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 @ 7:38 PM
Ignite Modification Date: 2025-12-25 @ 5:18 PM
NCT ID: NCT00702403
Description: None
Frequency Threshold: 0
Time Frame: Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
Study: NCT00702403
Study Brief: Nilotinib and Imatinib Mesylate After Donor Stem Cell Transplant in Treating Patients With ALL or CML
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Single Arm Nilotinib Relapse Prophylaxis Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO QD until day 80 and then nilotinib PO BID on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO BID beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity. 9 None 20 40 31 40 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute acalculous cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hepatic Failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Transaminitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Pseudomonas bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gram negative rod bacteremia with possible urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cytomegalovirus reactivation SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fever/URI SYSTEMATIC_ASSESSMENT Infections and infestations None View
Staph Aureus Bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Alpha-hemolytic Streptococcus SYSTEMATIC_ASSESSMENT Infections and infestations None View
Staph haemolyticus SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gram-negative Bacteremia and Septic emboli SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nodular pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bacterial pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acute lobular pneumonia with sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Haemophilus Influenza-Rhinovirus SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Malignant hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Yeast esophagitis-Odynophagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Cramping SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Transaminitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Apnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Non-specific interstitial pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Altered mental status SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Acute encephalopathy SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Death, NOS SYSTEMATIC_ASSESSMENT General disorders None View
Generalized weakness/fatiuge SYSTEMATIC_ASSESSMENT General disorders None View
Multiorgan failure SYSTEMATIC_ASSESSMENT General disorders None View
Hemorrhagic cystitis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Renal colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Palmar-plantar erythrodysesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Klebsiella pneumonia pyelonephritis and positive urine culture SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vancomycin resistant enterococcus and positive urine culture SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bacteremia enterococcus faecalis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations None View
CMV Reactivation SYSTEMATIC_ASSESSMENT Infections and infestations None View
Coagulase-negative staph SYSTEMATIC_ASSESSMENT Infections and infestations None View
CMV Enteritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Candidal esophagitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
BK Virus SYSTEMATIC_ASSESSMENT Infections and infestations None View
Klebsiella and E.Coli and Positive Urine Culture SYSTEMATIC_ASSESSMENT Infections and infestations None View
S. epidermidis bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pseudomonas maltophilia Bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations None View
GPC Bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Multiorganism sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Lymphocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
INR Increased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Elevated Serum AST/ALT SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Anorexia/Nausea SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Increased Bilirubin SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Increased Alkaline Phosphate SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypermagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Increased creatinine-renal insufficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Increased Lipase SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Localized Edema SYSTEMATIC_ASSESSMENT General disorders None View
Generalized Muscle Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Skin Ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Renal Disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Delerium SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View