Study: NCT03399318

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 128 at risk

Adverse event: Creatinine increase
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 128 at risk

Adverse event: Neurologic deficits at discharge
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 128 at risk

Adverse event: Any bleeding
Serious: no
Organ System: Vascular disorders
Frequency: 17 affected / 128 at risk

Adverse event: Clinical signs of bleeding
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 128 at risk

Adverse event: Creatinine increase
Serious: no
Organ System: Renal and urinary disorders
Frequency: 61 affected / 128 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 128 at risk

Adverse event: Elevated lactate
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 128 at risk

Adverse event: Fell from bed
Serious: no
Organ System: General disorders
Frequency: 2 affected / 128 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 64 affected / 128 at risk

Adverse event: Nasogastric tube injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 128 at risk

Adverse event: Bleeding occult
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 128 at risk

Adverse event: Drop in level of consciousness
Serious: no
Organ System: General disorders
Notes: Participant level of consciousness dropped from BCS 5/5 to BCS 4/5.
Frequency: 1 affected / 128 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 128 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 10 affected / 128 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 128 at risk

Adverse event: Any bleeding
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 128 at risk

Adverse event: Clinical signs of bleeding
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 128 at risk

Adverse event: Neurologic deficits at discharge
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 128 at risk

Adverse event: Shock
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 128 at risk

Adverse event: Shock with necrotic digits
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 128 at risk

Adverse event: Status epilepticus and prolonged apnea
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 128 at risk

Adverse event: Any bleeding
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 128 at risk

Adverse event: Clinical signs of bleeding
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 128 at risk

Adverse event: Creatinine increase
Serious: no
Organ System: Renal and urinary disorders
Frequency: 48 affected / 128 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 128 at risk

Adverse event: Elevated lactate
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 128 at risk

Adverse event: Fell from bed
Serious: no
Organ System: General disorders
Frequency: 2 affected / 128 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 66 affected / 128 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 128 at risk

Adverse event: Misc. lab change
Serious: no
Organ System: General disorders
Frequency: 1 affected / 128 at risk

Adverse event: Bleeding occult
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 128 at risk

Adverse event: Prolonged hospitalization.
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 128 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 128 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 9 affected / 128 at risk