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 @ 3:37 PM
Ignite Modification Date: 2025-12-25 @ 1:49 PM
NCT ID: NCT01346592
Description: Analysis was done on Full Safety Set - Subjects who received at least one study vaccination and provided post baseline safety data.
Frequency Threshold: 5
Time Frame: Solicited AEs collected from Day 1-7 after each vaccination, Unsolicited AEs, Adverse Events of Special Interest, New onset chronic disease, AEs leading to withdrawal and serious adverse events reported for through out the study (Day 1-Day 394)
Study: NCT01346592
Study Brief: Safety, Tolerability, and Immunogenicity of the Adjuvanted Trivalent Subunit Influenza Vaccine and the Non-Adjuvanted Trivalent Subunit Influenza Vaccine Compared to the Non-Adjuvanted Trivalent Split Influenza Vaccine in Children 6 to < 72 Months of Age
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
TIV (6 to <72 Months) Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29 None None 69 1477 905 1477 View
ATIV (6 to <72 Months) Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29 None None 115 3123 2106 3123 View
Comparator TIV (6 to <72 Months) Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29 None None 64 1474 917 1474 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Arthritis Bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bacterial Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchopneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Dengue Fever NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Diarrhoea Infectious NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Dysentery SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Encephalitis Viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Hepatitis A NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lower Respiratory Tract Infection Viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Mastoiditis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Measles NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Meningitis Pneumococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Otitis Media NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Otitis Media Bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Otitis Media Chronic NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Parasitic Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pharyngotonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia Bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia Viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pyelonephritis Acute NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory Syncytial Virus Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory Tract Infection Viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Septic Shock NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Shigella Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Subcutaneous abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tooth Abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Thypoid Fever NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper Respiratory Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Varicella NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral Rash NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Accidental Exposure NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Animal Bite NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Animal Scratch NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Concussion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Craniocerebral Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Eye Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Femur Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Forearm Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Head Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Humerus Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Multiple Injuries NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Radius Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Road Traffic Accident NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Skull Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Subdural Haemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Thermal Burn NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyponatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Malnutrition NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Acute Lymphocytic Leukaemia NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Cholesteatoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Febrile Convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Adenoidal Hypertrophy NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Asthmatic Crisis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Atelectasis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Bronchial Hyperreactivity NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Bronchospasm NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Tonsillary Hypertrophy NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dermatitis Allergic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Swelling Face NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Finger Amputation NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Roseola NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Coeliac Disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Upper Gastrointestinal Disorder Hamorrage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Drowning NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Type III Immune Complex Mediated Reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Abscess Limb NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Abscess Neck NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Amoebiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Metabolic Acidosis NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Tetany NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Crying SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site hemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site induration SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Irritability postvaccinal SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Hypersomnia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View