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 @ 10:23 PM
Ignite Modification Date: 2025-12-25 @ 7:55 PM
NCT ID: NCT00950235
Description: AE data collected between November 2009 and July 2011, 20 months
Frequency Threshold: 5
Time Frame: AE data collected at follow up visits (34wk gestation, 2 weeks post-partum, 6 and 12 months post partum)
Study: NCT00950235
Study Brief: Weight Management for Improved Pregnancy Outcomes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Usual Care This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group Usual Care: Standard nutrition counseling from Health Plan None None 2 60 40 60 View
Weight Management Counseling In-person and group session counseling Weight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy None None 0 58 30 58 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
miscarriage SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cesarean Section SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Pre-Term Birth <37 weeks SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
NICU admission SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Respiratory morbidity SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View