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: 2025-12-24 @ 4:57 PM

Ignite Modification Date: 2025-12-25 @ 2:39 PM

NCT ID: NCT01429350

Description: The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.

Frequency Threshold: 0

Time Frame: None

Study: NCT01429350

Study Brief: Assess the Penumbra System in the Treatment of Acute 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

IV rtPA	IV infusion of rtPA at 0.9mg/kg to a maximum of 90mg intravenous (IV) recombinant human tissue plasminogen activator (rtPA): 0.9mg/kg to a maximum of 90mg	None	None	32	62	58	62	View
IV rtPA and IA Penumbra System	Dual IV rtPA therapy (0.9mg/kg to a maximum of 90mg) and IA adjunctive treatment with the Penumbra System Penumbra System: The Penumbra System is an aspiration based mechanical thrombectomy device	None	None	20	43	42	43	View

Serious Events(If Any):

Serious Events

Term	Type	Organ System	Vocab	View

Acute myocardial infarction	None	Cardiac disorders	None	View
Arrhythmia	None	Cardiac disorders	None	View
Atrial fibrillation	None	Cardiac disorders	None	View
Cardiac arrest	None	Cardiac disorders	None	View
Cardiac failure congestive	None	Cardiac disorders	None	View
Cardiogenic shock	None	Cardiac disorders	None	View
Ventricular fibrillation	None	Gastrointestinal disorders	None	View
Dysphagia	None	Gastrointestinal disorders	None	View
Gastrointestinal haemorrhage	None	Gastrointestinal disorders	None	View
Haematochezia	None	Gastrointestinal disorders	None	View
Hematemesis	None	Gastrointestinal disorders	None	View
Chest pain	None	General disorders	None	View
Thrombosis in device	None	General disorders	None	View
Vessel puncture site haematoma	None	General disorders	None	View
Enterocolitis infectious	None	Infections and infestations	None	View
Pneumonia	None	Infections and infestations	None	View
Sepsis	None	Infections and infestations	None	View
Urinary tract infection	None	Infections and infestations	None	View
Gun shot wound	None	Injury, poisoning and procedural complications	None	View
Malnutrition	None	Metabolism and nutrition disorders	None	View
Aphasia	None	Nervous system disorders	None	View
Brain oedema	None	Nervous system disorders	None	View
Carotid artery occlusion	None	Nervous system disorders	None	View
Cerebral haemorrhage	None	Nervous system disorders	None	View
Cerebrovascular accident	None	Nervous system disorders	None	View
Haemorrhage intracranial	None	Nervous system disorders	None	View
Haemorrhagic transformation stroke	None	Nervous system disorders	None	View
Intraventricular haemorrhage	None	Nervous system disorders	None	View
Ischaemic stroke	None	Nervous system disorders	None	View
Partial seizures	None	Nervous system disorders	None	View
Subarachnoid haemorrhage	None	Nervous system disorders	None	View
Mental status changes	None	Psychiatric disorders	None	View
Haematuria	None	Renal and urinary disorders	None	View
Renal failure	None	Renal and urinary disorders	None	View
Renal failure acute	None	Renal and urinary disorders	None	View
Acute respiratory failure	None	Respiratory, thoracic and mediastinal disorders	None	View
Pneumonia aspiration	None	Respiratory, thoracic and mediastinal disorders	None	View
Pulmonary embolism	None	Respiratory, thoracic and mediastinal disorders	None	View
Respiratory failure	None	Respiratory, thoracic and mediastinal disorders	None	View
Deep vein thrombosis	None	Vascular disorders	None	View
Haemorrhage	None	Vascular disorders	None	View

Other Events(If Any):

