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: 2025-12-26 @ 5:21 PM
Ignite Modification Date: 2025-12-26 @ 5:21 PM
NCT ID: NCT00882206
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00882206
Study Brief: Pre-reinductive Decitabine and Vorinostat in Relapsed Lymphoblastic Lymphoma or Acute Lymphoblastic 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 / Vorinostat This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy. cytarabine: At baseline when peripheral blood draw and bone marrow aspirate performed. \*Intrathecal Cytarabine administered dependent upon age - ranging from 30 mg to 70 mg. decitabine: Days 1-4, 15 mg/m\^2 intravenously (IV) over 1 hour doxorubicin hydrochloride: Day 5, 60 mg/m\^2 intravenously (IV) over 15 minutes imatinib mesylate: 340 mg/m2 by mouth every day (rounded to the nearest 100 mg) for age \<18 years and 400 mg orally every day for \>18 years on Days 5-33. methotrexate: \*\*Intrathecal Methotrexate administered dependent upon age - ranging from 8 mg to 15 mg. pegaspargase: 2,500 IU/m2 IM or IV q week (days 6, 12, 19, 26) prednisone: 40mg/m2/day divided BID (days 5 - 33) vincristine sulfate: 1.5mg/m2 (max 2 mg) iv push q week (days 5, 12) None None 8 13 13 13 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Decreased respiratory rate SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Infection, blood SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pain, generalized body SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hypertriglyceridemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoxia - acute respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Lipase elevated SYSTEMATIC_ASSESSMENT Investigations None View
Cerebral hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pain, abdominal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypercholesteremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hemorrhage, bladder SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukocytes decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Platelets count decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Platelets SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Bone marrow cellularity SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukocytes SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neutrophils SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular arrythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Systolic murmur SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders None View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fluid retention, ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lower molar pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Edema, lower extremity SYSTEMATIC_ASSESSMENT General disorders None View
Edema, upper extremity SYSTEMATIC_ASSESSMENT General disorders None View
Generalised body aches SYSTEMATIC_ASSESSMENT General disorders None View
Weakness SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Infection, meningitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fungal infection, lung SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection, soft tissue SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection, neutopenia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection, positive blood culture SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pain uncontrolled SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pain, epigastric SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pain, headache SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pain, pedal bilateral SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pain, leg bilateral SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pain, stomach SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pain, left chest SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pain, low back/leg SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Lower lip swelling SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pain, NOS SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hyperbilirubinemia SYSTEMATIC_ASSESSMENT Investigations None View
Weight gain SYSTEMATIC_ASSESSMENT Investigations None View
Creatinine SYSTEMATIC_ASSESSMENT Investigations None View
Lipase elevated SYSTEMATIC_ASSESSMENT Investigations None View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
ALT increased SYSTEMATIC_ASSESSMENT Investigations None View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations None View
Fibrinogen increased SYSTEMATIC_ASSESSMENT Investigations None View
Amylase SYSTEMATIC_ASSESSMENT Investigations None View
Lipase SYSTEMATIC_ASSESSMENT Investigations None View
ANC SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Investigations None View
AST increased SYSTEMATIC_ASSESSMENT Investigations None View
AST SYSTEMATIC_ASSESSMENT Investigations None View
Hypermagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperchloremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypertriglyceridemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Albumin SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Calcium SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Glucose SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Uric acid increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Calcium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperphosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Calcium increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Obesity SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Knee pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hip pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headaches SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hemiparesis, right side SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mood alteration, NOS SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sleep apnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary infiltrate SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hand foot reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Demi Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Ulceration, decubitus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View