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:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
NCT ID:
NCT06729606
Description:
Adverse events were collected irrespective of mono or dual therapy assignment
Frequency Threshold:
0
Time Frame:
All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28.
Study:
NCT06729606
Study Brief:
Aviptadil for Severely Ill Inpatients With COVID-19 (An ACTIV-3b/TESICO Treatment Trial)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Aviptadil + SOC | Arm includes all participants who received Aviptadil, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761) Aviptadil: Administered by IV infusion over 12 hours per day for 3 days. The Day 1 infusion rate is 50 pmol/kg/hr, the Day 2 infusion rate is 100 pmol/kg/hr, and the Day 3 infusion rate is 150 pmol/kg/hr. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC. | 90 | None | 25 | 231 | 200 | 231 | View |
| Placebo + SOC | Arm includes all participants who received Aviptadil Placebo, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761) Aviptadil Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion over 12 hours per day for 3 days. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC. | 86 | None | 23 | 230 | 176 | 230 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Heparin-induced thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.1 | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| Pulseless electrical activity | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| Ventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Diverticular perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Intestinal ischaemia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Large intestine perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Barotrauma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| Subdural haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| Computerised tomogram thorax abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| Diabetic ketoacidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.1 | View |
| Mental status changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.1 | View |
| Aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Bronchial obstruction | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Haemothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Pneumomediastinum | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.1 | View |
| Blood loss anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.1 | View |
| Coagulopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.1 | View |
| Disseminated intravascular coagulation | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.1 | View |
| Heparin-induced thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.1 | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.1 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.1 | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| Acute right ventricular failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| Arrhythmia supraventricular | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| Cardiac failure acute | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| Cardiogenic shock | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| Extrasystoles | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| Pulseless electrical activity | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| Right ventricular failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| Supraventricular extrasystoles | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| Supraventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| Ventricular arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| Ventricular extrasystoles | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| Ventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 25.1 | View |
| Eye oedema | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 25.1 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Diverticular perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Haematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Intestinal ischaemia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Melaena | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Peptic ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Retroperitoneal haematoma | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Retroperitoneal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Salivary hypersecretion | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Chest discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Complication associated with device | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Flushing | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Hypothermia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Infusion site extravasation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Systemic inflammatory response syndrome | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Acute hepatic failure | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 25.1 | View |
| Cholestasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 25.1 | View |
| Hypertransaminasaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 25.1 | View |
| Multisystem inflammatory syndrome | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 25.1 | View |
| Multisystem inflammatory syndrome in adults | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 25.1 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 25.1 | View |
| Abdominal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Bronchopulmonary aspergillosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| COVID-19 pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Candida infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Clostridium difficile colitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Clostridium difficile infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Cytomegalovirus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Cytomegalovirus infection reactivation | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Enterobacter pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Enterococcal bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Escherichia bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Escherichia urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Fungaemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Fungal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Haemophilus bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Helicobacter infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Infectious pleural effusion | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Klebsiella sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Parotitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Pneumonia bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Pneumonia haemophilus | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Pneumonia klebsiella | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Pneumonia pseudomonal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Pneumonia staphylococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Respiratory tract infection fungal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Sinusitis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Staphylococcal bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Staphylococcal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Staphylococcal sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Streptococcal bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Urinary tract infection bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Urinary tract infection enterococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Urinary tract infection fungal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Urinary tract infection staphylococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Viral sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Barotrauma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| Post procedural hypotension | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| Subdural haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| Substance-induced psychotic disorder | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| Vascular access site erythema | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| Haemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| Urine output decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| Acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Hypernatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Hypertriglyceridaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Metabolic acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Metabolic alkalosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Type 2 diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Haematoma muscle | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| Areflexia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Cerebellar stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Haemorrhagic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Intensive care unit acquired weakness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Metabolic encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Polyneuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Toxic encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.1 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.1 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.1 | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.1 | View |
| Intensive care unit delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.1 | View |
| Mental status changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.1 | View |
| Suicidal ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.1 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.1 | View |
| Anuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.1 | View |
| Azotaemia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.1 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.1 | View |
| Oliguria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.1 | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.1 | View |
| Renal impairment | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.1 | View |
| Renal injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.1 | View |
| Renal tubular dysfunction | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.1 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.1 | View |
| Acute respiratory distress syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Bradypnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Bronchopleural fistula | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Dry throat | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Hypercapnia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Organising pneumonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Pneumomediastinum | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Pulmonary alveolar haemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Pulmonary hypertension | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Respiratory acidosis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Respiratory alkalosis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Respiratory arrest | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Respiratory distress | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Tachypnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Throat tightness | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Decubitus ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Drug eruption | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Subcutaneous emphysema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Endotracheal intubation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 25.1 | View |
| Haemofiltration | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 25.1 | View |
| Renal replacement therapy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 25.1 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.1 | View |
| Distributive shock | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.1 | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.1 | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.1 | View |
| Peripheral arterial occlusive disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.1 | View |
| Peripheral artery thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.1 | View |
| Peripheral ischaemia | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.1 | View |
| Shock | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.1 | View |
| Shock haemorrhagic | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.1 | View |
| Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.1 | View |
| Venous thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.1 | View |