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 @ 4:25 PM
Ignite Modification Date: 2025-12-25 @ 2:19 PM
NCT ID: NCT02996266
Description: In this study, an MAE was defined as one of the following: Pneumonia, Sepsis, Malignant cerebral edema, or Death. All Adverse Events were analyzed using the As Treated (AT) population. This is the same as the Intent to Treat (ITT) population but based on the actual treatment received, not based on randomization, if there are patients who received the treatment other than that which they were randomized to.
Frequency Threshold: 5
Time Frame: Data for all AEs was collected from randomization, up to 30 days. Data for Major Adverse Events was collected from randomization, up to 1 year.
Study: NCT02996266
Study Brief: Impact of Fever Prevention in Brain Injured Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fever Prevention Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia 75 None 150 331 122 331 View
Standard Care Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs 77 None 132 336 48 336 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Brain Oedema SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (23.1) View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (23.1) View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (23.1) View
Cerebral Vasoconstriction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (23.1) View
Pneumonia Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (23.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (23.1) View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA (23.1) View
Hypernatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (23.1) View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (23.1) View