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 @ 5:40 PM
Ignite Modification Date: 2025-12-25 @ 3:10 PM
NCT ID: NCT00490568
Description: All subject (Full population) was used for analysis.
Frequency Threshold: 5
Time Frame: Up to 76 Weeks
Study: NCT00490568
Study Brief: Open-Label Extension Study Of Rosiglitazone XR As Adjunctive Therapy In Subjects With Mild-to-Moderate Alzheimers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
RSG XR Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer's disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR. 20 None 126 1461 130 1461 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Spinal compression fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Drug toxicity SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Lumbar vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Pacemaker complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Soft tissue injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Subdural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Traumatic fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Upper limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Wrist fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dementia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dementia Alzheimer's type SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Coma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Loss of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Nerve root compression SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Optic neuritis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Subarachnoid haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Thalamic infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Sinus arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchopneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory tract infection viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Brain cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Brain neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Colon cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Endometrial cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Lung neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Metastases to bone SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Ovarian cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Paget's disease of the breast SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Refractory anaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Aggression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Behavioural and psychiatric symptoms of dementia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Hallucination SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Panic disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Iron deficiency anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Large intestine perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Lumbar hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Peritonitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Foot deformity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Osteoporotic fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Synovial disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Bile duct stone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Circulatory collapse SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Peripheral arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Post thrombotic syndrome SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Blood sodium increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Nephrotic syndrome SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Benign prostatic hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Uterine prolapse SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Lung disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Colonic polyp SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA View