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 @ 11:16 PM
Ignite Modification Date: 2025-12-25 @ 8:54 PM
NCT ID: NCT00325156
Description: None
Frequency Threshold: 5
Time Frame: Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) after vaccination. Unsolicited local and general AEs: during the 30-day (Days 0-29) after vaccination. Serious adverse events (SAEs): during the entire study period.
Study: NCT00325156
Study Brief: Assess the Safety & Reactogenicity of DTPa-IPV/Hib Vaccine Administered at 3, 4, 5 & 18 Mths of Age, in Healthy 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
Infanrix-IPV+Hib Group Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age. None None 380 2590 2167 2590 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Mouth ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Vesicoureteric reflux SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Swelling face SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Urticaria chronic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Failure to thrive SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Idiopathic thrombocytopenic purpura SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Lymphadenitis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Febrile convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Benign intracranial hypertension SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Intussusception SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Accidental exposure SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Burns second degree SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Asthmatic crisis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Localised infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Kawasaki's disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Milk allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 11.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Balanitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.0 View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Foreign body trauma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Skull fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Subdural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Upper limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Cardiac aneurysm SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Cryptorchism SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 11.0 View
Laryngomalacia SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 11.0 View
Lymphangioma SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 11.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Bronchial hyperreactivity SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Gastritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Escherichia urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Hand-foot-and-mouth disease SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Respiratory syncytial virus bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Gastroenteritis rotavirus SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Herpangina SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Abscess limb SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Gastroenteritis salmonella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Lobar pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Viral skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Bronchopneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Croup infectious SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Haematoma infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Perianal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Acarodermatitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Campylobacter gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Conjunctivitis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Dengue fever SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Epstein-barr virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Exanthema subitum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Gastroenteritis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Lymphadenitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Necrotising fasciitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Parainfluenzae viral laryngotracheobronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Parotitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Urinary tract infection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Viral pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Redness SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Drowsiness SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Fever (Axillary) SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Irritability SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Loss of appetite SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View