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: 2025-12-26 @ 10:45 PM
Ignite Modification Date: 2025-12-26 @ 10:45 PM
NCT ID: NCT02604212
Description: None
Frequency Threshold: 0
Time Frame: Through Day 169 (± 3 days)
Study: NCT02604212
Study Brief: A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Positive, Chronic Hepatitis B Virus Infection
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 Low Dose Comparator Placebo (low dose comparator) once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day) None None 0 6 4 6 View
Placebo High Dose Comparator Placebo (high dose comparator) once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day) None None 0 5 0 5 View
ARC-520 1.0 mg/kg Low dose (1.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day) None None 0 10 5 10 View
ARC-520 2.0 mg/kg High dose (2.0 mg/kg) ARC-520 once every 4 weeks for 4 doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day) None None 0 11 3 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Eosinophil count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View