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 @ 1:18 PM
Ignite Modification Date: 2025-12-25 @ 12:25 PM
NCT ID: NCT01734395
Description: Participants who received the study drug at least once were analysed. There was 9 serious adverse events in 7 participants were reported and no other adverse event in more than 5% of participants were reported.
Frequency Threshold: 5
Time Frame: Up to 16 weeks
Study: NCT01734395
Study Brief: A Study to Show That the Change of Attention Measure is Correlated With the Changes of Caregiver's Burden After Treatment With Galantamine in Patients With Alzheimer's Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Galantamine Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks. None None 7 1882 0 1882 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 15.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 15.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 15.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA version 15.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA version 15.0 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 15.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA version 15.0 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 15.0 View
Other Events(If Any):