Study: NCT04355728

Adverse event: GI Bleeding 2ry to Clostridium Difficile Infection
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Large intestine perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Cardiact Arrest-Death due to Difficult Intubation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Acute respiratory Failure 2ry to COVID-Death
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: [DEATH] Cardiac Arrest-Death/Cardiopulmonary Arrest-Death/Asystole -Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Exacerbation of COVID ARDS-Septic Shock
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 12 at risk

Adverse event: Mild Gastrointestinal Bleeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Abnormal Urinalysis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 12 at risk

Adverse event: Leukocytosis/Leukocytosis (Increased WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 12 at risk

Adverse event: Thrombocytopenia/Heparin-induced Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 12 at risk

Adverse event: Candida Albicans Fungemia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 12 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 12 at risk

Adverse event: Mild Hyponatremia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 12 at risk

Adverse event: MRSA Bacteremia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Paenebacillus Pabuli Bacteremia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Positive Blood Culture Streptococcus Mitis and Streptococcus Oralis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Staphylococcus Hominis Bacteremia/Staphylococcus Bacteremia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 12 at risk

Adverse event: Acute Kidney Injury/Oliguric Acute Kidney Injury/ Anuric Acute Kidney Injury/Acute Kidney Injury (AK
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 12 at risk

Adverse event: Aspiration Pneumonitis, suspected
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Enterococcus Faecalis, Klebsiella Pneumoniae, Candida Auris/Duobushaemulonis in bronchial aspirate
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Enterococcus Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: MRSA Hospital Acquired Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 12 at risk

Adverse event: Pneumomediastinum
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Respiratory Failure - Intubation/Hypoxemic respiratory failure requiring intubation and mechanical v
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Subcutaneous emphysema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Worsening of Hypoxemia/Deterioration of Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 12 at risk

Adverse event: Death-Acute Hypoxemic Respiratory Failure Secondary to COVID-19 Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 12 at risk

Adverse event: Cardiac Arrest/Pulseless Electrical Activity Cardiac Arrest/Cardiac Arrest Secondary to Acute Respir
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 12 at risk

Adverse event: Traumatic Tension Pneumotorax post-CPR
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Severe Respiratory Acidosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: [DEATH] Multisystem Organ Failure (Death)/Multiple Organ Dysfunction Syndrome-Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 12 at risk

Adverse event: [DEATH] Cardiac Arrest-Death/Cardiopulmonary Arrest-Death/Asystole -Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 12 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 12 at risk

Adverse event: Severe Metabolic Acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 12 at risk

Adverse event: Septic Shock-Hospital acquired Pseudomona Aeruginosa bacteremia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Tachycardia after infusion of Investigational Product
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 12 at risk

Adverse event: Clostridium difficile infection
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Transaminitis/Transaminitis-Liver Shock
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 12 at risk

Adverse event: Increased ALT, AST, and Alkaline Phosphatase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 12 at risk

Adverse event: Increased Direct Bilirubin
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 12 at risk

Adverse event: Urinary tract candidiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 12 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 12 at risk

Adverse event: Leukocytosis/Leukocytosis (Increased WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 12 at risk

Adverse event: Severe Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Thrombocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Bilateral Common Femoral Vein DVT
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 12 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

Adverse event: Mild Hyponatremia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 12 at risk

Adverse event: Staphylococcus haemolyticus bacteremia and Candida orthopsilosi Fungemia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Staphylococcus Hominis Bacteremia/Staphylococcus Bacteremia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Left Calf Collection
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Dysconjugated gaze
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 12 at risk

Adverse event: Acute Kidney Injury/Oliguric Acute Kidney Injury/ Anuric Acute Kidney Injury/Acute Kidney Injury (AK
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 12 at risk

Adverse event: Pneumoperitoneum
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Bradypnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Respiratory Failure - Intubation/Hypoxemic respiratory failure requiring intubation and mechanical v
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Ventilator Acquired Pneumonia (VAP) with Pseudomona aureginosa
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk