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 @ 2:05 PM

Ignite Modification Date: 2025-12-25 @ 12:48 PM

NCT ID: NCT00235495

Description: None

Frequency Threshold: 0

Time Frame: None

Study: NCT00235495

Study Brief: Albumin in Acute Ischemic Stroke Trial

Event Groups(If Any):

Event Groups

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

Albumin	Treatment with 25% Albumin, 2.0 g/kg	None	None	212	422	352	422	View
Saline	Treatment with same volume of normal saline	None	None	178	419	341	419	View

Serious Events(If Any):

Serious Events

Term	Type	Organ System	Vocab	View

FEVER	None	General disorders	None	View
BACTEREMIA	None	Infections and infestations	None	View
SEPTICEMIA OR SEPTIC SHOCK	None	Infections and infestations	None	View
OROLINGUAL ANGIOEDEMA	None	Immune system disorders	None	View
ARTHRITIS	None	Musculoskeletal and connective tissue disorders	None	View
LOCALIZED PAIN	None	General disorders	None	View
SYSTEMIC HEMORRHAGE	None	Blood and lymphatic system disorders	None	View
FAILURE TO THRIVE	None	General disorders	None	View
OTHER SYSTEMIC ADVERSE EVENT OR COMPLICATION	None	General disorders	None	View
PNEUMONIA	None	Infections and infestations	None	View
ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) OR RESPIRATORY FAILURE	None	Respiratory, thoracic and mediastinal disorders	None	View
PULMONARY EMBOLISM	None	Vascular disorders	None	View
APNEA OR RESPIRATORY ARREST	None	Respiratory, thoracic and mediastinal disorders	None	View
RESPIRATORY INSUFFICIENCY	None	Respiratory, thoracic and mediastinal disorders	None	View
PLEURAL EFFUSION	None	Respiratory, thoracic and mediastinal disorders	None	View
SHORTNESS OF BREATH	None	Respiratory, thoracic and mediastinal disorders	None	View
OTHER RESPIRATORY DISORDER OR COMPLICATION	None	Respiratory, thoracic and mediastinal disorders	None	View
ANGINA PECTORIS (STABLE)	None	Cardiac disorders	None	View
ACUTE CORONARY SYNDROME - MYOCARDIAL INFARCTION	None	Cardiac disorders	None	View
CARDIAC ARREST	None	Cardiac disorders	None	View
CARDIOGENIC SHOCK	None	Cardiac disorders	None	View
"CONGESTIVE HEART FAILURE, PULMONARY EDEMA"	None	Cardiac disorders	None	View
PERIPHERAL ARTERIAL OCCLUSION	None	Cardiac disorders	None	View
VENTRICULAR FIBRILLATION OR TACHYCARDIA	None	Cardiac disorders	None	View
ATRIAL FIBRILLATION/FLUTTER	None	Cardiac disorders	None	View
BRADYCARDIA	None	Cardiac disorders	None	View
"CONDUCTION BLOCKS (ATRIO-VENTRICULAR BLOCKS, BUNDLE-BRANCH BLOCKS)"	None	Cardiac disorders	None	View
SUPRAVENTRICULAR ARRHYTHMIAS	None	Cardiac disorders	None	View
DEEP VENOUS THROMBOSIS	None	Cardiac disorders	None	View
ARTERIAL DISSECTION	None	Cardiac disorders	None	View
ARTERIAL EMBOLUS	None	Cardiac disorders	None	View
HYPERTENSION-NOT INTENDED	None	Vascular disorders	None	View
HYPOTENSION-NOT INTENDED	None	Vascular disorders	None	View
ACUTE CORONARY SYNDROME - UNSTABLE ANGINA	None	Cardiac disorders	None	View
CHEST PAIN (INCLUDING ATYPICAL) WITHOUT MENTION OF CARDIAC ORIGEN	None	Cardiac disorders	None	View
TROPONIN LEAK	None	Cardiac disorders	None	View
VALVULAR HEART DISEASE	None	Cardiac disorders	None	View
PRE-CEREBRAL OR CEREBRAL VASCULAR DISEASE (INCLUDING STENOSIS OR OCCLUSION)	None	Vascular disorders	None	View
OTHER CARDIAC ARRHYTHMIAS	None	Cardiac disorders	None	View
OTHER CARDIOVASCULAR DISORDER OR COMPLICATION	None	Cardiac disorders	None	View
ABDOMINAL PAIN	None	Gastrointestinal disorders	None	View
GASTRIC OR DUODENAL ULCER	None	Gastrointestinal disorders	None	View
NAUSEA/VOMITING	None	Gastrointestinal disorders	None	View
