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 @ 11:52 PM
Ignite Modification Date: 2025-12-25 @ 9:47 PM
NCT ID: NCT00617851
Description: Of the 1507 subjects enrolled and randomized in this study, 96 were not included in the safety analysis (82 in the pooled influenza virus vaccine group and 14 in the comparator influenza vaccine group) as they had no safety data. These subjects have been excluded from the safety analysis to avoid underestimating the incidence rates of reactions.
Frequency Threshold: 5
Time Frame: Serious adverse events were collected for 6 months after vaccination. All adverse events were collected for 21 days after vaccination.
Study: NCT00617851
Study Brief: Study to Evaluate the Consistency of Three Consecutive Production Lots of Influenza Vaccine in Healthy Subjects 18 to 49 Years Old
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Comparator Influenza Vaccine One injection of the comparator influenza virus vaccine None None 4 202 0 202 View
Influenza Virus Vaccine (Pooled) One injection of the investigational influenza virus vaccine (all lots pooled) None None 11 1209 0 1209 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abortion Induced SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (10.0) View
Abortion Spontaneous SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA (10.0) View
Abscess Limb SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
Acute Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (10.0) View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (10.0) View
Fibroadenoma of Breast SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (10.0) View
Fractured Coccyx SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (10.0) View
Gas Gangrene SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
Goitre SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA (10.1) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
Hysterectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (10.0) View
Intracranial Aneurysm SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
Multi-Organ Failure SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Road Traffic Accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (10.0) View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
Uterine Leiomyoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (10.0) View
Other Events(If Any):