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 @ 11:00 PM
Ignite Modification Date: 2025-12-25 @ 8:29 PM
NCT ID: NCT02442869
Description: Adverse events were tracked using seven typologies: Death by Suicide, Other Death, Attempted Suicide, Non-Suicidal Self-Injury, Psychiatric Admission, Medical Hospitalization, \& Other Serious Adverse Event.
Frequency Threshold: 0
Time Frame: Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months).
Study: NCT02442869
Study Brief: Developing Adaptive Interventions for Suicidal College Students Seeking Treatment - SMART
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Stage 1 CAMS (Participant Responding to Treatment) Stage 1 CAMS: 4-8 weeks of Collaborative Assessment and Management of Suicidality (CAMS). Participant responded to CAMS, treatment ended. 0 None 0 29 0 29 View
Stage 2 DBT (Didn't Respond to Stage 1 TAU) Participant didn't respond to Stage 1 TAU treatment and was re-randomized to: Dialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT) 0 None 2 5 0 5 View
Stage 1 TAU (Participant Responding to Treatment) Treatment as usual (TAU): 4-8 weeks of treatment typically provided by that counselor with the caveat that neither DBT nor CAMS can be provided. Participant responded to TAU, treatment ended. 0 None 0 18 0 18 View
Stage 2 CAMS (Didn't Respond to Stage 1 TAU) Participant didn't respond to Stage 1 TAU and was re-randomized to: Stage 2 CAMS: 4-16 weeks of Collaborative Assessment and Management of Suicidality (CAMS) 0 None 0 6 0 6 View
Stage 2 CAMS (Didn't Respond to Stage 1 CAMS) Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to: Stage 2 CAMS: 4-16 additional weeks of Collaborative Assessment and Management of Suicidality (CAMS) 0 None 2 2 0 2 View
Stage 2 DBT (Didn't Respond to Stage 1 CAMS) Participant didn't respond to Stage 1 CAMS treatment and was re-randomized to: Dialectical Behavioral Therapy (DBT): 4-16 weeks of Dialectical Behavioral Therapy (DBT) 0 None 0 2 0 2 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death by Suicide NON_SYSTEMATIC_ASSESSMENT Social circumstances None View
Attempted Suicide NON_SYSTEMATIC_ASSESSMENT Social circumstances None View
Non-Suicidal Self-Injury NON_SYSTEMATIC_ASSESSMENT Social circumstances None View
Psychiatric Admission NON_SYSTEMATIC_ASSESSMENT Social circumstances None View
Medical Hospitalization NON_SYSTEMATIC_ASSESSMENT Social circumstances None View
Other Serious Adverse Event NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Death NON_SYSTEMATIC_ASSESSMENT Social circumstances None View
Other Events(If Any):