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The purpose of this exploratory study will be to examine changes in chronic low grade chronic adverse events, measured by Common Terminology Criteria for Adverse Events (CTCAE) grading, when patients are switched from imatinib to nilotinib therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nilotinib | Experimental | Participants received two 150 [a total of 300 mg at each dosing] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules [a total of 400 mg at each dosing] for patients enrolled prior to Protocol Amendment 1). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nilotinib | Drug | Participants received two 150 [a total of 300 mg at each dosing] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules [a total of 400 mg at each dosing] for patients enrolled prior to Protocol Amendment 1). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Improvement in Imatinib Related Chronic Low Grade Non Hematologic Adverse Event (AE) After Switch to Treatment With Nilotinib at End of Cycle 3 | A patient was considered improved if 50% or more of the chronic imatinib-related chronic low grade nonhematologic AEs showed improvement (a decrease in CTCAE [Common Terminology Criteria for Adverse Events] grade or complete resolution). | End of Cycles 1, 2, and 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Complete Cytogenetic Response (CCyR) After Switching to Nilotinib for Participants Not Reporting CCyR at Baseline | Time to complete cytogenetic response is defined as time from baseline to first time of CCyR as documented by bone marrow cytogenetics. Cytogenetic response was assessed as applicable by bone marrow cytogenetics 6, 12, and 18 months after starting imatinib therapy. Assess CCyR by bone marrow cytogenics |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Highlands Oncology Group | Fayetteville | Arkansas | 72703 | United States | ||
| Hematology Oncology Services of Arkansas SC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26993758 | Derived | Cortes JE, Lipton JH, Miller CB, Busque L, Akard LP, Pinilla-Ibarz J, Keir C, Warsi G, Lin FP, Mauro MJ. Evaluating the Impact of a Switch to Nilotinib on Imatinib-Related Chronic Low-Grade Adverse Events in Patients With CML-CP: The ENRICH Study. Clin Lymphoma Myeloma Leuk. 2016 May;16(5):286-96. doi: 10.1016/j.clml.2016.02.002. Epub 2016 Feb 16. |
| Label | URL |
|---|---|
| Related Info | View source |
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A total of 68 patients were screened out of which 52 enrolled and 40 completed the full duration of treatment.
The study was conducted at 15 centers in US and 4 centers in Canada from 10-December-2009 (first patient first visit) to 27-December-2012 (last patient last visit).
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| ID | Title | Description |
|---|---|---|
| FG000 | Nilotinib | Participants received two 150 [a total of 300 mg at each dosing] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules [a total of 400 mg at each dosing] for patients enrolled prior to Protocol Amendment 1). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Cycles 1, 2, 6, 9, and 12 |
| Percentage of Participants Achieving Major Molecular Response (MMR) After the Switch in the Therapy for Participants Not Reporting MMR at Baseline | Major Molecular Response (MMR) value at Molecular MD is designated a percentage, which is equivalent to a 3-log reduction from a standardized baseline value from the International Randomized Interferon versus STI571 (IRIS) study or 0.1% per International Scale (IS). Time to MMR is defined as time from baseline to first time of MMR as documented by RQ-PCR | Cycles 1,2,3,6,9,12 |
| Log Change in BCR-Abl Transcript Level From Baseline After the Switch Therapy | Levels of BCR-ABL transcripts were determined by quantitative RQ-PCR testing of peripheral blood and analyzed at a central testing laboratory. Log reduction in BCR-ABL transcripts levels from the standardized baseline value will be calculated for each sample from the reported percent ratio of BCR-ABL transcripts versus control gene transcripts converted to a reference standard. | Cycles 1,2,3,6,9, and 12 |
| Duration of Complete Cytogenetic Response | Duration of Complete Cytogenetic Response is defined as the time from first CCyR to first loss of CCyR as documented by bone marrow cytogenetics, or by FISH assay, whichever is earlier. The duration of CCyR begins on the day of enrollment for patients reporting CCyR at baseline. | 18 months of follow up from the first documented response |
| Time to Complete Cytogenetic Response in Participants Not Reporting at Baseline | For time to CCyR, an event is defined as achievement of CCyR documented by bone marrow cytogenetics. | Cycle 12 |
| Duration of Major Molecular Response | Duration of Major Molecular Response is defined as the time from first MMR to first loss of MMR as documented by RQ-PCR. The duration of MMR begins on the day of enrollment for patients reporting MMR at baseline. | 18 months of follow up from the first documented response |
| Time to Major Molecular Response (MMR) in Participants With MMR Absent at Baseline | For time to MMR, an event is defined as achievement of MMR documented by RQ-PCR. Patients with MMR at the Screening RQ-PCR assay are counted as having time to MMR equal to 0. | Cycles 1,2,3,6,9,12 |
| Time to Optimal Imatinib-related Adverse Event Improvement | Time to optimal improvement is defined as the time when the sum of the total CTCAE toxicity grades for a patient's chronic low-grade imatinib-related adverse events reaches its minimum value. | 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| USC Norris Cancer Center LAC & USC Medical Center | Los Angeles | California | 90033 | United States |
| Southwest Cancer Care Murrieta | Poway | California | 92064 | United States |
| Rocky Mountain Cancer Centers RMCC - Aurora | Greenwood Village | Colorado | United States |
| Florida Cancer Institute | New Port Richey | Florida | 34655 | United States |
| Cancer Centers of Florida PA Cancer Centers of FL-Orlando-4 | Ocoee | Florida | *see dep* | United States |
