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 @ 2:38 AM
Ignite Modification Date: 2025-12-26 @ 1:15 AM
NCT ID: NCT01396434
Description: The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Frequency Threshold: 0
Time Frame: None
Study: NCT01396434
Study Brief: Safety Surveillance of Pneumococcal 13-valent Conjugate Vaccine Among Filipinos
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
13vPnC (Prevenar 13), Cohort 1 Pneumococcal 13-valent conjugate vaccine (13vPnC) as prescribed by the physician based on approved product indication for infants and children 6 weeks through 5 years of age. None None 1 2817 68 2817 View
13vPnC (Prevenar 13), Cohort 2 13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older. None None 0 175 5 175 View
13vPnC (Prevenar 13), Cohort 3 13vPnC as prescribed by the physician based on approved product indication. These participants may have had incorrect documentation of their 13vPnC vaccine date(s) and were neither included in the 6 weeks through 5 years of age nor 50 years and older indication group. None None 0 14 0 14 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bronchopneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations WHO Drug Dictionary View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO Drug Dictionary View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders WHO Drug Dictionary View
Injection site pain NON_SYSTEMATIC_ASSESSMENT General disorders WHO Drug Dictionary View
Swelling NON_SYSTEMATIC_ASSESSMENT General disorders WHO Drug Dictionary View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders WHO Drug Dictionary View
Injection site swelling NON_SYSTEMATIC_ASSESSMENT General disorders WHO Drug Dictionary View
Injection site erythema NON_SYSTEMATIC_ASSESSMENT General disorders WHO Drug Dictionary View
Crying NON_SYSTEMATIC_ASSESSMENT General disorders WHO Drug Dictionary View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations WHO Drug Dictionary View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations WHO Drug Dictionary View
Viral rash NON_SYSTEMATIC_ASSESSMENT Infections and infestations WHO Drug Dictionary View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations WHO Drug Dictionary View
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations WHO Drug Dictionary View
Tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations WHO Drug Dictionary View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations WHO Drug Dictionary View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations WHO Drug Dictionary View
Bronchopneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations WHO Drug Dictionary View
Amoebiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations WHO Drug Dictionary View
Vaccination complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications WHO Drug Dictionary View
Myopathy NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders WHO Drug Dictionary View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders WHO Drug Dictionary View
Restlessness NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders WHO Drug Dictionary View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WHO Drug Dictionary View
Rash maculo-papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders WHO Drug Dictionary View
Dermatitis contact NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders WHO Drug Dictionary View
Dermatitis atopic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders WHO Drug Dictionary View
Angioedema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders WHO Drug Dictionary View