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 @ 4:02 AM
Ignite Modification Date: 2025-12-26 @ 2:55 AM
NCT ID: NCT02035202
Description: Adverse event: Any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. Serious Adverse Event: Any AE that results in any of the following outcomes: * Death * Life-threatening event requiring inpatient hospitalization or prolongation of existing hospitalization * Persistent or significant disability/incapacity
Frequency Threshold: 5
Time Frame: 6 months
Study: NCT02035202
Study Brief: Real-Time Mobile Cognitive Behavioral Intervention for Serious Mental Illness
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CBT2go Participants assigned to this condition will attend one session with a therapist to identify cognitive and behavioral strategies around four areas: 1) mood/psychotic symptoms, 2) medication adherence, 3) socialization, and 4) relapse prevention. Subsequently they will answer questions on a mobile device (smartphone) 3 times per day for 12 weeks, and they will receive personalized cognitive and behavioral strategies linked to their momentary responses with bi-monthly telephone support. CBT2go: CBT administered using mobile intervention. Smartphone: A smartphone platform will be used to deliver the CBT2go behavioral intervention and the surveys in the EMA-only arm. 0 None 0 85 10 85 View
EMA-only Participants assigned to this condition will answer questions on a mobile device (smartphone) 3 times per day for 12 weeks but will not receive personalized cognitive and behavioral strategies. Smartphone: A smartphone platform will be used to deliver the CBT2go behavioral intervention and the surveys in the EMA-only arm. 0 None 0 85 12 85 View
Standard Care Participants assigned to this condition will only participate in the assessments. 0 None 0 85 9 85 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders SNOMED CT View