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: 2025-12-25 @ 1:21 AM
Ignite Modification Date: 2025-12-25 @ 11:29 PM
NCT ID: NCT00509093
Description: None
Frequency Threshold: 0
Time Frame: Up to four weeks after off-study date, an average of 2.6 years
Study: NCT00509093
Study Brief: Imatinib Mesylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia Who Have Received Chemotherapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Imatinib Mesylate Imatinib mesylate: Participants will receive treatment with imatinib mesylate at a dose of 600 mg by mouth once a day for 12 months. Study dose can be split but the dose of 600 mg must be given within a 12 hour period. Gene expression analysis: Multidrug resistance genes: These studies will include: MDR1, MRP1, LRP, and BCRP. Bone marrow blocks or cut slides will be sent to Duke on the diagnostic AML samples. DNA will be eluted from the samples so that the above genes can be analyzed. Mutation analysis: FLT3 mutation analysis (on bone marrow aspirate or peripheral blood): These analyses will be performed by pathology at the time of diagnosis, at the participating institution. Samples will be analyzed for the FLT3 ITD and/or D835 mutation by PCR. PCR: AF1q gene analysis (on bone marrow aspirate) Flow cytometry: C-kit MFI on AML samples will be calculated by using a CD45/ orthogonal light scatter gate to isolate blasts. The MFI will be calculated a 20 None 5 32 30 32 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC V3 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTC V3 View
Pericardial effusion (non-malignant) NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTC V3 View
Urticaria (hives, welts, wheals) NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTC V3 View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC V3 View
Infection with unknown ANC - Blood NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTC V3 View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC V3 View
Pain - Bone NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC V3 View
Pain - Cardiac/heart NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC V3 View
Pain - Joint NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC V3 View
Adult Respiratory Distress Syndrome (ARDS) NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTC V3 View
Atelectasis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTC V3 View
Pleural effusion (non-malignant) NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTC V3 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hemoglobin NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC V3 View
Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis) NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC V3 View
Leukocytes (total WBC) NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC V3 View
Lymphopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC V3 View
Neutrophils/granulocytes (ANC/AGC) NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC V3 View
Platelets NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC V3 View
INR (International Normalized Ratio of prothrombin time) NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC V3 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTC V3 View
aches at base of skull NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
Dyspnea NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
edema in extremities NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
emesis NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
episode of flu NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
facial edema NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
facial itching NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
hand stiffness NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
Edema to face and legs NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
Insomnia NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
intermittent rash NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
loose stool NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
lower extremity edema NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
mild edema in general and particularly in eye area NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
nasal congestion NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
nausea NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
occasional mild sore throat NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
periorbital edema NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
peri-orbital itchiness NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
Periorbital swelling NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
post nasal discharge NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
post-herpetic neuralgia NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
puffiness of eyes NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
right heel pain NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
right shoulder discomfort NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
sore throat NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
soreness in left ear NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
stiff neck NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
stomach burning NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
upper back discomfort NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
Fatigue (asthenia, lethargy, malaise) NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
Sweating (diaphoresis) NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
Weight gain NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
Bruising (in absence of Grade 3 or 4 thrombocytopenia) NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
Dry skin NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
discoloration of face NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTC V3 View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTC V3 View
Hair loss/alopecia (scalp or body) NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTC V3 View
Nail changes NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTC V3 View
Pruritus/itching NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTC V3 View
Rash: acne/acneiform NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTC V3 View
Rash: dermatitis associated with radiation - Chemoradiation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTC V3 View
Constipation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTC V3 View
Esophagitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC V3 View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC V3 View
Heartburn/dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC V3 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC V3 View
