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 @ 9:34 PM
Ignite Modification Date: 2025-12-25 @ 7:17 PM
NCT ID: NCT01703832
Description: All adverse events that occurred after the participant has received at least one dose of the product under investigation were to be collected and reported
Frequency Threshold: 0
Time Frame: Randomization until individual study end
Study: NCT01703832
Study Brief: Explorative Open Label Study of Efficacy Profile of Neurexan® in Experimental Acute Stress Setting in Healthy Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Neurexan® At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours. None None 0 33 4 33 View
No Intervention At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention. None None 0 32 3 32 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Procedural Pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (15.1) View
Procedural dizziness SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (15.1) View
Procedural nausea SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (15.1) View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (15.1) View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (15.1) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (15.1) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (15.1) View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (15.1) View