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 @ 3:27 AM
Ignite Modification Date: 2025-12-26 @ 2:08 AM
NCT ID: NCT02088905
Description: None
Frequency Threshold: 0
Time Frame: The time frame that information on adverse events was collected depended on which treatment assignment was made. For individuals who were assigned to immediate PCIT training, adverse event data was collected over a period of 18 - 30 weeks, dependent on the subject's ability to schedule training. For individuals on the wait list for PCIT, adverse event data was collected over a period of 30 - 48 weeks, dependent on the subject's ability to schedule training.
Study: NCT02088905
Study Brief: Efficacy of Parent-Child Interaction Therapy With Autism Spectrum 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
Parent Child Interaction Therapy Families will either receive Parent Child Interaction Therapy or be placed on a wait-list control group Parent Child Interaction Therapy: Parent-Child Interaction Therapy (PCIT) is a research-supported parent coaching intervention that has been found to be highly effective among typically developing preschoolers presenting with a range of mental health concerns, especially defiance and noncompliance.6 PCIT holds considerable promise as a potentially effective treatment for children with ASD because it directly addresses the behaviors parents of children with ASD report to be most problematic for them - defiance, stubbornness, and temper tantrums. PCIT is theoretically consistent with other approaches that have shown promise in treating ASD (i.e., behaviorally-based); however, PCIT is unique in that it incorporates a socially-based initial phase which may have some unique benefits for children with ASD. 0 None 0 13 0 13 View
Wait List Control Families will wait 18 weeks for treatment, serving as controls. 0 None 0 10 0 10 View
Serious Events(If Any):
Other Events(If Any):