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: 2025-12-25 @ 12:17 AM
Ignite Modification Date: 2025-12-25 @ 10:20 PM
NCT ID: NCT00814658
Description: None
Frequency Threshold: 0
Time Frame: 24 weeks
Study: NCT00814658
Study Brief: The Use of Galantamine (Reminyl ER) in Patients With MIXed Dementia: Effects on Cognition and Quality of Life
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 + Nimodipine Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid. None None 1 9 8 9 View
Galantamine + Placebo Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid. None None 1 12 10 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Respiratory distress NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Cachexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Tinnitus NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sleepiness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Vertigo NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Gastrointestinal anomaly NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry lips NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Blood glucose floating NON_SYSTEMATIC_ASSESSMENT Investigations None View
Loss weight NON_SYSTEMATIC_ASSESSMENT Investigations None View
Murmur NON_SYSTEMATIC_ASSESSMENT Investigations None View
Respiratory airways bacterial infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory airways viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Aggressiveness NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Visual hallucination NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Confusional state NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Impatience NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Irritability NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Flu symptoms NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nervousness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypertensive crisis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View