Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:00 PM
NCT ID:
NCT02106156
Description:
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
Frequency Threshold:
5
Time Frame:
Up to Week 96
Study:
NCT02106156
Study Brief:
Observational Study Evaluating the Quality of Pegylated Interferon Alfa-2a and Ribavirin Treatment for Chronic Hepatitis C in Cooperation With the BNG (Association of German Resident Gastroenterologists)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Main Analysis Set | Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC. | None | None | 439 | 9620 | 5721 | 9620 | View |
| Elastography Analysis Set: Treated | Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those, who were treated with HCV treatment as indicated. | None | None | 4 | 90 | 82 | 90 | View |
| Elastography Analysis Set: Untreated | Participants with CHC in the untreated elastography analysis set includes those participants, who underwent elastography, were documented in the fibroscan module and were not treated with HCV treatment. | None | None | 0 | 518 | 0 | 518 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia macrocytic | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Pericarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Supraventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Factor VIII deficiency | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (15.0) | View |
| Intestinal atresia | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (15.0) | View |
| Middle ear inflammation | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (15.0) | View |
| Haematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Intestinal infarction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| No therapeutic response | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Serositis | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Sudden cardiac death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Acute hepatic failure | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (15.0) | View |
| Autoimmune hepatitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (15.0) | View |
| Cholangitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (15.0) | View |
| Empyema | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Endocarditis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Enterocolitis infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Febrile infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Furuncle | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Gastrointestinal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Groin abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Hepatitis C | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| HIV infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Infectious pleural effusion | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| Accident at home | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Bilirubin conjugated increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Biopsy liver | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Cachexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.0) | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.0) | View |
| Dysarthria | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Facial paresis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Haemorrhage intracranial | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Hemianopia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Hepatic encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Hyperaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Dependence | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| Depressed mood | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| Drug dependence | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| Psychotic disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| Schizophrenia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| Sleep disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| Suicidal ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| Suicide attempt | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| Calculus ureteric | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.0) | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.0) | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Pleurisy | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Pulmonary fibrosis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| Erythrodermic psoriasis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| Psoriasis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| Rash generalised | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| Skin discomfort | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| Diabetes mellitus inadequate control | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.0) | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| Autoimmune thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| Granulocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| Haematotoxicity | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| Haemolysis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| Haemorrhagic diathesis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| Normochromic normocytic anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| Pancytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Arteriospasm coronary | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Cardiac perforation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Cardiomyopathy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Cardiopulmonary failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Ossicle disorder | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (15.0) | View |
| Sudden hearing loss | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (15.0) | View |
| Basedow's disease | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (15.0) | View |
| Hyperthyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (15.0) | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (15.0) | View |
| Eyelid oedema | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (15.0) | View |
| Retinal disorder | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (15.0) | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Anal fistula | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Anal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Gastric ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Gastrointestinal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Haematemesis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Intestinal perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Melaena | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Oesophageal varices haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Periodontitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Teeth brittle | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Tooth loss | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Disease progression | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Drug ineffective | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| General physical health deterioration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Generalised oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Granuloma | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (15.0) | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (15.0) | View |
| Hepatic artery occlusion | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (15.0) | View |
| Hepatic cirrhosis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (15.0) | View |
| Hepatic failure | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (15.0) | View |
| Hepatic function abnormal | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (15.0) | View |
| Hydrocholecystis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (15.0) | View |
| Jaundice | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (15.0) | View |
| Decreased immune responsiveness | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (15.0) | View |
| Sarcoidosis | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (15.0) | View |
| Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Abscess jaw | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Anal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Bronchopneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Cytomegalovirus chorioretinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Device related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Infective exacerbation of chronic obstructive airways disease | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Injection site abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Intervertebral discitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Laryngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Latent tuberculosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Malaria | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Nasal vestibulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Oropharyngeal candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Pilonidal cyst | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Pneumonia bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Pneumonia fungal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Pneumonia pneumococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Pulmonary tuberculosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Tuberculosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Alcohol poisoning | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| Ankle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| Concussion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| Craniocerebral injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| Foot fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| Head injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| Laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| Overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| Road traffic accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| Shunt stenosis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| Tendon rupture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| Therapeutic agent toxicity | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| Toxicity to various agents | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| Transfusion reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Blood cholinesterase decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Blood count abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Blood glucose fluctuation | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Blood glucose increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Blood urea increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Electrocardiogram change | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Haemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Heart rate increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Hepatitis C RNA increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Prothrombin time prolonged | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Renal function test abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Transaminases increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Viral load increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Waist circumference increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| Bursa disorder | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| Intervertebral disc protrusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| Muscle oedema | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| Tenosynovitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| Bladder cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| Breast cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| Burkitt's lymphoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| Cholesteatoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| Germ cell cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| Hepatic neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| Hepatic neoplasm malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| Hepatic neoplasm malignant recurrent | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| Hepatic neoplasm malignant resectable | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| Lymphoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| Mycosis fungoides | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| Neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| Pancreatic carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| Seminoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| Testis cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
| Altered state of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Aphasia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Brain stem infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Carotid artery occlusion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Cerebral haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Cerebral ischaemia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Coma | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Cubital tunnel syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Dementia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Intercostal neuralgia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Loss of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Multiple sclerosis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Nervous system disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Polyneuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Pregnancy | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (15.0) | View |
| Acute psychosis | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| Aggression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| Alcohol abuse | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| Alcohol problem | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| Alcohol withdrawal syndrome | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| Alcoholism | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| Anger | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| Completed suicide | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| Renal failure acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.0) | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.0) | View |
| Breast induration | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (15.0) | View |
| Breast pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (15.0) | View |
| Endometriosis | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (15.0) | View |
| Scrotal ulcer | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (15.0) | View |
| Vaginal haemorrhage | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (15.0) | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Emphysema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Interstitial lung disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Lung disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Nasal polyps | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Obstructive airways disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Painful respiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Skin disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| Drug abuse | SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA (15.0) | View |
| Drug abuser | SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA (15.0) | View |
| Substance use | SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA (15.0) | View |
| Abortion induced | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (15.0) | View |
| Cardiac pacemaker insertion | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (15.0) | View |
| Detoxification | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (15.0) | View |
| Hospitalisation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (15.0) | View |
| Liver transplant | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (15.0) | View |
| Oophorectomy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (15.0) | View |
| Angiodysplasia | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| Circulatory collapse | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| Femoral artery embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| Haemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| Hypertensive crisis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| Venous thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Cheilitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Gastrointestinal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Irritability | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Oral candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Visual field defect | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Depressed mood | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| Sleep disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| Skin disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |