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 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 1:16 AM
NCT ID:
NCT02207634
Description:
Although there was no separate safety data collection, recording, or reporting planned in this study, an ad-hoc analysis of safety data collected in Study 20110118 was conducted for participants in Study 20130385 and is reported here.
Deaths by any cause were collected as adjudicated efficacy endpoints in Study 20110118 and were reported as a secondary endpoint in Study 20110118.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the 5% frequency threshold.
Frequency Threshold:
5
Time Frame:
From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.
Study:
NCT02207634
Study Brief:
Evaluating PCSK9 Binding antiBody Influence oN coGnitive HeAlth in High cardiovascUlar Risk Subjects
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo | Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference. Participants continued with their background statin therapy during the course of the study. | None | None | 204 | 990 | 257 | 990 | View |
| Evolocumab | Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference. Participants continued with their background statin therapy during the course of the study. | None | None | 212 | 983 | 272 | 983 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Chest discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.1 | View |
| Arteriogram coronary | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Autoimmune haemolytic anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 19.1 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 19.1 | View |
| Haemorrhagic anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 19.1 | View |
| Immune thrombocytopenic purpura | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 19.1 | View |
| Spleen disorder | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 19.1 | View |
| Acute coronary syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| Atrial flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| Atrioventricular block | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| Atrioventricular block complete | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| Atrioventricular block second degree | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| Bundle branch block left | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| Cardiac failure acute | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| Cardiac failure chronic | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| Cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| Cardiac tamponade | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| Cardiomyopathy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| Congestive cardiomyopathy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| Dressler's syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| Heart alternation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| Left ventricular dysfunction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| Left ventricular failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| Mitral valve incompetence | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| Mitral valve stenosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| Myocarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| Pericarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| Sinus arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| Sinus bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| Sinus node dysfunction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| Ventricular extrasystoles | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| Ventricular fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| Ventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| Intracranial lipoma | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 19.1 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 19.1 | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 19.1 | View |
| Iridocyclitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 19.1 | View |
| Retinal detachment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 19.1 | View |
| Strabismus | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 19.1 | View |
| Uveitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 19.1 | View |
| Visual impairment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 19.1 | View |
| Abdominal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Abdominal pain lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Coeliac artery stenosis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Colitis ischaemic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Colitis ulcerative | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Diverticulum | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Duodenal ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Duodenal ulcer haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Faecaloma | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Gastric disorder | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Gastric ulcer haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Gastric ulcer perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Gastritis erosive | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Gastritis haemorrhagic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Gastrointestinal polyp haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Haematemesis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Haematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Hiatus hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Large intestine polyp | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Mesenteric artery stenosis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Oesophageal ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Pancreatic cyst | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Peptic ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Reflux gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Retroperitoneal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Umbilical hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.1 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.1 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.1 | View |
| Soft tissue inflammation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.1 | View |
| Systemic inflammatory response syndrome | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.1 | View |
| Cholangitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 19.1 | View |
| Cholangitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 19.1 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 19.1 | View |
| Cholecystitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 19.1 | View |
| Cholecystitis chronic | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 19.1 | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 19.1 | View |
| Cholelithiasis obstructive | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 19.1 | View |
| Liver disorder | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 19.1 | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 19.1 | View |
| Appendiceal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Burkholderia cepacia complex infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Clostridium difficile infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Device related sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Escherichia sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Escherichia urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Hepatitis C | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Hepatitis E | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Infectious pleural effusion | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Mastoiditis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Orchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Osteomyelitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Peritonitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Pneumonia bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Streptococcal sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Upper respiratory tract infection bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Urinary tract infection bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Ankle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Arterial bypass occlusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Concussion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Coronary artery restenosis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Dislocation of sternum | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Eye injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Fibula fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Hip fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Incisional hernia | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Intentional overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Meniscus injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Peripheral arterial reocclusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Peripheral artery restenosis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Pneumoconiosis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Pneumonitis chemical | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Post concussion syndrome | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Post procedural constipation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Post procedural haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Post procedural swelling | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Rib fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Spinal column injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Tendon rupture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Tibia fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Upper limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Blood potassium increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Hepatic enzyme increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Liver function test abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Myocardial necrosis marker increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Thyroid function test abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Cachexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.1 | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.1 | View |
