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 @ 1:05 PM
Ignite Modification Date: 2025-12-25 @ 12:21 PM
NCT ID: NCT03880461
Description: None
Frequency Threshold: 5
Time Frame: Adverse outcome data were collected during pregnancy from enrollment to delivery (duration of up to 9 months).
Study: NCT03880461
Study Brief: A Mobile Health Intervention to Achieve Appropriate Gestational Weight Gain in Overweight/Obese Women
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intervention Arm - PATIENTS In addition to usual medical care, patients in the intervention arm will receive access to mHealth tools to manage gestational weight gain (GWG), including a scale, physical activity tracker, and smartphone application, and for those not meeting GWG guidelines, personalized text messages and personalized 1-1 coaching sessions. 0 None 0 714 44 714 View
Usual Care Arm - PATIENTS Patients in the usual care arm will receive the standard obstetric care offered at Kaiser Permanente Northern California. 0 None 0 621 29 621 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Total pregnancy loss or stillbirth NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View