GASTROINTESTINAL TRACT BLEEDING	None	Gastrointestinal disorders	None	View
DYSPHAGIA	None	Gastrointestinal disorders	None	View
PARALYTIC ILEUS/ BOWEL PSEUDO-OSTRUCTION	None	Gastrointestinal disorders	None	View
BOWEL OSBTRUCTION	None	Gastrointestinal disorders	None	View
OTHER DIGESTIVE DISORDER OR COMPLICATION	None	Gastrointestinal disorders	None	View
HYPOGLYCEMIA	None	Metabolism and nutrition disorders	None	View
HYPERGLYCEMIA	None	Metabolism and nutrition disorders	None	View
HYPONATREMIA	None	Metabolism and nutrition disorders	None	View
HYPOCALCEMIA	None	Metabolism and nutrition disorders	None	View
DEHYDRATION	None	Metabolism and nutrition disorders	None	View
OTHER ENDOCRINE OR METABOLIC DISORDER OR COMPLICATION	None	Metabolism and nutrition disorders	None	View
NON-CEREBRAL HEMORRHAGE	None	Blood and lymphatic system disorders	None	View
COAGULOPATHY	None	Blood and lymphatic system disorders	None	View
ANEMIA	None	Blood and lymphatic system disorders	None	View
THROMBOCYTOPENIA	None	Blood and lymphatic system disorders	None	View
THROMBOTIC THROMBOCYTOPENIC PURPURA	None	Blood and lymphatic system disorders	None	View
RECURRENT STROKE NOT SPECIFIED AS HEMORRHAGE OR INFARCTION	None	Nervous system disorders	None	View
DEPRESSION OF CONSCIOUSNESS	None	Nervous system disorders	None	View
BRAIN ABSCESS OR ENCEPHALITIS	None	Nervous system disorders	None	View
MENINGITIS OR VENTRICULITIS	None	Nervous system disorders	None	View
SYMPTOMATIC INTRACRANIAL HEMORRHAGE	None	Blood and lymphatic system disorders	None	View
ASYMPTOMATIC INTRACRANIAL HEMORRHAGE	None	Blood and lymphatic system disorders	None	View
TRANSIENT ISCHEMIC ATTACK	None	Nervous system disorders	None	View
CEREBRAL INFARCTION	None	Nervous system disorders	None	View
CEREBRAL EDEMA	None	Nervous system disorders	None	View
SEIZURE	None	Nervous system disorders	None	View
CONFUSION/ENCEPHALOPATHY/DELIRIUM	None	Nervous system disorders	None	View
ANXIETY	None	Nervous system disorders	None	View
HEADACHE	None	Nervous system disorders	None	View
INCREASED INTRA-CRANIAL PRESSURE	None	Nervous system disorders	None	View
PROGRESSION OF STROKE	None	Nervous system disorders	None	View
SYNCOPE OR PRE-SYNCOPE	None	Vascular disorders	None	View
OTHER NEUROLOGICAL DISORDER OR COMPLICATION	None	Nervous system disorders	None	View
URINARY TRACT INFECTION	None	Infections and infestations	None	View
HEMATURIA	None	Renal and urinary disorders	None	View
RENAL INSUFFICIENCY	None	Renal and urinary disorders	None	View
RENAL FAILURE	None	Renal and urinary disorders	None	View
URINARY RETENTION	None	Renal and urinary disorders	None	View
OTHER UROGENITAL DISORDER OR COMPLICATION	None	Renal and urinary disorders	None	View
FRACTURE	None	Musculoskeletal and connective tissue disorders	None	View
SURGICAL SITE INFECTION	None	Infections and infestations	None	View
SURGICAL WOUND HEMATOMA	None	Injury, poisoning and procedural complications	None	View
OTHER NON-INFECTIOUS SURGICAL WOUND COMPLICATION	None	Injury, poisoning and procedural complications	None	View
DECUBITUS ULCERS/PRESSURE SORES	None	Skin and subcutaneous tissue disorders	None	View
MALIGNANT NEOPLASM (EXCEPT SKIN)	None	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
PSYCHIATRIC DEPRESSION	None	Psychiatric disorders	None	View
FALL	None	Injury, poisoning and procedural complications	None	View
"HEMATOMA, NOT OTHERWISE SPECIFIED"	None	Vascular disorders	None	View
PSYCHIATRIC DISORDER	None	Psychiatric disorders	None	View
CELLULITIS/NON-SURGICAL SKIN INFECTION	None	Infections and infestations	None	View
OTHER UNCLASSIFIED ADVERSE EVENT	None	General disorders	None	View

