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 @ 5:44 PM
Ignite Modification Date: 2025-12-25 @ 3:12 PM
NCT ID: NCT00203268
Description: None
Frequency Threshold: 3
Time Frame: None
Study: NCT00203268
Study Brief: A Study Examining the Use of a Migraine Medicine in the Treatment of Two Migraine Attacks in Patients Who Have Increased Skin Sensitivity
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Early Treatment Subjects who treated a moderate to severe migraine 2 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe. None None 0 13 3 9 View
Late Treatment Subjects who treated a moderate to severe migraine 4 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe None None 0 13 3 9 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
burning at injection site NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders burning View
muscle spasm, quadricep NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Medicinal taste aversion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders taste aversion View
nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Nausea View