Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 15455B | |||
| N01CM62209 | U.S. NIH Grant/Contract | View source | |
| N01CM62201 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This phase II clinical trial is studying how well selumetinib works in treating patients with recurrent or refractory acute myeloid leukemia. Selumetinib may stop the growth of cancer by blocking some of the enzymes needed for cell growth
PRIMARY OBJECTIVES:
I. To determine the response rate (includes complete response-CR, complete response with incomplete count recovery CRi, partial response-PR, and minor response-MR) to AZD6244 (selumetinib).
SECONDARY OBJECTIVES:
I. To determine the effects of AZD6244 in AML samples on p-ERK and evaluate the potential utility of p-ERK inhibition as a surrogate marker of biologic activity.
II. To correlate the effects of AZD6244 with the presence (or absence) of mutated RAS or FLT-3 at baseline.
III. To assess the safety profile of AZD6244 in patients with AML.
OUTLINE:
Patients receive selumetinib orally (PO) twice daily (BID) on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 52 weeks.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (selumetinib) | Experimental | Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| selumetinib | Drug | Given PO |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate for Subjects Without FLT3 ITD Mutation | Responses were defined using standard criteria developed by an International Working Group. [Cheson BD, Bennett JM, Kopecky KJ, Buchner T, Willman CL, Estey EH, et al. Revised recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia. J Clin Oncol 2003;21:4642-9.] In this primary outcome, we report the proportion of subjects without FLT3 ITD mutation that experienced a complete response (CR), partial response (PR), minor response (MR), or unconfirmed minor response (uMR). | Up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With Baseline p-ERK Activation | Proportion of subjects with baseline p-ERK activation | baseline (0 weeks) |
| Proportion of Subjects With NRAS Mutation | Proportion of Subjects With NRAS Mutation |
Not provided
Inclusion Criteria:
Histologically or cytologically confirmed diagnosis of 1 of the following:
Elderly patients ≥ 60 years of age, previously untreated, and who are not candidates for or have refused standard chemotherapy are eligible for this trial
Patients with relapsed acute promyelocytic leukemia (APL) who are FLT3+ and have failed both tretinoin and arsenic therapy are eligible for this trial
No known active CNS disease
ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
Total bilirubin ≤ 2 mg/dL (unless due to disease, hemolysis, or Gilbert disease)
AST/ALT < 3 times upper limit of normal
Creatinine < 2 mg/dL
Baseline pulse oximetry > 92%
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception prior to, during, and for 4 weeks (16 week for males) after completion of study treatment
Recovered from prior therapy
At least 2 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) or radiotherapy
At least 4 weeks since prior investigational agents
No prior MEK inhibitors
No concurrent medication that can prolong the QT interval
No other concurrent investigational agents
No concurrent combination antiretroviral therapy for HIV-positive patients
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Olatoyosi Odenike | University of Chicago Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637-1470 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14673054 | Background | Cheson BD, Bennett JM, Kopecky KJ, Buchner T, Willman CL, Estey EH, Schiffer CA, Doehner H, Tallman MS, Lister TA, Lo-Coco F, Willemze R, Biondi A, Hiddemann W, Larson RA, Lowenberg B, Sanz MA, Head DR, Ohno R, Bloomfield CD; International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia. Revised recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia. J Clin Oncol. 2003 Dec 15;21(24):4642-9. doi: 10.1200/JCO.2003.04.036. | |
| 24178622 |
Not provided
Not provided
A Simon, optimal two-stage design was employed for subjects without FLT3 ITD mutations. The study also included a second cohort of subjects with FLT3 ITD mutations.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Selumetinib | Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. selumetinib: Given PO |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| baseline (0 weeks) |
| Proportion of Subjects With KRAS Mutation | Proportion of subjects with KRAS mutation | baseline (0 weeks) |
| Proportion of Subjects With FLT3 ITD Mutation | Proportion of subjects with FLT3 ITD mutation | baseline (0 weeks) |
| Proportion of Subjects With KIT Mutation | Proportion of subjects with KIT mutation | baseline (0 weeks) |
| Result |
| Jain N, Curran E, Iyengar NM, Diaz-Flores E, Kunnavakkam R, Popplewell L, Kirschbaum MH, Karrison T, Erba HP, Green M, Poire X, Koval G, Shannon K, Reddy PL, Joseph L, Atallah EL, Dy P, Thomas SP, Smith SE, Doyle LA, Stadler WM, Larson RA, Stock W, Odenike O. Phase II study of the oral MEK inhibitor selumetinib in advanced acute myelogenous leukemia: a University of Chicago phase II consortium trial. Clin Cancer Res. 2014 Jan 15;20(2):490-8. doi: 10.1158/1078-0432.CCR-13-1311. Epub 2013 Oct 31. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Selumetinib | Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. selumetinib: Given PO |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Response Rate for Subjects Without FLT3 ITD Mutation | Responses were defined using standard criteria developed by an International Working Group. [Cheson BD, Bennett JM, Kopecky KJ, Buchner T, Willman CL, Estey EH, et al. Revised recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia. J Clin Oncol 2003;21:4642-9.] In this primary outcome, we report the proportion of subjects without FLT3 ITD mutation that experienced a complete response (CR), partial response (PR), minor response (MR), or unconfirmed minor response (uMR). | Analysis only includes subjects without FLT3 ITD mutation. | Posted | Number | percentage of participants | Up to 52 weeks |
