Study: NCT03326583

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Pt was admitted to the hospital Sunday, 11/19/17 after collapsing at a relatives house. He was diagnosed with hypoglycemia. Potassium was 5.9. Pt began study drug on 11/15/17 but did not take in hospital. Pt also had high glucose, 400. Pt doing well
Frequency: 1 affected / 27 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Notes: Pt send to the emergency department mid dialysis with hypertensive urgency and headache. Given 20 mg IV hydralazine, which decreased BP. Pt was discharged on 2/14.
Frequency: 1 affected / 27 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pt presented in ED with SOB and cough, has history of asthma and seasonal allergies. Treated with steroids and albuterol. Drug not taking during hospitalization.
Frequency: 1 affected / 27 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Infections and infestations
Notes: Pt presented in Ed post dialysis with 6 days of fever, headache, sore throat, R side neck pain. Blood test revealed methicillin-resistant staphylococcus aureus (MRSA ) infection. Ppt treated with antibiotics
Frequency: 1 affected / 27 at risk

Adverse event: Hypoglcymia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Pt arrived at dialysis feeling drowsy, blood sugar was 41, admitted to ED where treated with glucose and food. Glucose levels improved and patient returned to normal dialysis.
Frequency: 1 affected / 27 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient admitted to the hospital for shortness of breath and hyperkalemia (8.0). Pt treated with Veltessa.
Frequency: 1 affected / 27 at risk

Adverse event: MRSA Infection
Serious: yes
Organ System: Infections and infestations
Notes: Pt reported being hospitalized during the week of July 27, 2018 for MRSA. Pt reported being treated with antibiotics.
Frequency: 1 affected / 27 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Pt admitted to hospital for arteriovenous (AV) fistula infection. Pt discharged on 10/10/18. Pt was off medication from 10/3-10/5.
Frequency: 1 affected / 27 at risk

Adverse event: Dizzy and Disoriented
Serious: yes
Organ System: General disorders
Notes: Pt had been complaining of feeling dizzy and disoriented w/o nausea. Bloodwork and MRI came back normal. Pt treated for vertigo and discharged.
Frequency: 1 affected / 27 at risk

Adverse event: Nasuea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Pt presented to ER on 11/14/19 with nausea/vomiting and shortness of breath (SOB). No findings on imagining studies. Pt dx w/ intractable vomiting w/ mild epigastric tenderness. Treated with ondansetron and metoclopramide and discharged
Frequency: 1 affected / 27 at risk

Adverse event: Right Arm Collulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Pt presented to ER@ request of dialysis unit. Pt c/o R arm swelling, pain, erythema. Treated with vancomycin and compression wrap. Discharged with antibiotics.
Frequency: 1 affected / 27 at risk