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 @ 6:56 PM
Ignite Modification Date: 2025-12-25 @ 4:29 PM
NCT ID: NCT04733157
Description: None
Frequency Threshold: 0
Time Frame: 1 week
Study: NCT04733157
Study Brief: The Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Caesarean Section
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Study Group/Group A_(Tranexamic Acid) The study group will receive TXA 1g intravenously at the onset of skin incision. Tranexamic acid injection: Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section 0 None 0 611 50 611 View
Control Group/Group B_(Placebo) There is an equivalent volume of normal saline for the control group. Normal saline placebo: 10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group 0 None 1 613 48 613 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT General disorders None View