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 @ 3:21 AM
Ignite Modification Date: 2025-12-26 @ 1:59 AM
NCT ID: NCT01509105
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: NCT01509105
Study Brief: Prevenar13 Post Market Surveillance
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Prevenar 13 Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination. None None 3 649 165 649 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
MEDICINE INEFFECTIVE NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART 092 View
PHARYNGITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations WHO-ART 092 View
PNEUMONIA NON_SYSTEMATIC_ASSESSMENT Infections and infestations WHO-ART 092 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
INJECTION SITE RASH NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications WHO-ART 092 View
CRYING ABNORMAL NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART 092 View
FEVER NON_SYSTEMATIC_ASSESSMENT General disorders WHO-ART 092 View
ANOREXIA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART 092 View
CONSTIPATION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART 092 View
DIARRHOEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART 092 View
ENTERITIS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART 092 View
GASTRO-INTESTINAL DISORDER NOS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART 092 View
GASTROENTERITIS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART 092 View
VOMITING NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHO-ART 092 View
EAR ACHE NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders WHO-ART 092 View
LIGAMENT DISORDER NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders WHO-ART 092 View
NAEVUS NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) WHO-ART 092 View
INSOMNIA NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders WHO-ART 092 View
NERVOUSNESS NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders WHO-ART 092 View
ANAEMIA HYPOCHROMIC NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders WHO-ART 092 View
BRONCHITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations WHO-ART 092 View
CYSTITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations WHO-ART 092 View
FURUNCULOSIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations WHO-ART 092 View
INFECTION VIRAL NON_SYSTEMATIC_ASSESSMENT Infections and infestations WHO-ART 092 View
OTITIS MEDIA NON_SYSTEMATIC_ASSESSMENT Infections and infestations WHO-ART 092 View
PHARYNGITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations WHO-ART 092 View
PNEUMONIA NON_SYSTEMATIC_ASSESSMENT Infections and infestations WHO-ART 092 View
PYELONEPHRITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations WHO-ART 092 View
RHINITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations WHO-ART 092 View
SINUSITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations WHO-ART 092 View
UPPER RESPIRATORY TRACT INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations WHO-ART 092 View
COUGHING NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WHO-ART 092 View
SPUTUM DISORDER NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WHO-ART 092 View
DERMATITIS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders WHO-ART 092 View
ECZEMA NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders WHO-ART 092 View
PRURITUS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders WHO-ART 092 View
RASH NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders WHO-ART 092 View
URTICARIA NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders WHO-ART 092 View
CONJUNCTIVITIS NON_SYSTEMATIC_ASSESSMENT Eye disorders WHO-ART 092 View
HETEROPHORIA NON_SYSTEMATIC_ASSESSMENT Eye disorders WHO-ART 092 View
LACRIMAL DUCT OBSTRUCTION NON_SYSTEMATIC_ASSESSMENT Eye disorders WHO-ART 092 View
INJECTION SITE REACTION NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications WHO-ART 092 View
DERMATITIS CONTACT NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders WHO-ART 092 View
SEBORRHOEA NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders WHO-ART 092 View
SKIN DISORDER NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders WHO-ART 092 View