Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the efficacy, safety and tolerability of AZD1152 alone and in combination with low dose cytosine arabinoside (LDAC) in comparison with LDAC alone in AML patients.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD1152 1200 mg | Experimental | AZD1152 1200 mg, iv, 7 day infusion monotherapy |
|
| LDAC 20 mg | Active Comparator | LDAC 20 mg, sc, bd, 10 days (400mg per cycle) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1152 | Drug | 1200 mg, iv, 7 day infusion |
| |
| LDAC |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Overall Complete Response for Stage I | Percentage of patients achieving either a complete response (CR) or a confirmed complete remission with incomplete recovery of neutrophils or platelets (confirmed CRi). Per Cheson Criteria: Confirmed complete remission (CRi) is defined as a disappearance of blasts in the peripheral blood; a decrease in bone marrow blasts to <5% total bone marrow nucleated cells demonstrated in bone marrow aspirate; absence of Auer rods; no persistent extramedullary leukaemia. Complete response (CR) is defined as all requirements to meet CRi and in addition: recovery of neutrophils to ≥1.0 x 109/L and platelets to ≥100 x 109/L; transfusion-independence. | IWG Cheson criteria every 28 days from randomization for study duration (24 months, between 2009 - 2011) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DoR): Stage I and Transition Phase | DoR was defined for the median of days which showed a confirmed CRi or CR, as the time from first documented evidence of CRi or CR until the first documented sign of disease progression or death. Duration of Response was measured from the Response Start date until evidence of patient relapse or death. Stage I : 45 patients randomized in a 2:1 ratio to AZD1152 or LDAC. Transition phase: enrollment of up to 30 additional patients randomized as per stage I. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Paul Stockman | AstraZeneca | Study Director |
| Hagop Kantarjian | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Atlanta | Georgia | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23071272 | Derived | Quintas-Cardama A, Ravandi F, Liu-Dumlao T, Brandt M, Faderl S, Pierce S, Borthakur G, Garcia-Manero G, Cortes J, Kantarjian H. Epigenetic therapy is associated with similar survival compared with intensive chemotherapy in older patients with newly diagnosed acute myeloid leukemia. Blood. 2012 Dec 6;120(24):4840-5. doi: 10.1182/blood-2012-06-436055. Epub 2012 Oct 15. |
Not provided
Not provided
Not provided
First patient was randomized on 22/07/2009 and last patient last visit has occurred on 27/06/2011.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | AZD1152 1200mg | AZD1152 1200 mg, iv, 7 day infusion monotherapy |
| FG001 | LDAC 20mg | LDAC 20 mg, sc, bd, 10 days (400mg per cycle) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
20 mg, sc, bd, 10 days |
|
| DoR was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011) |
| Disease Free Survival (DFS) | Disease-free Survival is defined as the time from randomisation to relapse or death from any cause. | DFS was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011) |
| Time To Complete Response (TTCR) | TTCR is measured as time from randomization to either a complete response (CR) or a confirmed complete remission with incomplete recovery of neutrophils or platelets (confirmed CRi) | Response was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011) |
| Overall Survival (OS) | Overall Survival is defined as the median time from randomisation to death from any cause. Patients who were not known to have died at the time of the analysis were censored at the date they were last known to be alive. | Assessed from randomisation until the date of death from any cause, assessed up to 24 months |
| Percent of Patients With Worsened Trial Outcome Index (TOI) | TOI is derived from the sum of the Functional Well Being (FWB), Physical Well Being (PWB) and additional subscales of the FACT-Leu. The TOI subscale consists of 31 items with TOI scores ranging from 0 to 124. The TOI is described as a summary measure of HRQoL. Higher scores indicate better HRQoL. Negative changes from baseline indicate a worsening of HRQoL while positive changes indicate an improvement in HRQoL. A response of "Worsened" was a change from baseline in score of less than or equal to -9. | TOI was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011) |
