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: NCT04566861
Description: We only had still births, miscarriages and child deaths of the participants who were giving births
Frequency Threshold: 0
Time Frame: 5 months
Study: NCT04566861
Study Brief: Happy Mother - Healthy Baby: Supplement Study on Biological Processes Underlying Anxiety During Pregnancy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Anxious Pregnant Women - Intervention Group 100 pregnant women who have at least mild anxiety will be randomized to the intervention group where they will receive six one-on-one core sessions of Cognitive Behavioral Therapy during pregnancy (plus possible booster sessions) Cognitive Behavioral Therapy (CBT) for anxiety during pregnancy: Women who are randomized to the intervention group will receive six core Cognitive Behavioral Therapy (CBT) sessions for anxiety during pregnancy (and possible booster sessions) to treat symptoms of anxiety. 0 None 9 26 0 26 View
Anxious Pregnant Women - Enhanced Usual Care Group 100 pregnant women who have at least mild anxiety will be randomized to the enhanced usual care group. They will not receive intervention sessions but will receive transportation vouchers to come to the hospital and facilitation by study staff to attend to their regular antenatal care visits. 0 None 14 31 0 31 View
Non-anxious Pregnant Women - Healthy Control 100 pregnant women who do not have symptoms of anxiety or depression be followed in the healthy control group. They will not receive intervention sessions but will receive transportation vouchers to come to the hospital and facilitation by study staff to attend to their regular antenatal care visits. 0 None 20 60 0 60 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Miscarriage NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Still birth NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Child death NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Other Events(If Any):