Study: NCT04348656

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 70 affected / 614 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 57 affected / 614 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 12 affected / 614 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 14 affected / 614 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 614 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 614 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 614 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 614 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 614 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 614 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 614 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 614 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 614 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 614 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 614 at risk

Adverse event: Infections and infestations - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 614 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 614 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 614 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 614 at risk

Adverse event: Transfusion associated circulatory overload
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: TACO is characterized by any four of the following: acute respiratory distress, tachycardia, increased blood pressure, acute or worsening pulmonary edema on chest xray, evidence of positive fluid balance within 6h of completion of transfusion
Frequency: 2 affected / 614 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 614 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 614 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 614 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 614 at risk

Adverse event: Pulmonary fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 614 at risk

Adverse event: Renal and urinary disorders - Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 614 at risk

Adverse event: Transfusion associated dyspnea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory distress within 24h of transfusion that does meet criteria for TACO, TRALI, or allergic reaction. Respiratory distress should be the most prominent clinical feature and should not be explained by the pt's condition or another known cause
Frequency: 1 affected / 614 at risk

Adverse event: Possible transfusion related acute lung injury
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: In patients with no acute lung injury prior to transfusion, a new acute lung injury meeting ISBT criteria that is present during or within 6 hours of transfusion.
Frequency: 1 affected / 614 at risk

Adverse event: Cardiac disorders - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 614 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 614 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 614 at risk

Adverse event: Disseminated intravascular coagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 614 at risk

Adverse event: Duodenal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 614 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 614 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 614 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 614 at risk

Adverse event: Hepatic pain
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 614 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 614 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 614 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 614 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 614 at risk

Adverse event: Metabolism and nutrition disorders - Other
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 614 at risk

Adverse event: Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 614 at risk

Adverse event: Pregnancy, puerperium and perinatal conditions - Other
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 614 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 614 at risk

Adverse event: Surgical and medical procedures - Other
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 614 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 614 at risk

Adverse event: Urine output decreased
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 614 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 614 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 17 affected / 614 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 614 at risk

Adverse event: Infections and infestations, other
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 614 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 614 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 614 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 614 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 614 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 614 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 614 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 33 affected / 307 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 307 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 307 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 307 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 307 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 307 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 307 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 307 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 307 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 307 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 307 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 307 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 307 at risk

Adverse event: Infections and infestations - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 307 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 307 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 307 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 307 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 307 at risk

Adverse event: Pulmonary fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 307 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 307 at risk

Adverse event: Troponin T increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 307 at risk

Adverse event: Haemolytic uraemic syndrome
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 307 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 307 at risk

Adverse event: Retroperitoneal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 307 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 307 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 307 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 307 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 307 at risk

Adverse event: Infections and infestations, other
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 307 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 307 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 307 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 307 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 307 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 307 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 307 at risk