|
|
| ||||||||||||||||||||||||||
| Secondary | Proportion of Subjects With Baseline p-ERK Activation | Proportion of subjects with baseline p-ERK activation | The analysis includes the 20 patients with samples available for analysis. | Posted | Number | percentage of participants | baseline (0 weeks) |
|
| |||||||||||||||||||||||||||
| Secondary | Proportion of Subjects With NRAS Mutation | Proportion of Subjects With NRAS Mutation | The analysis includes the 41 patients with samples available for analysis. | Posted | Number | percentage of participants | baseline (0 weeks) |
|
| |||||||||||||||||||||||||||
| Secondary | Proportion of Subjects With KRAS Mutation | Proportion of subjects with KRAS mutation | The analysis includes the 41 patients with samples available for analysis. | Posted | Number | percentage of participants | baseline (0 weeks) |
|
| |||||||||||||||||||||||||||
| Secondary | Proportion of Subjects With FLT3 ITD Mutation | Proportion of subjects with FLT3 ITD mutation | FLT3 ITD mutation status was not available for one patient. | Posted | Number | percentage of participants | baseline (0 weeks) |
|
| |||||||||||||||||||||||||||
| Secondary | Proportion of Subjects With KIT Mutation | Proportion of subjects with KIT mutation | The analysis includes the 41 patients with samples available for analysis. | Posted | Number | percentage of participants | baseline (0 weeks) |
|
|
1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Selumetinib | Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. selumetinib: Given PO | 38 | 47 | 47 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by an reduction in the amount of hemoglobin in 100 ml of blood. |
|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by an ANC <1000/mm3 and a single temperature of >38.3 degrees C (101 degrees F) or a sustained temperature of >=38 degrees C (100.4 degrees F) for more than one hour |
|
| Ventricular tachycardia | Cardiac disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by a dysrhythmia with a heart rate greater than 100 beats per minute that originates distal to the bundle of His. |
|
| Diarrhea | Gastrointestinal disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by frequent and watery bowel movements. |
|
| Dry mouth | Gastrointestinal disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by reduced salivary flow in the oral cavity. |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by inflammation of the oral mucosal. |
|
| Nausea | Gastrointestinal disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by a queasy sensation and/or the urge to vomit. |
|
| Vomiting | Gastrointestinal disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by the reflexive act of ejecting the contents of the stomach through the mouth. |
|
| Death NOS | General disorders | CTCAE 4.0 | Non-systematic Assessment | A cessation of life that cannot be attributed to a CTCAE term associated with Grade 5. |
|
| Fatigue | General disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by a state of generalized weakness with a pronounced inability to summon sufficient energy to accomplish daily activities. |
|
| Fever | General disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by elevation of the body's temperature above the upper limit of normal. |
|
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Blood | Infections and infestations | CTCAE 4.0 | Non-systematic Assessment |
| |
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Lung (pneumonia) | Infections and infestations | CTCAE 4.0 | Non-systematic Assessment |
| |
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Rectum | Infections and infestations | CTCAE 4.0 | Non-systematic Assessment |
| |
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Salivary gland | Infections and infestations | CTCAE 4.0 | Non-systematic Assessment |
| |
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Skin (cellulitis) | Infections and infestations | CTCAE 4.0 | Non-systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils: Blood | Infections and infestations | CTCAE 4.0 | Non-systematic Assessment |
| |
| Infections and infestations - Other | Infections and infestations | CTCAE 4.0 | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by an infectious process involving the lungs. |
|
| peritonsillar abscess | Infections and infestations | CTCAE 4.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by inflammation of the throat. |
|
| Sepsis | Infections and infestations | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by the presence of pathogenic microorganisms in the blood stream that cause a rapidly progressing systemic reaction that may lead to shock. |
|
| Upper respiratory infection | Infections and infestations | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by an infectious process involving the upper respiratory tract (nose, paranasal sinuses, pharynx, larynx, or trachea). |
