Adverse Events Module

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Adverse Events Module

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

Adverse Events Module path is as follows:

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

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

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

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 2:03 AM
Ignite Modification Date: 2025-12-26 @ 12:28 AM
NCT ID: NCT00195260
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: 5
Time Frame: None
Study: NCT00195260
Study Brief: Study Evaluating SKI-606 (Bosutinib) In Advanced Malignant Solid Tumors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
RP2D 400 mg Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal. None None 47 100 99 100 View
Bosutinib 200 mg Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal. None None 2 6 6 6 View
Bosutinib 400 mg Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal. None None 5 7 7 7 View
Bosutinib 500 mg Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal. None None 2 7 7 7 View
Bosutinib 600 mg Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal. None None 7 10 10 10 View
MTD lead-in Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal. None None 3 6 6 6 View
Bosutinib 50 mg Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal. None None 4 4 4 4 View
Bosutinib 100 mg Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal. None None 3 4 4 4 View
Bosutinib 300 mg Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal. None None 3 7 7 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pericardial effusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Hepatic failure NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Activated partial thromboplastin time prolonged NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Hyponatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Coagulopathy NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Leukocytosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Sinus tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardio-respiratory arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Small intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Duodenal ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Faecaloma NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Haematemesis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Intestinal ischaemia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Large intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Ileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Peptic ulcer haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Ascites NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Upper gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Oesophageal stenosis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pancreatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Varices oesophageal NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Death NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Bile duct obstruction NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Hyperbilirubinaemia NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Cholangitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia staphylococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Systemic candida NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection staphylococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Abdominal abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Clostridium difficile colitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Klebsiella bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Parotitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia klebsiella NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Procedural pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Feeding tube complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Femur fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Liver function test abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
International normalised ratio increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Prothrombin time prolonged NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Failure to thrive NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperammonaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Flank pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Neck mass NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Metastases to central nervous system NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Metastases to rectum NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Metastasis NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Metastatic malignant melanoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Pancreatic carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Colorectal cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Malignant neoplasm progression NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hepatic encephalopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Delirium NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Mental status changes NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Nephrolithiasis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal failure acute NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal impairment NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Menorrhagia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Vaginal haemorrhage NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Acute respiratory distress syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pneumonia aspiration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rash maculo-papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Hospitalisation NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Circulatory collapse NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Haemorrhage NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Thrombophlebitis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Colorectal cancer metastatic NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypercoagulation NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Lymphadenopathy NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Ascites NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Lip dry NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Lactic acidosis NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Metabolic alkalosis NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypoalbuminaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Neck mass NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscular weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Hyperhidrosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Ecchymosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Periorbital oedema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Petechiae NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Lymphopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Sinus tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac failure congestive NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Pericardial effusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Supraventricular tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Extrasystoles NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Tinnitus NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Vision blurred NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Lacrimation increased NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Dry eye NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye oedema NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Visual acuity reduced NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Diplopia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Orbital oedema NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Visual impairment NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Photophobia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea 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
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Eructation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dyspepsia 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
Cheilitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dental caries NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrointestinal disorder NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Haemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrointestinal oedema NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Melaena NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Small intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Haematemesis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Haematochezia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Impaired gastric emptying NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Early satiety NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Catheter thrombosis NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chest discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Crepitations NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Gait disturbance NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Nodule NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Catheter site related reaction NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Local swelling NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Temperature intolerance NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Feeling hot NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Localised oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Hyperbilirubinaemia NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchitis 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
Oral herpes NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Postoperative wound infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Septic shock NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Staphylococcal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Incision site pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Post procedural complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Procedural pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Procedural site reaction NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Excoriation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Spinal compression fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Arthropod bite NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Contrast media reaction NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Drug toxicity NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Transfusion reaction NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Wound NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Breath sounds abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Electrocardiogram QT prolonged NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Electrocardiogram T wave abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Pulmonary function test decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
White blood cell count increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Activated partial thromboplastin time prolonged NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood albumin decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood phosphorus decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Body temperature increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Haemoglobin decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
International normalised ratio increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Urine analysis abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
White blood cells urine positive NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood phosphorus increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood urea decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Cardiac murmur NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Gamma-glutamyltransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Urine output decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypomagnesaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypocalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyponatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypercalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperkalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypernatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypovolaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal chest pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Flank pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Joint swelling NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Joint range of motion decreased NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Cervix neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Haemangioma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Basal cell carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Melanocytic naevus NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Metastases to central nervous system NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cervical cord compression NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hypoaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Migraine NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Neuralgia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Amnesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Ataxia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dysgeusia 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
Sinus headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Transient ischaemic attack NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Memory impairment NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Peripheral sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Lethargy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Confusional state NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Restlessness NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Anger NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Mood altered NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Mental status changes NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Urinary incontinence NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Bladder spasm NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Dysuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Micturition urgency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Hydronephrosis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Pollakiuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Glycosuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal failure acute NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Urinary hesitation NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Oedema genital NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Endometriosis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Haemorrhagic ovarian cyst NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Menstruation irregular 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
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
Atelectasis 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
Hiccups NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pneumothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Haemoptysis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash follicular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash macular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin discolouration NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin exfoliation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermatitis acneiform NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Night sweats NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash maculo-papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash pruritic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash erythematous 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
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Pallor NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Flushing NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hot flush NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Lymphoedema NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View