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 @ 5:34 PM
Ignite Modification Date: 2025-12-25 @ 3:06 PM
NCT ID: NCT03750968
Description: None
Frequency Threshold: 0
Time Frame: 8 months
Study: NCT03750968
Study Brief: Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Carotenoid Group The Carotenoid group will receive a commercially available prenatal vitamin/mineral/DHA softgel plus a softgel containing lutein/zeaxanthin in safflower oil. Mother and infant are considered one unit enrolled in the Carotenoid group. Carotenoid Group: Softgel active ingredients: Lutein 10 mg and Zeaxanthin 2 mg in safflower oil 0 None 2 24 6 24 View
Control Group The Control group will receive the same prenatal vitamin/mineral/DHA softgel plus a softgel containing only safflower oil. Mother and infant are considered one unit enrolled in the Control group. Control Group: Placebo ingredients: Safflower oil 0 None 0 23 8 23 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Down syndrome SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Multiple congenital abnormalities SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gestational diabetes SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Gestational hypertension SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Pre-eclampsia SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Anemia SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Exacerbated acne SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Itching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Torn placenta at delivery SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Cholestasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Sinus infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Worsening depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Nose laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Preterm delivery SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View