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: 2025-12-25 @ 3:32 AM
Ignite Modification Date: 2025-12-26 @ 2:14 AM
NCT ID: NCT01306305
Description: None
Frequency Threshold: 1
Time Frame: Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.
Study: NCT01306305
Study Brief: A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2010/2011 Influenza Virus Strains for the Northern Hemisphere
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Adults Adults from 18 to 60 years old inclusive None None 0 55 30 55 View
Elderly Elderly subjects aged over 60 years None None 1 55 26 55 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (13.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.0) View
Odynophagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.0) View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA (13.0) View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA (13.0) View
Injection site haemorrhage (ecchymosis) SYSTEMATIC_ASSESSMENT General disorders MedDRA (13.0) View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (13.0) View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA (13.0) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.0) View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (13.0) View
Heat stroke SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (13.0) View
Joint sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (13.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (13.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (13.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.0) View
Injection site induration SYSTEMATIC_ASSESSMENT General disorders MedDRA (13.0) View
Pyrexia (Fever) SYSTEMATIC_ASSESSMENT General disorders MedDRA (13.0) View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (13.0) View