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:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2025-12-25 @ 7:00 PM
NCT ID:
NCT00464204
Description:
Regular assessment by Pharmacovigilance and Safety Assessor
Frequency Threshold:
0
Time Frame:
None
Study:
NCT00464204
Study Brief:
Effects of Voluven on Hemodynamics and Tolerability of Enteral Nutrition in Patients With Severe Sepsis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Voluven® Arm | 6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day | None | None | 53 | 100 | 99 | 100 | View |
| NaCl 0.9 % Arm | NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day | None | None | 44 | 96 | 95 | 96 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 13.1 | View |
| Acute right ventricular failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| Bradyarrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| Cardiac tamponade | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| Pericardial haemorrhage | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| Supraventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| Colitis ischaemic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 13.1 | View |
| Duodenal perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 13.1 | View |
| Intestinal ischaemia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 13.1 | View |
| Intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 13.1 | View |
| Peritonitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 13.1 | View |
| Condition aggravated | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 13.1 | View |
| Multi-organ failure | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 13.1 | View |
| Oedema due to cardiac disease | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 13.1 | View |
| Sudden death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 13.1 | View |
| Abdominal sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Pseudomembranous colitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Haemodilution | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 13.1 | View |
| Tracheal haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 13.1 | View |
| Blood chloride increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 13.1 | View |
| Venous oxygen saturation decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 13.1 | View |
| Hyperchloraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 13.1 | View |
| Hypernatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 13.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 13.1 | View |
| Hypoproteinaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 13.1 | View |
| Lactic acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 13.1 | View |
| Marasmus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 13.1 | View |
| Tumour lysis syndrome | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 13.1 | View |
| Bronchial carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.1 | View |
| Pleural carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.1 | View |
| Tonsil cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.1 | View |
| Cerebral disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 13.1 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 13.1 | View |
| Coma | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 13.1 | View |
| Haemorrhage intracranial | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 13.1 | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 13.1 | View |
| Renal failure acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 13.1 | View |
| Renal impairment | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 13.1 | View |
| Acute pulmonary oedema | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 13.1 | View |
| Acute respiratory distress syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Lung disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Respiratory distress | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Respiratory fatigue | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Toxic epidermal necrolysis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 13.1 | View |
| Withdrawal of life support | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA Version 13.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 13.1 | View |
| Peripheral ischaemia | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 13.1 | View |
| Shock | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 13.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 13.1 | View |
| Anaemia of chronic disease | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 13.1 | View |
| Coagulopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 13.1 | View |
| Disseminated intravascular coagulation | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 13.1 | View |
| Hypocoagulable state | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 13.1 | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 13.1 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 13.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 13.1 | View |
| Thrombocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 13.1 | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| Atrial flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| Cyanosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| Low cardiac output syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| Supraventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| Tachyarrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| Ventricular arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| Diabetes insipidus | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA Version 13.1 | View |
| Pupils unequal | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 13.1 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 13.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 13.1 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 13.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 13.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 13.1 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 13.1 | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 13.1 | View |
| Gastrointestinal necrosis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 13.1 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 13.1 | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 13.1 | View |
| Impaired gastric emptying | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 13.1 | View |
| Intestinal perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 13.1 | View |
| Malaena | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 13.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 13.1 | View |
| Rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 13.1 | View |
| Regurgitation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 13.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 13.1 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 13.1 | View |
| Device breakage | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 13.1 | View |
| Generalised oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 13.1 | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 13.1 | View |
| Oedema due to cardiac disease | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 13.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 13.1 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 13.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 13.1 | View |
| Cholangiolitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 13.1 | View |
| Cholestasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 13.1 | View |
| Cytolytic hepatitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 13.1 | View |
| Hyperbilirubinaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 13.1 | View |
| Jaundice cholestatic | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 13.1 | View |
| Acute sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Fungal skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Herpes simplex | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Lung infection pseudomonal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Peritoneal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Pneumonia pneumococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Post procedural infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Tuberculosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Airway complication of anaesthesia | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 13.1 | View |
| Failure to anastomose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 13.1 | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 13.1 | View |
| Haemodilution | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 13.1 | View |
| Mechanical ventilation complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 13.1 | View |
| Open wound | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 13.1 | View |
| Post procedural haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 13.1 | View |
| Activated partial thromboplastin time prolonged | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 13.1 | View |
| Aspiration bronchial | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 13.1 | View |
| Blood bicarbonate decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 13.1 | View |
| Blood bicarbonate increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 13.1 | View |
| Blood creatine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 13.1 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 13.1 | View |
| Blood potassium decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 13.1 | View |
| Blood pressure diastolic increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 13.1 | View |
| Blood pressure systolic increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 13.1 | View |
| Blood urea increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 13.1 | View |
| Central venous pressure decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 13.1 | View |
| Coagulation test abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 13.1 | View |
| Haemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 13.1 | View |
| Mean arterial pressure decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 13.1 | View |
| Oxygen saturation decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 13.1 | View |
| PO2 decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 13.1 | View |
| PO2 increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 13.1 | View |
| Red blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 13.1 | View |
| Urine output decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 13.1 | View |
| Venous oxygen saturation decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 13.1 | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 13.1 | View |
| Acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 13.1 | View |
| Alkalosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 13.1 | View |
| Food intolerance | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 13.1 | View |
| Hyperchloraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 13.1 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 13.1 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 13.1 | View |
| Hyperlactacidaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 13.1 | View |
| Hypernatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 13.1 | View |
| Hyperproteinaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 13.1 | View |
| Hyperuricaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 13.1 | View |
| Hypervolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 13.1 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 13.1 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 13.1 | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 13.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 13.1 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 13.1 | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 13.1 | View |
| Hypoproteinaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 13.1 | View |
| Hypovolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 13.1 | View |
| Lactic acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 13.1 | View |
| Metabolic acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 13.1 | View |
| Metabolic alkalosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 13.1 | View |
| Vitamin K deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 13.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 13.1 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 13.1 | View |
| Rhabdomyolysis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 13.1 | View |
| Brain injury | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 13.1 | View |
| Convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 13.1 | View |
| Critical illness polyneuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 13.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 13.1 | View |
| Myoclonus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 13.1 | View |
| Neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 13.1 | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 13.1 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 13.1 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 13.1 | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 13.1 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 13.1 | View |
| Hallucination | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 13.1 | View |
| Azotaemia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 13.1 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 13.1 | View |
| Oliguria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 13.1 | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 13.1 | View |
| Renal failure acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 13.1 | View |
| Renal failure chronic | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 13.1 | View |
| Renal impairment | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 13.1 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 13.1 | View |
| Vaginal haemorrhage | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 13.1 | View |
| Acute pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Acute respiratory distress syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Atelectasis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Bronchial obstruction | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Bronchospasm | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Hypercapnia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Hyperventilation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Hypocapnia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Lung disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Pleurisy | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Respiratory acidosis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Respiratory alkalosis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Decubitus ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 13.1 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 13.1 | View |
| Livedo reticularis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 13.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 13.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 13.1 | View |
| Rash erythematous | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 13.1 | View |
| Haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 13.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 13.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 13.1 | View |
| Labile hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 13.1 | View |
| Peripheral ischaemia | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 13.1 | View |
| Venous thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 13.1 | View |