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 @ 2:08 AM
Ignite Modification Date: 2025-12-26 @ 12:34 AM
NCT ID: NCT04291560
Description: None
Frequency Threshold: 5
Time Frame: From the time of randomization (about 27 weeks gestation) through 8 weeks after delivery, an approximate total of 21 weeks.
Study: NCT04291560
Study Brief: Promoting Stretching Exercise to Reduce Cardiovascular Health Risk in Late Pregnant Women With Obesity
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Prenatal Heart Smart Intervention This group will have usual care completed and supportive calls from a facilitator to discuss adherence to the home exercise. In addition, the group will complete a sequential static stretching exercise 5 days per week for 10 weeks. The stretching exercise consists of 20 seconds of stretching, for 3 repetitions per muscle group. Stretching Exercise Intervention: Sequential static stretching of the large skeletal muscle group 5 days per week. Each skeletal group is stretched for 20 seconds for 3 repetitions. 0 None 5 53 35 53 View
Usual Care (Control) This group will have usual care completed and supportive calls from a facilitator to discuss adherence to the home exercise. In addition, this group will complete moderate-intensity walking 5 days per week for 10 weeks in accordance to usual care. 0 None 8 55 41 55 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Preeclampsia SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Hospitalization for Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fetal abnormality (abdominal mass) detected via ultrasound NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Reported contracting respiratory virus (cold, flu, RSV, or Covid) NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Shortness of breath while exercising NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dizziness while exercising NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Gastrointestinal virus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pregnancy-related pain or soreness NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Delivery via Caesarean section SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Gestational hypertension SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Gestational diabetes SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View