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 @ 4:18 AM
Ignite Modification Date: 2025-12-26 @ 3:19 AM
NCT ID: NCT00590720
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00590720
Study Brief: A Phase 2A Study to Evaluate the Safety and Effect on Exercise Challenge Testing of MEDI-528 in Adults With Asthma
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 None None None 0 4 4 4 View
MEDI528 50 mg None None None 1 7 5 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Nuclear magnetic resonance imaging abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site irritation SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 11.1 View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Eye infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Nasal polyps SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
Post-traumatic pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
Blood bicarbonate increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Skin papilloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.1 View
Hyposmia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Nerve root compression SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Cyst SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View