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 @ 9:08 PM
Ignite Modification Date: 2025-12-25 @ 6:59 PM
NCT ID: NCT01276704
Description: When individual (non-serious) adverse events are diverse, with small numbers in any one event type, total numbers of participants reporting the most severe AE grade are reported.
Frequency Threshold: 5
Time Frame: 12 months
Study: NCT01276704
Study Brief: Prevention Strategy for Pre-Menopausal Women at High Risk for Development of Breast Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Flaxseed Lignan, SDG Secoisolariciresinol diglycoside secoisolariciresinol: 1 capsule daily of secoisolariciresinol diglycoside (SDG)50mg 0 None 2 115 84 115 View
Placebo Matched Placebo Placebo: The placebo contains same filler materials as commercially available Brevail® but without active SDG. 0 None 4 62 45 62 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
musculoskeletal connective tissue disorder NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (version 4.0) View
Breast abnormality NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE (version 4.0) View
Unintended pregnancy NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions CTCAE (version 4.0) View
vestibular disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (version 4.0) View
sinus disorder NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (version 4.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (version 4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Grade 1 AE NON_SYSTEMATIC_ASSESSMENT Product Issues CTCAE (version 4.0) View
Grade 2 AE NON_SYSTEMATIC_ASSESSMENT Product Issues CTCAE (version 4.0) View
Grade 3 AE NON_SYSTEMATIC_ASSESSMENT Product Issues CTCAE (version 4.0) View