Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 3:02 PM
Ignite Modification Date: 2025-12-25 @ 1:25 PM
NCT ID: NCT00644059
Description: 15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
Frequency Threshold: 5
Time Frame: 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
Study: NCT00644059
Study Brief: Study to Evaluate the Efficacy, Safety and Immunogenicity of Influenza Vaccine in Healthy Subjects (Aged 6 to <72 Months) Versus Control Vaccines
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Flu-control_0.25 Subjects aged 6 to \< 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine None None 104 1069 989 1069 View
Flu-control_0.5 Subjects aged 36 to \< 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine None None 65 777 686 777 View
Non-Flu-control (TBE/Men C Vaccine) Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine None None 65 607 567 607 View
Non-Flu-control (TBE Vaccine) Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine None None 45 422 375 422 View
TIV-adj_0.25 Subjects aged 6 to \< 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine None None 91 1177 1101 1177 View
TIV-adj_0.5 Subjects aged 36 to \< 72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine None None 31 835 769 835 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Enteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Developmental delay NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Gait disturbance NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Craniocerebral injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Upper limb fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Vaccination failure NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Paracentesis NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Acetonaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Diabetes mellitus NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Feeding disorder of Infancy or Early childhood NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Fistula NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Synovial cyst NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Ataxia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Febrile convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Petit mal epilepsy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Attention deficit / Hyperactivity disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Dysphemia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Nephrolithiasis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Scrotal oedema NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Apnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Bronchitis chronic NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Tonsillar haemorrhage NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Tonsillar hypertrophy NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Wheezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Erythema multiforme NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Henoch-schonlein purpura NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Child abuse NON_SYSTEMATIC_ASSESSMENT Social circumstances MedDRA View
Adenoidectomy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Brain tumour operation NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Patent ductus arteriosus repair NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Toe amputation NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Tonsillectomy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Photosensitivity reaction NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 17.1 View
Abnormal behaviour NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 17.1 View
Brain neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 17.1 View
Colonoscopy NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 17.1 View
Foreign body NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 17.1 View
Femur fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 17.1 View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 17.1 View
Brain contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 17.1 View
Arthropod bite NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 17.1 View
Accidental poisoning NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.1 View
Rotavirus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.1 View
Lice infestation NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.1 View
Gastroenteritis norovirus NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.1 View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.1 View
Malabsorption NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Inguinal hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Epilepsy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.1 View
Adenoidal hypertrophy NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Laceration NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Exposure via ingestion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Encephalitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Acquired epileptic aphasia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Lymphadenitis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Cyanosis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 17.1 View
Supraventricular tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Hydrocele NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Autoimmune thyroiditis NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Aphthous stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Allergy to arthropod bite NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Drug hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Arthropod infestation NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchiolitis 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
Campylobacter infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Exanthema subitum NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Febrile infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis rotavirus NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
H1N1 influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Hand-foot and mouth disease NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Laryngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lymphangitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Oral herpes NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Otitis media NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Peritonsillar abscess 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
Pneumococcal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumococcal sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pseudocroup 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 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
Tracheitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Accidental exposure to product NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Concussion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Toxicity to various agents NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Electric shock NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Foot fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Humerus fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Limb injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Perineal Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Poisoning NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Post procedural haemorrhage 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
Skull fractured base NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
spinal cord injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Injection site haemorrhage NON_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
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Ear infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis 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
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Crying NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Eating disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dermatitis diaper NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 17.1 View
Hyperhidrosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 17.1 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 17.1 View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.1 View
Enteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View