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 @ 12:01 AM
Ignite Modification Date: 2025-12-25 @ 9:58 PM
NCT ID: NCT03162458
Description: Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=142, Safety Population)
Frequency Threshold: 0
Time Frame: Adverse/Serious adverse events were registered from Day 1 to Day 14
Study: NCT03162458
Study Brief: Clinical Trial of Efficacy and Safety of Anaferon for Children Liquid Dosage Form in the Treatment of Acute Upper Respiratory Infections
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 Placebo (liquid dosage form): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily. None None 0 71 4 71 View
Anaferon for Children Anaferon for children (liquid dosage form): 10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily. None None 0 71 7 71 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bilateral otitis media SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 10.0 View
Herpes Labialis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Eustachitis SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 10.0 View
Acute bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Purulent conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 10.0 View
Daytime sleepiness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Right otitis media (acute, non-suppurative) SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 10.0 View
Rhinitis purulent SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Hyperactivity SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
Administration related reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 10.0 View