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 @ 4:35 PM
Ignite Modification Date: 2025-12-25 @ 2:26 PM
NCT ID: NCT04495166
Description: Given that the intervention in this study is non-invasive, with a very low risk for participants of serious adverse events and mortality, then adverse events were collected qualitatively throughout the trial by the assessors, who asked participants about psychological distress and discomfort from the interventions.
Frequency Threshold: 0
Time Frame: Adverse events were collected throughout the trial by psychotherapist during their sessions with participants. Moreover, assessors collected information on adverse events during the assessments at baseline (T0), mid-treatment (T1), posttreatment (T3).
Study: NCT04495166
Study Brief: A Smartphone-Assisted Brief Behavioral Intervention for Pregnant Women With Depression
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Motherly App With Brief Psychotherapy Participants in this arm received intervention via Motherly 1.0, an app that delivers behavioral activation strategies and psychoeducational content to promote changes in sleep, nutrition, and physical activity habits. It has also functionalities that help participants to engage in prenatal care, breastfeeding, and social support, and to stimulate child development. In addition they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation. 0 None 0 37 0 37 View
Educational App (Active Control) Participants in this arm had access to a psychoeducational app (active control) which delivers content about gestation, maternal health and mental health, and child development. In addition, they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation. 0 None 0 44 0 44 View
Serious Events(If Any):
Other Events(If Any):