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 @ 3:04 PM
Ignite Modification Date: 2025-12-25 @ 1:26 PM
NCT ID: NCT01944059
Description: Blinding information is not available from Funder. Data analysis was not completed and adverse event terms for non-serious adverse events are only available by Organ System.
Frequency Threshold: 0
Time Frame: None
Study: NCT01944059
Study Brief: Theramine® in the Prevention of Migraine Headache
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
All Participants 2 capsules before breakfast and dinner (BID) for 16 weeks. Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine. Theramine (medical food/old drug): Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors. Placebo (l-alanine): Theramine like placebo comparator None None 1 31 23 31 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diabetic Ketoacidosis NON_SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE (4.0) View
Asthma Exacerbation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Psychiatric disorders NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Metabolism and nutritional disorders NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Reproductive system and breast disoders NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (4.0) View
Surigical and Medical Procedures NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures CTCAE (4.0) View
Musculoskeletal and connective tissue disorders NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Gastrointestinal Disorders NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
General Disorders NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Skin and subcutaneious tissue disorders NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Eye Disoders NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
Infections and Infestations NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Nervous System Disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Respiratory, thoracic and mediastinal disorders NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View