Study: NCT03038126

Adverse event: In-Center Hypoglycemia
Serious: no
Organ System: Endocrine disorders
Notes: Blood glucose \< 70 with or without symptoms. Detected on study visit labs.
Frequency: 7 affected / 63 at risk

Adverse event: In-Center Hyperglycemia
Serious: no
Organ System: Endocrine disorders
Notes: Blood Glucose \>350 mg/dL. Detected on study visit labs.
Frequency: 2 affected / 63 at risk

Adverse event: In-Center Hypotension
Serious: no
Organ System: Cardiac disorders
Notes: Systolic Blood Pressure \< 90 mmHg or Diastolic Blood Pressure \< 45 mmHg. Detected during study visit vital signs.
Frequency: 11 affected / 63 at risk

Adverse event: In-Center Orthostasis
Serious: no
Organ System: Cardiac disorders
Notes: Drop \>20 mmHg from sitting blood pressure to standing blood pressure and/or increase \>15 bpm from sitting pulse to standing pulse. Detected during study visit vital signs.
Frequency: 30 affected / 63 at risk

Adverse event: Patient-Reported Hyperkalemia
Serious: no
Organ System: Renal and urinary disorders
Notes: Patient-reported high potassium blood level that required a change in medication, change in diet, and/or taking a prescription of kayexelate or polystyrene.
Frequency: 5 affected / 63 at risk

Adverse event: Patient-Reported Dizziness
Serious: no
Organ System: General disorders
Frequency: 5 affected / 63 at risk

Adverse event: Patient-Reported Falls
Serious: no
Organ System: General disorders
Frequency: 3 affected / 63 at risk

Adverse event: Patient-Reported Bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 63 at risk

Adverse event: Patient-Reported Nausea, Vomiting, and/or Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 63 at risk

Adverse event: Patient-Reported New or Worseneing Ankle Swelling
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 63 at risk

Adverse event: Patient-Reported Muscle Weakness or Cramps
Serious: no
Organ System: General disorders
Frequency: 9 affected / 63 at risk

Adverse event: In-Center Hypoglycemia
Serious: no
Organ System: Endocrine disorders
Notes: Blood glucose \< 70 with or without symptoms. Detected on study visit labs.
Frequency: 7 affected / 55 at risk

Adverse event: In-Center Hyperglycemia
Serious: no
Organ System: Endocrine disorders
Notes: Blood Glucose \>350 mg/dL. Detected on study visit labs.
Frequency: 3 affected / 55 at risk

Adverse event: In-Center Hypotension
Serious: no
Organ System: Cardiac disorders
Notes: Systolic Blood Pressure \< 90 mmHg or Diastolic Blood Pressure \< 45 mmHg. Detected during study visit vital signs.
Frequency: 10 affected / 55 at risk

Adverse event: In-Center Orthostasis
Serious: no
Organ System: Cardiac disorders
Notes: Drop \>20 mmHg from sitting blood pressure to standing blood pressure and/or increase \>15 bpm from sitting pulse to standing pulse. Detected during study visit vital signs.
Frequency: 36 affected / 55 at risk

Adverse event: Patient-Reported Hyperkalemia
Serious: no
Organ System: Renal and urinary disorders
Notes: Patient-reported high potassium blood level that required a change in medication, change in diet, and/or taking a prescription of kayexelate or polystyrene.
Frequency: 4 affected / 55 at risk

Adverse event: Patient-Reported Dizziness
Serious: no
Organ System: General disorders
Frequency: 7 affected / 55 at risk

Adverse event: Patient-Reported Falls
Serious: no
Organ System: General disorders
Frequency: 4 affected / 55 at risk

Adverse event: Patient-Reported Bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 55 at risk

Adverse event: Patient-Reported Nausea, Vomiting, and/or Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 55 at risk

Adverse event: Patient-Reported New or Worseneing Ankle Swelling
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 55 at risk

Adverse event: Patient-Reported Muscle Weakness or Cramps
Serious: no
Organ System: General disorders
Frequency: 8 affected / 55 at risk