| Stroger Cook County Hospital John H. Stroger Hospital | Chicago | Illinois | 60612 | United States |
| St. Francis Hospital and Health Centers IndianaBlood&MarrowTransplantn | Beech Grove | Indiana | 46107 | United States |
| St. Agnes Hospital | Baltimore | Maryland | 21229 | United States |
| St. Louis University Cancer Center | St Louis | Missouri | 63110 | United States |
| Northwest Cancer Specialists Salmon Creek Office | Portland | Oregon | 97210 | United States |
| Oregon Health Sciences University | Portland | Oregon | 97239 | United States |
| The Jones Clinic | Germantown | Tennessee | 38138 | United States |
| Texas Oncology, P.A. | Bedford | Texas | 76022 | United States |
| Presbyterian Hospital of Dallas TexasOncology@PresbyterianHosp | Dallas | Texas | 75231 | United States |
| Texas Oncology Texas Oncology - Sugar Land | Dallas | Texas | 75246 | United States |
| MD Anderson Cancer Center/University of Texas | Houston | Texas | 77031 | United States |
| Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2) | San Antonio | Texas | 78229 | United States |
| Novartis Investigative Site | Brampton | Ontario | L6R 3J7 | Canada |
| Novartis Investigative Site | Toronto | Ontario | M5G 2M9 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H1T 2M4 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H3A 1A1 | Canada |
| COMPLETED |
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| NOT COMPLETED |
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Safety Set : All participants who received at least one dose of study drug and had at least one post-baseline safety assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Nilotinib | Participants received two 150 [a total of 300 mg at each dosing] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules [a total of 400 mg at each dosing] for patients enrolled prior to Protocol Amendment 1). |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
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| 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 Participants With Improvement in Imatinib Related Chronic Low Grade Non Hematologic Adverse Event (AE) After Switch to Treatment With Nilotinib at End of Cycle 3 | A patient was considered improved if 50% or more of the chronic imatinib-related chronic low grade nonhematologic AEs showed improvement (a decrease in CTCAE [Common Terminology Criteria for Adverse Events] grade or complete resolution). | Full Analysis Set (FAS): All participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | End of Cycles 1, 2, and 3 |
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| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Complete Cytogenetic Response (CCyR) After Switching to Nilotinib for Participants Not Reporting CCyR at Baseline | Time to complete cytogenetic response is defined as time from baseline to first time of CCyR as documented by bone marrow cytogenetics. Cytogenetic response was assessed as applicable by bone marrow cytogenetics 6, 12, and 18 months after starting imatinib therapy. Assess CCyR by bone marrow cytogenics | FAS : All participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | Cycles 1, 2, 6, 9, and 12 |
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| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Major Molecular Response (MMR) After the Switch in the Therapy for Participants Not Reporting MMR at Baseline | Major Molecular Response (MMR) value at Molecular MD is designated a percentage, which is equivalent to a 3-log reduction from a standardized baseline value from the International Randomized Interferon versus STI571 (IRIS) study or 0.1% per International Scale (IS). Time to MMR is defined as time from baseline to first time of MMR as documented by RQ-PCR | FAS : All participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | Cycles 1,2,3,6,9,12 |
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| Secondary | Log Change in BCR-Abl Transcript Level From Baseline After the Switch Therapy | Levels of BCR-ABL transcripts were determined by quantitative RQ-PCR testing of peripheral blood and analyzed at a central testing laboratory. Log reduction in BCR-ABL transcripts levels from the standardized baseline value will be calculated for each sample from the reported percent ratio of BCR-ABL transcripts versus control gene transcripts converted to a reference standard. | FAS: All participants who received at least one dose of study drug. | Posted | Mean | Standard Deviation | log change from Baseline | Cycles 1,2,3,6,9, and 12 |
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| Secondary | Duration of Complete Cytogenetic Response | Duration of Complete Cytogenetic Response is defined as the time from first CCyR to first loss of CCyR as documented by bone marrow cytogenetics, or by FISH assay, whichever is earlier. The duration of CCyR begins on the day of enrollment for patients reporting CCyR at baseline. | FAS: All participants who received at least one dose of study drug. | Posted | Mean | Standard Deviation | days | 18 months of follow up from the first documented response |
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| ||||||||||||||||||||||||||||||||||||
| Secondary | Time to Complete Cytogenetic Response in Participants Not Reporting at Baseline | For time to CCyR, an event is defined as achievement of CCyR documented by bone marrow cytogenetics. | FAS: All participants who received at least one dose of study drug. | Posted | Median | 95% Confidence Interval | months | Cycle 12 |
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| Secondary | Duration of Major Molecular Response | Duration of Major Molecular Response is defined as the time from first MMR to first loss of MMR as documented by RQ-PCR. The duration of MMR begins on the day of enrollment for patients reporting MMR at baseline. | FAS : All participants who received at least one dose of study drug. | Posted | Mean | Standard Deviation | days | 18 months of follow up from the first documented response |
