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 @ 12:30 PM
Ignite Modification Date: 2025-12-25 @ 12:09 PM
NCT ID: NCT01955161
Description: Treatment-Emergent Adverse Events are reported in this section
Frequency Threshold: 5
Time Frame: Baseline to end of study at Week 24
Study: NCT01955161
Study Brief: Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With Donepezil
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Idalopirdine 60 mg Idalopirdine adjunct to 10 mg Donezepil 3 None 20 309 49 309 View
Idalopirdine 30 mg Idalopirdine adjunct to 10 mg Donezepil 1 None 18 313 56 313 View
Placebo Placebo adjunct to 10 mg Donepezil 1 None 12 308 39 308 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Sinus node dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Sudden death SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Bacterial diarrhoea SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Bacterial sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Urinary tract infection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Radius fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Wrist fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Bilirubin conjugated increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Spinal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Metastases to peritoneum SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Cerebral arteriosclerosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Cerebral haematoma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Cerebral ischaemia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Dementia alzheimer's type SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Impulse-control disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Calculus bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Metrorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.0 View
Vaginal fistula SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.0 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Colostomy closure SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 19.0 View
Rehabilitation therapy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 19.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Peripheral artery thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Accidental overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View