Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 4:27 AM

Ignite Modification Date: 2025-12-26 @ 3:31 AM

NCT ID: NCT04333420

Description: All adverse events are reported including non-treatment-emergent adverse events.

Frequency Threshold: 5

Time Frame: Phase II study part: 4 weeks; Phase III study part: 60 days;

Study: NCT04333420

Study Brief: Randomized, Controlled Study of IFX-1 in Patients With Severe COVID-19 Pneumonia

Event Groups(If Any):

Event Groups

Title	Description	Deaths # Affected	Deaths # At Risk	Serious # Affected	Serious # At Risk	Other # Affected	Other # At Risk	View

Phase II: BSC	Phase II study part: BSC: Best supportive care	4	None	7	15	14	15	View
Phase III: IFX-1 + SOC	Phase III study part: IFX-1: 800mg intravenously administered, SOC: Standard of care; with at least one IMP administration;	62	None	103	175	147	175	View
Phase III: Placebo + SOC	Phase III study part: Placebo: placebo infusion intravenously administered, SOC: Standard of care; with at least one IMP administration;	86	None	122	189	154	189	View
Phase III: Randomized Non-treated Patients	Phase III study part: patients who were randomized but never treated.	1	None	2	5	0	5	View
Phase II: IFX-1 + BSC	Phase II study part: IFX-1: 800mg intravenously administered, BSC: Best supportive care	2	None	9	15	14	15	View

Serious Events(If Any):

Serious Events

Term	Type	Organ System	Vocab	View

Pneumonia	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Device related sepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Pseudomonas infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Sepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Staphylococcal infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Urinary tract infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Vascular device infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Septic shock	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Pulmonary sepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Klebsiella infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Pneumonia staphylococcal	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Bronchopulmonary aspergillosis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Pneumonia klebsiella	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Acinetobacter infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Pneumonia acinetobacter	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Pneumonia pseudomonal	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Staphylococcal sepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Enterococcal sepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Urosepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Aspergillus infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Tracheobronchitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Device related bacteraemia	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Enterococcal infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Herpes simplex pneumonia	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Pneumonia escherichia	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Pseudomonal sepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Stenotrophomonas infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Urinary tract infection enterococcal	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Acinetobacter sepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
COVID-19 pneumonia	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Citrobacter infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Enterobacter pneumonia	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Enterococcal bacteraemia	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Escherichia infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Escherichia urinary tract infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Klebsiella sepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Lung abscess	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Nosocomial infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Pneumonia aspiration	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Pneumonia bacterial	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Pneumonia cytomegaloviral	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Pneumonia serratia	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Superinfection bacterial	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Tracheobronchitis bacterial	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Bacteraemia	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Bacterial infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Bronchitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Candida sepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Cholangitis infective	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Corynebacterium sepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Device related infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Empyema	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Enterobacter infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Enterobacter sepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Enterobacter tracheobronchitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Epstein-Barr virus infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Herpes simplex reactivation	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Infectious pleural effusion	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Klebsiella bacteraemia	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Liver abscess	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Morganella infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Peritonitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Pneumonia haemophilus	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Pneumonia streptococcal	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Providencia infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Pseudomonal bacteraemia	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Severe acute respiratory syndrome	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Staphylococcal bacteraemia	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Stenotrophomonas sepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Streptococcal sepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Systemic candida	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Urinary tract infection pseudomonal	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Pulmonary embolism	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Respiratory failure	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Hypoxia	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Dyspnoea	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pneumothorax	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Acute respiratory distress syndrome	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Laryngeal oedema	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pneumomediastinum	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Aspiration	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Haemoptysis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Respiratory distress	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Acute respiratory failure	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Anoxia	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Bronchial obstruction	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Bronchopleural fistula	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Cough	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Haemothorax	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Hypercapnia	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Lung opacity	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Mediastinal shift	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Organising pneumonia	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pleural effusion	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pulmonary fibrosis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pulmonary hypertension	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pulmonary infarction	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pulmonary necrosis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Sputum retention	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Acute kidney injury	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Renal failure	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Renal impairment	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Anuria	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Oliguria	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Multiple organ dysfunction syndrome	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Hyperthermia	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Fibrosis	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Medical device site haemorrhage	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Oedema peripheral	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Cardiac arrest	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Cardio-respiratory arrest	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Acute myocardial infarction	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Bradycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Cardiogenic shock	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Ventricular tachycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Arrhythmia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Atrial fibrillation	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Atrioventricular block	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Atrioventricular block complete	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Cardiac failure	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Cardiac failure acute	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Cardiac perforation	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Cardiomyopathy	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Cardiopulmonary failure	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Myocardial infarction	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Supraventricular tachycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Ventricular arrhythmia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Ventricular extrasystoles	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Ventricular fibrillation	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Epilepsy	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Ischaemic cerebral infarction	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Depressed level of consciousness	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Cerebral infarction	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Autonomic nervous system imbalance	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Ischaemic stroke	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Haemorrhagic cerebral infarction	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Seizure	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Stroke in evolution	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Subarachnoid haemorrhage	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Toxic encephalopathy	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Transient ischaemic attack	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Peripheral artery thrombosis	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Shock haemorrhagic	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Distributive shock	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Deep vein thrombosis	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Jugular vein thrombosis	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Thrombosis	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Circulatory collapse	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Hypertensive crisis	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Obstructive shock	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Shock	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Liver injury	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	None	View
Acute hepatic failure	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	None	View
Hepatic failure	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	None	View
Ischaemic hepatitis	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	None	View
Cholangitis sclerosing	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	None	View
Drug-induced liver injury	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	None	View
Hepatic function abnormal	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	None	View
Hepatic infarction	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	None	View
Dysphagia	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Salivary hypersecretion	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Intra-abdominal haemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Large intestine perforation	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Diverticulum intestinal haemorrhagic	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Duodenal ulcer haemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Gastrointestinal haemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Gastrointestinal necrosis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Intestinal ischaemia	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Mouth haemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Pancreatitis acute	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Pancreatitis necrotising	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Rectal haemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
End-tidal CO2 increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Oxygen saturation decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Staphylococcus test positive	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Bronchoalveolar lavage abnormal	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Aspergillus test positive	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Herpes simplex test positive	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood culture positive	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Glutamate dehydrogenase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Hepatic enzyme abnormal	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Hepatic enzyme increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Klebsiella test positive	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Sputum culture positive	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Transaminases increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Anaemia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Thrombocytopenia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Heparin-induced thrombocytopenia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Splenic infarction	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Hyperkalaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Acid-base balance disorder mixed	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Acidosis	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hyperglycaemic hyperosmolar nonketotic syndrome	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypovolaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Endotracheal intubation complication	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Post procedural complication	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Post procedural haemorrhage	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Subcutaneous emphysema	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Muscle haemorrhage	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Device leakage	SYSTEMATIC_ASSESSMENT	Product Issues	None	View
Device dislocation	SYSTEMATIC_ASSESSMENT	Product Issues	None	View
Delirium	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Agitation	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Pneumococcal sepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Coagulopathy	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Right ventricular failure	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Overdose	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Hypertensive emergency	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View

