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 @ 7:16 PM
Ignite Modification Date:
2025-12-25 @ 4:54 PM
NCT ID:
NCT00894803
Description:
Adverse events were documented as recorded in the medical record until discharge. The occurrence of adverse events from the time of hospital discharge to the 90 day visit was collected at the time of the 90 day visit.
Frequency Threshold:
0
Time Frame:
Up to 90 days from initiation of therapy
Study:
NCT00894803
Study Brief:
Study of the Combination Therapy of Rt-PA and Eptifibatide to Treat Acute Ischemic Stroke
Event Groups(If Any):
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemias nonhaemolytic and marrow depression | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedRA, version 16.0 | View |
| Pulmonary vascular disorders | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedRA, version 16.0 | View |
| Arteriosclerosis, stenosis, vascular insufficiency and necrosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedRA, version 16.0 | View |
| Cardiac therapeutic procedures | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedRA, version 16.0 | View |
| Central nervous system vascular disorders | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedRA, version 16.0 | View |
| Communication disorders and disturbances | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedRA, version 16.0 | View |
| Coronary artery disorders | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedRA, version 16.0 | View |
| Deliria (incl confusion) | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedRA, version 16.0 | View |
| Embolism and thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedRA, version 16.0 | View |
| Gallbladder disorders | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedRA, version 16.0 | View |
| Gastrointestinal haemorrhages NEC | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedRA, version 16.0 | View |
| Gastrointestinal inflammatory conditions | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedRA, version 16.0 | View |
| Gastrointestinal signs and symptoms | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedRA, version 16.0 | View |
| General system disorders NEC | SYSTEMATIC_ASSESSMENT | General disorders | MedRA, version 16.0 | View |
| Genitourinary tract disorders NEC | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedRA, version 16.0 | View |
| Heart failures | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedRA, version 16.0 | View |
| Increased intracranial pressure and hydrocephalus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedRA, version 16.0 | View |
| Infections - pathogen unspecified | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA, version 16.0 | View |
| Injuries NEC | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedRA, version 16.0 | View |
| Muscle disorders | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedRA, version 16.0 | View |
| Neurological disorders NEC | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedRA, version 16.0 | View |
| Neuromuscular disorders | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedRA, version 16.0 | View |
| Renal disorders (excl nephropathies) | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedRA, version 16.0 | View |
| Respiratory disorders NEC | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedRA, version 16.0 | View |
| Respiratory tract infections | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedRA, version 16.0 | View |
| Seizures (incl subtypes) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedRA, version 16.0 | View |
| Vascular haemorrhagic disorders | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedRA, version 16.0 | View |
| Vascular therapeutic procedures | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedRA, version 16.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Administration site reactions | SYSTEMATIC_ASSESSMENT | General disorders | MedRA, version 16.0 | View |
| Administration site reactions | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedRA, version 16.0 | View |
| Allergic conditions | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedRA, version 16.0 | View |
| Anaemias nonhaemolytic and marrow depression | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedRA, version 16.0 | View |
| Angioedema and urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedRA, version 16.0 | View |
| Anxiety disorders and symptoms | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedRA, version 16.0 | View |
| Arteriosclerosis, stenosis, vascular insufficiency and necrosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedRA, version 16.0 | View |
| Bacterial infectious disorders | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA, version 16.0 | View |
| Body temperature conditions | SYSTEMATIC_ASSESSMENT | General disorders | MedRA, version 16.0 | View |
| Bone, calcium, magnesium and phosphorus metabolism disorders | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedRA, version 16.0 | View |
| Bronchial disorders (excl neoplasms) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedRA, version 16.0 | View |
| Cardiac arrhythmias | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedRA, version 16.0 | View |
| Cardiac disorder signs and symptoms | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedRA, version 16.0 | View |
| Central nervous system vascular disorders | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedRA, version 16.0 | View |
