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 @ 5:47 PM
Ignite Modification Date: 2025-12-25 @ 3:14 PM
NCT ID: NCT00101868
Description: None
Frequency Threshold: 5
Time Frame: 6 months
Study: NCT00101868
Study Brief: Value of Technology to Transfer Discharge Information
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Discharge Communication Software Computerized-Physician-Order-Entry software application to facilitate communication at time of hospital discharge to patients, retail pharmacists, community physicians. Software had required fields, pick lists, standard drug doses, alerts, reminders, online reference information. Software prompted discharging physician to enter pending tests, order tests after discharge. Hospital physicians used software on day of discharge to generate four documents automatically: personalized letter to outpatient physician, legible prescriptions, and legible discharge order None None 10 316 17 316 View
Usual Care Discharge Process Hospital physicians and ward nurses completed handwritten discharge forms on the day of discharge. The forms contained blanks for discharge diagnoses, discharge medications, medication instructions, post discharge activities and restrictions, post discharge diet, post discharge diagnostic and therapeutic interventions, and appointments. Patients received handwritten copies of the forms, one page of which also included medication instructions and prescriptions None None 10 315 17 315 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
adverse drug event SYSTEMATIC_ASSESSMENT General disorders None View