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: 2025-12-24 @ 11:35 PM
Ignite Modification Date: 2025-12-25 @ 9:24 PM
NCT ID: NCT00615056
Description: The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Frequency Threshold: 0
Time Frame: None
Study: NCT00615056
Study Brief: A Study Combining FOLFOX or FOLFIRI With AG-013736 or Bevacizumab (Avastin) in Patients With Metastatic Colorectal Cancer After Failure Of One First Line Regimen
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Axitinib + FOLFIRI Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m\^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m\^2 (or levo-leucovarin \[l-LV\] 200 mg /m\^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle. None None 17 46 45 46 View
Bevacizumab + FOLFIRI Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m\^2 90 minutes IV infusion, concurrently with LV 400 mg/m\^2 (or l-LV 200 mg /m\^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle. None None 9 51 51 51 View
Axitinib + FOLFOX Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m\^2 120 minutes IV infusion, concurrently with LV 400 mg/m\^2 (or l-LV 200 mg /m\^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle. None None 11 36 35 36 View
Bevacizumab + FOLFOX Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m\^2 120 minutes IV infusion, concurrently with LV 400 mg/m\^2 (or l-LV 200 mg /m\^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle. None None 5 35 33 35 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Otosalpingitis NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Colonic obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Haematochezia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Ileal ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Ileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Oesophagitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Rectal perforation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Anal inflammation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrointestinal ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Performance status decreased NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
General physical health deterioration NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Disease progression NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Hyperbilirubinaemia NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Hepatic mass NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Cellulitis pharyngeal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Escherichia sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Anal abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lung infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lumbar vertebral fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypovolaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Cerebral haemorrhage NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Peripheral sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Renal failure acute NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pneumothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Bile duct stone NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Subileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Haemorrhagic ascites NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Coagulopathy NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Lymphopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Cardiac failure congestive NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Left ventricular dysfunction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Ear discomfort NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Ear disorder NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Ear pain NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
External ear inflammation NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Hyperacusis NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Otosalpingitis NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Tinnitus NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Hyperthyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Hypothyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Age-related macular degeneration NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Asthenopia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Cataract NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Conjunctival oedema NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Dry eye NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye discharge NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye haemorrhage NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye irritation NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye pain NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye pruritus NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Lacrimation increased NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Mydriasis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Vision blurred NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Visual impairment NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain lower NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Anal fissure NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Anal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Anal inflammation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Anorectal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Ascites NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Cheilitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Defaecation urgency NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dental discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Enteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Epigastric discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Eructation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Faecal incontinence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Faeces discoloured NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrointestinal toxicity NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gingival pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gingivitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Haemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Hernial eventration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Large intestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Lip ulceration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Mouth ulceration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Odynophagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Oesophagitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Oral pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Painful defaecation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Periodontitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Peristalsis visible NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Proctalgia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Proctitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Rectal fissure NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Rectal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Rectal tenesmus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Subileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Tooth erosion NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chest discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Device occlusion NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Implant site haematoma NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Influenza like illness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Infusion site extravasation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site reaction NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Mucosal dryness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Mucosal inflammation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Performance status decreased NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Temperature intolerance NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Thrombosis in device NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Cholangitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Hepatic function abnormal NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Hepatic pain NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Hyperbilirubinaemia NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Hyperplastic cholecystopathy NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Jaundice NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Jaundice cholestatic NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Portal vein thrombosis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Drug hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Seasonal allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Anal abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Clostridial infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Clostridium difficile colitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Device related infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Ear infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Herpes simplex NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Herpes zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Hordeolum NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Infected sebaceous cyst NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Laryngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lung infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Oral candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Oral herpes NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pelvic abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tooth abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Anal injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Excoriation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Face injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Post procedural haemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Scapula fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Sunburn NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Thermal burn NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Tooth fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Upper limb fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Alanine aminotransferase NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Aspartate aminotransferase NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood albumin decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood alkaline phosphatase NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood bilirubin NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood cholesterol increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood creatine increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood creatinine NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood glucose increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood lactate dehydrogenase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood potassium decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood pressure increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood thyroid stimulating hormone increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood triglycerides increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Breath sounds abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Carcinoembryonic antigen increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Clostridium test positive NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Lymphocyte count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Neutrophil count NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Platelet count NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Visual field tests NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Weight increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
White blood cell count NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
White blood cell count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
White blood cell count increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypercalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypercholesterolaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperkalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypoalbuminaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypocalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypomagnesaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyponatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Lactic acidosis NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Metabolic acidosis NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Bone pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Flank pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscle atrophy NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscle contracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscular weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal chest pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal disorder NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Spinal osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Cancer pain NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Malignant pleural effusion NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Tumour haemorrhage NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Ageusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Aphasia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cerebral ischaemia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cholinergic syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dysaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hyperaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hypoaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Myelopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Neuropathy peripheral NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Peripheral sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Toxic neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Transient ischaemic attack NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Confusional state NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Delirium NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Disorientation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Mood altered NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Nervousness NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Sleep disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Bladder spasm NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Chromaturia NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Dysuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Glycosuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Hydronephrosis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Proteinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Ureteric obstruction NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Urinary incontinence NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Urinary retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Dysmenorrhoea NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Epididymitis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Erectile dysfunction NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Gynaecomastia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Metrorrhagia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Ovarian cyst NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Pelvic pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Uterine haemorrhage NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Vaginal discharge NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Vaginal haemorrhage NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Vulvovaginal pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Vulvovaginal pruritus NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Bronchospasm NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dysphonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnoea exertional NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Hiccups NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Lung disorder NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Nasal discomfort NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Nasal disorder NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Nasal ulcer NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Oropharyngeal discomfort NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Painful respiration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Paranasal sinus hypersecretion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pneumonitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pulmonary artery thrombosis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Reflux laryngitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Respiratory alkalosis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rhinitis allergic NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Sinus congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Throat irritation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Throat tightness NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Wheezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermatitis allergic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Facial wasting NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Hyperhidrosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Nail disorder NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Nail toxicity NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Night sweats NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Palmar-plantar erythrodysaesthesia syndrome NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash pruritic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin discolouration NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin disorder NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin hyperpigmentation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin lesion NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin toxicity NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Subcutaneous nodule NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Embolism NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Embolism venous NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Flushing NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Haematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Haemorrhage NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Pallor NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Phlebitis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Thrombophlebitis superficial NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Vasculitis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Chapped lips NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Haemorrhoidal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Colostomy infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Septic shock NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gamma-glutamyltransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
General physical condition normal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Haemoglobin NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Haemoglobin decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Productive cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View