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 @ 2:15 AM
Ignite Modification Date: 2025-12-26 @ 12:45 AM
NCT ID: NCT05609760
Description: No adverse events were reported.
Frequency Threshold: 0
Time Frame: Adverse events were collected from the day the intervention was applied until the end of the follow-up period (60 days). Patients were provided with the principal investigator's phone number to report any adverse events that occurred after the 60-day period. No adverse events were reported.
Study: NCT05609760
Study Brief: Pictograms to Facilitate Comprehension of Medical Indications
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pictogram Group This intervention consists of using a pictogram system called SIMAP which was developed and validated in previous research. Participants allocated to this arm will received a pictographic decription of their medical indications generated by an automated system. Information will include a description of inhaler functions, inhaler technique and correct aerochamber use. SIMAP: Pictographic description of medical indications alongside standard communication of these recommendations. 0 None 0 9 0 9 View
Usual Care Group These patients will receive their medical indications in the usual way, as established by the health team of the participating clinics. In addition, these patients will receive a bronchial asthma information leaflet as part of the usual education when explaining the disease. No pictograms will be included in these leaflets. Usual Care: Standard communication by medical staff of treatment indications for asthma. An informative leaflet will be delivered as well. 0 None 0 12 0 12 View
Serious Events(If Any):
Other Events(If Any):