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 @ 4:32 AM
Ignite Modification Date: 2025-12-26 @ 3:34 AM
NCT ID: NCT01289418
Description: None
Frequency Threshold: 1
Time Frame: 6 months
Study: NCT01289418
Study Brief: Surveillance for Adverse Events Following Pandemic H1N1 Immunization
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Health Care Workers From CHUQ Hospitals None None None 35 3064 383 4984 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Breast cancer None Reproductive system and breast disorders None View
pancreas cancer None Endocrine disorders None View
cervix precancerous cells None Reproductive system and breast disorders None View
gynecologic problems/obstetrical None Pregnancy, puerperium and perinatal conditions None View
gynecologic problems None Reproductive system and breast disorders None View
Respiratory infection None Infections and infestations None View
toxic shock syndrome None Infections and infestations None View
Musculoskeletal problems None Musculoskeletal and connective tissue disorders None View
depression None Psychiatric disorders None View
Chronic pericarditis None Cardiac disorders None View
Eye problem None Eye disorders None View
ear surgery None Surgical and medical procedures None View
severe headaches None General disorders None View
Asthma None Respiratory, thoracic and mediastinal disorders None View
Vaso-vasectomy None Surgical and medical procedures None View
no diagnosis None Injury, poisoning and procedural complications None View
Gastroenteritis None Gastrointestinal disorders None View
cutaneous infection None Infections and infestations None View
abdominal problems None Gastrointestinal disorders None View
Anaphylactic shock None Immune system disorders None View
lung cancer None Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Local reaction None Skin and subcutaneous tissue disorders None View
myalgia None General disorders None View
respiratory problems None Respiratory, thoracic and mediastinal disorders None View
gastroenteritis None Gastrointestinal disorders None View