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 @ 4:05 PM
Ignite Modification Date: 2025-12-25 @ 2:06 PM
NCT ID: NCT00301366
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00301366
Study Brief: The Safety and Tolerability of Alpha-1 Modified Process (MP) In Subjects With Alpha-1-antitrypsin (AAT) Deficiency
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Alpha-1MP Treatment Group All subjects received open-label weekly IV infusions of 60 mg/kg body weight of functional Alpha-1 MP for 20 weeks None None 2 38 26 38 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia None Infections and infestations None View
Rash None Skin and subcutaneous tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Influenza like illness None General disorders None View
Nausea None Gastrointestinal disorders None View
Chest pain None General disorders None View
Chills None General disorders None View
Nasopharyngitis None Infections and infestations None View
Oral candidiasis None Infections and infestations None View
Upper respiratory tract infection None Infections and infestations None View
Urinary tract infection None Infections and infestations None View
Arthralgia None Musculoskeletal and connective tissue disorders None View
Back pain None Musculoskeletal and connective tissue disorders None View
Muscle spasms None Musculoskeletal and connective tissue disorders None View
Dizziness None Nervous system disorders None View
Headache None Nervous system disorders None View
Anxiety None Psychiatric disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Dyspnoea None Respiratory, thoracic and mediastinal disorders None View
Pharyngolaryngeal pain None Respiratory, thoracic and mediastinal disorders None View
Hot flush None Vascular disorders None View