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 @ 10:56 AM
Ignite Modification Date: 2025-12-26 @ 10:56 AM
NCT ID: NCT02738008
Description: TEAEs are presented. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
Frequency Threshold: 0
Time Frame: From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
Study: NCT02738008
Study Brief: Extension Study of the Safety and Efficacy of Multi-dose Intravenous ARC-520 in Patients With Chronic Hepatitis B (HBV) 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
Heparc-2002: ARC-520 1.0 mg/kg ARC-520 2.0 mg/kg administered by IV infusion to participants previously enrolled in the Heparc-2002 study and receiving ARC-520 1.0 mg/kg. Participants continued their ongoing entecavir therapy (0.5 or 1.0 mg/day) or tenofovir therapy (300 mg/day). None None 0 1 1 1 View
Heparc-2002: ARC-520 2.0 mg/kg ARC-520 2.0 mg/kg administered by IV infusion to participants previously enrolled in the Heparc-2002 study and receiving ARC-520 2.0 mg/kg. Participants continued their ongoing entecavir therapy (0.5 or 1.0 mg/day) or tenofovir therapy (300 mg/day). None None 0 6 4 6 View
Heparc-2003: ARC-520 2.0 mg/kg ARC-520 2.0 mg/kg administered by IV infusion to participants previously enrolled in the Heparc-2003 study and receiving ARC-520 2.0 mg/kg. Participants continued their ongoing entecavir therapy (0.5 or 1.0 mg/day) or tenofovir therapy (300 mg/day). None None 0 5 4 5 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
Hordeolum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 17.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 17.0 View
Hyposaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 17.0 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 17.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 17.0 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 17.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 17.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View