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 @ 1:46 AM
Ignite Modification Date: 2025-12-26 @ 12:04 AM
NCT ID: NCT00138294
Description: Non-serious adverse events were not captured during the course of this study except for pregnancy(ies).
Frequency Threshold: 0
Time Frame: None
Study: NCT00138294
Study Brief: Control of Epidemic Influenza Through a School-based Influenza Vaccination Program
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
All Enrolled Study Participants Children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland) with be offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program. Children living in the comparison cities (Waco, Bryan and College Station) which are within 90 miles of the intervention cites will received their influenza vaccines (live attenuated or inactivated influenza vaccines) by the local healthcare providers None None 57 29255 1 29255 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Psychiatric Disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Trauma/Skeletal Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Migraine/Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Elective Surgery SYSTEMATIC_ASSESSMENT Investigations None View
Soft tissue and/or bone infection SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Sepsis SYSTEMATIC_ASSESSMENT General disorders None View
Meningitis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pharyngitis/Group A Strep/Abscess SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lower Respiratory Tract Infection (LRTI) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
2009 H1N1 Pneumonia/LRTI SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Acute Asthma Attack SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sickle Cell Crisis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Gastroenteritis/Mesentric Adenitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Emesis and Weight Loss SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Appendicitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acute abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Intussususception SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Henoch-Schonlein Purpura SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Optic neuritis SYSTEMATIC_ASSESSMENT Eye disorders None View
Guillain Barre Syndrom SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Oilgoarticular post-infectious arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Death SYSTEMATIC_ASSESSMENT General disorders None View
Carbon Monoxide Poisoning SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pregnancy SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View