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| Secondary | Time to Major Molecular Response (MMR) in Participants With MMR Absent at Baseline | For time to MMR, an event is defined as achievement of MMR documented by RQ-PCR. Patients with MMR at the Screening RQ-PCR assay are counted as having time to MMR equal to 0. | FAS : All participants who received at least one dose of study drug. | Posted | Median | 95% Confidence Interval | months | Cycles 1,2,3,6,9,12 |
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| Secondary | Time to Optimal Imatinib-related Adverse Event Improvement | Time to optimal improvement is defined as the time when the sum of the total CTCAE toxicity grades for a patient's chronic low-grade imatinib-related adverse events reaches its minimum value. | FAS: All participants who received at least one dose of study drug. | Posted | Median | 95% Confidence Interval | months | 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events |
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18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nilotinib | Participants received two 150 [a total of 300 mg at each dosing] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules [a total of 400 mg at each dosing] for patients enrolled prior to Protocol Amendment 1). | 0 | 52 | 9 | 52 | 49 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA (??.?) | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA (??.?) | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA (??.?) | Systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA (??.?) | Systematic Assessment |
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| Pain | General disorders | MedDRA (??.?) | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA (??.?) | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (??.?) | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (??.?) | Systematic Assessment |
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| Vulval cellulitis | Infections and infestations | MedDRA (??.?) | Systematic Assessment |
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| Wound infection bacterial | Infections and infestations | MedDRA (??.?) | Systematic Assessment |
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| Wound infection staphylococcal | Infections and infestations | MedDRA (??.?) | Systematic Assessment |
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| Cartilage injury | Injury, poisoning and procedural complications | MedDRA (??.?) | Systematic Assessment |
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| Scapula fracture | Injury, poisoning and procedural complications | MedDRA (??.?) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (??.?) | Systematic Assessment |
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| Facial palsy | Nervous system disorders | MedDRA (??.?) | Systematic Assessment |
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| Ovarian torsion | Reproductive system and breast disorders | MedDRA (??.?) | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (??.?) | Systematic Assessment |
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| Arteriosclerosis | Vascular disorders | MedDRA (??.?) | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (??.?) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry eye | Eye disorders | MedDRA (??.?) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (??.?) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (??.?) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (??.?) | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA (??.?) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (??.?) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (??.?) | Systematic Assessment |
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| Chest pain | General disorders | MedDRA (??.?) | Systematic Assessment |
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| Chills | General disorders | MedDRA (??.?) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (??.?) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (??.?) | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (??.?) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (??.?) | Systematic Assessment |
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| Lipase increased | Investigations | MedDRA (??.?) | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA (??.?) | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA (??.?) | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (??.?) | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (??.?) | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (??.?) | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (??.?) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (??.?) | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (??.?) | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (??.?) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (??.?) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (??.?) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (??.?) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (??.?) | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA (??.?) | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA (??.?) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (??.?) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (??.?) | Systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (??.?) | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (??.?) | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (??.?) | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (??.?) | Systematic Assessment |
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| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (??.?) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (??.?) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (??.?) | Systematic Assessment |
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| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (??.?) | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA (??.?) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C498826 | nilotinib |
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