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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018419-14 | EudraCT Number |
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This study will assess the pharmacokinetics of nilotinib in Ph+ CML pediatric patients that are newly diagnosed or resistant or intolerant to imatinib or dasatinib or refractory or relapsed Ph+ ALL compared to the adult populations. It will also evaluate safety and activity of nilotinib as secondary objectives.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | 1 year to < 10 years pediatric patients with newly diagnosed CP-Ph+ CML, or CP or AP-Ph+ CML resistant/intolerant to imatinib and/or dasatinib, or relapsed/refractory Ph+ ALL (acute lymphoblastic leukemia) treated at the proposed dose of 230 mg/m2 bid. |
|
| Group 2 | Experimental | >= 10 years to <18 years pediatric patients with newly diagnosed CP-Ph+ CML, or CP or AP-Ph+ CML resistant/intolerant to imatinib and/or dasatinib, or relapsed/refractory Ph+ ALL (acute lymphoblastic leukemia) treated at the proposed dose of 230 mg/m2 bid. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nilotinib | Drug | Nilotinib capsules were delivered in bottles with dose strengths of 50mg, 150mg and 200mg. Patients were administered nilotinib 230 mg/m2 (per BSA) bid, orally, rounded to the nearest 50 mg (max single dose 400 mg) for 28 days (1 cycle) for up to 12 cycles prior to protocol amendment 3 and up to 24 cycles post amendment 3. Capsules were to be swallowed whole with water. Apple sauce (puréed apple) may have been used as a vehicle for dosing where capsules were not able to be swallowed whole with water. |
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Nilotinib Non-compartmental PK Parameters: Cmax | The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1. | Cycle 1 Day 1 |
| Summary of Nilotinib Non-compartmental PK Parameters: Tmax | The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1. | Cycle 1 Day 1 |
| Summary of Nilotinib Non-compartmental PK Parameters: AUClast (Last = 24h) | The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1. | Cycle 1 Day 1 |
| Summary of Nilotinib Non-compartmental PK Parameters: AUC0-12h | The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1. | Cycle 1 Day 1 |
| Summary of Nilotinib Steady-state PK Parameters: AUCss | The steady-state PK profiles of nilotinib in pediatric patients were estimated using trough sampling following multiple 230 mg/m2 bid doses | Cycle 1 Day 8 - Cycle 1 Day 28 |
| Summary of Nilotinib Steady-state PK Parameters: CLF (Body Surface Area (BSA) Adjusted) | The steady-state PK profiles of nilotinib in pediatric patients were estimated using trough sampling following multiple 230 mg/m2 bid doses | Cycle 1 Day 8 - Cycle 1 day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Ph+ CML Participants With Confirmed Complete Hematologic Response (CHR) | A confirmed complete hematological response (CHR) is defined when all of the following criteria are achieved at two consecutive assessments, at least 4 weeks apart: white blood cell (WBC) count < 10 × 109/L; platelet < 450 × 109/L; basophils < 5%; no blasts and promyelocytes in peripheral blood (PB); myelocytes + metamyelocytes < 5% in PB; and no extramedullary involvement. The information used for hematological assessment was to be obtained from the laboratory and extramedullary data, all merged by patient and date. |
Not provided
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 |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Bordeaux | Aquitaine | 33076 | France | ||
| Novartis Investigative Site |
Not provided
| Label | URL |
|---|---|
| Results for CAMN107A2120 can be found on the Novartis Clinical Trial Results Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | 1 year to < 10 years pediatric patients |
| FG001 | Group 2 | >= 10 years to <18 years pediatric patients |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
|
| Summary of Nilotinib Steady-state PK Parameters: Cmin | The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose. | Cycle 1 Day 8 - Cycle 1 Day 28 |
| minimum of 12 cycles (28 days per cycle) |
| Number of Ph+ CML Participants With Cytogenic Response | Cytogenetic response was initially assessed as the percentage of Ph+ metaphases in the bone marrow (BM) and performed within 21 days prior to study entry. A major cytogenetic response (0% to 35% Ph+ metaphases test positive for the Philadelphia chromosome) combines both complete cytogenetic (CCyR) and partial cytogenetic response (PCyR). CCyR implies 0% Ph+ metaphases in the BM, PCyR is > 0% to 35%, minor cytogenetic response (mCyR) is > 35% to 65%, minimal response is > 65% to 95% and no response is > 95% Ph+ metaphases in the BM. | minimum of 12 cycles (28 days per cycle) |
