Adverse Events Module

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 @ 9:21 PM
Ignite Modification Date: 2025-12-25 @ 7:08 PM
NCT ID: NCT01707004
Description: AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Frequency Threshold: 0
Time Frame: Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
Study: NCT01707004
Study Brief: Decitabine and Total-Body Irradiation Followed By Donor Bone Marrow Transplant and Cyclophosphamide in Treating Patients With Relapsed or Refractory 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
Decitabine (N=20) Pre-transplant Decitabine 15 None 0 20 20 20 View
Transplant (N=17) Pre-transplant Decitabine followed by Bone Marrow Transplant 13 None 12 17 17 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.0 View
Enterocolitis infectious NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v4.0 View
Infections and infestations - Other, specify NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v4.0 View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v4.0 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v4.0 View
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE v4.0 View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v4.0 View
Delirium NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v4.0 View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.0 View
Immune system disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE v4.0 View
Anorectal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v4.0 View
Encephalitis infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v4.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v4.0 View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v4.0 View
Platelet Count Decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.0 View
White Blood Cell Decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.0 View
Weight gain SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.0 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v4.0 View
Metabolism and nutrition disorders - Other, specify SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v4.0 View
Gastrointestinal disorders - Other, specify SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v4.0 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v4.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v4.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v4.0 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v4.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v4.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v4.0 View
Skin and subcutaneous tissue disorders - Other, specify SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v4.0 View
Pain of skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v4.0 View
Palmar-plantar erythrodysesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v4.0 View
Skin ulceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v4.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v4.0 View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v4.0 View
Skin hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v4.0 View
Infections and infestations - Other, specify SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v4.0 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v4.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v4.0 View
Mucosal infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v4.0 View
Anorectal infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v4.0 View
Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v4.0 View
Encephalitis infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v4.0 View
Enterocolitis infectious SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v4.0 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v4.0 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v4.0 View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v4.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v4.0 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v4.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v4.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v4.0 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v4.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v4.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v4.0 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v4.0 View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v4.0 View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v4.0 View
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v4.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v4.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v4.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v4.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v4.0 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v4.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v4.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v4.0 View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v4.0 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v4.0 View
Renal and urinary disorders - Other, specify SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v4.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v4.0 View
Cystitis noninfective SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v4.0 View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v4.0 View
Urinary tract pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v4.0 View
Hemoglobinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v4.0 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v4.0 View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v4.0 View
Urinary urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v4.0 View
Urine discoloration SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v4.0 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v4.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v4.0 View
Cardiac disorders - Other, specify SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v4.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v4.0 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v4.0 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v4.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v4.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v4.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v4.0 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v4.0 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v4.0 View
Eye disorders - Other, specify SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v4.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v4.0 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v4.0 View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v4.0 View
Immune system disorders - Other, specify SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE v4.0 View
Allergic reaction SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE v4.0 View
Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v4.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v4.0 View
Vascular access complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v4.0 View
Breast pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE v4.0 View
Genital edema SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE v4.0 View
Gynecomastia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE v4.0 View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE v4.0 View
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE v4.0 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE v4.0 View
Hearing impaired SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE v4.0 View
Apnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v4.0 View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v4.0 View
Laryngeal mucositis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v4.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v4.0 View
Pharyngeal mucositis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v4.0 View
Pleuritic pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v4.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v4.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v4.0 View
Neutrophil Count Decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.0 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.0 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.0 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.0 View
GGT increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.0 View
INR increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.0 View
Electrocardiogram QT corrected interval prolonged SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.0 View
Lymphocyte count increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.0 View
CD4 lymphocytes decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.0 View
Cholesterol high SYSTEMATIC_ASSESSMENT Investigations CTCAE v4.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v4.0 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v4.0 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v4.0 View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v4.0 View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v4.0 View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v4.0 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v4.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v4.0 View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v4.0 View
Hypermagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v4.0 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v4.0 View
Hypertriglyceridemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v4.0 View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v4.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE v4.0 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders CTCAE v4.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE v4.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE v4.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE v4.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders CTCAE v4.0 View
Facial pain SYSTEMATIC_ASSESSMENT General disorders CTCAE v4.0 View
Edema face SYSTEMATIC_ASSESSMENT General disorders CTCAE v4.0 View
Infusion related reaction SYSTEMATIC_ASSESSMENT General disorders CTCAE v4.0 View
Localized edema SYSTEMATIC_ASSESSMENT General disorders CTCAE v4.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders CTCAE v4.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.0 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.0 View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.0 View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.0 View
Esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.0 View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.0 View
Lower gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.0 View
Rectal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.0 View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.0 View
Hemorrhoidal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.0 View
Lip pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.0 View
Oral hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.0 View
Rectal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v4.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v4.0 View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v4.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v4.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v4.0 View