| Percent of Patients With Worsened Functional Assessment of Cancer Therapy - Leukaemia (FACT-Leu) Score. | The total FACT-Leu score consists of 44 items with total scores ranging from 0 to 176. Higher scores indicate better HRQoL. Negative changes from baseline indicate a worsening of HRQoL while positive changes indicate an improvement in HRQoL. A response of "Worsened" was a change from baseline in score of less than or equal to -11. | FACT-Leu was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011) |
| Chicago |
| Illinois |
| United States |
| Research Site | New York | New York | United States |
| Research Site | Cleveland | Ohio | United States |
| Research Site | Portland | Oregon | United States |
| Research Site | Greenville | South Carolina | United States |
| Research Site | Nashville | Tennessee | United States |
| Research Site | Houston | Texas | United States |
| Research Site | Westmead | New South Wales | Australia |
| Research Site | Herston | Queensland | Australia |
| Research Site | Melbourne | Victoria | Australia |
| Research Site | Parkville | Victoria | Australia |
| Research Site | Angers | France |
| Research Site | Clermont-Ferrand | France |
| Research Site | Grenoble | France |
| Research Site | Lyon | France |
| Research Site | Marseille | France |
| Research Site | Nantes | France |
| Research Site | Duisburg | Germany |
| Research Site | Erlangen | Germany |
| Research Site | Frankfurt | Germany |
| Research Site | Münster | Germany |
| Research Site | Villingen-Schwenningen | Germany |
| Research Site | Bologna | BO | Italy |
| Research Site | Genova | GE | Italy |
| Research Site | Orbassano | TO | Italy |
| Research Site | Udine | UD | Italy |
| Research Site | Roma | Italy |
| Research Site | Nagoya | Aichi-ken | Japan |
| Research Site | Yoshida-gun | Fukui | Japan |
| Research Site | Maebashi | Gunma | Japan |
| Research Site | Isehara | Kanagawa | Japan |
| Research Site | Yokohama | Kanagawa | Japan |
| Research Site | Chūō | Tokyo | Japan |
| Research Site | Fukuoka | Japan |
| Research Site | Brasov | Romania |
| Research Site | TG Mures | Romania |
| Research Site | Badalona(barcelona) | Catalonia | Spain |
| Research Site | Barcelona | Catalonia | Spain |
| Research Site | Madrid | Madrid | Spain |
| Research Site | Majadahonda | Madrid | Spain |
| Research Site | Oviedo | Principality of Asturias | Spain |
| Research Site | Valencia | Valencia | Spain |
| Research Site | Brighton | United Kingdom |
| Research Site | London | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AZD1152 1200mg | AZD1152 1200 mg, iv, 7 day infusion monotherapy |
| BG001 | LDAC 20mg | LDAC 20 mg, sc, bd, 10 days (400mg per cycle) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | 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 | Percentage of Patients With Overall Complete Response for Stage I | Percentage of patients achieving either a complete response (CR) or a confirmed complete remission with incomplete recovery of neutrophils or platelets (confirmed CRi). Per Cheson Criteria: Confirmed complete remission (CRi) is defined as a disappearance of blasts in the peripheral blood; a decrease in bone marrow blasts to <5% total bone marrow nucleated cells demonstrated in bone marrow aspirate; absence of Auer rods; no persistent extramedullary leukaemia. Complete response (CR) is defined as all requirements to meet CRi and in addition: recovery of neutrophils to ≥1.0 x 109/L and platelets to ≥100 x 109/L; transfusion-independence. | modified Intent to Treat (ITT) | Posted | Number | percentage of participants | IWG Cheson criteria every 28 days from randomization for study duration (24 months, between 2009 - 2011) |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR): Stage I and Transition Phase | DoR was defined for the median of days which showed a confirmed CRi or CR, as the time from first documented evidence of CRi or CR until the first documented sign of disease progression or death. Duration of Response was measured from the Response Start date until evidence of patient relapse or death. Stage I : 45 patients randomized in a 2:1 ratio to AZD1152 or LDAC. Transition phase: enrollment of up to 30 additional patients randomized as per stage I. | modified Intent to Treat (mITT) | Posted | Median | Inter-Quartile Range | days | DoR was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011) |
|
| |||||||||||||||||||||||||||||
| Secondary | Disease Free Survival (DFS) | Disease-free Survival is defined as the time from randomisation to relapse or death from any cause. | modified Intent to Treat (mITT) | Posted | Median | Inter-Quartile Range | months | DFS was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011) |
|
| |||||||||||||||||||||||||||||
| Secondary | Time To Complete Response (TTCR) | TTCR is measured as time from randomization to either a complete response (CR) or a confirmed complete remission with incomplete recovery of neutrophils or platelets (confirmed CRi) | modified Intent to Treat (mITT) | Posted | Median | Inter-Quartile Range | days | Response was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011) |