| Number of Ph+ CML Participants With Major Molecular Response (MMR) | The bcr-abl gene fusion encodes for a BCR-ABL fusion protein. Depending on the precise location of the fusion, the molecular weight of this protein can range from 185 to 210 kDa. Consequently BCR-ABL is referred to as p185 or p210 transcript. For the patients expressing the major BCR-ABL transcript p210, molecular response was defined and reported as the percent ratio of BCR-ABL transcripts/control gene transcripts converted to a reference standard according to the International Scale (IS). A major molecular response (MMR) is defined as a BCR-ABL/control gene ratio ≤ 0.1% (equal to a 3 log reduction in BCR-ABL transcripts) on the IS. In this study, the control gene was abl. | minimum of 12 cycles (28 days per cycle) |
| Efficacy Endpoints for Ph+ ALL Patients | Best Response in Ph+ ALL patients was defined as either Complete Remission (CR) with platelet recovery, Complete Remission (CR) with incomplete platelet recovery, Partial Remission (PR) or Stable disease. Stable disease was defined is defined as failure to qualify for either CR, PR, or progressive disease. | minimum of 12 cycles (28 days per cycle) |
| Lille |
| 59037 |
| France |
| Novartis Investigative Site | Paris | 75571 | France |
| Novartis Investigative Site | Poitiers | 86021 | France |
| Novartis Investigative Site | Monza | MB | 20900 | Italy |
| Novartis Investigative Site | Padova | PD | 35128 | Italy |
| Novartis Investigative Site | Roma | RM | 00161 | Italy |
| Novartis Investigative Site | Amsterdam | 1081 HV | Netherlands |
| Novartis Investigative Site | Rotterdam | 3015 CN | Netherlands |
| Novartis Investigative Site | West Midlands | Birmingham | B4 6NH | United Kingdom |
| Novartis Investigative Site | Sutton | Surrey | SM2 5PT | United Kingdom |
| Novartis Investigative Site | Bristol | BS2 8BJ | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full analysis set (FAS): consists of all patients who passed the screening and are enrolled into the study. Patients may or may not have taken study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | 1 year to < 10 years pediatric patients |
| BG001 | Group 2 | >= 10 years to <18 years pediatric patients |
| 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 |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Height | Mean | Standard Deviation | cm |
| |||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| 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 | Summary of Nilotinib Non-compartmental PK Parameters: Cmax | The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1. | Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Cycle 1 Day 1 |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Ph+ CML Participants With Confirmed Complete Hematologic Response (CHR) | A confirmed complete hematological response (CHR) is defined when all of the following criteria are achieved at two consecutive assessments, at least 4 weeks apart: white blood cell (WBC) count < 10 × 109/L; platelet < 450 × 109/L; basophils < 5%; no blasts and promyelocytes in peripheral blood (PB); myelocytes + metamyelocytes < 5% in PB; and no extramedullary involvement. The information used for hematological assessment was to be obtained from the laboratory and extramedullary data, all merged by patient and date. | Full analysis set (FAS): consists of all patients who passed the screening and are enrolled into the study. Patients may or may not have taken study drug. | Posted | Number | Participants | minimum of 12 cycles (28 days per cycle) |
|
| ||||||||||||||||||||||||||||||
| Primary | Summary of Nilotinib Non-compartmental PK Parameters: Tmax | The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1. | Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration. | Posted | Median | Full Range | h | Cycle 1 Day 1 |
|
| |||||||||||||||||||||||||||||
| Primary | Summary of Nilotinib Non-compartmental PK Parameters: AUClast (Last = 24h) | The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1. | Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Cycle 1 Day 1 |
|
| |||||||||||||||||||||||||||||
| Primary | Summary of Nilotinib Non-compartmental PK Parameters: AUC0-12h | The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1. | Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Cycle 1 Day 1 |
|
| |||||||||||||||||||||||||||||
| Primary | Summary of Nilotinib Steady-state PK Parameters: AUCss | The steady-state PK profiles of nilotinib in pediatric patients were estimated using trough sampling following multiple 230 mg/m2 bid doses | Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Cycle 1 Day 8 - Cycle 1 Day 28 |