Other Events(If Any):

Other Events

Term	Type	Organ System	Vocab	View

Pneumonia	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Aspergillus infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Bronchopulmonary aspergillosis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Cellulitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Enterococcal infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Fungal infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Staphylococcal infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Vascular device infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Herpes simplex	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Deep vein thrombosis	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Hypertension	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Phlebitis	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Thrombophlebitis	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Hypotension	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Jugular vein thrombosis	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Shock	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Systolic hypertension	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Hypernatraemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypophosphataemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypokalaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hyperglycaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypercalcaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hyperkalaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hyponatraemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Fluid overload	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hyperchloraemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypermagnesaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypomagnesaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Metabolic alkalosis	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Refeeding syndrome	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Delirium	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Anxiety	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Hallucination	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Nightmare	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Panic attack	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Restlessness	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Intensive care unit delirium	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Oedema peripheral	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Pyrexia	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Chest discomfort	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Chills	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Face oedema	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Hypothermia	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Infusion site discolouration	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Infusion site extravasation	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Infusion site vesicles	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Medical device site haemorrhage	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Hepatic enzyme increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood bicarbonate increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood potassium decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Electrocardiogram QT prolonged	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Fluid balance positive	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood alkaline phosphatase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood culture positive	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood fibrinogen increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood phosphorus decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood urea increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Computerised tomogram abnormal	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Culture negative	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Liver function test abnormal	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Oxygen saturation decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Platelet count increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Protein urine present	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Sputum culture positive	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Staphylococcus test positive	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Supraventricular tachycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Atrial fibrillation	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Atrioventricular block second degree	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Bradycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Cardiac failure	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Defect conduction intraventricular	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Sinus tachycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Tachycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Impaired gastric emptying	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Constipation	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Diarrhoea	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Dysphagia	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Frequent bowel movements	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Gastric haemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Ileus	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Ileus paralytic	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Mouth ulceration	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Nausea	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Rectal haemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Vomiting	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Pulmonary embolism	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Respiratory failure	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Hypoxia	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Bradypnoea	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Hypoventilation	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pneumothorax	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Sleep apnoea syndrome	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Anaemia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Acute kidney injury	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Oliguria	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Glycosuria	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Urinary retention	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Decubitus ulcer	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Actinic keratosis	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Alopecia	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Angioedema	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Urticaria	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Fall	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Infusion related reaction	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Limb injury	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Post procedural haematoma	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Headache	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Hemiparesis	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Hypoaesthesia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Intensive care unit acquired weakness	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Metabolic encephalopathy	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Peripheral nerve lesion	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Somnolence	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Subarachnoid haemorrhage	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Arthralgia	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Muscular weakness	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Ocular hyperaemia	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Eye irritation	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Miosis	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Pupils unequal	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Meningioma	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Device leakage	SYSTEMATIC_ASSESSMENT	Product Issues	None	View
Vertigo	SYSTEMATIC_ASSESSMENT	Ear and labyrinth disorders	None	View
Culture urine	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Cytomegalovirus test positive	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Enterococcus test positive	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Eosinophil count increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Fibrin D dimer increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Gamma-glutamyltransferase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View