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 @ 2:18 AM
Ignite Modification Date: 2025-12-26 @ 12:49 AM
NCT ID: NCT00616434
Description: None
Frequency Threshold: 5
Time Frame: Up to 16 weeks
Study: NCT00616434
Study Brief: A Phase 2 Study of Interferon Beta-1a (Avonex®) in Ulcerative Colitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Interferon Beta-1a Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks None None 1 62 44 62 View
Placebo Placebo IM injection twice weekly for 12 weeks None None 3 61 20 61 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Colitis Ulcerative None Gastrointestinal disorders MedDRA 12.1 View
Tibia Fracture None Injury, poisoning and procedural complications MedDRA 12.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper Respiratory Tract Infection None Infections and infestations MedDRA 12.1 View
Anaemia None Blood and lymphatic system disorders MedDRA 12.1 View
Headache None Nervous system disorders MedDRA 12.1 View
Hypertension None Vascular disorders MedDRA 12.1 View
Colitis Ulcerative None Gastrointestinal disorders MedDRA 12.1 View
Myalgia None Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Influenza Like Illness None General disorders MedDRA 12.1 View
Pyrexia None General disorders MedDRA 12.1 View
Malaise None General disorders MedDRA 12.1 View