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 @ 12:27 AM
Ignite Modification Date: 2025-12-25 @ 10:32 PM
NCT ID: NCT01981967
Description: None
Frequency Threshold: 5.00
Time Frame: Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
Study: NCT01981967
Study Brief: Post-licensure Safety Study of IMOJEV® in Thailand
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Primary Vaccination Group Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination. None None 204 6851 0 6851 View
Booster Vaccination Group Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster. None None 59 3149 0 3149 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Oral herpes NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Otitis media acute NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Pharyngitis bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Pharyngotonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Pneumonia bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Pneumonia respiratory syncytial viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Pneumonia viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Pyelonephritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Respiratory syncytial virus bronchiolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Respiratory syncytial virus bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Respiratory syncytial virus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Scarlet fever NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Scrotal abcess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Urinary track infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Viral diarrhoea NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Viral rash NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Femur fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.0 View
Acute myeloid leukaemia NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16.0 View
Convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Epilepsy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Febrile convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Frontal lobe epilepsy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 16.0 View
Kawasaki's disease NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View
Mouth ulceration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Influenza like illness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Herpangina NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Pneumonitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Diarrhoea infectious NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Exanthema subitum NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Gastritis bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Gastroenteritis rotavirus NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Gastroenteritis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Hand-foot-mouth disease NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Infectious mononucleosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Laryngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Croup infectious NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Dengue fever NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Enteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Food poisoning NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Allergy to arthropod sting NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 16.0 View
Abscess limb NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Acute tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Anal abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Bronchiolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Bronchitis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Burkholderia pseudomallei infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Other Events(If Any):