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 @ 2:08 AM
Ignite Modification Date: 2025-12-26 @ 12:34 AM
NCT ID: NCT00577460
Description: None
Frequency Threshold: 5
Time Frame: 80 weeks
Study: NCT00577460
Study Brief: Long-term Safety Study of Open-label Pramipexole ER in Patients With Advanced PD
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PPX ER (Previous Placebo) Pramipexole ER Treatment with placebo in previous trial None None 14 129 87 129 View
PPX ER (Previous PPX ER) Pramipexole ER Treatment with Pramipexole ER in previous trial None None 11 123 74 123 View
PPX ER (Previous PPX IR) Pramipexole ER Treatment with Pramipexole IR in previous trial None None 14 139 81 139 View
Total PPX ER Pramipexole ER, all patients None None 39 391 242 391 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Rectal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Drug withdrawal syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Eyeball rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Facial bones fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Joint sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Muscle injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Radius fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Cerebellar haematoma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Hallucination SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Paramnesia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Pathological gambling SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Psychotic disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Aortic stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.0 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Muscle rigidity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Osteoporosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Spinal osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Bile duct cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
Rectal neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Cervicobrachial syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Dyskinesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Dystonia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Hypertensive encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
On and off phenomenon SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Parkinson's disease SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Cardiac neurosis SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Aortic valve stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Cardiovascular insufficiency SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Inguinal hernia strangulated SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Thoracic vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hallucination SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Muscle rigidity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Dyskinesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Dystonia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View