Study: NCT03039738

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 206 at risk

Adverse event: AGITATED DELIRIUM
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 206 at risk

Adverse event: ALTERED MENTAL STATUS
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 206 at risk

Adverse event: Aphasia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 206 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 206 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 206 at risk

Adverse event: Aphasia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 206 at risk

Adverse event: FACIAL EDEMA (CONCERN FOR ALLERGIC REACTION VS. ATYPICAL ANGIOEDEMA)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 206 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 206 at risk

Adverse event: GROSS HEMATURIA
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 206 at risk

Adverse event: HEMORRHAGIC SHOCK (GI BLEED SOURCE)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 206 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 206 at risk

Adverse event: HYPERCARBIC RESPIRATORY FAILURE
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 206 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 206 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 206 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 206 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 206 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 206 at risk

Adverse event: Lethargy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 206 at risk

Adverse event: NEW ONSET ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 206 at risk

Adverse event: NEW ONSET ATRIAL FIBRILLATION/FLUTTER
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 206 at risk

Adverse event: NON ST ELEVATION MYOCARDIAL INFARCTION
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 206 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 206 at risk

Adverse event: NON SUSTAINED VENTRICULAR TACHYCARDIA
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 206 at risk

Adverse event: RECURRENT HYPOGLYCEMIA
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 206 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 206 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 206 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 206 at risk

Adverse event: SYMPTOMATIC BRADYCARDIA
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 206 at risk

Adverse event: TRANSFUSION-INDUCED PULMONARY EDEMA
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 206 at risk

Adverse event: UNRESPONSIVENESS/HYPOGLYCEMIA
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 206 at risk

Adverse event: UNRESPONSIVENESS/RESPIRATORY FAILURE
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 206 at risk

Adverse event: WORSENING ACUTE KIDNEY INJURY
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 206 at risk

Adverse event: WORSENING ANEMIA
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 206 at risk

Adverse event: WORSENING AV FISTULA INFECTION
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 206 at risk

Adverse event: WORSENING CONGESTIVE HEART FAILURE
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 206 at risk

Adverse event: WORSENING COPD EXACERBATION
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 206 at risk

Adverse event: WORSENING DIABETIC KETOACIDOSIS
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 206 at risk

Adverse event: WORSENING GASTROINTESTINAL BLEED
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 206 at risk

Adverse event: WORSENING HYERKALEMIA
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 206 at risk

Adverse event: WORSENING HYPERGLYCEMIA
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 206 at risk

Adverse event: WORSENING HYPERKALEMIA
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 206 at risk

Adverse event: WORSENING HYPERTENSION
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 206 at risk

Adverse event: WORSENING HYPOKALEMIA
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 206 at risk

Adverse event: WORSENING HYPONATREMIA
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 206 at risk

Adverse event: WORSENING HYPOTENSION
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 206 at risk

Adverse event: WORSENING METABOLIC ACIDOSIS
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 206 at risk

Adverse event: WORSENING QT PROLONGATION
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 206 at risk

Adverse event: WORSENING SEVERE SEPSIS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 206 at risk

Adverse event: WORSENING SINUS BRADYCARDIA
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 206 at risk

Adverse event: WORSENING SINUS TACHYCARDIA
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 206 at risk

Adverse event: WORSENING TACHYCARDIA
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 206 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 206 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 206 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 206 at risk

Adverse event: INCREASED ALTERED MENTAL STATUS
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 206 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 206 at risk

Adverse event: WORSENING LETHARGY
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 206 at risk