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 @ 3:53 AM
Ignite Modification Date: 2025-12-26 @ 2:42 AM
NCT ID: NCT05584202
Description: Safety Set included participants who received at least 1 dose of study drug.
Frequency Threshold: 5
Time Frame: Day 1 up to Day 422
Study: NCT05584202
Study Brief: Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273.214 SARS-CoV-2 (COVID-19) Vaccine in 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
mRNA-1273.214 5 ug Participants received at least 1 of 2 doses of mRNA-1273.214 5 μg by IM injection approximately 8 weeks apart (Day 1 and Day 57). 0 None 1 50 40 50 View
mRNA-1273.214 10 ug Participants received at least 1 of 2 doses of mRNA-1273.214 10 μg by IM injection approximately 8 weeks apart (Day 1 and Day 57). 1 None 1 18 16 18 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Drowning SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Rhinovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Hypoxic-ischaemic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Otorrhoea SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 23.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Teething SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Beta haemolytic streptococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Candida nappy rash SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Conjunctivitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Coronavirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Hand-foot-and-mouth disease SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Otitis media acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Otosalpingitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Respiratory syncytial virus bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Respiratory syncytial virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Rhinovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Blood lead increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Speech disorder developmental SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Bronchial hyperreactivity SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Dermatitis atopic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View