Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 8:03 PM
Ignite Modification Date: 2025-12-25 @ 5:36 PM
NCT ID: NCT00256204
Description: Each Delayed Start arm was preceded by 36 weeks placebo followed by 36 weeks Rasagiline either 1mg or 2mg; therefore, the placebo groups were combined into one group for the placebo analysis.
Frequency Threshold: 5
Time Frame: 2 years, 6 months
Study: NCT00256204
Study Brief: A Randomized Placebo Controlled Study to Show That Rasagiline May Slow Disease Progression for Parkinson'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
Placebo Combined Group 1mg \& 2mg combined placebo group includes those patients in 1mg Delayed start and the 2mg Delayed start arms who received placebo for the first 36 weeks. None None 22 593 82 593 View
1mg Active Treatment 1mg Active \& 1mg Delayed. This group includes those patients who received 1mg Rasagiline in both the early start active treatment arm (72 weeks active)and those patients who transitioned to active treatment in the 1mg Delayed start treatment arm (36 weeks active treatment) None None 37 288 40 288 View
2mg Active Treatment 2mg Active \& 2mg Delayed. This group includes those patients who received 2mg Rasagiline in both the early start active treatment arm (72 weeks active)and those patients who transitioned to active treatment in the 2mg Delayed start treatment arm (36 weeks active treatment) None None 44 293 34 293 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Coronary Artery Disease None Cardiac disorders None View
Cardiac failure None Cardiac disorders None View
Angina Pectoris None Cardiac disorders None View
Myocardial Infarction None Cardiac disorders None View
Atrial Fibrilation None Cardiac disorders None View
Atrial Flutter None Cardiac disorders None View
Vitreous Haemorrhage None Eye disorders None View
Eyelid Ptosis None Eye disorders None View
Abdominal Pain None Gastrointestinal disorders None View
Abdominal Pain Lower None Gastrointestinal disorders None View
Parasthesia Oral None Gastrointestinal disorders None View
Pyrexia None General disorders None View
Chest Discomfort None General disorders None View
Chest pain None General disorders None View
Non-Cardiac Chest Pain None General disorders None View
Drug Hypersensitivity None Immune system disorders None View
Appendicitis None Infections and infestations None View
Cellulitis None Infections and infestations None View
Labyrinthitis None Infections and infestations None View
Bronchitis None Infections and infestations None View
Pneumonia None Infections and infestations None View
Urosepsis None Infections and infestations None View
Laryngitis None Infections and infestations None View
Femur Fracture None Injury, poisoning and procedural complications None View
Hip Fracture None Injury, poisoning and procedural complications None View
Fall None Injury, poisoning and procedural complications None View
Hypokalaemia None Metabolism and nutrition disorders None View
Hyponatraemia None Metabolism and nutrition disorders None View
Dehydration None Metabolism and nutrition disorders None View
Myalgia None Musculoskeletal and connective tissue disorders None View
Muscle Hemorrhage None Musculoskeletal and connective tissue disorders None View
Osteoarthritis None Musculoskeletal and connective tissue disorders None View
Diffuse Large B-Cell Lymphoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Thyroid Neoplasm None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Endometrial Cancer Stage I None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Lung Adenocarcinoma Metastic None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Benign Laryngeal Neoplasm None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Rectal cancer Metastic None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Cerebral Haemorrhage None Nervous system disorders None View
Subarachnoid Haemorrhage None Nervous system disorders None View
Lacunar Infarction None Nervous system disorders None View
Syncope None Nervous system disorders None View
Akinesia None Nervous system disorders None View
Headache None Nervous system disorders None View
Hydrocephalus None Nervous system disorders None View
Parkinson's Disease None Nervous system disorders None View
Major Depression None Psychiatric disorders None View
Alcohol Abuse None Psychiatric disorders None View
Renal Colic None Renal and urinary disorders None View
Dyspnoea None Respiratory, thoracic and mediastinal disorders None View
Laryngeal Leukoplakia None Reproductive system and breast disorders None View
Atelectasis None Reproductive system and breast disorders None View
Hypoaesthesia Facial None Skin and subcutaneous tissue disorders None View
Coronary Artery Bypass None Surgical and medical procedures None View
Cardioversion None Surgical and medical procedures None View
Open reduction of fracture None Surgical and medical procedures None View
Incisional Hernia Repair None Surgical and medical procedures None View
Inguinal Hernia Repair None Surgical and medical procedures None View
Knee Operation None Surgical and medical procedures None View
Colon Polypectomy None Surgical and medical procedures None View
Hysterectomy None Surgical and medical procedures None View
Hypotension None Vascular disorders None View
Cardiac Failure Congestive None Cardiac disorders None View
Myocardial Ischaemia None Cardiac disorders None View
Tachycardia None Cardiac disorders None View
Vertigo None Ear and labyrinth disorders None View
Cataract None Eye disorders None View
Retinal Vein Occlusion None Eye disorders None View
Duodenal Ulcer Haemorrhage None Gastrointestinal disorders None View
Gastritis None Gastrointestinal disorders None View
Heus None Gastrointestinal disorders None View
Inguinal Hernia None Gastrointestinal disorders None View
Gastrointestinal Haemorrhage None Gastrointestinal disorders None View
Malaise None General disorders None View
Diverticulitis None Infections and infestations None View
Rectal Abscess None Infections and infestations None View
Peridiverticular Abscess None Infections and infestations None View
Lower respiratory Tract Infection None Infections and infestations None View
Erysipelas None Infections and infestations None View
Femoral Neck Fracture None Injury, poisoning and procedural complications None View
Arteriogram Coronary Abnormal None Investigations None View
Back Pain None Musculoskeletal and connective tissue disorders None View
Breast cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Colon Cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Squamous Cell Carcinoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Ovarian Epithelial Cancer Metastatic None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Prostrate Cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Renal cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Basal Cell Carcinoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Carotid Artery Stenosis None Nervous system disorders None View
Loss of Consciousness None Nervous system disorders None View
Sciatica None Nervous system disorders None View
Aphasia None Nervous system disorders None View
Transient Ischaemic Attack None Nervous system disorders None View
Neurosis None Psychiatric disorders None View
Hallucination, Visual None Psychiatric disorders None View
Suicidal Ideation None Psychiatric disorders None View
Nephrolithiasis None Renal and urinary disorders None View
Colpocele None Reproductive system and breast disorders None View
Pulmonary Embolism None Respiratory, thoracic and mediastinal disorders None View
Pulmonary Infarction None Respiratory, thoracic and mediastinal disorders None View
Rash None Skin and subcutaneous tissue disorders None View
Abdominal Operation None Surgical and medical procedures None View
Arterial Stent Insertion None Surgical and medical procedures None View
Coronary Angioplasty None Surgical and medical procedures None View
Bone operation None Surgical and medical procedures None View
Hip Arthroplasty None Surgical and medical procedures None View
Hip Surgery None Surgical and medical procedures None View
Knee Arthroplasty None Surgical and medical procedures None View
Cataract Operation None Surgical and medical procedures None View
Transurethral Prostatectomy None Surgical and medical procedures None View
Aortic Aneurysm None Vascular disorders None View
Aortic Aneurysm Rupture None Vascular disorders None View
Deep Vein Thrombosis None Vascular disorders None View
Thrombophlebitis None Vascular disorders None View
Hypertension None Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue None General disorders None View
Back Pain None Musculoskeletal and connective tissue disorders None View
Headache None Nervous system disorders None View