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 @ 5:32 PM
Ignite Modification Date: 2025-12-25 @ 3:05 PM
NCT ID: NCT03136068
Description: does not differ from clinicaltrials.gov
Frequency Threshold: 0
Time Frame: two days, day one and day two
Study: NCT03136068
Study Brief: Intrafetal Digoxin as an Adjuvant for Dilation and Evacuation at 20 to 24 Weeks' Gestation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Digoxin Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance Digoxin: Trans-abdominal injection 0 None 0 86 7 86 View
Placebo Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume Placebo: Trans-abdominal injection 0 None 1 89 3 89 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
blood transfusion NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
pregnancy labor NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
severe nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
hemmorhage NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
anxiety NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
cramping NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
mass NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View