| Diabetes mellitus inadequate control | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.1 | View |
| Diabetic ketoacidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.1 | View |
| Fluid retention | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.1 | View |
| Gout | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.1 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.1 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.1 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.1 | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.1 | View |
| Type 2 diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| Exostosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| Foot deformity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| Gouty arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| Lumbar spinal stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| Myalgia intercostal | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| Pain in jaw | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| Polyarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| Polymyalgia rheumatica | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| Rhabdomyolysis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| Spinal osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| Synovial cyst | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| Tendonitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| Adenocarcinoma gastric | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | View |
| Adenocarcinoma of colon | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | View |
| Benign pancreatic neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | View |
| Bladder cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | View |
| Bladder transitional cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | View |
| Bladder transitional cell carcinoma stage III | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | View |
| Bronchial carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | View |
| Colon adenoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | View |
| Colon cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | View |
| Diffuse large B-cell lymphoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | View |
| Gastric cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | View |
| Invasive ductal breast carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | View |
| Laryngeal cancer stage 0 | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | View |
| Lip and/or oral cavity cancer stage III | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | View |
| Lung adenocarcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | View |
| Lung adenocarcinoma metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | View |
| Lung neoplasm malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | View |
| Lung squamous cell carcinoma stage III | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | View |
| Lymphoproliferative disorder | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | View |
| Meningioma benign | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | View |
| Metastases to liver | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | View |
| Metastatic malignant melanoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | View |
| Metastatic squamous cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | View |
| Non-small cell lung cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | View |
| Pancreatic carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | View |
| Papillary thyroid cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | View |
| Prostate cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | View |
| Renal cancer metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | View |
| Renal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | View |
| Small cell lung cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | View |
| Squamous cell carcinoma of lung | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | View |
| Tonsil cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | View |
| Transitional cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | View |
| Uterine leiomyoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | View |
| Arachnoid cyst | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Balance disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Carotid artery disease | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Carotid artery stenosis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Carpal tunnel syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Cerebral ischaemia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Cervical myelopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Cervicobrachial syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Epilepsy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Facial paralysis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Generalised tonic-clonic seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Guillain-Barre syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Ischaemic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Meralgia paraesthetica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Neuralgia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Paraparesis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Parkinsonism | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Radiculopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Transient ischaemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Device malfunction | SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA 19.1 | View |
| Device occlusion | SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA 19.1 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 19.1 | View |
| Major depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 19.1 | View |
| Mental status changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 19.1 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 19.1 | View |
| Calculus urethral | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 19.1 | View |
| Chronic kidney disease | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 19.1 | View |
| End stage renal disease | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 19.1 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 19.1 | View |
| Hydronephrosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 19.1 | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 19.1 | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 19.1 | View |
| Tubulointerstitial nephritis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 19.1 | View |
| Ureterolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 19.1 | View |
| Urethral stenosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 19.1 | View |
| Urinary incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 19.1 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 19.1 | View |
| Benign prostatic hyperplasia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 19.1 | View |
| Metrorrhagia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 19.1 | View |
| Postmenopausal haemorrhage | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 19.1 | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | View |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | View |
| Dyspnoea exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | View |
| Pleurisy | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | View |
| Pulmonary mass | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | View |
| Pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | View |
| Angioedema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.1 | View |
| Decubitus ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.1 | View |
| Dermal cyst | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.1 | View |
| Diabetic foot | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.1 | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.1 | View |
| Eczema nummular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.1 | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.1 | View |
| Psoriasis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.1 | View |
| Skin ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.1 | View |
| Fracture treatment | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 19.1 | View |
| Gastric banding reversal | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 19.1 | View |
| Accelerated hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.1 | View |
| Aortic aneurysm | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.1 | View |
| Aortic aneurysm rupture | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.1 | View |
| Aortic stenosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.1 | View |
| Arterial occlusive disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.1 | View |
| Circulatory collapse | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.1 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.1 | View |
| Hypertensive crisis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.1 | View |
| Iliac artery occlusion | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.1 | View |
| Intermittent claudication | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.1 | View |
| Leriche syndrome | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.1 | View |
| Peripheral arterial occlusive disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.1 | View |
| Peripheral artery occlusion | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.1 | View |
| Peripheral artery stenosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.1 | View |
| Peripheral artery thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.1 | View |
| Peripheral ischaemia | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.1 | View |
| Peripheral vascular disorder | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.1 | View |
| Subclavian artery stenosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.1 | View |
| Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.1 | View |
| Iron deficiency anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 19.1 | View |
| Angina unstable | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 19.1 | View |
| Post procedural sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Lung neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.1 | View |