Other Events(If Any):

Other Events

Term	Type	Organ System	Vocab	View

FEVER	None	General disorders	None	View
BACTEREMIA	None	Infections and infestations	None	View
ALLERGIC REACTION TO STUDY DRUG	None	Immune system disorders	None	View
ARTHRITIS	None	Musculoskeletal and connective tissue disorders	None	View
LOCALIZED PAIN	None	General disorders	None	View
GENERALIZED PAIN	None	General disorders	None	View
CRAMPING	None	Reproductive system and breast disorders	None	View
SYSTEMIC HEMORRHAGE	None	Blood and lymphatic system disorders	None	View
FATIGUE	None	General disorders	None	View
DIZZINESS	None	Nervous system disorders	None	View
OTHER SYSTEMIC ADVERSE EVENT OR COMPLICATION	None	General disorders	None	View
PNEUMONIA	None	Infections and infestations	None	View
ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) OR RESPIRATORY FAILURE	None	Respiratory, thoracic and mediastinal disorders	None	View
PULMONARY EMBOLISM	None	Vascular disorders	None	View
BRONCHOSPASM	None	Respiratory, thoracic and mediastinal disorders	None	View
HYPOXEMIA	None	Respiratory, thoracic and mediastinal disorders	None	View
HYPERCARBIA	None	Respiratory, thoracic and mediastinal disorders	None	View
CRACKLES/RALES	None	Respiratory, thoracic and mediastinal disorders	None	View
APNEA OR RESPIRATORY ARREST	None	Respiratory, thoracic and mediastinal disorders	None	View
TACHYPNEA	None	Respiratory, thoracic and mediastinal disorders	None	View
RESPIRATORY INSUFFICIENCY	None	Respiratory, thoracic and mediastinal disorders	None	View
PLEURAL EFFUSION	None	Respiratory, thoracic and mediastinal disorders	None	View
SHORTNESS OF BREATH	None	Respiratory, thoracic and mediastinal disorders	None	View
UPPER REPIRATORY INFECTION	None	Infections and infestations	None	View
COUGH	None	Respiratory, thoracic and mediastinal disorders	None	View
BRONCHITIS	None	Infections and infestations	None	View
OTHER RESPIRATORY DISORDER OR COMPLICATION	None	Respiratory, thoracic and mediastinal disorders	None	View
ANGINA PECTORIS (STABLE)	None	Cardiac disorders	None	View
ACUTE CORONARY SYNDROME - MYOCARDIAL INFARCTION	None	Cardiac disorders	None	View
"CONGESTIVE HEART FAILURE, PULMONARY EDEMA"	None	Cardiac disorders	None	View
VENTRICULAR FIBRILLATION OR TACHYCARDIA	None	Cardiac disorders	None	View
ATRIAL FIBRILLATION/FLUTTER	None	Cardiac disorders	None	View
BRADYCARDIA	None	Cardiac disorders	None	View
TACHYCARDIA	None	Cardiac disorders	None	View
"CONDUCTION BLOCKS (ATRIO-VENTRICULAR BLOCKS, BUNDLE-BRANCH BLOCKS)"	None	Cardiac disorders	None	View
SUPRAVENTRICULAR ARRHYTHMIAS	None	Cardiac disorders	None	View
DEEP VENOUS THROMBOSIS	None	Vascular disorders	None	View
SUPERFICIAL VENOUS THROMBOSIS	None	Vascular disorders	None	View
ARTERIAL DISSECTION	None	Injury, poisoning and procedural complications	None	View
ARTERIAL THROMBOSIS	None	Vascular disorders	None	View
HYPERTENSION-NOT INTENDED	None	Vascular disorders	None	View
HYPOTENSION-NOT INTENDED	None	Vascular disorders	None	View
CHEST PAIN (INCLUDING ATYPICAL) WITHOUT MENTION OF CARDIAC ORIGEN	None	Cardiac disorders	None	View
TROPONIN LEAK	None	Cardiac disorders	None	View
VALVULAR HEART DISEASE	None	Cardiac disorders	None	View
EKG ABNORMALITIES	None	Investigations	None	View
PHLEBITIS	None	Infections and infestations	None	View
