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 @ 7:39 PM
Ignite Modification Date: 2025-12-25 @ 5:19 PM
NCT ID: NCT00421603
Description: None
Frequency Threshold: 5
Time Frame: during 14 weeks of trial or length of participants participation
Study: NCT00421603
Study Brief: A Placebo-Controlled Study of Mixed Amphetamine Salts and Topiramate for the Treatment of Cocaine Dependence
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Adderall-XR and Topiramate Adderall-XR doses were titrated over two weeks to a maximum dose of 60 mg daily and topiramate doses were titrated over six weeks to a maximum dose of 150 mg twice daily. None None 1 39 33 39 View
Placebo Placebo daily dose None None 1 42 21 42 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
substance-induced mood syndrome SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
residential drug treatment SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Increased/decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
GI upset SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT General disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Irritable SYSTEMATIC_ASSESSMENT General disorders None View