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 @ 6:47 PM
Ignite Modification Date: 2025-12-25 @ 4:18 PM
NCT ID: NCT06118957
Description: Complications by study group
Frequency Threshold: 0
Time Frame: Within 6 Weeks Postpartum
Study: NCT06118957
Study Brief: Low Molecular Weight Heparin or no Treatment Following Cesarean Delivery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
No Treatment- Participants will receive no enoxaparin treatment. 0 None 0 32 3 32 View
Enoxaparin Participants will receive weight-based dosing of enoxaparin at 0.5 mg/kg rounded to the nearest 10 mg every 12 hours based on delivery admission weight. Participants will receive therapy for 14 days. Enoxaparin: Participants will receive weight-based dosing of enoxaparin at 0.5 mg/kg rounded to the nearest 10 mg every 12 hours based on delivery admission weight. Participants will receive therapy for 14 days. 0 None 0 32 4 32 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Blood in Breast Milk SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
cholelithiasis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Uterine Rupture with broad ligament hematoma SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Surgical site infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Superficial incision separation SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View