Adverse Events Module

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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 @ 3:47 AM
Ignite Modification Date: 2025-12-26 @ 2:35 AM
NCT ID: NCT00410202
Description: None
Frequency Threshold: 5
Time Frame: Up to Week 96
Study: NCT00410202
Study Brief: Entecavir Plus Adefovir Combination Therapy Versus Entecavir Monotherapy vs Therapy With Adefovir Plus Lamivudine for Chronic Hepatitis B Infected Subjects With Lamivudine-resistant Virus
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ADV + LVD Combination Therapy ADV 10 mg + LVD 100 mg; QD for 100 weeks None None 13 137 62 137 View
ETV Monotherapy ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees. None None 21 140 75 140 View
ETV + ADV Combination Therapy ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks None None 14 138 63 138 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Lower limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Oesophageal varices haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Intracranial hypotension SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Melaena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Pelvic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Benign prostatic hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Plasmacytoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Spondylolisthesis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Wrist fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.0 View
Facial bones fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Hepatitis B SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Meningitis tuberculous SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Optic atrophy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Anal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Hepatic neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Hydrocephalus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Limb crushing injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Colon adenoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.0 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Aneurysm ruptured SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
Concussion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Congenital cystic kidney disease SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 15.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Fibroadenoma of breast SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Ligament sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Ureteric stenosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Calculus ureteric SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Erosive oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 15.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Hepatic steatosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View