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall Survival is defined as the median time from randomisation to death from any cause. Patients who were not known to have died at the time of the analysis were censored at the date they were last known to be alive. | modified Intent to Treat (mITT) | Posted | Median | Full Range | months | Assessed from randomisation until the date of death from any cause, assessed up to 24 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Percent of Patients With Worsened Trial Outcome Index (TOI) | TOI is derived from the sum of the Functional Well Being (FWB), Physical Well Being (PWB) and additional subscales of the FACT-Leu. The TOI subscale consists of 31 items with TOI scores ranging from 0 to 124. The TOI is described as a summary measure of HRQoL. Higher scores indicate better HRQoL. Negative changes from baseline indicate a worsening of HRQoL while positive changes indicate an improvement in HRQoL. A response of "Worsened" was a change from baseline in score of less than or equal to -9. | modified Intent to Treat (mITT) | Posted | Number | percentage of participants | TOI was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percent of Patients With Worsened Functional Assessment of Cancer Therapy - Leukaemia (FACT-Leu) Score. | The total FACT-Leu score consists of 44 items with total scores ranging from 0 to 176. Higher scores indicate better HRQoL. Negative changes from baseline indicate a worsening of HRQoL while positive changes indicate an improvement in HRQoL. A response of "Worsened" was a change from baseline in score of less than or equal to -11. | modified Intent to Treat (mITT) | Posted | Number | percentage of participants | FACT-Leu was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011) |
|
|
Not provided
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 | AZD1152 1200mg | AZD1152 1200 mg, iv, 7 day infusion monotherapy | 23 | 48 | 33 | 48 | ||
| EG001 | LDAC 20mg | LDAC 20 mg, sc, bd, 10 days (400mg per cycle) | 10 | 26 | 10 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Febrile Bone Marrow Aplasia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Myocardial Ischaemia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Device Occlusion | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Arthritis Infective | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Clostridium Difficile Sepsis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Enterococcal Bacteraemia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Escherichia Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Lobar Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Lung Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Neutropenic Sepsis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Oral Candidiasis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Pulmonary Mycosis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Subdural Haematoma | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| White Blood Cell Count Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Blast Cell Proliferation | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Acute Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Lung Infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Conjunctival Haemorrhage | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Oral Pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Tongue Ulceration | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Gingival Bleeding | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Catheter Site Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Catheter Site Related Reaction | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Catheter Site Haematoma | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Injection Site Haematoma | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Oral Candidiasis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Breath Sounds Abnormal | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Blood Pressure Decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Weight Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pallor | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca | 1-877-240-9479 | information.center@astrazeneca.com |
| ID | Term |
|---|---|
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C520647 | 2-((3-((4-((5-(2-((3-fluorophenyl)amino)-2-oxoethyl)-1H-pyrazol-3-yl)amino)quinazolin-7-yl)oxy)propyl)(ethyl)amino)ethyl dihydrogen phosphate |
Not provided
Not provided
Not provided
| Male |
|
|
|
|
|
|
|