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 @ 4:32 PM
Ignite Modification Date: 2025-12-25 @ 2:24 PM
NCT ID: NCT00353366
Description: None
Frequency Threshold: 5
Time Frame: Serious Adverse Events: during the entire study period; Solicited local and general symptoms: During the 15-day (Days 0-14) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
Study: NCT00353366
Study Brief: To Evaluate Safety & Reactogenicity of GSK Bio's Human Rotavirus (HRV) Vaccine in Filipino Infants at Least 6 Weeks of Age at First Vaccination
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Rotarix Group Subjects received 2 doses of Rotarix administered at an interval of not less than 4 weeks between the doses. The first dose was administered at the age of 6 weeks and the vaccination course completed by the age of 24 weeks. 0 None 33 1439 827 1439 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Amoebic dysentery NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Bronchopneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Amoebiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Bronchiolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Diarrhoea infections NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Exanthema subitum NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Hypersomnia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Hypophagia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Intussusception NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Milk anyergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 15.0 View
Pneumonia aspiration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Pneumonia bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Roseola NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Urinary tract infection enterococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Viral rash NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cough SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Irritability SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Loss of appetite SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Vomiting SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View