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 @ 2:35 PM
Ignite Modification Date: 2025-12-25 @ 1:07 PM
NCT ID: NCT01355159
Description: One participant (in the Folic Acid group) withdrew consent on the same day of randomization; participants is excluded from being considered "at risk" for AE/SAEs.
Frequency Threshold: 0
Time Frame: None
Study: NCT01355159
Study Brief: High Dose Folic Acid Supplementation Throughout Pregnancy for Preeclampsia Prevention
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Folic Acid 4 mg Folic Acid 1.0 mg x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid Folic Acid 4 mg: Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid None None 227 1227 961 1227 View
Placebo Women will be randomised in a 1:1 ratio to folic acid 4.0 mg or placebo Placebo: Placebo x 4 tablets will be taken daily by oral administration. None None 195 1236 968 1236 View
Serious Events(If Any):

Serious Events

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

Other Events

Term Type Organ System Vocab View
Other AE SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View