|
| |||||||||||||||||||||||||||||
| Primary | Summary of Nilotinib Steady-state PK Parameters: CLF (Body Surface Area (BSA) Adjusted) | The steady-state PK profiles of nilotinib in pediatric patients were estimated using trough sampling following multiple 230 mg/m2 bid doses | Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/h/m^2) | Cycle 1 Day 8 - Cycle 1 day 28 |
|
| |||||||||||||||||||||||||||||
| Primary | Summary of Nilotinib Steady-state PK Parameters: Cmin | The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose. | Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Cycle 1 Day 8 - Cycle 1 Day 28 |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Ph+ CML Participants With Cytogenic Response | Cytogenetic response was initially assessed as the percentage of Ph+ metaphases in the bone marrow (BM) and performed within 21 days prior to study entry. A major cytogenetic response (0% to 35% Ph+ metaphases test positive for the Philadelphia chromosome) combines both complete cytogenetic (CCyR) and partial cytogenetic response (PCyR). CCyR implies 0% Ph+ metaphases in the BM, PCyR is > 0% to 35%, minor cytogenetic response (mCyR) is > 35% to 65%, minimal response is > 65% to 95% and no response is > 95% Ph+ metaphases in the BM. | FAS consist of all patients (pts) who passed screening & are enrolled into study. Patients may or may not have taken study drug. One (1) Ph+ CML patient in Group 2 was Ph+ at baseline & discontinued study prior to subsequent cytogenetic assessment. This pt doesn't appear in any cytogenic response category. | Posted | Number | Participants | minimum of 12 cycles (28 days per cycle) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Ph+ CML Participants With Major Molecular Response (MMR) | The bcr-abl gene fusion encodes for a BCR-ABL fusion protein. Depending on the precise location of the fusion, the molecular weight of this protein can range from 185 to 210 kDa. Consequently BCR-ABL is referred to as p185 or p210 transcript. For the patients expressing the major BCR-ABL transcript p210, molecular response was defined and reported as the percent ratio of BCR-ABL transcripts/control gene transcripts converted to a reference standard according to the International Scale (IS). A major molecular response (MMR) is defined as a BCR-ABL/control gene ratio ≤ 0.1% (equal to a 3 log reduction in BCR-ABL transcripts) on the IS. In this study, the control gene was abl. | Full analysis set (FAS): consists of all patients who passed the screening and are enrolled into the study. Patients may or may not have taken study drug. | Posted | Number | Participants | minimum of 12 cycles (28 days per cycle) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Efficacy Endpoints for Ph+ ALL Patients | Best Response in Ph+ ALL patients was defined as either Complete Remission (CR) with platelet recovery, Complete Remission (CR) with incomplete platelet recovery, Partial Remission (PR) or Stable disease. Stable disease was defined is defined as failure to qualify for either CR, PR, or progressive disease. | Full analysis set (FAS): consists of all patients who passed the screening and are enrolled into the study. Patients may or may not have taken study drug. | Posted | Number | Participants | minimum of 12 cycles (28 days per cycle) |
|
|
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 | Group 1 | 1 year to < 10 years pediatric patients | 2 | 8 | 8 | 8 | ||
| EG001 | Group 2 | >= 10 years to <18 years pediatric patients | 3 | 7 | 7 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Appendix disorder | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Xerosis | General disorders | MedDRA | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Lip infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood bilirubin unconjugated increased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA | Systematic Assessment |
| |
| Haematocrit decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Red blood cell count decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Tendon pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Dyshidrotic eczema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 82-778-8300 | trialandresults.registries@novartis.com |
| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| 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 |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C498826 | nilotinib |
Not provided
Not provided
Not provided
| Male |
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| Participants |
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| Participants |
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