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 @ 2:04 PM
Ignite Modification Date:
2025-12-25 @ 12:48 PM
NCT ID:
NCT01544595
Description:
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Frequency Threshold:
2
Time Frame:
Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
Study:
NCT01544595
Study Brief:
Extension Study of Secukinumab Prefilled Syringes in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Any AIN457 150 mg | safety data from patients while on AIN457 150 mg | 0 | None | 61 | 545 | 386 | 545 | View |
| Any AIN457 300 mg | safety data from patients while on AIN457 300 mg | 2 | None | 143 | 890 | 679 | 890 | View |
| Any AIN457 Dose | safety data from patients while on any dose of AIN457 | 2 | None | 198 | 1113 | 889 | 1113 | View |
| AIN457 300 mg - Placebo | safety data from patients of corresponding randomized withdrawal group while on placebo | 0 | None | 13 | 181 | 86 | 181 | View |
| AIN457 150 mg - Placebo | safety data from patients of corresponding randomized withdrawal group while on placebo | 0 | None | 4 | 150 | 75 | 150 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (20.1) | View |
| Acute coronary syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.1) | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.1) | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.1) | View |
| Angina unstable | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.1) | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.1) | View |
| Atrioventricular block complete | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.1) | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.1) | View |
| Coronary artery stenosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.1) | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.1) | View |
| Myocardial ischaemia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.1) | View |
| Stress cardiomyopathy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.1) | View |
| Tachycardia paroxysmal | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.1) | View |
| Ventricular fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.1) | View |
| Malformation venous | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (20.1) | View |
| Hyperandrogenism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (20.1) | View |
| Thyroid mass | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (20.1) | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (20.1) | View |
| Retinal detachment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (20.1) | View |
| Diverticulum | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Diverticulum intestinal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Duodenal ulcer haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Enterocolitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Functional gastrointestinal disorder | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Gastric ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Incarcerated inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Intestinal perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Intestinal polyp | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Intestinal pseudo-obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Irritable bowel syndrome | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Large intestinal stenosis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Large intestine perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Pancreatitis acute | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Umbilical hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Umbilical hernia, obstructive | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Chest discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Face oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Impaired healing | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Medical device site granuloma | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Multiple organ dysfunction syndrome | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Autoimmune hepatitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (20.1) | View |
| Bile duct stone | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (20.1) | View |
| Cholangitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (20.1) | View |
| Cholangitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (20.1) | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (20.1) | View |
| Cholecystitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (20.1) | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (20.1) | View |
| Hepatic steatosis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (20.1) | View |
| Hepatitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (20.1) | View |
| Hepatitis toxic | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (20.1) | View |
| Jaundice | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (20.1) | View |
| Drug hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (20.1) | View |
| Sarcoidosis | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (20.1) | View |
| Abscess limb | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Abscess neck | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Acute sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Appendicitis perforated | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Cholecystitis infective | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Chronic sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Chronic tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Device related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Enterococcal bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Epididymitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Erysipelas | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Escherichia infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Gallbladder empyema | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Graft infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Hepatitis A | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Implant site infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Localised infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Oesophageal candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Oophoritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Osteomyelitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Periorbital cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Peritonitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Peritonsillar abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Pharyngeal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Pneumonia influenzal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Post procedural infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Streptococcal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Tick-borne viral encephalitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Tooth infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Viral pericarditis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Ankle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Cardiac procedure complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Clavicle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Concussion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Fibula fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Foot fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Head injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Humerus fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Incisional hernia | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Jaw fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Kidney rupture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Ligament injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Ligament rupture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Limb injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Lower limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Meniscus injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Multiple fractures | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Muscle rupture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Soft tissue injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Spinal fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Tendon injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Tendon rupture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Tibia fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Ulna fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Wrist fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.1) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Dupuytren's contracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Haemarthrosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Intervertebral disc degeneration | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Intervertebral disc protrusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Psoriatic arthropathy | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Rotator cuff syndrome | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Spinal column stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Spinal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Acute leukaemia | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | View |
| Adenocarcinoma of colon | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | View |
| Anal squamous cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | View |
| Breast cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | View |
| Gallbladder cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | View |
| Gastric cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | View |
| Haemangioma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | View |
| Hepatic cancer metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | View |
| Metastases to lung | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | View |
| Papillary thyroid cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | View |
| Prostate cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | View |
| Small cell lung cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | View |
| Uterine leiomyoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | View |
| Cerebral infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Cerebral ischaemia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Complex regional pain syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Cranial nerve paralysis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Diabetic neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Drooling | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Epilepsy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Lumbar radiculopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Parkinson's disease | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Transient ischaemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Abortion spontaneous | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (20.1) | View |
| Abortion spontaneous complete | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (20.1) | View |
| Device dislocation | SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (20.1) | View |
| Device loosening | SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (20.1) | View |
| Alcoholism | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.1) | View |
| Aversion | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.1) | View |
| Completed suicide | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.1) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.1) | View |
| Hypomania | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.1) | View |
| Suicide attempt | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.1) | View |
| Calculus urinary | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.1) | View |
| Chronic kidney disease | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.1) | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.1) | View |
| Nephrotic syndrome | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.1) | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.1) | View |
| Ureterolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.1) | View |
| Urethral stenosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.1) | View |
| Menorrhagia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (20.1) | View |
| Ovarian cyst | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (20.1) | View |
| Vaginal cyst | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (20.1) | View |
| Acute respiratory distress syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | View |
| Laryngeal oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | View |
| Nasal septum deviation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | View |
| Nasal turbinate hypertrophy | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | View |
| Pulmonary alveolar haemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | View |
| Pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | View |
| Sinus polyp | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | View |
| Sleep apnoea syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | View |
| Angioedema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.1) | View |
| Dermal cyst | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.1) | View |
| Dermatitis contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.1) | View |
| Diabetic foot | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.1) | View |
| Drug eruption | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.1) | View |
| Psoriasis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.1) | View |
| Circulatory collapse | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (20.1) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (20.1) | View |
| Hypertensive crisis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (20.1) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (20.1) | View |
| Varicose vein | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (20.1) | View |
| Immune thrombocytopenic purpura | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (20.1) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Ileus paralytic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Large intestine polyp | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Lower gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Postoperative wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Facial bones fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Post-traumatic neck syndrome | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Procedural hypertension | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Radius fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Joint instability | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Lumbar spinal stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Osteitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Intraductal proliferative breast lesion | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | View |
| Invasive breast carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | View |
| Malignant melanoma in situ | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | View |
| Meningioma benign | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Intracranial aneurysm | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Ischaemic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Schizophrenia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.1) | View |
| Substance abuse | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.1) | View |
| Suicidal ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Seasonal allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (20.1) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Folliculitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Oral candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Tinea pedis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Tooth infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Muscle strain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Hyperlipidaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.1) | View |
| Hypertriglyceridaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.1) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Psoriatic arthropathy | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Tendonitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.1) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.1) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.1) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | View |
| Psoriasis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.1) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (20.1) | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Procedural pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.1) | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.1) | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | View |
| Dermatitis contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.1) | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.1) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.1) | View |