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 @ 2:28 AM
Ignite Modification Date:
2025-12-26 @ 1:02 AM
NCT ID:
NCT00784134
Description:
None
Frequency Threshold:
5
Time Frame:
180 days since symptom onset
Study:
NCT00784134
Study Brief:
Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses | None | None | 151 | 251 | 178 | 251 | View |
| Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | None | None | 114 | 249 | 165 | 249 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| Acute coronary syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Acute renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (12.0) | View |
| Adult respiratory distress syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Allergic reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (12.0) | View |
| Altered mental status | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (12.0) | View |
| Anoxic brain damage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Anoxic brain injury | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Aphasia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Atelectasis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Bacteremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| Brain and catheter related infection | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Brainstorming/autonomic dysfunction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Bronchial infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| COPD | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Cerebrospinal fluid leakage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Cerebrovascular death (brain death) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Chronic kidney disease | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (12.0) | View |
| Cognitive disturbance | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Congestive heart failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (12.0) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (12.0) | View |
| Duodenal hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| Edema cerebral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Enterocolitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Esophageal hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.0) | View |
| Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.0) | View |
| Gastric hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| Gastrointestinal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| Heart failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Hepatic failure | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (12.0) | View |
| Hepatorenal syndrome | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (12.0) | View |
| Hydrocephalus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Hydrocephalus, obstructive | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Hypernatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| Hypoglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.0) | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| INR increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.0) | View |
| Intercardiac clot | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Intracranial hemorrhage: Ventricular system, Enlargement | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Intracranial hemorrhage: Ventricular system, New | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Intracranial hypertension | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Intrahepatic cholestasis of unk etiology | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (12.0) | View |
| Ischemia cerebrovascular | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Laryngeal edema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Lower gastrointestinal hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| Meningitis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Multi-organ failure | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.0) | View |
| Muscle weakness left-sided | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Myocarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| PEG Tube complication | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (12.0) | View |
| Peritoneal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| Personality change | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (12.0) | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.0) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Pulmonary edema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Pulmonary hypertension | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Rash acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (12.0) | View |
| Renal calculi | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (12.0) | View |
| Renal insufficiency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (12.0) | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Reversible cerebral vasoconstriction vs vasculitis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| Sinus bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Stridor | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Sudden death NOS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.0) | View |
| Supraventricular tachydysrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Swollen tongue | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| Tachypnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Tracheal mucositis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Tracheitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| Tracheostomy site bleeding | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.0) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| VP shunt dysfunction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Vasospasm or DIND | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Ventricular fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Ventriculitis, bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| Ventriculitis, bacterial | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Ventriculitis, non-bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| Ventriculitis, non-bacterial | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| Wound infection, non-neurologic | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| Interstitial nephritis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (12.0) | View |
| Intracranial abcess | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Intracranial hemorrhage: Catheter Tract, Enlargement | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Intracranial hemorrhage: Catheter Tract, New | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Intracranial hemorrhage: Hematoma, subdural | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Intracranial hemorrhage: Subarachnoid Space, New | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Intracranial hemorrhage: Tissue, Enlargement | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Intracranial hemorrhage: Tissue, New | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Chest wall pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| Colonic perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| Death due to index bleeding event | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Death due to index bleeding event | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.0) | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.0) | View |
| Depressed level of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Diabetes mellitus, Type I | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| Diencephalic storming | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Extensor posturing | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Gastroparesis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| Herniation | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Hydrocephalus, communicating | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.0) | View |
| Asystole | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Cerebrovascular death (brain death) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.0) | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.0) | View |
| Takotsubo syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (12.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Bacteremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| Intracranial hemorrhage: Catheter Tract, New | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Intracranial hypertension | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.0) | View |
| Depressed level of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.0) | View |
| Hydrocephalus, communicating | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |