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 @ 9:21 PM
Ignite Modification Date: 2025-12-25 @ 7:08 PM
NCT ID: NCT00897104
Description: Although a participant may have had two or more adverse experiences the participant is counted only once in a category. The same participant may appear in different categories. The At Risk population are the participants that received study treatment.
Frequency Threshold: 1
Time Frame: During the 24 hours treatment period, and up to and including 7 days after the last dose of study therapy.
Study: NCT00897104
Study Brief: MK0462 5 mg, Sumatriptan 50 mg, and Placebo Comparison Study (0462-029)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Rizatriptan 5 mg Rizatriptan 5 mg orally once for treatment of single migraine attack None None 0 355 92 355 View
Sumatriptan 5 mg Sumatriptan 5 mg orally once for treatment of single migraine attack None None 0 357 108 357 View
Placebo Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack None None 0 80 16 80 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Asthenia/Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders CRISP Dictionary View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders CRISP Dictionary View
Pain, Abdominal NON_SYSTEMATIC_ASSESSMENT General disorders CRISP Dictionary View
Pain, Chest NON_SYSTEMATIC_ASSESSMENT General disorders CRISP Dictionary View
Warm Sensation NON_SYSTEMATIC_ASSESSMENT General disorders CRISP Dictionary View
Palpitation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CRISP Dictionary View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CRISP Dictionary View
Dry Mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CRISP Dictionary View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CRISP Dictionary View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CRISP Dictionary View
Pain, Mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CRISP Dictionary View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CRISP Dictionary View
Heaviness, Regional NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CRISP Dictionary View
Pain, Back NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CRISP Dictionary View
Pain, Neck NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CRISP Dictionary View
Stiffness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CRISP Dictionary View
Strain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CRISP Dictionary View
Apathy NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CRISP Dictionary View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CRISP Dictionary View
Dream Abnormality NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CRISP Dictionary View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CRISP Dictionary View
Hypesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CRISP Dictionary View
Mental Acuity Decreased NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CRISP Dictionary View
Paresthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CRISP Dictionary View
Somnolence NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CRISP Dictionary View
Vertigo NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CRISP Dictionary View
Discomfort, Pharyngeal NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CRISP Dictionary View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CRISP Dictionary View