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 @ 9:58 PM
Ignite Modification Date: 2025-12-25 @ 7:36 PM
NCT ID: NCT00925132
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00925132
Study Brief: Treatment of Resistant Metastatic Melanoma Using Decitabine, Temozolomide and Panobinostat
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Temozolomide, Decitabine, Panobinostat Temozolomide - given each cycle. Decitabine - 6 cohorts with dose escalation. Panobinostat - 6 cohorts with dose escalation. Temozolomide, Decitabine, Panobinostat: Temozolomide - given each cycle. Decitabine - 6 cohorts with dose escalation. Panobinostat - 6 cohorts with dose escalation. None None 5 39 39 39 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Edema-lower extremity SYSTEMATIC_ASSESSMENT Vascular disorders None View
Obstruction, GI (small bowel) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Obstruction, GU (ureter) SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Leukocytes SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
RBC Decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hemoglobin SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neutrophils SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Platelets SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ALT SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Albumin SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Bicarbonate-Serum low SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Bilirubin SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Creatinine SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
GGT SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Chloride decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Musculoskeletal joint pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Gastrointestinal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Left Sided Weakness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Alkaline Phosphatase SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Coagulation PTT SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Failure to thrive SYSTEMATIC_ASSESSMENT General disorders None View
Albumin-Serum low (hypoalbuminemia) SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Potassium-Serum low (hypokalemia) SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Phosphorous SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Confusion SYSTEMATIC_ASSESSMENT General disorders None View
Neuropathy SYSTEMATIC_ASSESSMENT General disorders None View
Weight Loss SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
Taste alteration (dysgeusia) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Speech impairment SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness SYSTEMATIC_ASSESSMENT General disorders None View
General pain: chest and body SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Calcium, serum-low (hypocalcemia) SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Somnolence SYSTEMATIC_ASSESSMENT General disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Flu-like symptoms SYSTEMATIC_ASSESSMENT General disorders None View