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 @ 12:04 PM
Ignite Modification Date:
2025-12-25 @ 11:58 AM
NCT ID:
NCT00410761
Description:
The safety population included all participants who received at least 1 dose of vandetanib/placebo. All-cause mortality (deaths) was assessed in all randomized participants.
Frequency Threshold:
5
Time Frame:
Serious adverse events(SAEs) and all-cause mortality(deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 212 months. Other (non-serious) AEs were reported from randomization (Day 1) up to data cut-off date 01-Jun-2010, approximately 42 months. AEs and SAEs were collected from Day 1 to cut-off date 01-Jun-2010 and were presented in clinical database. After this cut-off date, SAEs were reported in pharmacovigilance database, but no non-serious AEs were reported.
Study:
NCT00410761
Study Brief:
An Efficacy Study Comparing ZD6474 to Placebo in Medullary Thyroid Cancer
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Randomized Treatment Period: Vandetanib 300 mg | Participants received vandetanib 300 mg orally once daily until objective disease progression, any other withdrawal criteria was met or at the investigator's discretion, the approval and implementation of protocol amendment 6 during the blinded randomized treatment period. | 66 | None | 92 | 231 | 226 | 231 | View |
| Open-Label Treatment Period: Vandetanib 300 mg/Vandetanib 300 mg | Participants who received vandetanib 300 mg during the blinded randomized treatment period and who were unblinded due to disease progression or as a result of protocol amendment 6 were given the option to continue to receive vandetanib 300 mg orally once daily in the open-label treatment period for as long as they still benefitted of it per investigator judgement or until they were given another anti-cancer therapy. | 52 | None | 53 | 109 | 32 | 109 | View |
| Open-Label Treatment Period: Placebo/Vandetanib 300 mg | Participants who received placebo matched to vandetanib during the blinded randomized treatment period and who were unblinded due to disease progression or as a result of protocol amendment 6 were given the option to receive vandetanib 300 mg orally once daily in the open-label treatment period for as long as they still benefitted of it per investigator judgement or until they were given another anti-cancer therapy. | 41 | None | 36 | 79 | 70 | 79 | View |
| Randomized Treatment Period: Placebo | Participants received placebo matched to vandetanib orally once daily until objective disease progression, any other withdrawal criteria was met or at the investigator's discretion, the approval and implementation of protocol amendment 6 during the blinded randomized treatment period. | 10 | None | 16 | 99 | 87 | 99 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 13 - 25.1 | View |
| Gastrointestinal Haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 13 - 25.1 | View |
| Intestinal Perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 13 - 25.1 | View |
| Pneumatosis Intestinalis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 13 - 25.1 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 13 - 25.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 13 - 25.1 | View |
| Sudden Death | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 13 - 25.1 | View |
| Swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 13 - 25.1 | View |
| Bartholin's Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Bronchitis Bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Covid-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Dermatitis Infected | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 13 - 25.1 | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 13 - 25.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 13 - 25.1 | View |
| Acute Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 13 - 25.1 | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 13 - 25.1 | View |
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 13 - 25.1 | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 13 - 25.1 | View |
| Cardiac Failure Acute | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 13 - 25.1 | View |
| Cardiac Failure Congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 13 - 25.1 | View |
| Cardio-Respiratory Arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 13 - 25.1 | View |
| Cardiovascular Insufficiency | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 13 - 25.1 | View |
| Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 13 - 25.1 | View |
| Pericardial Effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 13 - 25.1 | View |
| Pericardial Haemorrhage | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 13 - 25.1 | View |
| Pericarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 13 - 25.1 | View |
| Stress Cardiomyopathy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 13 - 25.1 | View |
| Patent Ductus Arteriosus | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDra 13 - 25.1 | View |
| Cushing's Syndrome | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDra 13 - 25.1 | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 13 - 25.1 | View |
| Glaucoma | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 13 - 25.1 | View |
| Retinal Artery Occlusion | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 13 - 25.1 | View |
| Retinal Detachment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 13 - 25.1 | View |
| Vision Blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 13 - 25.1 | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 13 - 25.1 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 13 - 25.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 13 - 25.1 | View |
| Dry Mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 13 - 25.1 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 13 - 25.1 | View |
| Faecaloma | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 13 - 25.1 | View |
| Gastrointestinal Inflammation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 13 - 25.1 | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 13 - 25.1 | View |
| Intestinal Obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 13 - 25.1 | View |
| Mechanical Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 13 - 25.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 13 - 25.1 | View |
| Obstructive Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 13 - 25.1 | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 13 - 25.1 | View |
| Pancreatitis Acute | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 13 - 25.1 | View |
| Pancreatitis Chronic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 13 - 25.1 | View |
| Pancreatitis Haemorrhagic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 13 - 25.1 | View |
| Peritonitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 13 - 25.1 | View |
| Reflux Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 13 - 25.1 | View |
| Subileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 13 - 25.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 13 - 25.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 13 - 25.1 | View |
| General Physical Health Deterioration | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 13 - 25.1 | View |
| Mucosal Inflammation | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 13 - 25.1 | View |
| Biliary Colic | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDra 13 - 25.1 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDra 13 - 25.1 | View |
| Cholecystitis Acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDra 13 - 25.1 | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDra 13 - 25.1 | View |
| Cholestasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDra 13 - 25.1 | View |
| Jaundice | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDra 13 - 25.1 | View |
| Iodine Allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDra 13 - 25.1 | View |