Other Events

Term	Type	Organ System	Vocab	View

Constipation	None	Gastrointestinal disorders	None	View
Diarrhoea	None	Gastrointestinal disorders	None	View
Dysphagia	None	Gastrointestinal disorders	None	View
Gastritis	None	Gastrointestinal disorders	None	View
Gastrointestinal haemorrhage	None	Gastrointestinal disorders	None	View
Gastrooesophageal reflux disease	None	Gastrointestinal disorders	None	View
Gingival bleeding	None	Gastrointestinal disorders	None	View
Haematochezia	None	Gastrointestinal disorders	None	View
Hematesis	None	Gastrointestinal disorders	None	View
Mouth haemorrhage	None	Gastrointestinal disorders	None	View
Nausea	None	Gastrointestinal disorders	None	View
Peptic ulcer	None	General disorders	None	View
Vomiting	None	General disorders	None	View
Asthenia	None	General disorders	None	View
Chest pain	None	General disorders	None	View
Facial pain	None	General disorders	None	View
Fatigue	None	General disorders	None	View
Impaired healing	None	General disorders	None	View
Oedema	None	General disorders	None	View
Oedema peripheral	None	General disorders	None	View
Pain	None	General disorders	None	View
Pyrexia	None	General disorders	None	View
Thrombosis in device	None	General disorders	None	View
Unevaluable event	None	General disorders	None	View
Vessel puncture site haematoma	None	General disorders	None	View
Vessel puncture site haemorrhage	None	General disorders	None	View
Hypersensitivity	None	Immune system disorders	None	View
Bronchitis	None	Infections and infestations	None	View
Bronchopneumonia	None	Infections and infestations	None	View
Candidiasis	None	Infections and infestations	None	View
Cellulitis	None	Infections and infestations	None	View
Clostridal infection	None	Infections and infestations	None	View
Clostridium difficile colitis	None	Infections and infestations	None	View
Enterocolitis infectious	None	Infections and infestations	None	View
Eosophageal candiasis	None	Infections and infestations	None	View
Oral candiasis	None	Infections and infestations	None	View
Oral infection	None	Infections and infestations	None	View
Parotitis	None	Infections and infestations	None	View
Pneumonia	None	Infections and infestations	None	View
Sepsis	None	Infections and infestations	None	View
Sinusitis	None	Infections and infestations	None	View
Upper respiratory tract infection	None	Infections and infestations	None	View
Urinary tract infection	None	Infections and infestations	None	View
Contusion	None	Injury, poisoning and procedural complications	None	View
Fall	None	Injury, poisoning and procedural complications	None	View
Gun shot wound	None	Injury, poisoning and procedural complications	None	View
Haematuria traumatic	None	Injury, poisoning and procedural complications	None	View
Incision site complication	None	Injury, poisoning and procedural complications	None	View
Incision site haemorrhage	None	Injury, poisoning and procedural complications	None	View
Incision site hypoaesthesia	None	Injury, poisoning and procedural complications	None	View
Joint dislocation	None	Injury, poisoning and procedural complications	None	View
Laceration	None	Injury, poisoning and procedural complications	None	View
Procedural nausea	None	Injury, poisoning and procedural complications	None	View
Scrotal haematoma	None	Injury, poisoning and procedural complications	None	View
Subdural haemorrhage	None	Injury, poisoning and procedural complications	None	View
Tongue injury	None	Injury, poisoning and procedural complications	None	View
Transfusion reaction	None	Injury, poisoning and procedural complications	None	View
Wound	None	Injury, poisoning and procedural complications	None	View
Activated partial thromboplastin time prolonged	None	Investigations	None	View
Antithrombin III decreased	None	Investigations	None	View
Blood calcium decreased	None	Investigations	None	View
Blood magnesium decreased	None	Investigations	None	View
Body temperature increased	None	Investigations	None	View
Electrocardiogram QT prolonged	None	Investigations	None	View
Haemoglobin decreased	None	Investigations	None	View
Hepatic enzyme increased	None	Investigations	None	View
Troponin increased	None	Investigations	None	View
White blood cell count increased	None	Investigations	None	View
Dehydration	None	Metabolism and nutrition disorders	None	View
Diabetes mellitus	None	Metabolism and nutrition disorders	None	View
Dyslipidaemia	None	Metabolism and nutrition disorders	None	View
Electrolyte imbalance	None	Metabolism and nutrition disorders	None	View
Gout	None	Metabolism and nutrition disorders	None	View
Hyperchloraemia	None	Metabolism and nutrition disorders	None	View
Hypercholesterolaemia	None	Metabolism and nutrition disorders	None	View
Hyperglycaemia	None	Metabolism and nutrition disorders	None	View
Hyperkalaemia	None	Metabolism and nutrition disorders	None	View
Hyperlipidaemia	None	Metabolism and nutrition disorders	None	View
Hypernatraemia	None	Metabolism and nutrition disorders	None	View
