Worsening renal function
Serious: no
Organ System: Renal and urinary disorders
Notes: Increase of the serum creatinine level \>0.3 mg/dL during the 72 h treatment interval
Frequency: 3 affected / 9 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Notes: Mean arterial blood pressure \<65 mmHg or systolic blood pressure \<100 mmHg during the 72 h treatment interval
Frequency: 3 affected / 9 at risk

Adverse event: Hospital readmission due to heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 9 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Renal and urinary disorders
Notes: Serum bicarbonate level \<22.0 mEq/L during the 72 h treatment interval
Frequency: 3 affected / 9 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Renal and urinary disorders
Notes: Serum potassium level \<3.5 mmol/L during the 72 h treatment interval
Frequency: 2 affected / 9 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Notes: Mean arterial blood pressure \<65 mmHg or systolic blood pressure \<100 mmHg during the 72 h treatment interval
Frequency: 3 affected / 9 at risk