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 @ 3:52 AM
Ignite Modification Date: 2025-12-26 @ 2:41 AM
NCT ID: NCT00667602
Description: Data collected from one site were not included in the data analysis for outcome measures and the AE section.
Frequency Threshold: 5
Time Frame: Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180.
Study: NCT00667602
Study Brief: Safety and Immunogenicity Evaluation After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants and Toddlers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MenACWY-CRM197 (2dose) + Concomitant Vaccines Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. None None 13 195 192 195 View
MenACWY-CRM197 (1dose) + Concomitant Vaccines Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. None None 19 192 184 192 View
MenC (1dose) + Concomitant Vaccines Infants received one dose of MenC vaccine at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months. None None 12 179 170 179 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Thermal burn NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Malaria NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Otitis media NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lymphadenitis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Amphthous stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Intussusception NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Hyperpyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Food Allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Croup infectious NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Febrile infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia respiratory syncytial viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Accidental exposure NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Concussion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Neuroblastoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Febrile convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Enteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Teething NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site induration SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Irritability SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Otitis media NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Crying SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Eating disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dermatitis Diaper NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View