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 @ 2:21 PM
Ignite Modification Date: 2025-12-25 @ 12:58 PM
NCT ID: NCT00937495
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00937495
Study Brief: Vorinostat and Bortezomib in Treating Patients With Advanced Soft Tissue Sarcoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment (Vorinostat, Bortezomib) Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m\^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. None None 6 16 16 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
INR increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
Erythema multiforme SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders 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
Optic nerve edema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 10 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Oral hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Aspartate 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
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Rash desquamating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10 View
Ear, nose and throat examination abnormal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Intra-abdominal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Upper gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Mucosal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View