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 @ 11:53 AM
Ignite Modification Date: 2025-12-25 @ 11:54 AM
NCT ID: NCT04375761
Description: Adverse events (including SAEs) were discovered by interviewing the participants through specific questions that were incorporated in the study questionnaires. Adverse events were also discovered if a participant had an unsolicited complaint. The two main groups of interest in this study were "Index Participants" (the cohort-participating child) and "All Participants Combined" (index participant and household contacts).
Frequency Threshold: 0
Time Frame: Adverse events were collected from the time of first procedure, which occurred at study week 2, until a participant completed the study, until 48 hours after he/she prematurely withdrew, or is withdrawn from the study. Participants were followed for 24 or 28 weeks, or until they withdrew.
Study: NCT04375761
Study Brief: COVID-19: Human Epidemiology and Response to SARS-CoV-2
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Index Participants Index participants are participants who are part of National Institutes of Health-funded cohorts that focused on asthma and/or allergic disease. This group will be index participants who enrolled in the study by completing the date on the electronic registration form and who also contributed at least 1 nasal swab while on study. This group is a subset of the group "All Participants Combined". 0 None 0 1387 14 1387 View
Non-Index Participants A minimum of 2 family members (index participant and a caregiver) and a maximum of 4 total family members (additional caregiver and/or sibling) were enrolled per family. This group is all participants except Index Participants who enrolled in the study by completing the date on the electronic registration form and who also contributed at least 1 nasal swab while on study. 0 None 0 2755 4 2755 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vessel puncture site bruise SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Vessel puncture site haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Vessel puncture site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Facial bones fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Vessel puncture site hypoaesthesia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Vessel puncture site rash SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Vessel puncture site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Concussion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View