Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 4:17 AM
Ignite Modification Date: 2025-12-26 @ 3:17 AM
NCT ID: NCT01765920
Description: None
Frequency Threshold: 0
Time Frame: 8 days (during the study).
Study: NCT01765920
Study Brief: Clinical Trial of Safety and Efficacy of Ergoferon in Liquid Dosage Form in Treatment of Acute Upper Respiratory Tract Infections in Adults
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ergoferon (5 ml 3 Times a Day) Oral use. Dose per administration: 1 dosing spoon (5ml) without food. For best effect, the solution should be held in the mouth before swallowing. Dosing scheme. One dose every 30 minutes for the first 2 hours, followed by three more doses spaced regularly during the rest of the day. From day 2 to 5: 1 spoon taken 3 times daily. Ergoferon: 5 ml 3 times a day 0 None 0 169 7 169 View
Placebo (5 ml 3 Times a Day) Oral use. Placebo using Ergoferon scheme. Placebo: 5 ml 3 times a day 0 None 0 173 6 173 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Acute anal fissure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Increased lymphocytes SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Decreased level of segmented neutrophils SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Increased levels of transaminases (ALT, AST) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
A large amount of salts in the urine (urates) SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Increased red blood cells in the urine SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
The presence of mucus in the urine SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Acute bilateral rhinosinusitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Acute bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Community-acquired pneumonia of the lower lobe of the right lung SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Facial hyperemia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View