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 @ 5:24 PM
Ignite Modification Date: 2025-12-25 @ 2:59 PM
NCT ID: NCT00475150
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00475150
Study Brief: Cediranib Maleate in Treating Patients With Relapsed, Refractory, or Untreated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
All Patients Receiving Cediranib Maleate All patients receiving oral cediranib maleate, regardless of diagnosis were analyzed for toxicity. None None 23 39 39 39 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10 View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Lower gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Upper gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
INR 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 loss 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
Serum potassium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Chest wall pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Joint 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 lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Intracranial hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Bladder hemorrhage SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10 View
Protein urine positive SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Petechiae 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
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10 View
Left ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine 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
Ear, nose and throat examination abnormal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Lower gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Rectal pain 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
Bladder infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Colitis, infectious (e.g., Clostridium difficile) SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
INR increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Laboratory test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Leukocyte 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 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 phosphate decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Chest wall pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Joint pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Hemorrhage urinary tract SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10 View
Protein urine positive SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10 View
Allergic rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal 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
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Voice alteration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Sweating 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