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 @ 3:16 PM
Ignite Modification Date: 2025-12-25 @ 1:38 PM
NCT ID: NCT00176592
Description: Adverse events were recorded spontaneously and upon questioning by nurse at MRI for the hour of the MRI. Additional events were recorded at follow up visit within three months of MRI. Additional lab results were studied at follow up visit within three months of MRI. Finally, lab results and clinical adverse events were studied at three interim analyses by data monitoring committee.
Frequency Threshold: 5
Time Frame: Adverse events in the form of symptoms were gathered over the duration of the study (24 months).
Study: NCT00176592
Study Brief: Phase IV Study, Betaseron Versus Copaxone for Relapsing Remitting or CIS Forms of MS Using Triple Dose Gad 3 T MRI
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Betaseron Betaseron 250 micrograms SQ every other day Betaseron: Betaseron 250 micrograms injected SQ every other day None None 7 36 2 36 View
Copaxone 20 mg daily SQ Copaxone: Copaxone 20 mg injected SQ every day (glatiramer acetate) None None 7 39 7 39 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pregnancy NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Malignant Nodule in Lung NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Loss of Hearing NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Pain near IV Site NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Venous Thromboembolism NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Aneurysm NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pancreatitis NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Myelitis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Balance Impairment NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain/Burning at Injection Site NON_SYSTEMATIC_ASSESSMENT General disorders None View
Headache/Dizziness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View