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: 2025-12-25 @ 1:24 AM
Ignite Modification Date: 2025-12-25 @ 11:33 PM
NCT ID: NCT03463993
Description: The risk of serious adverse events is zero as these are rare events with tranexamic acid administration. The all-cause mortality is zero again as this is a rare event. The common adverse effects include headaches (50.4 - 60.4%), backaches (20.7 - 31.4%), nasal sinus congestion (25.4%), abdominal pain (12 - 19.8%), diarrhoea (12.2%), fatigue (5.2%) and anaemia (5.6%). The WOMAN Trial collaborators found that TXA reduces mortality due to bleeding in women with PPH with no adverse effects.
Frequency Threshold: 0
Time Frame: Adverse event data was collected up to the time the patient and baby were discharged from hospital which on average is on the third day post-caesarean section.
Study: NCT03463993
Study Brief: Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Elective 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
Group A Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby. Tranexamic Acid: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision. Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section. 0 None 0 224 7 224 View
Group B Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section. 0 None 0 227 3 227 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypotension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View