PRE-CEREBRAL OR CEREBRAL VASCULAR DISEASE (INCLUDING STENOSIS OR OCCLUSION)	None	Vascular disorders	None	View
FLUID OVERLOAD ALONE	None	Metabolism and nutrition disorders	None	View
OTHER CARDIAC ARRHYTHMIAS	None	Cardiac disorders	None	View
OTHER CARDIOVASCULAR DISORDER OR COMPLICATION	None	Cardiac disorders	None	View
ABDOMINAL PAIN	None	Gastrointestinal disorders	None	View
GASTRIC OR DUODENAL ULCER	None	Gastrointestinal disorders	None	View
NAUSEA/VOMITING	None	Gastrointestinal disorders	None	View
GASTROINTESTINAL TRACT BLEEDING	None	Gastrointestinal disorders	None	View
"HEPATITIS, JAUNDICE, OR LIVER FAILURE"	None	Hepatobiliary disorders	None	View
DIARRHEA	None	Gastrointestinal disorders	None	View
CONSTIPATION	None	Gastrointestinal disorders	None	View
FECAL INCONTINENCE	None	Gastrointestinal disorders	None	View
LIVER ENZYMES ELEVATION	None	Investigations	None	View
DYSPHAGIA	None	Gastrointestinal disorders	None	View
PARALYTIC ILEUS/ BOWEL PSEUDO-OSTRUCTION	None	Gastrointestinal disorders	None	View
BOWEL OSBTRUCTION	None	Gastrointestinal disorders	None	View
OTHER DIGESTIVE DISORDER OR COMPLICATION	None	Gastrointestinal disorders	None	View
HYPOGLYCEMIA	None	Metabolism and nutrition disorders	None	View
HYPERGLYCEMIA	None	Metabolism and nutrition disorders	None	View
DIABETES INSIPIDUS	None	Metabolism and nutrition disorders	None	View
DIABETES MELLITUS	None	Metabolism and nutrition disorders	None	View
HYPONATREMIA	None	Metabolism and nutrition disorders	None	View
HYPERNATREMIA	None	Metabolism and nutrition disorders	None	View
HYPOKALEMIA	None	Metabolism and nutrition disorders	None	View
HYPERKALEMIA	None	Metabolism and nutrition disorders	None	View
HYPERLIPIDEMIA	None	Metabolism and nutrition disorders	None	View
HYPOCALCEMIA	None	Metabolism and nutrition disorders	None	View
HYPERCALCEMIA	None	Metabolism and nutrition disorders	None	View
HYPOMAGNESEMIA	None	Metabolism and nutrition disorders	None	View
DEHYDRATION	None	Metabolism and nutrition disorders	None	View
ACID-BASE IMBALANCE	None	Metabolism and nutrition disorders	None	View
HYPOCHLOREMIA	None	Metabolism and nutrition disorders	None	View
HYPERCHLOREMIA	None	Metabolism and nutrition disorders	None	View
OTHER ENDOCRINE OR METABOLIC DISORDER OR COMPLICATION	None	Metabolism and nutrition disorders	None	View
NON-CEREBRAL HEMORRHAGE	None	Blood and lymphatic system disorders	None	View
ECCHYMOSIS	None	Skin and subcutaneous tissue disorders	None	View
COAGULOPATHY	None	Blood and lymphatic system disorders	None	View
ANEMIA	None	Blood and lymphatic system disorders	None	View
POLYCYTEMIA	None	Blood and lymphatic system disorders	None	View
THROMBOCYTOPENIA	None	Blood and lymphatic system disorders	None	View
LEUKOPENIA	None	Blood and lymphatic system disorders	None	View
LEUKOCYTOSIS	None	Blood and lymphatic system disorders	None	View
TROMBOCYTOSIS	None	Blood and lymphatic system disorders	None	View
OTHER COAGULATION OR HEMATOLOGIC DISORDER OR COMPLICATION	None	Blood and lymphatic system disorders	None	View
RECURRENT STROKE NOT SPECIFIED AS HEMORRHAGE OR INFARCTION	None	Blood and lymphatic system disorders	None	View
DEPRESSION OF CONSCIOUSNESS	None	Nervous system disorders	None	View
SYMPTOMATIC INTRACRANIAL HEMORRHAGE	None	Blood and lymphatic system disorders	None	View
