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 @ 10:17 PM
Ignite Modification Date: 2025-12-26 @ 10:17 PM
NCT ID: NCT01982812
Description: None
Frequency Threshold: 0
Time Frame: 1 month post enrollment
Study: NCT01982812
Study Brief: A Safety and Feasibility Study of Enteral LVT vs. Standard of Care for Seizure Control in Pediatric CM
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Oral Levetiracetam Oral Levetiracetam administered by NG tube. Oral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days None None 5 23 15 23 View
Comparison Group 2014: Children randomized to routine care who then recieved 20mg/kg phenobarbital with additional doses at the managing clinicians discretion 2015: Children randomized to routine care will phenobarbital given at the discretion of the managing clinician but with a max od 20mg/kg load None None 8 21 18 21 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
death SYSTEMATIC_ASSESSMENT Nervous system disorders Grade 5 View
elevated AST SYSTEMATIC_ASSESSMENT Hepatobiliary disorders Grade 1-5 View
thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders Grade 1-5 View
hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders Grade 1-5 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders Grade 1-5 View
respiratory suppression or aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Grade 1-5 View
Anemia (persistent) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders Grade 1-5 View
elevated ALT SYSTEMATIC_ASSESSMENT Hepatobiliary disorders Grade 1-5 View
elevated alkaline phosphatase SYSTEMATIC_ASSESSMENT Hepatobiliary disorders Grade 1-5 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
myoclonus SYSTEMATIC_ASSESSMENT Nervous system disorders Grade 1-5 View
Anemia with persistent low retics SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders Grade 1-5 View
Increased AST SYSTEMATIC_ASSESSMENT Hepatobiliary disorders Grade 1-5 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders Grade 1-5 View
elevated platelet count SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders Grade 1-5 View
Decreased reticulocyte count SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders Grade 1-5 View
Abnormal ECG SYSTEMATIC_ASSESSMENT Cardiac disorders Grade 1-5 View
Excess sedation SYSTEMATIC_ASSESSMENT Nervous system disorders Grade 1-5 View
Increased ALT SYSTEMATIC_ASSESSMENT Hepatobiliary disorders Grade 1-5 View
Increased alkaline phosphotase SYSTEMATIC_ASSESSMENT Hepatobiliary disorders Grade 1-5 View
Increased potassium SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders Grade 1-5 View
Increased chloride SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders Grade 1-5 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Grade 1-5 View
increased phosphate SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders Grade 1-5 View
increased calcium SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders Grade 1-5 View