Hypertriglyceridaemia	None	Metabolism and nutrition disorders	None	View
Hypervolaemia	None	Metabolism and nutrition disorders	None	View
Hypocalcaemia	None	Metabolism and nutrition disorders	None	View
Hypochloraemia	None	Metabolism and nutrition disorders	None	View
Hypoglycaemia	None	Metabolism and nutrition disorders	None	View
Hypokalaemia	None	Metabolism and nutrition disorders	None	View
Hypomagnesaemia	None	Metabolism and nutrition disorders	None	View
Hyponatraemia	None	Metabolism and nutrition disorders	None	View
Hypophosphataemia	None	Metabolism and nutrition disorders	None	View
Hypovolaemia	None	General disorders	None	View
Malnutrition	None	Metabolism and nutrition disorders	None	View
Metabolic acidosis	None	Metabolism and nutrition disorders	None	View
Vitamin B12 deficiency	None	Metabolism and nutrition disorders	None	View
Vitamin D deficiency	None	Metabolism and nutrition disorders	None	View
Arthralgia	None	Musculoskeletal and connective tissue disorders	None	View
Back pain	None	Musculoskeletal and connective tissue disorders	None	View
Muscle spasms	None	Musculoskeletal and connective tissue disorders	None	View
Muscular weakness	None	Musculoskeletal and connective tissue disorders	None	View
Musculoskeletal stiffness	None	Musculoskeletal and connective tissue disorders	None	View
Myalgia	None	Musculoskeletal and connective tissue disorders	None	View
Neck pain	None	Musculoskeletal and connective tissue disorders	None	View
Pain in extremity	None	Musculoskeletal and connective tissue disorders	None	View
Aphasia	None	Nervous system disorders	None	View
Basal ganglia haemorrhage	None	Nervous system disorders	None	View
Brain oedema	None	Nervous system disorders	None	View
Carotid artery dissection	None	Nervous system disorders	None	View
Carotid artery occlusion	None	Nervous system disorders	None	View
Cerebellar infarction	None	Nervous system disorders	None	View
Cerebral artery embolism	None	Nervous system disorders	None	View
Cerebral artery occlusion	None	Nervous system disorders	None	View
Cerebral artery stenosis	None	Nervous system disorders	None	View
Cerebral haemorrhage	None	Nervous system disorders	None	View
Cerebral infarction	None	Nervous system disorders	None	View
Cerebral thrombosis	None	Nervous system disorders	None	View
Cerebrovascular accident	None	Nervous system disorders	None	View
Cerebrovascular spasm	None	Nervous system disorders	None	View
Complex regional pain syndrome	None	Nervous system disorders	None	View
Convulsion	None	Nervous system disorders	None	View
Dementia Alzheimer's type	None	Nervous system disorders	None	View
Dizziness	None	Nervous system disorders	None	View
Haemorrhage intracranial	None	Nervous system disorders	None	View
Haemorrhagic cerebral infarction	None	Nervous system disorders	None	View
Haemorrhagic transformation stroke	None	Nervous system disorders	None	View
Headache	None	Nervous system disorders	None	View
Hydrocephalus	None	Nervous system disorders	None	View
Hypertonia	None	Nervous system disorders	None	View
Hypoaesthesia	None	Nervous system disorders	None	View
Intracranial pressure increased	None	Nervous system disorders	None	View
Intraventricular haemorrhage	None	Nervous system disorders	None	View
Ischaemic stroke	None	Nervous system disorders	None	View
Lethargy	None	Nervous system disorders	None	View
Loss of consciousness	None	Nervous system disorders	None	View
Memory impairment	None	Nervous system disorders	None	View
Neurological decompensation	None	Nervous system disorders	None	View
Neuropathy peripheral	None	Nervous system disorders	None	View
Partial seizures	None	Nervous system disorders	None	View
Somnolence	None	Nervous system disorders	None	View
Stroke in evolution	None	Nervous system disorders	None	View
Subarachnoid haemorrhage	None	Nervous system disorders	None	View
Syncope	None	Nervous system disorders	None	View
Agitation	None	Psychiatric disorders	None	View
Anxiety	None	Psychiatric disorders	None	View
Anxiety disorder	None	Psychiatric disorders	None	View
Confusional state	None	Psychiatric disorders	None	View
Delirium	None	Psychiatric disorders	None	View
Depression	None	Psychiatric disorders	None	View
Hallucination	None	Psychiatric disorders	None	View
Insomnia	None	Psychiatric disorders	None	View
Mental status changes	None	Psychiatric disorders	None	View
Restlessness	None	Psychiatric disorders	None	View
Sleep disorder	None	Psychiatric disorders	None	View
Calculus urinary	None	Psychiatric disorders	None	View
Cystitis noninfective	None	Renal and urinary disorders	None	View
Haematuria	None	Renal and urinary disorders	None	View
Incontinence	None	Renal and urinary disorders	None	View
Renal failure	None	Renal and urinary disorders	None	View
Renal failure acute	None	Renal and urinary disorders	None	View
Renal impairment	None	Renal and urinary disorders	None	View
Urinary retention	None	Reproductive system and breast disorders	None	View
