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 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:47 PM
NCT ID:
NCT00761267
Description:
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety population.
Frequency Threshold:
0
Time Frame:
Baseline up to 6 weeks after end of treatment (up to 91 days)
Study:
NCT00761267
Study Brief:
Study To Assess Pharmacokinetics, Safety & Efficacy of Anidulafungin When Treating Children With Invasive Candidiasis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Participants received Anidulafungin loading dose of 3 milligrams per kg(mg/kg) intravenously(IV) on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed invasive candidiasis/candidemia(ICC) and who fulfilled protocol specified criteria \[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC,could switch to oral fluconazole(6-12 mg/kg/day,maximum 800mg/day) upto 49 days. First 6 participants received second antifungal agent, if required at Investigator's discretion. | 1 | None | 7 | 19 | 17 | 19 | View |
| Anidulafungin: Participants Aged 5 to <18 Years | Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria (\[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\]and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days. | 5 | None | 13 | 30 | 30 | 30 | View |
| Anidulafungin: Participants Aged 2 to <5 Years | Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria \[1)afebrile for \>=24 2hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) for upto 49 days. | 2 | None | 10 | 19 | 17 | 19 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Aspiration bronchial | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v20.1 | View |
| Mental status changes | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v20.1 | View |
| Respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | View |
| Brachiocephalic vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v20.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v20.1 | View |
| Escherichia infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Lower respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Metabolic acidosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v20.1 | View |
| Seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v20.1 | View |
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v20.1 | View |
| Pancytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v20.1 | View |
| Gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v20.1 | View |
| Pancreatic pseudocyst | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v20.1 | View |
| General physical health deterioration | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v20.1 | View |
| Abdominal sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Device related infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Herpes zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Meningitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Oral herpes | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Pharyngitis streptococcal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Septic shock | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Staphylococcal bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Transaminases increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v20.1 | View |
| Hypoglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v20.1 | View |
| Haemorrhage intracranial | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v20.1 | View |
| Acute respiratory distress syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | View |
| Acute respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | View |
| Respiratory distress | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | View |
| Coagulopathy | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v20.1 | View |
| Catheter site infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Streptococcal sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Unintentional medical device removal | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v20.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Agranulocytosis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v20.1 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v20.1 | View |
| Disseminated intravascular coagulation | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v20.1 | View |
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v20.1 | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v20.1 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v20.1 | View |
| Pancytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v20.1 | View |
| Splenomegaly | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v20.1 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v20.1 | View |
| Thrombocytosis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v20.1 | View |
| Bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v20.1 | View |
| Sinus arrhythmia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v20.1 | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v20.1 | View |
| Thyroiditis | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA v20.1 | View |
| Pupil fixed | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v20.1 | View |
| Strabismus | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v20.1 | View |
| Abdominal distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v20.1 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v20.1 | View |
| Anorectal discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v20.1 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v20.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v20.1 | View |
| Dry mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v20.1 | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v20.1 | View |
| Flatulence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v20.1 | View |
| Gastric haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v20.1 | View |
| Gastrointestinal motility disorder | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v20.1 | View |
| Gastrooesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v20.1 | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v20.1 | View |
| Haematochezia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v20.1 | View |
| Ileus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v20.1 | View |
| Intra-abdominal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v20.1 | View |
| Mouth ulceration | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v20.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v20.1 | View |
| Pancreatic disorder | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v20.1 | View |
| Pancreatic pseudocyst | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v20.1 | View |
| Pancreatitis acute | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v20.1 | View |
| Saliva altered | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v20.1 | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v20.1 | View |
| Upper gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v20.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v20.1 | View |
| Catheter site erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v20.1 | View |
| Catheter site haematoma | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v20.1 | View |
| Catheter site haemorrhage | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v20.1 | View |
| Catheter site inflammation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v20.1 | View |
| Catheter site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v20.1 | View |
| Catheter site rash | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v20.1 | View |
| Catheter site related reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v20.1 | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v20.1 | View |
| Generalised oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v20.1 | View |
| Hyperpyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v20.1 | View |
| Hypothermia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v20.1 | View |
| Infusion site extravasation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v20.1 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v20.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v20.1 | View |
| Hepatitis acute | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v20.1 | View |
| Hepatomegaly | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v20.1 | View |
| Hyperbilirubinaemia | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v20.1 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Clostridium difficile colitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Clostridium difficile infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Enterococcal bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Enterococcal sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Herpes virus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Liver abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Lower respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Otitis media acute | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Purulent discharge | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Relapsing fever | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Splenic abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Staphylococcal bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Staphylococcal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Systemic candida | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Uterine abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Viral infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Viral upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Arthropod bite | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v20.1 | View |
| Gastrointestinal stoma complication | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v20.1 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v20.1 | View |
| Amylase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v20.1 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v20.1 | View |
| Bacterial test positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v20.1 | View |
| C-reactive protein increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v20.1 | View |
| Enterobacter test positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v20.1 | View |
| Klebsiella test positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v20.1 | View |
| Liver function test abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v20.1 | View |
| Oxygen saturation decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v20.1 | View |
| Platelet count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v20.1 | View |
| Prothrombin time prolonged | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v20.1 | View |
| Transaminases increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v20.1 | View |
| Urine output decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v20.1 | View |
| Atypical pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Catheter site infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Acidosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v20.1 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v20.1 | View |
| Electrolyte imbalance | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v20.1 | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v20.1 | View |
| Hypernatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v20.1 | View |
| Hyperuricaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v20.1 | View |
| Hypoalbuminaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v20.1 | View |
| Hypocalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v20.1 | View |
| Hypoglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v20.1 | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v20.1 | View |
| Hypomagnesaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v20.1 | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v20.1 | View |
| Hypoproteinaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v20.1 | View |
| Metabolic acidosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v20.1 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | View |
| Muscular weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | View |
| Musculoskeletal pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | View |
| Endometrial neoplasm | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | View |
| Areflexia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v20.1 | View |
| Seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v20.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v20.1 | View |
| Loss of consciousness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v20.1 | View |
| Tremor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v20.1 | View |
| Agitation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v20.1 | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v20.1 | View |
| Irritability | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v20.1 | View |
| Dysuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v20.1 | View |
| Henoch-Schonlein purpura nephritis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v20.1 | View |
| Acute kidney injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v20.1 | View |
| Urinary retention | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v20.1 | View |
| Genital erythema | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v20.1 | View |
| Penile oedema | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v20.1 | View |
| Scrotal oedema | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v20.1 | View |
| Uterine haematoma | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v20.1 | View |
| Vulvovaginal pain | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v20.1 | View |
| Atelectasis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | View |
| Haemoptysis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | View |
| Lung disorder | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | View |
| Pleural effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | View |
| Pneumonia aspiration | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | View |
| Productive cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | View |
| Respiratory distress | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | View |
| Rhinalgia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | View |
| Tachypnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | View |
| Blister | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v20.1 | View |
| Decubitus ulcer | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v20.1 | View |
| Dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v20.1 | View |
| Ecchymosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v20.1 | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v20.1 | View |
| Hyperhidrosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v20.1 | View |
| Livedo reticularis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v20.1 | View |
| Petechiae | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v20.1 | View |
| Pruritus generalised | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v20.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v20.1 | View |
| Rash generalised | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v20.1 | View |
| Rash macular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v20.1 | View |
| Scar pain | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v20.1 | View |
| Skin discolouration | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v20.1 | View |
| Skin haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v20.1 | View |
| Skin hyperpigmentation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v20.1 | View |
| Skin lesion | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v20.1 | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v20.1 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v20.1 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v20.1 | View |
| Phlebitis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v20.1 | View |
| Poor venous access | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v20.1 | View |
| Shock | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v20.1 | View |
| Thrombophlebitis superficial | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v20.1 | View |
| Lymphadenopathy | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v20.1 | View |
| Eye discharge | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v20.1 | View |
| Eye irritation | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v20.1 | View |
| Eyelid oedema | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v20.1 | View |
| Periorbital oedema | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v20.1 | View |
| Food poisoning | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v20.1 | View |
| Oral pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v20.1 | View |
| Salivary hypersecretion | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v20.1 | View |
| Face oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v20.1 | View |
| Oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v20.1 | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v20.1 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v20.1 | View |
| Cholestasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v20.1 | View |
| Ocular icterus | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v20.1 | View |
| Bacterial infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| catheter site cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Device related infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Pseudomonas infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Pyelonephritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Rash pustular | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Skin infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Urinary tract infection bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v20.1 | View |
| Accidental overdose | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v20.1 | View |
| Excoriation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v20.1 | View |
| Post procedural haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v20.1 | View |
| Blood bicarbonate decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v20.1 | View |
| Blood lactate dehydrogenase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v20.1 | View |
| Candida test positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v20.1 | View |
| Carbon dioxide decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v20.1 | View |
| Gamma-glutamyltransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v20.1 | View |
| Liver function test increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v20.1 | View |
| Device dislocation | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA v20.1 | View |
| Device malfunction | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA v20.1 | View |
| Bronchospasm | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | View |
| Laryngospasm | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | View |
| Respiratory disorder | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | View |
| Tonsillar erythema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | View |
| Dermatitis diaper | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v20.1 | View |
| Toxic skin eruption | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v20.1 | View |
| Deep vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v20.1 | View |
| Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v20.1 | View |