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 @ 10:46 PM
Ignite Modification Date: 2025-12-26 @ 10:46 PM
NCT ID: NCT01990612
Description: The primary and secondary outcomes comprise all the adverse events that occurred. We expect this is different than, for example, a medication trial in which adverse events other than those related to the outcomes may occur.
Frequency Threshold: 1
Time Frame: Adverse event data were collected and evaluated from the date of randomization (between 38 weeks, 0 days gestation and 38 weeks, 6 days gestation) through approximately 8 weeks postpartum. This time frame encompasses between 9 and 12 weeks.
Study: NCT01990612
Study Brief: A Randomized Trial of Induction Versus Expectant Management
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Expectant Management Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. 3 None 3 3037 0 3037 View
Elective Induction of Labor Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days Elective Induction of Labor: Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises. 2 None 2 3059 0 3059 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Perinatal Death NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Other Events(If Any):