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 @ 2:55 AM
Ignite Modification Date: 2025-12-26 @ 1:35 AM
NCT ID: NCT03351933
Description: None
Frequency Threshold: 5
Time Frame: Adverse events occurring at any time between signing of the subject's ICF and the last day of the subject's participation in the clinical trial were reported. The total time period for the adverse event data collection was 178 days.
Study: NCT03351933
Study Brief: Anti-Hepatitis A Virus, Pharmacokinetics, and Safety of Immune Globulin (Human)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Immune Globulin (Human) GamaSTAN The healthy subjects received a single IM dose of GamaSTAN (0.2 mL/kg), followed by a PK sampling period of 150 days. Immune Globulin (Human): A single 0.2 mL/kg IM injection of Immune Globulin (Human) (GamaSTAN) was administered in healthy subjects. 0 None 0 28 28 28 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Vascular access site haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.1 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.1 View