|
| Urinary tract infection | Infections and infestations | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by an infectious process involving the urinary tract, most commonly the bladder and the urethra. |
|
| Alanine aminotransferase increased | Investigations | CTCAE 4.0 | Non-systematic Assessment | A finding based on laboratory test results that indicate an increase in the level of alanine aminotransferase (ALT or SGPT) in the blood specimen. |
|
| Creatinine increased | Investigations | CTCAE 4.0 | Non-systematic Assessment | A finding based on laboratory test results that indicate increased levels of creatinine in a biological specimen. |
|
| Neutrophil count decreased | Investigations | CTCAE 4.0 | Non-systematic Assessment | A finding based on laboratory test results that indicate a decrease in number of neutrophils in a blood specimen. |
|
| Platelet count decreased | Investigations | CTCAE 4.0 | Non-systematic Assessment | A finding based on laboratory test results that indicate a decrease in number of platelets in a blood specimen. |
|
| White blood cell decreased | Investigations | CTCAE 4.0 | Non-systematic Assessment | A finding based on laboratory test results that indicate an decrease in number of white blood cells in a blood specimen. |
|
| Acidosis | Metabolism and nutrition disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by abnormally high acidity (high hydrogen-ion concentration) of the blood and other body tissues. |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by a loss of appetite. |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by excessive loss of water from the body. It is usually caused by severe diarrhea, vomiting or diaphoresis. |
|
| Hyperuricemia | Metabolism and nutrition disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by laboratory test results that indicate an elevation in the concentration of uric acid. |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by laboratory test results that indicate a low concentration of albumin in the blood. |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by laboratory test results that indicate a low concentration of potassium in the blood. |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by laboratory test results that indicate a low concentration of sodium in the blood. |
|
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by a reduction in the strength of the lower limb muscles. |
|
| Dizziness | Nervous system disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by a disturbing sensation of lightheadedness, unsteadiness, giddiness, spinning or rocking. |
|
| Dysphasia | Nervous system disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by impairment of verbal communication skills, often resulting from brain damage. |
|
| Intracranial hemorrhage | Nervous system disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by bleeding from the cranium. |
|
| Psychosis | Psychiatric disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by personality change, impaired functioning, and loss of touch with reality. It may be a manifestation of schizophrenia, bipolar disorder or brain tumor. |
|
| Urine discoloration | Renal and urinary disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by a change in the color of the urine. |
|
| Bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by bleeding from the bronchial wall and/or lung parenchyma. |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by an uncomfortable sensation of difficulty breathing. |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by bleeding from the nose. |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by a decrease in the level of oxygen in the body. |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by inflammation focally or diffusely affecting the lung parenchyma. |
|
| Hypotension | Vascular disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by a blood pressure that is below the normal expected for an individual in a given environment. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by an reduction in the amount of hemoglobin in 100 ml of blood. |
|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by an ANC <1000/mm3 and a single temperature of >38.3 degrees C (101 degrees F) or a sustained temperature of >=38 degrees C (100.4 degrees F) for more than one hour |
|
| Atrial fibrillation | Cardiac disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by a dysrhythmia without discernible P waves and an irregular ventricular response due to multiple reentry circuits. The rhythm disturbance originates above the ventricles. |
|
| Paroxysmal atrial tachycardia | Cardiac disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by a dysrhythmia with abrupt onset and sudden termination of atrial contractions with a rate of 150-250 beats per minute. The rhythm disturbance originates in the atria. |
|
| Sinus tachycardia | Cardiac disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by a dysrhythmia with a heart rate greater than 100 beats per minute that originates in the sinus node. |
|
| Abdominal distension | Gastrointestinal disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by swelling of the abdomen. |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by a sensation of marked discomfort in the abdominal region. |
|
