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 @ 4:05 AM
Ignite Modification Date: 2025-12-26 @ 3:01 AM
NCT ID: NCT04922502
Description: The definition of an adverse event does not differ from that used on clinicaltrials.gov
Frequency Threshold: 0
Time Frame: Participants were assessed up to 16 weeks. Non-responders to bibliotherapy had the option to participate in standard SPACE, and were possibly followed for an additional 8 weeks (for a total of 24 weeks). Adverse event data were collected for child participants only and were collected for the duration of a participant's involvement in the study.
Study: NCT04922502
Study Brief: Parent-based Treatment for Youth With Anxiety and Obsessive-compulsive Disorder
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 SPACE 12 one hour parent sessions over 12 weeks in which the therapist guides the parent to target anxious behaviors and support adaptive child behaviors. Standard SPACE: 12 one hour parent sessions over 12 weeks in which the therapist guides the parent to target anxious behaviors and support adaptive child behaviors. 0 None 0 33 0 33 View
Bibliotherapy, Low Therapist Contact SPACE 4 one hour parent sessions over 12 weeks in which the therapist supports the parent in understanding and implementing content reviewed in the book "Breaking Free of Child Anxiety and OCD". Bibliotherapy, low therapist contact SPACE: 4 one hour parent sessions over 12 weeks in which the therapist supports the parent in understanding and implementing content reviewed in the book "Breaking Free of Child Anxiety and OCD". 0 None 0 35 0 35 View
Serious Events(If Any):
Other Events(If Any):