Benign prostatic hyperplasia	None	Reproductive system and breast disorders	None	View
Acute pulmonary oedema	None	Respiratory, thoracic and mediastinal disorders	None	View
Acute respiratory failure	None	Respiratory, thoracic and mediastinal disorders	None	View
Atelectasis	None	Respiratory, thoracic and mediastinal disorders	None	View
Chronic obstructive pulmonary disease	None	Respiratory, thoracic and mediastinal disorders	None	View
Cough	None	Respiratory, thoracic and mediastinal disorders	None	View
Diaphragmatic hernia	None	Respiratory, thoracic and mediastinal disorders	None	View
Dyspnoea	None	Respiratory, thoracic and mediastinal disorders	None	View
Epistaxis	None	Respiratory, thoracic and mediastinal disorders	None	View
Hyperventilation	None	Respiratory, thoracic and mediastinal disorders	None	View
Hypoxia	None	Respiratory, thoracic and mediastinal disorders	None	View
Lung infiltration	None	Respiratory, thoracic and mediastinal disorders	None	View
Nasal congestion	None	Respiratory, thoracic and mediastinal disorders	None	View
Pleural effusion	None	Respiratory, thoracic and mediastinal disorders	None	View
Pneumonia aspiration	None	Respiratory, thoracic and mediastinal disorders	None	View
Pulmonary congestion	None	Respiratory, thoracic and mediastinal disorders	None	View
Pulmonary embolism	None	Respiratory, thoracic and mediastinal disorders	None	View
Pulmonary oedema	None	Respiratory, thoracic and mediastinal disorders	None	View
Respiratory failure	None	Respiratory, thoracic and mediastinal disorders	None	View
Wheezing	None	Respiratory, thoracic and mediastinal disorders	None	View
Blister	None	Skin and subcutaneous tissue disorders	None	View
Ecchymosis	None	Skin and subcutaneous tissue disorders	None	View
Rash	None	Skin and subcutaneous tissue disorders	None	View
Skin lesion	None	Skin and subcutaneous tissue disorders	None	View
Skin ulcer	None	Skin and subcutaneous tissue disorders	None	View
Accelerated hypertension	None	Vascular disorders	None	View
Deep vein thrombosis	None	Vascular disorders	None	View
Haematoma	None	Vascular disorders	None	View
Haemorrhage	None	Vascular disorders	None	View
Hypertension	None	Vascular disorders	None	View
Hypotension	None	Vascular disorders	None	View
Orthostatic hypotension	None	Vascular disorders	None	View
Peripheral arterial occlusive disease	None	Vascular disorders	None	View
Thrombophlebitis	None	Vascular disorders	None	View
Thrombophlebitis superficial	None	Vascular disorders	None	View
Thrombosis	None	Vascular disorders	None	View
Vascular calcification	None	Vascular disorders	None	View
Vasospasm	None	Vascular disorders	None	View
Bradycardia	None	Cardiac disorders	None	View
Cardiac arrest	None	Cardiac disorders	None	View
Cardiac failure congestive	None	Cardiac disorders	None	View
Cardiogenic shock	None	Cardiac disorders	None	View
Cardiomegaly	None	Cardiac disorders	None	View
Diastolic dysfunction	None	Cardiac disorders	None	View
Extrasystoles	None	Cardiac disorders	None	View
Heart valve incompetence	None	Cardiac disorders	None	View
Left valve incomptence	None	Cardiac disorders	None	View
Left atrial dilatation	None	Cardiac disorders	None	View
Mitral valve calcification	None	Cardiac disorders	None	View
Palpitations	None	Cardiac disorders	None	View
Sinus tachycardia	None	Cardiac disorders	None	View
Supraventricular tachycardia	None	Cardiac disorders	None	View
Tachycardia	None	Cardiac disorders	None	View
Ventricular extrasystoles	None	Cardiac disorders	None	View
Ventricular fibrillation	None	Cardiac disorders	None	View
Ventricular hypokinesia	None	Cardiac disorders	None	View
Ventricular tachycardia	None	Cardiac disorders	None	View
Atrial septal defect	None	Congenital, familial and genetic disorders	None	View
Congenital cystic kidney disease	None	Congenital, familial and genetic disorders	None	View
Ear pain	None	Ear and labyrinth disorders	None	View
Conjunctivitis	None	Eye disorders	None	View
Dry Eye	None	Eye disorders	None	View
Eye pain	None	Eye disorders	None	View
Abdominal distension	None	Gastrointestinal disorders	None	View
Abdominal pain	None	Gastrointestinal disorders	None	View
Anaemia	None	Blood and lymphatic system disorders	None	View
Anaemia macrocytic	None	Blood and lymphatic system disorders	None	View
Leukocytosis	None	Blood and lymphatic system disorders	None	View
Leukopenia	None	Blood and lymphatic system disorders	None	View
Thrombocytopenia	None	Blood and lymphatic system disorders	None	View
Thrombocytosis	None	Blood and lymphatic system disorders	None	View
Acute Myocardial Infarction	None	Cardiac disorders	None	View
Aortic valve sclerosis	None	Cardiac disorders	None	View
Arrhythmia	None	Cardiac disorders	None	View
Atrial Fibrillation	None	Cardiac disorders	None	View
Atrial flutter	None	Cardiac disorders	None	View
Atrial thrombosis	None	Cardiac disorders	None	View
Atrioventricular block first degree	None	Cardiac disorders	None	View