| Changes in physical activity | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedRA, version 16.0 | View |
| Cognitive and attention disorders and disturbances | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedRA, version 16.0 | View |
| Coronary artery disorders | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedRA, version 16.0 | View |
| Decreased and nonspecific blood pressure disorders and shock | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedRA, version 16.0 | View |
| Dental and gingival conditions | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedRA, version 16.0 | View |
| Depressed mood disorders and disturbances | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedRA, version 16.0 | View |
| Device issues | SYSTEMATIC_ASSESSMENT | General disorders | MedRA, version 16.0 | View |
| Electrolyte and fluid balance conditions | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedRA, version 16.0 | View |
| Enzyme investigations NEC | SYSTEMATIC_ASSESSMENT | Investigations | MedRA, version 16.0 | View |
| Epidermal and dermal conditions | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedRA, version 16.0 | View |
| Eye disorders NEC | SYSTEMATIC_ASSESSMENT | Eye disorders | MedRA, version 16.0 | View |
| Fungal infectious disorders | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA, version 16.0 | View |
| Gastrointestinal motility and defaecation conditions | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedRA, version 16.0 | View |
| Gastrointestinal signs and symptoms | SYSTEMATIC_ASSESSMENT | General disorders | MedRA, version 16.0 | View |
| General system disorders NEC | SYSTEMATIC_ASSESSMENT | General disorders | MedRA, version 16.0 | View |
| Genitourinary tract disorders NEC | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedRA, version 16.0 | View |
| Glucose metabolism disorders (incl diabetes mellitus) | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedRA, version 16.0 | View |
| Glucose metabolism disorders (incl diabetes mellitus) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedRA, version 16.0 | View |
| Haematology investigations (incl blood groups) | SYSTEMATIC_ASSESSMENT | Investigations | MedRA, version 16.0 | View |
| Headaches | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedRA, version 16.0 | View |
| Heart failures | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedRA, version 16.0 | View |
| Increased intracranial pressure and hydrocephalus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedRA, version 16.0 | View |
| Infections - pathogen unspecified | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA, version 16.0 | View |
| Injuries NEC | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedRA, version 16.0 | View |
| Joint disorders | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedRA, version 16.0 | View |
| Lower respiratory tract disorders (excl obstruction and infection) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedRA, version 16.0 | View |
| Muscle disorders | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedRA, version 16.0 | View |
| Musculoskeletal and connective tissue disorders NEC | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedRA, version 16.0 | View |
| Neurological disorders NEC | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedRA, version 16.0 | View |
| Neuromuscular disorders | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedRA, version 16.0 | View |
| Penile and scrotal disorders (excl infections and inflammations) | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedRA, version 16.0 | View |
| Physical examination and organ system status topics | SYSTEMATIC_ASSESSMENT | Investigations | MedRA, version 16.0 | View |
| Pleural disorders | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedRA, version 16.0 | View |
| Procedural related injuries and complications NEC | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedRA, version 16.0 | View |
| Renal disorders (excl nephropathies) | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedRA, version 16.0 | View |
| Respiratory disorders NEC | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedRA, version 16.0 | View |
| Respiratory tract infections | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedRA, version 16.0 | View |
| Seizures (incl subtypes) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedRA, version 16.0 | View |
| Sleep disorders and disturbances | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedRA, version 16.0 | View |
| Sleep disturbances (incl subtypes) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedRA, version 16.0 | View |
| Tongue conditions | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedRA, version 16.0 | View |
| Upper respiratory tract disorders (excl infections) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedRA, version 16.0 | View |
| Urinary tract signs and symptoms | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedRA, version 16.0 | View |
| Urolithiases | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedRA, version 16.0 | View |
| Vascular haemorrhagic disorders | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedRA, version 16.0 | View |
| Water, electrolyte and mineral investigations | SYSTEMATIC_ASSESSMENT | Investigations | MedRA, version 16.0 | View |
| White blood cell disorders | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedRA, version 16.0 | View |
| Embolism and thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedRA, version 16.0 | View |