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 @ 1:56 PM
Ignite Modification Date: 2025-12-25 @ 12:44 PM
NCT ID: NCT00574795
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00574795
Study Brief: Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Infants
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
13vPnC Infant Series Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series). None None 9 193 192 193 View
13vPnC Post-Infant Series Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series). None None 14 193 19 193 View
13vPnC Toddler Dose Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12-15 months (toddler dose). None None 1 185 171 185 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Adenovirus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bronchiolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cellulitis staphylococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Enteritis infectious NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Exanthema subitum NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Febrile convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pertussis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia respiratory syncytial viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory syncytial virus bronchiolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory syncytial virus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rotavirus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Staphylococcal sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Subdural haematoma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Enterocolitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Haematochezia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Umbilical hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Injection site erythema NON_SYSTEMATIC_ASSESSMENT General disorders None View
Injection site swelling NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Irritability NON_SYSTEMATIC_ASSESSMENT General disorders None View
Injection site pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Injection site induration NON_SYSTEMATIC_ASSESSMENT General disorders None View
Injection site eczema NON_SYSTEMATIC_ASSESSMENT General disorders None View
Injection site mass NON_SYSTEMATIC_ASSESSMENT General disorders None View
Injection site irritation NON_SYSTEMATIC_ASSESSMENT General disorders None View
Injection site warmth NON_SYSTEMATIC_ASSESSMENT General disorders None View
Swelling NON_SYSTEMATIC_ASSESSMENT General disorders None View
Vaccination site induration NON_SYSTEMATIC_ASSESSMENT General disorders None View
Solvent sensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Viral diarrhoea NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Iron deficiency anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pulmonary valve stenosis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dacryostenosis congenital NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Cryptorchism NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Pectus excavatum NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Cerumen impaction NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye discharge NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Ocular hyperaemia NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Keratitis NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anal fissure NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vessel puncture site reaction NON_SYSTEMATIC_ASSESSMENT General disorders None View
Liver disorder NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Food allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Milk allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Exanthema subitum NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Varicella NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Enteritis infectious NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Otitis media NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Otitis media acute NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchiolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Croup infectious NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Molluscum contagiosum NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Adenovirus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory syncytial virus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Conjunctivitis bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fungal skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis rotavirus NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin candida NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral rash NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Enterocolitis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Enterovirus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Herpes simplex NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Impetigo NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Laryngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Omphalitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oral candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Paronychia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pertussis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia respiratory syncytial viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory syncytial virus bronchiolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rotavirus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Subcutaneous abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Herpangina NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Adenoviral upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchopneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Enterocolitis infectious NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Arthropod bite NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Animal bite NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Excoriation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Joint dislocation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Joint injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Skin laceration NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Thermal burn NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Clavicle fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Mouth injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Liver function test abnormal NON_SYSTEMATIC_ASSESSMENT Investigations None View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Lactose intolerance NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypocalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Lymphangioma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Fibroma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Hypersomnia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Crying NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Head banging NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Vesicoureteric reflux NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Balanoposthitis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Upper respiratory tract inflammation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dysphonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinitis allergic NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Wheezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fibrinous bronchitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dermatitis diaper NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Eczema infantile NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Heat rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Petechiae NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis atopic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hyperkeratosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Asteatosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Blister NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis contact NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Drug eruption NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Eczema asteatotic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash erythematous NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Seborrhoeic dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis allergic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Tenderness (Any) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Tenderness (Any) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Tenderness (Any) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Tenderness (Significant) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Tenderness (Significant) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Tenderness (Significant) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Induration (Any) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Induration (Any) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Induration (Any) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Induration(Mild) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Induration(Mild) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Induration(Mild) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Induration (Moderate) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Induration (Moderate) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Induration (Moderate) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Induration (Severe) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Induration (Severe) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Induration (Severe) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Erythema (Any) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Erythema (Any) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Erythema (Any) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Erythema (Mild) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Erythema (Mild) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Erythema (Mild) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Erythema (Moderate) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Erythema (Moderate) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Erythema (Moderate) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Erythema (Severe) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Erythema (Severe) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Erythema (Severe) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Local Reactions View
Any fever (≥37.5°C) SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Any fever (≥37.5°C) SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Any fever (≥37.5°C) SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever ≥38°C but ≤39°C (mild) SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever ≥38°C but ≤39°C (mild) SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever ≥38°C but ≤39°C (mild) SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever >39°C but ≤40°C (moderate) SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever >39°C but ≤40°C (moderate) SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever >39°C but ≤40°C (moderate) SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever >40°C (severe) SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever >40°C (severe) SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Fever >40°C (severe) SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Decreased appetite SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Decreased appetite SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Decreased appetite SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Irritability SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Irritability SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Irritability SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Increased sleep SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Increased sleep SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Increased sleep SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Decreased sleep SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Decreased sleep SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Decreased sleep SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Hives (urticaria) SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Hives (urticaria) SYSTEMATIC_ASSESSMENT General disorders Systemic Events View
Hives (urticaria) SYSTEMATIC_ASSESSMENT General disorders Systemic Events View