| Abdominal Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Abdominal Wall Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Appendicitis Perforated | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Biliary Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Folliculitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Gastroenteritis Bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Gastroenteritis Viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Gastrointestinal Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Infected Bites | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Laryngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Lower Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Lung Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Meningitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Meningitis Bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Peridiverticular Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Peritonitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Postoperative Wound Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Staphylococcal Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Staphylococcal Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Streptococcal Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Urinary Tract Infection Pseudomonal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Compression Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 13 - 25.1 | View |
| Exposure During Pregnancy | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 13 - 25.1 | View |
| Jaw Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 13 - 25.1 | View |
| Joint Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 13 - 25.1 | View |
| Overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 13 - 25.1 | View |
| Post Procedural Haematuria | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 13 - 25.1 | View |
| Seroma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 13 - 25.1 | View |
| Spinal Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 13 - 25.1 | View |
| Venomous Bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 13 - 25.1 | View |
| Wound Necrosis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 13 - 25.1 | View |
| Blood Creatinine Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 13 - 25.1 | View |
| C-Reactive Protein Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 13 - 25.1 | View |
| Electrocardiogram Qt Prolonged | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 13 - 25.1 | View |
| Hepatic Enzyme Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 13 - 25.1 | View |
| International Normalised Ratio Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 13 - 25.1 | View |
| Prostatic Specific Antigen Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 13 - 25.1 | View |
| Acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 13 - 25.1 | View |
| Decreased Appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 13 - 25.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 13 - 25.1 | View |
| Diabetes Mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 13 - 25.1 | View |
| Hypercalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 13 - 25.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 13 - 25.1 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 13 - 25.1 | View |
| Ketoacidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 13 - 25.1 | View |
| Malnutrition | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 13 - 25.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 13 - 25.1 | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 13 - 25.1 | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 13 - 25.1 | View |
| Bone Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 13 - 25.1 | View |
| Flank Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 13 - 25.1 | View |
| Musculoskeletal Chest Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 13 - 25.1 | View |
| Myopathy | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 13 - 25.1 | View |
| Neck Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 13 - 25.1 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 13 - 25.1 | View |
| Pancreatic Neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 13 - 25.1 | View |
| Phaeochromocytoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 13 - 25.1 | View |
| Prostate Cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 13 - 25.1 | View |
| Renal Cell Carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 13 - 25.1 | View |
| Squamous Cell Carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 13 - 25.1 | View |
| Squamous Cell Carcinoma Of Skin | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 13 - 25.1 | View |
| Testicular Seminoma (Pure) | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 13 - 25.1 | View |
| Brain Oedema | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 13 - 25.1 | View |
| Internal Capsule Infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 13 - 25.1 | View |
| Loss Of Consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 13 - 25.1 | View |
| Neuralgia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 13 - 25.1 | View |
| Peripheral Sensorimotor Neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 13 - 25.1 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 13 - 25.1 | View |
| Spinal Cord Compression | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 13 - 25.1 | View |
| Subarachnoid Haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 13 - 25.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 13 - 25.1 | View |
| Transient Ischaemic Attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 13 - 25.1 | View |
| Abortion Spontaneous | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDra 13 - 25.1 | View |
| Ovarian Cyst Ruptured | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDra 13 - 25.1 | View |
| Acute Respiratory Distress Syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 13 - 25.1 | View |
| Asthmatic Crisis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 13 - 25.1 | View |
| Bronchospasm | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 13 - 25.1 | View |
| Chylothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 13 - 25.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 13 - 25.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 13 - 25.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 13 - 25.1 | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 13 - 25.1 | View |
| Pulmonary Oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 13 - 25.1 | View |
| Pulmonary Thrombosis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 13 - 25.1 | View |
| Respiratory Arrest | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 13 - 25.1 | View |
| Respiratory Failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 13 - 25.1 | View |
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 13 - 25.1 | View |
| Dermatitis Acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 13 - 25.1 | View |
| Photosensitivity Reaction | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 13 - 25.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 13 - 25.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 13 - 25.1 | View |
| Skin Exfoliation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 13 - 25.1 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDra 13 - 25.1 | View |
| Bipolar Disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDra 13 - 25.1 | View |
| Completed Suicide | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDra 13 - 25.1 | View |
| Confusional State | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDra 13 - 25.1 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDra 13 - 25.1 | View |
| Suicide Attempt | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDra 13 - 25.1 | View |
| Anuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 13 - 25.1 | View |
| Calculus Ureteric | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 13 - 25.1 | View |
| Calculus Urinary | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 13 - 25.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 13 - 25.1 | View |
| Disseminated Intravascular Coagulation | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 13 - 25.1 | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 13 - 25.1 | View |
| Rectal Haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 13 - 25.1 | View |
| Small Intestinal Perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 13 - 25.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 13 - 25.1 | View |
| Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 13 - 25.1 | View |
| Device Occlusion | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 13 - 25.1 | View |
| Tracheitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Post Procedural Complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 13 - 25.1 | View |
| Road Traffic Accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 13 - 25.1 | View |
| Spinal Compression Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 13 - 25.1 | View |
| Tibia Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 13 - 25.1 | View |
| Wound Dehiscence | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 13 - 25.1 | View |
| Blood Creatine Phosphokinase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 13 - 25.1 | View |
| Basal Cell Carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 13 - 25.1 | View |
| Breast Cancer Female | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 13 - 25.1 | View |
| Chronic Myeloid Leukaemia | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 13 - 25.1 | View |
| Colorectal Adenoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 13 - 25.1 | View |
| Germ Cell Cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 13 - 25.1 | View |
| Hepatic Cancer Metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 13 - 25.1 | View |
| Lung Neoplasm Malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 13 - 25.1 | View |
| Metastases To Bone | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 13 - 25.1 | View |
| Carotid Artery Stenosis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 13 - 25.1 | View |
| Cerebellar Syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 13 - 25.1 | View |
| Cerebral Ischaemia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 13 - 25.1 | View |
| Cerebrovascular Accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 13 - 25.1 | View |
| Convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 13 - 25.1 | View |
| Depressed Level Of Consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 13 - 25.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 13 - 25.1 | View |
| Epilepsy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 13 - 25.1 | View |
| Hemiparesis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 13 - 25.1 | View |
| Chronic Kidney Disease | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 13 - 25.1 | View |
| Hydronephrosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 13 - 25.1 | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 13 - 25.1 | View |
| Obstructive Uropathy | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 13 - 25.1 | View |
| Renal Colic | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 13 - 25.1 | View |
| Renal Failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 13 - 25.1 | View |
| Renal Failure Acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 13 - 25.1 | View |
| Tubulointerstitial Nephritis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 13 - 25.1 | View |
| Intermenstrual Bleeding | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDra 13 - 25.1 | View |
| Interstitial Lung Disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 13 - 25.1 | View |
| Lung Disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 13 - 25.1 | View |
| Lung Infiltration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 13 - 25.1 | View |
| Pleural Effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 13 - 25.1 | View |
| Pneumonia Aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 13 - 25.1 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 13 - 25.1 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 13 - 25.1 | View |
| Pulmonary Embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 13 - 25.1 | View |
| Skin Ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 13 - 25.1 | View |
| Accelerated Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 13 - 25.1 | View |
| Deep Vein Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 13 - 25.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 13 - 25.1 | View |
| Hypertensive Crisis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 13 - 25.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 13 - 25.1 | View |
| Jugular Vein Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 13 - 25.1 | View |
| Pelvic Venous Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 13 - 25.1 | View |
| Vena Cava Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 13 - 25.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDra 13 - 25.1 | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDra 13 - 25.1 | View |
| Corneal Opacity | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 13 - 25.1 | View |
| Vision Blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 13 - 25.1 | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 13 - 25.1 | View |
| Abdominal Pain Upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 13 - 25.1 | View |
| Dry Mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 13 - 25.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 13 - 25.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 13 - 25.1 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 13 - 25.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 13 - 25.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 13 - 25.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 13 - 25.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 13 - 25.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Folliculitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 13 - 25.1 | View |
| Electrocardiogram Qt Prolonged | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 13 - 25.1 | View |
| Weight Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 13 - 25.1 | View |
| Weight Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 13 - 25.1 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 13 - 25.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 13 - 25.1 | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 13 - 25.1 | View |
| Bone Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 13 - 25.1 | View |
| Muscle Spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 13 - 25.1 | View |
| Musculoskeletal Chest Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 13 - 25.1 | View |
| Musculoskeletal Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 13 - 25.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 13 - 25.1 | View |
| Neck Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 13 - 25.1 | View |
| Pain In Extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 13 - 25.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 13 - 25.1 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 13 - 25.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 13 - 25.1 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 13 - 25.1 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 13 - 25.1 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDra 13 - 25.1 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDra 13 - 25.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDra 13 - 25.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 13 - 25.1 | View |
| Dysphonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 13 - 25.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 13 - 25.1 | View |
| Dyspnoea Exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 13 - 25.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 13 - 25.1 | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 13 - 25.1 | View |
| Oropharyngeal Pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 13 - 25.1 | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 13 - 25.1 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 13 - 25.1 | View |
| Dermatitis Acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 13 - 25.1 | View |
| Dry Skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 13 - 25.1 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 13 - 25.1 | View |
| Photosensitivity Reaction | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 13 - 25.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 13 - 25.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 13 - 25.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 13 - 25.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 13 - 25.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 13 - 25.1 | View |
| Decreased Appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 13 - 25.1 | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 13 - 25.1 | View |