Study: NCT04530604

Adverse event: Pulmonary Bacterial Infection
Serious: yes
Organ System: Infections and infestations
Notes: during treatment
Frequency: 4 affected / 12 at risk

Adverse event: ECMO
Serious: yes
Organ System: Surgical and medical procedures
Notes: during treatment
Frequency: 1 affected / 12 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: did not occur during treatment, but occurred within 30 days following completion of defibrotide therapy
Frequency: 1 affected / 12 at risk

Adverse event: bleeding/ hemorraghic
Serious: yes
Organ System: Cardiac disorders
Notes: did not occur during treatment, but occurred within 30 days following completion of defibrotide therapy
Frequency: 2 affected / 12 at risk

Adverse event: Pulmonary fungal infection
Serious: yes
Organ System: Infections and infestations
Notes: did not occur during treatment, but occurred within 30 days following completion of defibrotide therapy
Frequency: 1 affected / 12 at risk

Adverse event: Pulmonary Bacterial infection
Serious: yes
Organ System: Infections and infestations
Notes: did not occur during treatment, but occurred within 30 days following completion of defibrotide therapy
Frequency: 2 affected / 12 at risk

Adverse event: Bacterial Infections (Other)
Serious: yes
Organ System: Infections and infestations
Notes: did not occur during treatment, but occurred within 30 days following completion of defibrotide therapy
Frequency: 3 affected / 12 at risk

Adverse event: Neurologic (Other)
Serious: yes
Organ System: Nervous system disorders
Notes: did not occur during treatment, but occurred within 30 days following completion of defibrotide therapy
Frequency: 1 affected / 12 at risk

Adverse event: Skin (rash)
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: did not occur during treatment, but occurred within 30 days following completion of defibrotide therapy
Frequency: 1 affected / 12 at risk

Adverse event: Tracheostomy
Serious: yes
Organ System: Surgical and medical procedures
Notes: did not occur during treatment, but occurred within 30 days following completion of defibrotide therapy
Frequency: 2 affected / 12 at risk

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

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

Adverse event: Thrombocytosis
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 12 at risk

Adverse event: Pulmonary Infections (bacterial)
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 12 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 12 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 12 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 12 at risk

Adverse event: Increased ALT
Serious: no
Organ System: Investigations
Frequency: 3 affected / 12 at risk

Adverse event: Increased AST
Serious: no
Organ System: Investigations
Frequency: 3 affected / 12 at risk

Adverse event: Azotaemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 12 at risk

Adverse event: Alkalosis
Serious: no
Organ System: Investigations
Frequency: 1 affected / 12 at risk

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

Adverse event: ECMO
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 12 at risk