| Constipation | Gastrointestinal disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by irregular and infrequent or difficult evacuation of the bowels. |
|
| Diarrhea | Gastrointestinal disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by frequent and watery bowel movements. |
|
| Dry mouth | Gastrointestinal disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by reduced salivary flow in the oral cavity. |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by an uncomfortable, often painful feeling in the stomach, resulting from impaired digestion. Symptoms include burning stomach, bloating, heartburn, nausea and vomiting. |
|
| Hemorrhoids | Gastrointestinal disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by the presence of dilated veins in the rectum and surrounding area. |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by inflammation of the oral mucosal. |
|
| Nausea | Gastrointestinal disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by a queasy sensation and/or the urge to vomit. |
|
| Oral hemorrhage | Gastrointestinal disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by bleeding from the mouth. |
|
| Vomiting | Gastrointestinal disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by the reflexive act of ejecting the contents of the stomach through the mouth. |
|
| Chills | General disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by a sensation of cold that often marks a physiologic response to sweating after a fever. |
|
| Edema limbs | General disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by swelling due to excessive fluid accumulation in the upper or lower extremities. |
|
| Fatigue | General disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by a state of generalized weakness with a pronounced inability to summon sufficient energy to accomplish daily activities. |
|
| Fever | General disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by elevation of the body's temperature above the upper limit of normal. |
|
| Non-cardiac chest pain | General disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by discomfort in the chest unrelated to a heart disorder. |
|
| Pain | General disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by the sensation of marked discomfort, distress or agony. |
|
| Allergic reaction | Immune system disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by an adverse local or general response from exposure to an allergen. |
|
| Infections and infestations - Other | Infections and infestations | CTCAE 4.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by an infectious process involving the urinary tract, most commonly the bladder and the urethra. |
|
| Bruising | Injury, poisoning and procedural complications | CTCAE 4.0 | Non-systematic Assessment | A finding of injury of the soft tissues or bone characterized by leakage of blood into surrounding tissues. |
|
| Alanine aminotransferase increased | Investigations | CTCAE 4.0 | Non-systematic Assessment | A finding based on laboratory test results that indicate an increase in the level of alanine aminotransferase (ALT or SGPT) in the blood specimen. |
|
| Alkaline phosphatase increased | Investigations | CTCAE 4.0 | Non-systematic Assessment | A finding based on laboratory test results that indicate an increase in the level of alkaline phosphatase in a blood specimen. |
|
| Aspartate aminotransferase increased | Investigations | CTCAE 4.0 | Non-systematic Assessment | A finding based on laboratory test results that indicate an increase in the level of aspartate aminotransferase (AST or SGOT) in a blood specimen. |
|
| Blood bilirubin increased | Investigations | CTCAE 4.0 | Non-systematic Assessment | A finding based on laboratory test results that indicate an abnormally high level of bilirubin in the blood. Excess bilirubin is associated with jaundice. |
|
| Creatinine increased | Investigations | CTCAE 4.0 | Non-systematic Assessment | A finding based on laboratory test results that indicate increased levels of creatinine in a biological specimen. |
|
| Lymphocyte count decreased | Investigations | CTCAE 4.0 | Non-systematic Assessment | A finding based on laboratory test results that indicate a decrease in number of lymphocytes in a blood specimen. |
|
| Neutrophil count decreased | Investigations | CTCAE 4.0 | Non-systematic Assessment | A finding based on laboratory test results that indicate a decrease in number of neutrophils in a blood specimen. |
|
| Platelet count decreased | Investigations | CTCAE 4.0 | Non-systematic Assessment | A finding based on laboratory test results that indicate a decrease in number of platelets in a blood specimen. |
|
| Weight loss | Investigations | CTCAE 4.0 | Non-systematic Assessment | A finding characterized by a decrease in overall body weight; for pediatrics, less than the baseline growth curve. |
|
| White blood cell decreased | Investigations | CTCAE 4.0 | Non-systematic Assessment | A finding based on laboratory test results that indicate an decrease in number of white blood cells in a blood specimen. |
|
| Acidosis | Metabolism and nutrition disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by abnormally high acidity (high hydrogen-ion concentration) of the blood and other body tissues. |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by a loss of appetite. |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by excessive loss of water from the body. It is usually caused by severe diarrhea, vomiting or diaphoresis. |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by laboratory test results that indicate an elevation in the concentration of blood sugar. It is usually an indication of diabetes mellitus or glucose intolerance. |
