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 @ 7:14 PM
Ignite Modification Date: 2025-12-25 @ 4:50 PM
NCT ID: NCT05819203
Description: Reporting of adverse events and of incidents (Incident: any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect).
Frequency Threshold: 0
Time Frame: Adverse events were collected during the intervention through the study completion , up to day 18
Study: NCT05819203
Study Brief: BАbykids Spray In Common Cold
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Healsea Babykids Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Healsea Babykids: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) . 0 None 0 100 11 100 View
Placebo The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Placebo: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) . 0 None 0 100 14 100 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Scarlet fever SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
otitis media acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 25.0 View
inner ear inflammation SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 25.0 View
epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.0 View