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 @ 9:33 PM
Ignite Modification Date: 2025-12-25 @ 7:17 PM
NCT ID: NCT04715932
Description: Subjects reporting multiple TEAEs within a given system organ class/preferred term were counted only once within the category. Results are based on safety population. Table of adverse events includes serious adverse events. Number of Participants at Risk differs from the number of participants assigned to the arm or comparison group. One participant from the placebo group is not part of the safety population. However, "All-Cause Mortality" is on the intention to treat population.
Frequency Threshold: 0
Time Frame: Adverse event data were collected between randomization/baseline until the end of study visit (up to 14 days).
Study: NCT04715932
Study Brief: Study of Hesperidin Therapy on COVID-19 Symptoms (HESPERIDIN)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Hesperidin 1000mg Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water. 0 None 4 107 20 107 View
Placebo 1000mg Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water. 0 None 1 108 16 108 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Arthritis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.1 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
Cheilitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
Arthritis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.1 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
Loss of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
Increased bronchial secretion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.1 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.1 View