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 @ 2:06 AM
Ignite Modification Date: 2025-12-26 @ 12:31 AM
NCT ID: NCT01131260
Description: None
Frequency Threshold: 1
Time Frame: Data on adverse events was collected on a continuous basis for each participant from the time of randomization up through the time of hospital discharge.
Study: NCT01131260
Study Brief: Fetal ST Segment and T Wave Analysis in Labor
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Open Group S31 monitors in the open mode displayed ECG ST-segment information intended for use when uncertain fetal heart-rate patterns were detected. Management of the labor and delivery for women in this group was dictated by the ST-segment analysis guidelines None None 35 5532 0 5532 View
Masked Group The masked S31 monitors functioned as conventional electronic fetal heart-rate monitors. The care of patients in the masked group was managed at the discretion of the attending physician or midwife. None None 21 5576 0 5576 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Postpartum Hemorrhage NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Uterine Rupture NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Maternal Infection (bacteremia) NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Maternal Seizure (eclampsia) NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Acute Respiratory Distress Syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Congenital malformation NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Scalp abscess/pustules (neonatal) NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Neonatal death NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Neonatal Encephalopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neonatal Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Subgaleal hematoma (neonate) NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Brachial plexus injury NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Infection/sepsis (neonate) NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):