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: 2025-12-25 @ 2:50 AM
Ignite Modification Date: 2025-12-26 @ 1:32 AM
NCT ID: NCT02675933
Description: This study involved collection of patient and parent preference data through the use of a questionnaire. There were no medications or devices involved in the study.
Frequency Threshold: 0
Time Frame: through study completion, 1 day (clinic visit)
Study: NCT02675933
Study Brief: Satisfaction Rates Among Parents of Children With Autism in the ED
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Standard of Care The control arm participants will receive only a satisfaction survey once disposition is determined by the physician provider. The satisfaction survey will be collected by the research associated and kept in a protected location, along with all other study materials. All patients will receive standard of care, which at this institution is the help of Child Life Specialists, when they are available and requested by the physician. Physicians will be instructed to request Child Life Specialists with the same discretion as with all patients. 0 None 0 32 0 32 View
Questionnaire Participants who are randomized to the questionnaire arm will receive a patient-centered questionnaire at the beginning of their visit. This single page document will ask questions about their child including, but not limited to, diagnoses, suggestions for distraction, sensory issues that may affect their visit, and method to best administer medications. The research associate will ask them to fill it out to the best of their ability and will collect the questionnaire prior to a physician provider seeing the patient. At least one physician provider must review the questionnaire prior to seeing the patient. Once disposition is determined, the satisfaction survey will be distributed by the research associate along with an envelope for the parent to seal their survey within. Questionnaire: There will be a single page document, a patient-centered questionnaire, distributed to parents of study participants who have been randomized to the intervention arm. 0 None 0 31 0 31 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Data breach SYSTEMATIC_ASSESSMENT Investigations Breach View
Other Events(If Any):