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 @ 12:36 AM
Ignite Modification Date: 2025-12-25 @ 10:46 PM
NCT ID: NCT01437267
Description: None
Frequency Threshold: 5
Time Frame: Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Study: NCT01437267
Study Brief: Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Children, Older Infants and 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
Vi-CRM, Children Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine None None 0 20 14 20 View
Vi-CRM, Older Infants Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine None None 0 20 17 20 View
PNC13, Older Infants Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine None None 0 20 20 20 View
Vi-CRM, Infants Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine None None 0 20 20 20 View
PNC13, Infants Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine None None 1 20 19 20 View
Vi-PS, Children Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine None None 1 20 14 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Animal bite NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Crying SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Induration SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Injection site induration SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Irritability SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 15.0 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Impetigo NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Mumps NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Respiratory tract infections NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Eating disorders SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View