ASYMPTOMATIC INTRACRANIAL HEMORRHAGE	None	Blood and lymphatic system disorders	None	View
CRANIAL NERVE INJURY	None	Injury, poisoning and procedural complications	None	View
TRANSIENT ISCHEMIC ATTACK	None	Vascular disorders	None	View
CEREBRAL INFARCTION	None	Nervous system disorders	None	View
CEREBRAL EDEMA	None	Nervous system disorders	None	View
SEIZURE	None	Nervous system disorders	None	View
CONFUSION/ENCEPHALOPATHY/DELIRIUM	None	Psychiatric disorders	None	View
ANXIETY	None	Psychiatric disorders	None	View
HEADACHE	None	Nervous system disorders	None	View
AGITATION	None	Nervous system disorders	None	View
APHASIA	None	Psychiatric disorders	None	View
INCREASED INTRA-CRANIAL PRESSURE	None	Nervous system disorders	None	View
PROGRESSION OF STROKE	None	Nervous system disorders	None	View
RETINAL VASCULAR ACCIDENT	None	Eye disorders	None	View
SYNCOPE OR PRE-SYNCOPE	None	Vascular disorders	None	View
OTHER NEUROLOGICAL DISORDER OR COMPLICATION	None	Nervous system disorders	None	View
URINARY TRACT INFECTION	None	Infections and infestations	None	View
HEMATURIA	None	Renal and urinary disorders	None	View
RENAL INSUFFICIENCY	None	Renal and urinary disorders	None	View
RENAL FAILURE	None	Renal and urinary disorders	None	View
UROGENITAL INCONTINENCE (WAS 410)	None	Renal and urinary disorders	None	View
URINARY RETENTION	None	Renal and urinary disorders	None	View
OTHER UROGENITAL DISORDER OR COMPLICATION	None	Renal and urinary disorders	None	View
FRACTURE	None	Injury, poisoning and procedural complications	None	View
INFILTRATION OF IV SITE	None	Injury, poisoning and procedural complications	None	View
SURGICAL SITE INFECTION	None	Injury, poisoning and procedural complications	None	View
SURGICAL WOUND HEMATOMA	None	Injury, poisoning and procedural complications	None	View
OTHER NON-INFECTIOUS SURGICAL WOUND COMPLICATION	None	Injury, poisoning and procedural complications	None	View
DECUBITUS ULCERS/PRESSURE SORES	None	Skin and subcutaneous tissue disorders	None	View
BLISTER	None	Injury, poisoning and procedural complications	None	View
MALIGNANT NEOPLASM (EXCEPT SKIN)	None	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
MALIGNANT NEOPLASM (SKIN)	None	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
ACCIDENTAL TRAUMA	None	Injury, poisoning and procedural complications	None	View
PSYCHIATRIC DEPRESSION	None	Psychiatric disorders	None	View
FALL	None	Injury, poisoning and procedural complications	None	View
PERIPHERAL EDEMA	None	General disorders	None	View
OTHER ENZYME/S ELEVATION	None	Investigations	None	View
INSOMNIA	None	Psychiatric disorders	None	View
"HEMATOMA, NOT OTHERWISE SPECIFIED"	None	Vascular disorders	None	View
DERMATITIS	None	Skin and subcutaneous tissue disorders	None	View
PSYCHIATRIC DISORDER	None	Psychiatric disorders	None	View
CELLULITIS/NON-SURGICAL SKIN INFECTION	None	Infections and infestations	None	View
OTHER UNCLASSIFIED ADVERSE EVENT	None	General disorders	None	View
SEPTICEMIA OR SEPTIC SHOCK	None	Blood and lymphatic system disorders	None	View
OROLINGUAL ANGIOEDEMA	None	Immune system disorders	None	View
RASH	None	Skin and subcutaneous tissue disorders	None	View
ITCHING	None	Skin and subcutaneous tissue disorders	None	View
GASTRITIS/ ESOPHAGITIS/GERD	None	Gastrointestinal disorders	None	View