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 @ 12:04 AM

Ignite Modification Date: 2025-12-25 @ 10:03 PM

NCT ID: NCT00650858

Description: None

Frequency Threshold: 0

Time Frame: None

Study: NCT00650858

Study Brief: Clinical Trial on Treatment of Intraventricular Hemorrhage

Event Groups(If Any):

Event Groups

Title	Description	Deaths # Affected	Deaths # At Risk	Serious # Affected	Serious # At Risk	Other # Affected	Other # At Risk	View

0.3 mg Rt-PA q12h	Stage 1 (Dose Finding)	None	None	3	8	7	8	View
1.0 mg Rt-PA q12h	Stage 1 (Dose Finding)	None	None	2	8	8	8	View
1.0 mg Rt-PA q8h	Stage 2 (Dose Optimization)	None	None	11	36	32	36	View

Serious Events(If Any):

Serious Events

Term	Type	Organ System	Vocab	View

Accidental Extubation	None	Respiratory, thoracic and mediastinal disorders	None	View
Cardiac Arrest	None	Cardiac disorders	None	View
Cerebral Infarction	None	Nervous system disorders	None	View
Hemorrhage new catheter tract >5 mm with mass effect, symptomatic	None	Nervous system disorders	None	View
Hydrocephalus, Communicating	None	Nervous system disorders	None	View
ICH Hemorrhage, new symptomatic	None	Nervous system disorders	None	View
IVH Hemorrhage enlargement - asymptomatic	None	Nervous system disorders	None	View
IVH Hemorrhage enlargement - symptomatic	None	Nervous system disorders	None	View
IVH hemorrhage, new symptomatic	None	Nervous system disorders	None	View
Myocardial Infarction	None	Cardiac disorders	None	View
Seizure	None	Nervous system disorders	None	View
Suspected cardiac or pulmonary embolism	None	Respiratory, thoracic and mediastinal disorders	None	View
Tracheal stricture	None	Respiratory, thoracic and mediastinal disorders	None	View
Ventilatory failure, mechanical	None	Respiratory, thoracic and mediastinal disorders	None	View
Ventriculitis, Bacterial	None	Nervous system disorders	None	View
Ventriculitis, non-bacterial	None	Nervous system disorders	None	View

Other Events(If Any):

Other Events

Term	Type	Organ System	Vocab	View

Acute Renal Failure	None	Renal and urinary disorders	None	View
Adult Respiratory Distress Syndrome	None	Respiratory, thoracic and mediastinal disorders	None	View
Anemia	None	Blood and lymphatic system disorders	None	View
Aspiration	None	Respiratory, thoracic and mediastinal disorders	None	View
Atelectasis	None	Respiratory, thoracic and mediastinal disorders	None	View
Atrial Fibrillation	None	Cardiac disorders	None	View
Bacteremia	None	Blood and lymphatic system disorders	None	View
Bradycardia	None	Cardiac disorders	None	View
Brain Edema / Swelling	None	Nervous system disorders	None	View
CSF Leak	None	Nervous system disorders	None	View
Cerebral Infarction	None	Nervous system disorders	None	View
Cerebral infarction, extension	None	Nervous system disorders	None	View
Congestive Heart Failure	None	Cardiac disorders	None	View
Decreased Level of counciousness	None	Nervous system disorders	None	View
Decubitus ulcer	None	Skin and subcutaneous tissue disorders	None	View
Diarrhea	None	Renal and urinary disorders	None	View
Edema (metabolic causes)	None	Metabolism and nutrition disorders	None	View
Encephalopathy	None	Nervous system disorders	None	View
Fever of unknown origin	None	General disorders	None	View
Headache	None	Nervous system disorders	None	View
Hemorrhage enl, cath tract >5mm w/o mass, asym	None	Nervous system disorders	None	View
Hemorrhage enlargement, catheter tract > 5 mm with mass effect, asymptomatic	None	Nervous system disorders	None	View
Hemorrhage, new catheter tract <= 5 mm, asymptomatic	None	Nervous system disorders	None	View
Hemorrhage, new catheter tract > 5 mm with mass effect, asymptomatic	None	Nervous system disorders	None	View
Hemorrhage, new catheter tract > 5 mm with mass effect, symptomatic	None	Nervous system disorders	None	View
Herniation, Brain	None	Nervous system disorders	None	View
Hydrocephalus, Obstructive	None	Nervous system disorders	None	View
Hydrocephalus, communicating	None	Nervous system disorders	None	View
Hyperglycemia	None	Blood and lymphatic system disorders	None	View
Hypertension	None	Cardiac disorders	None	View
Hypokalemia	None	Blood and lymphatic system disorders	None	View
Hyponatremia	None	Blood and lymphatic system disorders	None	View
Hypoxemia	None	Blood and lymphatic system disorders	None	View
ICH hemorrhage enlargement, asymptomatic	None	Nervous system disorders	None	View
ICH hemorrhage, new asymptomatic	None	Nervous system disorders	None	View
ICH hemorrhage, new symptomatic	None	Nervous system disorders	None	View
IVH hemorrhage enlargement - asymptomatic	None	Nervous system disorders	None	View
Increased Blood Urea Nitrogen	None	Blood and lymphatic system disorders	None	View
Increased midline shift	None	Nervous system disorders	None	View
Intracranial hypertension	None	Nervous system disorders	None	View
Peri-hemorrhagic ischemic change	None	Nervous system disorders	None	View
Pleural effusion	None	Respiratory, thoracic and mediastinal disorders	None	View
Pneumonia	None	Respiratory, thoracic and mediastinal disorders	None	View
Pneumonia, aspiration	None	Respiratory, thoracic and mediastinal disorders	None	View
Pulmonary edema	None	Respiratory, thoracic and mediastinal disorders	None	View
SAH Hemorrhage, new asymptomatic	None	Nervous system disorders	None	View
Siezure	None	Nervous system disorders	None	View
Sinus tachycardia	None	Cardiac disorders	None	View
Skin Exanthema	None	Infections and infestations	None	View
Tracheitis	None	Respiratory, thoracic and mediastinal disorders	None	View
Urinary tract infection	None	Renal and urinary disorders	None	View
Ventilatory failure	None	Respiratory, thoracic and mediastinal disorders	None	View
Ventriculitis, bacterial	None	Nervous system disorders	None	View
Ventriculitis, non-bacterial	None	Nervous system disorders	None	View