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 @ 11:32 PM
Ignite Modification Date: 2025-12-25 @ 9:20 PM
NCT ID: NCT00310856
Description: None
Frequency Threshold: 5
Time Frame: Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)
Study: NCT00310856
Study Brief: Immunogenicity and Safety of MenACWY in Infants (6 & 12 Months)
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-CRM_6-12M Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months) None None 3 64 62 64 View
MenACWY-CRM_12M Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months) None None 2 61 58 61 View
MenC-CRM_12M_MenACWY-CRM_18M Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months). Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib- IPV (at 18 months) None None 2 50 50 50 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Infectious mononucleosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory syncytial virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea 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 SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Eating disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View