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 @ 2:52 PM
Ignite Modification Date: 2025-12-25 @ 1:18 PM
NCT ID: NCT00715559
Description: Adverse events are recorded with the SAFTEE at each weekly visit during the 8 week study. All items reported here are endorsed with a severity greater than mild (e.g. moderate or severe) and represent a change from baseline.
Frequency Threshold: 5
Time Frame: 8 weeks
Study: NCT00715559
Study Brief: Cysteamine Therapy for Major Depressive Disorder
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cysteamine Bitartrate Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily None None 0 3 3 3 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT General disorders None View
Drooling SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomach discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
loss of sexual interest SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
appetite decrease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
word finding difficulty SYSTEMATIC_ASSESSMENT Nervous system disorders None View
bruising SYSTEMATIC_ASSESSMENT Vascular disorders None View
hot flashes SYSTEMATIC_ASSESSMENT Endocrine disorders None View
apathy SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Numbness or tingling SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View