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: 2025-12-26 @ 5:18 PM
Ignite Modification Date: 2025-12-26 @ 5:18 PM
NCT ID: NCT00641706
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00641706
Study Brief: Vorinostat and Bortezomib in Treating Patients With Progressive, Recurrent Glioblastoma Multiforme
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm A (Not Undergoing Surgery) vorinostat : Given orally None None 18 37 36 37 View
Arm B (Undergoing Surgery) vorinostat : Given orally None None 0 7 7 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Serum sodium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Facial nerve disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Intracranial hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Neurological disorder NOS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Speech disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
Personality change SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Opportunistic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10 View
Dry eye syndrome SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 10 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 10 View
Watering eyes SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 10 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Ear, nose and throat examination abnormal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Leukocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Weight gain SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Serum calcium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Serum calcium increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Serum glucose decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Serum potassium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Serum potassium increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Serum sodium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Serum sodium increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Muscle weakness left-sided SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Acoustic nerve disorder NOS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Cognitive disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Facial nerve disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Hydrocephalus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Mini mental status examination abnormal SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Speech disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Taste alteration SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
Libido decreased SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Hemorrhage nasal SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Hiccough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Erythema multiforme SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Nail disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Rash desquamating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10 View