Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 9:31 PM
Ignite Modification Date: 2025-12-25 @ 7:16 PM
NCT ID: NCT00357032
Description: "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Frequency Threshold: 0
Time Frame: Adverse events were collected over a period of 12 months.
Study: NCT00357032
Study Brief: PXD101 in Treating Patients With Acute Myeloid Leukemia
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 (Belinostat) Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity. belinostat: Given IV laboratory biomarker analysis: Correlative studies None None 8 12 10 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders meddra9.0 View
Hemoglobin decreased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders meddra9.0 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders meddra9.0 View
Ear, nose and throat examination abnormal NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders meddra9.0 View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders meddra9.0 View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders meddra9.0 View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders meddra9.0 View
Bladder infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations meddra9.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations meddra9.0 View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations meddra9.0 View
Skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations meddra9.0 View
Electrocardiogram QTc interval prolonged NON_SYSTEMATIC_ASSESSMENT Investigations meddra9.0 View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations meddra9.0 View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders meddra9.0 View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders meddra9.0 View
Muscle weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders meddra9.0 View
Muscle weakness lower limb NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders meddra9.0 View
Intracranial hemorrhage NON_SYSTEMATIC_ASSESSMENT Nervous system disorders meddra9.0 View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders meddra9.0 View
Adult respiratory distress syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders meddra9.0 View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders meddra9.0 View
Hematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders meddra9.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders meddra9.0 View
Hemoglobin decreased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders meddra9.0 View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders meddra9.0 View
Sinus bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders meddra9.0 View
Hearing loss NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders meddra9.0 View
Eye disorder NON_SYSTEMATIC_ASSESSMENT Eye disorders meddra9.0 View
Photophobia NON_SYSTEMATIC_ASSESSMENT Eye disorders meddra9.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders meddra9.0 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders meddra9.0 View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders meddra9.0 View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders meddra9.0 View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders meddra9.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders meddra9.0 View
Oral hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders meddra9.0 View
Rectal hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders meddra9.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders meddra9.0 View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders meddra9.0 View
Disease progression NON_SYSTEMATIC_ASSESSMENT General disorders meddra9.0 View
Edema limbs NON_SYSTEMATIC_ASSESSMENT General disorders meddra9.0 View
Facial pain NON_SYSTEMATIC_ASSESSMENT General disorders meddra9.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders meddra9.0 View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders meddra9.0 View
Flu-like symptoms NON_SYSTEMATIC_ASSESSMENT General disorders meddra9.0 View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations meddra9.0 View
Bruising NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications meddra9.0 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations meddra9.0 View
Alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations meddra9.0 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations meddra9.0 View
Creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations meddra9.0 View
Hyperbilirubinemia NON_SYSTEMATIC_ASSESSMENT Investigations meddra9.0 View
INR increased NON_SYSTEMATIC_ASSESSMENT Investigations meddra9.0 View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Investigations meddra9.0 View
Lymphopenia NON_SYSTEMATIC_ASSESSMENT Investigations meddra9.0 View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations meddra9.0 View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations meddra9.0 View
Weight loss NON_SYSTEMATIC_ASSESSMENT Investigations meddra9.0 View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders meddra9.0 View
Blood bicarbonate decreased NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders meddra9.0 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders meddra9.0 View
Hypercalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders meddra9.0 View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders meddra9.0 View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders meddra9.0 View
Hypermagnesemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders meddra9.0 View
Hypernatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders meddra9.0 View
Hyperuricemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders meddra9.0 View
Hypoalbuminemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders meddra9.0 View
Hypocalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders meddra9.0 View
Hypoglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders meddra9.0 View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders meddra9.0 View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders meddra9.0 View
Hypophosphatemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders meddra9.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders meddra9.0 View
Bone pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders meddra9.0 View
Chest wall pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders meddra9.0 View
Joint pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders meddra9.0 View
Muscle weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders meddra9.0 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders meddra9.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders meddra9.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders meddra9.0 View
Mental status changes NON_SYSTEMATIC_ASSESSMENT Nervous system disorders meddra9.0 View
Taste alteration NON_SYSTEMATIC_ASSESSMENT Nervous system disorders meddra9.0 View
Confusion NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders meddra9.0 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders meddra9.0 View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders meddra9.0 View
Hemorrhage nasal NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders meddra9.0 View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders meddra9.0 View
Skin hyperpigmentation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders meddra9.0 View
Hematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders meddra9.0 View
Hemorrhage NON_SYSTEMATIC_ASSESSMENT Vascular disorders meddra9.0 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders meddra9.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders meddra9.0 View