Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 9:45 PM
Ignite Modification Date: 2025-12-25 @ 7:25 PM
NCT ID: NCT01216332
Description: None
Frequency Threshold: 0
Time Frame: AEs were collected for 28 days after last vaccination, and SAEs were collected through 180 days after their final vaccination via phone call and medical chart review.
Study: NCT01216332
Study Brief: Standard Versus High-Dose Trivalent Inactivated Flu Vaccine in Pediatric Acute Lymphoblastic Leukemia 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
High-Dose Trivalent Inactivated Influenza Vaccine 0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine. High-dose trivalent inactivated influenza vaccine: 0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine. 0 None 9 34 21 34 View
Standard Dose Trivalent Inactivated Influenza Vaccine 0.5 mL standard dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine Standard dose trivalent inactivated influenza vaccine: 0.5 mL standard dose trivalent inactivated influenza vaccine 0 None 6 16 14 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute Otitis Media SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 20.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Viral Illness SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
New Onset Seizures SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Influenza B SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Coronavirus SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tenderness SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Headache SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Redness at injection site SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Pain at Injection Site SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Intense Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Decrease in Activity SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Nausea SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Body Aches SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Vomiting SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View