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 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:55 PM
NCT ID:
NCT00200356
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00200356
Study Brief:
Edaravone-Sodium Ozagrel Comparative Post-Marketing Study on Acute Ischemic Stroke
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Edaravone | Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening. | None | None | 27 | 194 | 102 | 194 | View |
| Ozagrel | Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening. | None | None | 28 | 198 | 107 | 198 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Thrombotic stroke | None | Nervous system disorders | MedDRA 9.1 | View |
| Transient ischemic attack | None | Nervous system disorders | MedDRA 9.1 | View |
| Upper limb fracture | None | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Urinary tract infection | None | Infections and infestations | MedDRA 9.1 | View |
| Vertigo | None | Ear and labyrinth disorders | MedDRA 9.1 | View |
| Vomiting | None | Gastrointestinal disorders | MedDRA 9.1 | View |
| Anastomotic ulcer haemorrhage | None | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Angina pectoris | None | Cardiac disorders | MedDRA 9.1 | View |
| Anti-neutrophil cytoplasmic antibody positive vasculitis | None | Immune system disorders | MedDRA 9.1 | View |
| Arrhythmia | None | Cardiac disorders | MedDRA 9.1 | View |
| Arteriosclerosis | None | Vascular disorders | MedDRA 9.1 | View |
| Asthma | None | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | View |
| Bladder cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | View |
| Brain herniation | None | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Cardiac failure | None | Cardiac disorders | MedDRA 9.1 | View |
| Carpal tunnel syndrome | None | Nervous system disorders | MedDRA 9.1 | View |
| Cerebral haemorrhage | None | Nervous system disorders | MedDRA 9.1 | View |
| Cerebral infarction | None | Nervous system disorders | MedDRA 9.1 | View |
| Constipation | None | Gastrointestinal disorders | MedDRA 9.1 | View |
| Depression | None | Psychiatric disorders | MedDRA 9.1 | View |
| Duodenal ulcer | None | Gastrointestinal disorders | MedDRA 9.1 | View |
| Duodenal ulcer haemorrhage | None | Gastrointestinal disorders | MedDRA 9.1 | View |
| Erysipelas | None | Infections and infestations | MedDRA 9.1 | View |
| Femoral neck fracture | None | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Femur fracture | None | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Haemorrhagic cerebral infarction | None | Nervous system disorders | MedDRA 9.1 | View |
| Hemiplegia | None | Nervous system disorders | MedDRA 9.1 | View |
| Ileus | None | Gastrointestinal disorders | MedDRA 9.1 | View |
| Inguinal hernia | None | Gastrointestinal disorders | MedDRA 9.1 | View |
| Liver disorder | None | Hepatobiliary disorders | MedDRA 9.1 | View |
| Loss of consciousness | None | Nervous system disorders | MedDRA 9.1 | View |
| Lymphoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | View |
| Pelvic fracture | None | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Pharyngitis | None | Infections and infestations | MedDRA 9.1 | View |
| Pneumonia | None | Infections and infestations | MedDRA 9.1 | View |
| Pneumonia aspiration | None | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | View |
| Psychotic disorder due to a general medical condition | None | Psychiatric disorders | MedDRA 9.1 | View |
| Pulmonary embolism | None | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | View |
| Renal failure acute | None | Renal and urinary disorders | MedDRA 9.1 | View |
| Sciatica | None | Nervous system disorders | MedDRA 9.1 | View |
| Shock haemorrhagic | None | Vascular disorders | MedDRA 9.1 | View |
| Spinal compression fracture | None | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Constipation | None | Gastrointestinal disorders | MedDRA 9.1 | View |
| Diarrhea | None | Gastrointestinal disorders | MedDRA 9.1 | View |
| Headache | None | Nervous system disorders | MedDRA 9.1 | View |
| Insomnia | None | Psychiatric disorders | MedDRA 9.1 | View |
| Nasopharyngitis | None | Infections and infestations | MedDRA 9.1 | View |
| Pruritus | None | Skin and subcutaneous tissue disorders | MedDRA 9.1 | View |
| Urinary tract infection | None | Infections and infestations | MedDRA 9.1 | View |
| Back pain | None | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | View |