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: 2025-12-24 @ 10:49 PM
Ignite Modification Date: 2025-12-25 @ 8:18 PM
NCT ID: NCT02791269
Description: Safety analysis population included participants who received at least one dose of study medication and had one subsequent post baseline safety assessment.
Frequency Threshold: 5
Time Frame: Baseline up to end of follow-up period (Approximately 72 weeks)
Study: NCT02791269
Study Brief: A Study of Peginterferon Alfa-2a in Participants With Chronic Hepatitis B Virus (HBV) in an Expanded Access Program
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
HBeAg Negative Participants HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period. None None 1 4 3 4 View
HBeAg Positive Participants HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period. None None 0 20 7 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
chest pain NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (Unspecified) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Depression NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (Unspecified) View
Itchy skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (Unspecified) View
Hypothyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA (Unspecified) View
Glaucoma NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (Unspecified) View
Eye infection NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (Unspecified) View
Non-productive cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (Unspecified) View
Sore throat NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (Unspecified) View
Blood in semen NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (Unspecified) View
Muscle spasm NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (Unspecified) View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (Unspecified) View
Urinary frequency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (Unspecified) View
Mood disturbance NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Tiredness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (Unspecified) View