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 @ 7:12 PM
Ignite Modification Date: 2025-12-25 @ 4:47 PM
NCT ID: NCT00833703
Description: The analysis was performed on the intent-to-treat population and included all AE that developed/worsened during the 'on-treatment period' (i.e. from inclusion in the extension study up to 28 days after treatment discontinuation).
Frequency Threshold: 5
Time Frame: Up to a maximum of 6 months. All Adverse Events (AE) experienced during the study period were collected regardless of seriousness or relationship to the drug .
Study: NCT00833703
Study Brief: Long Term Safety of Clopidogrel in Neonates/Infants With Systemic to Pulmonary Artery Shunt Palliation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo 0.2 mL/kg/day matching placebo solution once daily None None 3 23 7 23 View
Clopidogrel 0.2 mg/kg/Day 0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily None None 6 26 17 26 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bronchiolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Croup infectious NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Low cardiac output syndrome NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Nodal arrhythmia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Diaphragmatic paralysis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Pulmonary artery stenosis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Ischaemic stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Any infections and infestations NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Ear infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Lower respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Any gastrointestinal disorders NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Any general disorders and administration site conditions NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Any respiratory, thoracic and mediastinal disorders NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Any injury, poisoning and procedural complications NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Any skin and subcutaneous tissue disorders NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Any cardiac disorders NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View