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 @ 3:18 AM
Ignite Modification Date: 2025-12-26 @ 1:57 AM
NCT ID: NCT02580305
Description: Safety population is considered for reporting total number of participants at risk.
Frequency Threshold: 5
Time Frame: 26 Weeks
Study: NCT02580305
Study Brief: SUVN-502 With Donepezil and Memantine for the Treatment of Moderate Alzheimer's Disease- Phase 2a Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SUVN-502 Low Dose (50 mg) SUVN-502 Low dose (50 mg) adjunct to base treatment with Donepezil and Memantine 3 None 10 187 50 187 View
SUVN-502 High Dose (100 mg) SUVN-502 High dose (100 mg) adjunct to base treatment with Donepezil and Memantine 2 None 14 181 44 181 View
Placebo Placebo adjunct to base treatment with Donepezil and Memantine 1 None 12 188 40 188 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 18.1. View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 18.1. View
Klebsiella sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 18.1. View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 18.1. View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 18.1. View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 18.1. View
Dementia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 18.1. View
Haemorrhage intracranial SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 18.1. View
Loss of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 18.1. View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 18.1. View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 18.1. View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 18.1. View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 18.1. View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 18.1. View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 18.1. View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 18.1. View
Accidental overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 18.1. View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 18.1. View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 18.1. View
Completed suicide SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 18.1. View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 18.1. View
Bladder transitional cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 18.1. View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 18.1. View
Pelvic fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 18.1. View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 18.1. View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 18.1. View
Diaphragmatic hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 18.1. View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 18.1. View
Incarcerated inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 18.1. View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 18.1. View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 18.1. View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA version 18.1. View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders MedDRA version 18.1. View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 18.1. View
Malignant neoplasm of unknown primary site SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 18.1. View
Haemorrhagic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 18.1. View
Bile duct obstruction SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA version 18.1. View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA version 18.1. View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 18.1. View
Asphyxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 18.1. View
Aortic aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 18.1. View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 18.1. View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 18.1. View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 18.1. View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 18.1. View