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 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:24 PM
NCT ID:
NCT02224456
Description:
Safety analysis population was used to collect the adverse events
Frequency Threshold:
0
Time Frame:
All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Study:
NCT02224456
Study Brief:
Efficacy and Safety Study of Tenofovir Disoproxil Fumarate (TDF) in Chinese Chronic Hepatitis B (CHB) Subjects With Advanced Fibrosis & Compensated Cirrhosis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Tenofovir Disoproxil Fumarate 300 mg | Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks. | 2 | None | 34 | 195 | 129 | 195 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hepatocellular carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Ovarian germ cell teratoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Foot fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Lower limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Post procedural bile leak | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Radius fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Spinal compression fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Tibia fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Bile duct stone | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 21.1 | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 21.1 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 21.1 | View |
| Cholecystitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 21.1 | View |
| Hepatic cirrhosis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 21.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Rheumatic fever | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Synovial cyst | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Nasal polyps | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Nasal septum deviation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Rhinitis hypertrophic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.1 | View |
| Uterine adhesions | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 21.1 | View |
| Ureterolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 21.1 | View |
| Hypersplenism | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 21.1 | View |
| Rheumatic heart disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 21.1 | View |
| Chest X-ray abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Malignant melanoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Vertigo positional | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 21.1 | View |
| Chronic gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Pulmonary tuberculosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Urethritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Vulvovaginal mycotic infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Myringitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Herpes virus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Tonsillitis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Vaginal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Epigastric discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Gastric ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Chronic gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Haemorrhoidal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Gastrointestinal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Abdominal mass | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Dysbacteriosis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Duodenitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Dental caries | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Haemorrhoids thrombosed | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Intestinal polyp | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Protein urine present | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Blood phosphorus decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Alpha 1 foetoprotein increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Blood urine present | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Blood uric acid increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Blood glucose increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Red blood cells urine positive | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Hepatitis B DNA increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Glomerular filtration rate decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Creatinine renal clearance decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Blood urine | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Blood lactate dehydrogenase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 21.1 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 21.1 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 21.1 | View |
| Hyperuricaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 21.1 | View |
| Hypermagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 21.1 | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 21.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 21.1 | View |
| Iron deficiency anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 21.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 21.1 | View |
| Splenomegaly | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 21.1 | View |
| Coagulopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 21.1 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 21.1 | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 21.1 | View |
| Hepatic pain | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 21.1 | View |
| Liver injury | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 21.1 | View |
| Hyperbilirubinaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 21.1 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 21.1 | View |
| Hepatic steatosis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 21.1 | View |
| Hepatic function abnormal | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 21.1 | View |
| Gallbladder polyp | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 21.1 | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 21.1 | View |
| Renal impairment | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 21.1 | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 21.1 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 21.1 | View |
| Renal injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 21.1 | View |
| Renal cyst | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 21.1 | View |
| Hypertonic bladder | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 21.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Osteoporosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Spinal osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Intervertebral disc protrusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Animal bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Joint injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Ligament injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Thermal burn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Skin wound | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Nasal dryness | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Nasal obstruction | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.1 | View |
| Psoriasis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.1 | View |
| Leukoderma | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.1 | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Menstruation irregular | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 21.1 | View |
| Uterine enlargement | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 21.1 | View |
| Pelvic fluid collection | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 21.1 | View |
| Breast hyperplasia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 21.1 | View |
| Menstruation delayed | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 21.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 21.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.1 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.1 | View |
| Sleep disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 21.1 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 21.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 21.1 | View |
| Hepatocellular carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Uterine leiomyoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Vitreous floaters | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Retinal vein occlusion | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 21.1 | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 21.1 | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 21.1 | View |
| Transaminases increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 21.1 | View |