|
| Hyperuricemia | Metabolism and nutrition disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by laboratory test results that indicate an elevation in the concentration of uric acid. |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by laboratory test results that indicate a low concentration of albumin in the blood. |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by laboratory test results that indicate a low concentration of calcium (corrected for albumin) in the blood. |
|
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by laboratory test results that indicate a low concentration of glucose in the blood. |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by laboratory test results that indicate a low concentration of potassium in the blood. |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by laboratory test results that indicate a low concentration of magnesium in the blood. |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by laboratory test results that indicate a low concentration of sodium in the blood. |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by laboratory test results that indicate a low concentration of phosphates in the blood. |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by a sensation of marked discomfort in a joint. |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by marked discomfort sensation in the back region. |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by a reduction in the strength of muscles in multiple anatomic sites. |
|
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by a reduction in the strength of the lower limb muscles. |
|
| Dizziness | Nervous system disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by a disturbing sensation of lightheadedness, unsteadiness, giddiness, spinning or rocking. |
|
| Headache | Nervous system disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by a sensation of marked discomfort in various parts of the head, not confined to the area of distribution of any nerve. |
|
| Confusion | Psychiatric disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by a lack of clear and orderly thought and behavior. |
|
| Depression | Psychiatric disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by melancholic feelings of grief or unhappiness. |
|
| Proteinuria | Renal and urinary disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by laboratory test results that indicate the presence of excessive protein in the urine. It is predominantly albumin, but also globulin. |
|
| Urinary retention | Renal and urinary disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by accumulation of urine within the bladder because of the inability to urinate. |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by sudden, often repetitive, spasmodic contraction of the thoracic cavity, resulting in violent release of air from the lungs and usually accompanied by a distinctive sound. |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by an uncomfortable sensation of difficulty breathing. |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by bleeding from the nose. |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by a decrease in the level of oxygen in the body. |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by marked discomfort sensation in the pharyngolaryngeal region. |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by an increase in amounts of fluid within the pleural cavity. Symptoms include shortness of breath, cough and marked chest discomfort. |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by inflammation focally or diffusely affecting the lung parenchyma. |
|
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by flaky and dull skin; the pores are generally fine, the texture is a papery thin texture. |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by excessive perspiration. |
|
| Purpura | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by hemorrhagic areas of the skin and mucous membrane. Newer lesions appear reddish in color. Older lesions are usually a darker purple color and eventually become a brownish-yellow color. |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by the presence of macules (flat) and papules (elevated). Also known as morbillform rash. |
|
| Skin and subcutaneous tissue disorders - Other | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by a pathological increase in blood pressure; a repeatedly elevation in the blood pressure exceeding 140 over 90 mm Hg. |
|
| Hypotension | Vascular disorders | CTCAE 4.0 | Non-systematic Assessment | A disorder characterized by a blood pressure that is below the normal expected for an individual in a given environment. |
|
| Vascular disorders - Other | Vascular disorders | CTCAE 4.0 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Olatoyosi Odenike, MD | The University of Chicago Medicine | (773) 702-6149 | todenike@medicine.bsd.uchicago.edu |
| ID | Term |
|---|---|
| D015473 | Leukemia, Promyelocytic, Acute |
| D009190 | Myelodysplastic Syndromes |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C517975 | AZD 6244 |
Not provided
Not provided
Not provided
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|