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 @ 11:58 PM
Ignite Modification Date: 2025-12-25 @ 9:56 PM
NCT ID: NCT01827358
Description: For days 1-7, study staff were responsible for identifying solicited adverse events (AEs), unsolicited moderate and severe AEs and serious adverse events (SAEs) on a daily basis. Solicited adverse events of apnea within 3-5 minutes of mupirocin application and pain within 3-5 minutes of mupirocin application, were not applicable to the control group since they did not receive mupirocin.
Frequency Threshold: 5
Time Frame: Adverse events were collected on days 1-7.
Study: NCT01827358
Study Brief: Safety and Efficacy of Mupirocin in Eradicating Colonization With S. Aureus in Critically Ill Infants
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Mupirocin (Treatment) Participants receive a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses None None 3 80 60 78 View
No Mupirocin (Control) Participants received no treatment and no placebo. None None 0 75 50 77 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Staphylococcal bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Heart disease congenital NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA (19.0) View
Incarcerated inguinal hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (19.0) View
Infantile apnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (19.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (19.0) View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (19.0) View
Apnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (19.0) View
Administration related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (19.0) View
Application site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (19.0) View