Taste alteration (dysgeusia) NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC V3 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC V3 View
Infected cyst in left groin area; draining pus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC V3 View
Infection with normal ANC or Grade 1 or 2 neutrophils - Conjunctiva NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTC V3 View
Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia) NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTC V3 View
Infection with normal ANC or Grade 1 or 2 neutrophils - Sinus NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTC V3 View
Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTC V3 View
Infection with unknown ANC - Urinary tract NOS NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTC V3 View
Edema: head and neck NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTC V3 View
Edema: limb NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTC V3 View
Edema: trunk/genital NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC V3 View
Edema: viscera NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC V3 View
Small Preauricular Left Node NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC V3 View
Albumin, serum-low (hypoalbuminemia) NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC V3 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Investigations CTC V3 View
Neuropathy: sensory NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTC V3 View
Syncope (fainting) NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC V3 View
Mood alteration - Anxiety NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC V3 View
Mood alteration - Depression NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC V3 View
Eye Swelling and Redness NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTC V3 View
occasional burning of eyes NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTC V3 View
Optic disc edema NON_SYSTEMATIC_ASSESSMENT Eye disorders CTC V3 View
Vision-blurred vision NON_SYSTEMATIC_ASSESSMENT Eye disorders CTC V3 View
Pain - Abdomen NOS NON_SYSTEMATIC_ASSESSMENT Eye disorders CTC V3 View
Pain - Back NON_SYSTEMATIC_ASSESSMENT Eye disorders CTC V3 View
Pain - Bone NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC V3 View
Pain - External ear NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC V3 View
Pain - Extremity-limb NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC V3 View
Pain - Head/headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC V3 View
Pain - Joint NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC V3 View
Pain - Muscle NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC V3 View
Mild Generalized Body Aches NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC V3 View
rt ankle pain NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC V3 View
chronic hip pain NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC V3 View
lower extremity pain NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC V3 View
mild cramping NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC V3 View
sciatica NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC V3 View
Pain - Pain NOS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC V3 View
Pain - Stomach NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC V3 View
Pain - Throat/pharynx/larynx NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC V3 View
Bronchospasm, wheezing NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC V3 View
Cough NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC V3 View
Dyspnea (shortness of breath) NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTC V3 View
Nasal cavity/paranasal sinus reactions NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTC V3 View
Nasal Congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTC V3 View
Increased Bladder Pressure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTC V3 View
No Menstrual NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTC V3 View
aural stuffiness NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
body aches and chills NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
Decreased total protein in blood NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
mild swelling/edema NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
mild tingling and discomfort rt lower extremity NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
muscle cramping NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
Bilirubin (hyperbilirubinemia) NON_SYSTEMATIC_ASSESSMENT Investigations CTC V3 View
Calcium, serum-low (hypocalcemia) NON_SYSTEMATIC_ASSESSMENT Investigations CTC V3 View
Creatinine NON_SYSTEMATIC_ASSESSMENT Investigations CTC V3 View
Glucose, serum-high (hyperglycemia) NON_SYSTEMATIC_ASSESSMENT Investigations CTC V3 View
Magnesium, serum-low (hypomagnesemia) NON_SYSTEMATIC_ASSESSMENT Investigations CTC V3 View
Potassium, serum-high (hyperkalemia) NON_SYSTEMATIC_ASSESSMENT Investigations CTC V3 View
Potassium, serum-low (hypokalemia) NON_SYSTEMATIC_ASSESSMENT Investigations CTC V3 View
Sodium, serum-low (hyponatremia) NON_SYSTEMATIC_ASSESSMENT Investigations CTC V3 View
Muscle weakness, generalized or specific area (not due to neuropathy) - Extraocular NON_SYSTEMATIC_ASSESSMENT Investigations CTC V3 View
upper respiratory infection NON_SYSTEMATIC_ASSESSMENT General disorders CTC V3 View
blisters on feet NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTC V3 View
Rash/desquamation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTC V3 View
Anorexia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTC V3 View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC V3 View
Upset Stomach NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC V3 View
gastroenteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC V3 View
Hemorrhage, GU - Urinary NOS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC V3 View
Infection with normal ANC or Grade 1 or 2 neutrophils - Bladder (urinary) NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTC V3 View
Infection with normal ANC or Grade 1 or 2 neutrophils - Nerve-peripheral NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTC V3 View
"Clear Liquid" coming from left ear NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC V3 View
Alkaline phosphatase NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC V3 View
ALT, SGPT (serum glutamic pyruvic transaminase) NON_SYSTEMATIC_ASSESSMENT Investigations CTC V3 View
AST, SGOT(serum glutamic oxaloacetic transaminase) NON_SYSTEMATIC_ASSESSMENT Investigations CTC V3 View
Fullness in Right Ear NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTC V3 View