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 @ 4:02 PM
Ignite Modification Date: 2025-12-25 @ 2:04 PM
NCT ID: NCT03945266
Description: Adverse events were tracked/collected if any woman experienced any obstetric issues with the physical activity sessions or healthy eating demonstrations. Our protocol stated that ALL physical activity sessions and healthy eating demonstrations were performed and monitored by a certified prenatal exercise specialist or a registered dietician and all sessions were monitored by a Penn State employed nurse and a member of the study team. Any events were immediately reported to the PI and the IRB.
Frequency Threshold: 0
Time Frame: Tracking of adverse events was done over a 6 month period.
Study: NCT03945266
Study Brief: Healthy Mom Zone: A Gestational Weight Gain Management Intervention
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 Group Participants receive the allocated intervention to help manage gestational weight gain that includes education on weight regulation, healthy eating, physical activity, and goal setting. Intervention group: During the intervention, all participants will start out at the Baseline level. The baseline level will last 2 weeks and there will be an assessment to determine weight gain over those 2 weeks. If weight gain has succeeded the recommended amount, participants will be adapted up to a new level of intervention that includes education on GWG, healthy eating and physical activity. After every 4 weeks, an assessment will be performed and adaptations up will be made if necessary. Adaptations include addition of exercise sessions, healthy eating recipe demonstrations, and meal replacements. Participants will weigh themselves daily, wear an activity monitor, record their diet, and complete paper and online surveys. 0 None 0 15 8 15 View
Control Group Participants do not receive the allocated intervention but self-monitor their behaviors, complete study tasks and receive prenatal care as normal. Control group: Participants will follow the same self-monitoring/assessment schedule but will not receive the GWG, healthy eating, and physical activity education or adaptations. 0 None 0 16 7 16 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fetal Growth and Abnormalities SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Depressive Symptoms SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Gestational Diabetes SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Maternal Blood Draw and Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View