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: 2025-12-26 @ 11:48 AM
Ignite Modification Date: 2025-12-26 @ 11:48 AM
NCT ID: NCT03111316
Description: None
Frequency Threshold: 0
Time Frame: adverse events data was collected beginning when the patient was randomized up until 30 days following delivery.
Study: NCT03111316
Study Brief: Foley Catheter Compared to the Foley Catheter Alone for Cervical Ripening
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Nulliparous Foley Catheter & Dinoprostone Insert patients with no prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the dinoprostone insert and intracervical Foley catheter concurrently 0 None 0 26 3 26 View
Nulliparous Foley Catheter Alone patients with no prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the intracervical Foley catheter alone 0 None 4 24 0 24 View
Parous Foley Catheter & Dinoprostone Insert patients with one or more prior pregnancies at or beyond 20 weeks who were randomized to have labor induction started with the dinoprostone insert and intracervical Foley catheter concurrently 0 None 0 25 3 25 View
Parous Foley Catheter Alone patients with one or more prior pregnancies at or beyond 20 weeks who were randomized to have labor induction with the intracervical Foley catheter alone 0 None 1 25 4 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Superimposed preeclampsia NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Endometritis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Pyelonephritis NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neonatal ICU admission SYSTEMATIC_ASSESSMENT Social circumstances None View