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| Name | Class |
|---|---|
| University of Chicago | OTHER |
| University of California, San Francisco | OTHER |
| University of Utah | OTHER |
| Dana-Farber Cancer Institute |
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This is a non-randomized, prospective, single-group longitudinal study. The purpose of this study is to improve the decision making process used by physicians and patients when they are considering stopping their Tyrosine Kinase Inhibitor (TKI) medication.
This is a non-randomized, prospective, single-group longitudinal study. The overall objective is to improve decision making for TKI discontinuation in eligible chronic myelogenous leukemia (CML) patients. Patients with CML on treatment with imatinib, dasatinib, nilotinib, or bosutinib and are in confirmed deep molecular response will stop their TKI. Confirmed deep (> 4 log reduction) molecular response (>MR4) defined as p210 (bcr-abl) fusion protein (BCR-ABL) < 0.01%, for at least two years. The study will closely monitor patients using standard real-time Quantitative Polymerase Chain Reaction (RQ-PCR) testing for molecular recurrence, testing them monthly for six months, then every other month until 24 months, and then quarterly until 36 months. Concurrently, the study will assess a wide range of patient-reported outcomes (PROs) before stopping TKIs and after discontinuation in conjunction with Polymerase Chain Reaction (PCR) testing, though at fewer time points, utilizing online and/or phone questionnaires. Patients who have molecular CML recurrence based on RQ-PCR will restart imatinib, dasatinib, nilotinib, or bosutinib and will continue to be monitored for disease status and health status until the end of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Discontinuation of TKI medication | Other | Patients with CML on treatment with imatinib, dasatinib, nilotinib, or bosutinib and are in confirmed deep molecular response will stop their TKI. Confirmed deep (> 4 log reduction) molecular response (>MR4) defined as p210 (bcr-abl) fusion protein (BCR-ABL) < 0.01%, for at least two years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imatinib (Stopping their TKI) | Drug | Patients with CML on treatment with imatinib and are in confirmed deep molecular response will stop their TKI. Confirmed deep (> 4 log reduction) molecular response (>MR4) defined as p210 (bcr-abl) fusion protein (BCR-ABL) < 0.01%, for at least two years. Concurrently, the study will assess a wide range of PROs before stopping TKIs and after discontinuation in conjunction with PCR testing, though at fewer time points, utilizing online and/or phone questionnaires. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Chronic Myeloid Leukemia (CML) Who Develop Molecular Recurrence After Discontinuing TKIs. | The number of patients who develop molecular recurrence after discontinuing TKIs. This will be reported as the number of new occurrences from the end of the prior time frame. | 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 27, 30, 33, 36 months |
| Patient-reported Health Status Related to Fatigue of Patients at Baseline (Before Stopping Tyrosine Kinase Inhibitors (TKIs) | Patient-reported health status of fatigue using the Patient-Reported Outcomes Measurement Information System (PROMIS) scales. The research team used five questions. The responses are in a Likert -style scale numbered one to five -- 1 (not at all) and 5 (very much). PROMIS scales use a T-score metric for interpretation of results. The mean score for a relevant reference population (United States general population in this case) is 50 and 10 is the standard deviation of that population. T-score range is 20 to 80. Thus, a score of 40 is one standard deviation lower than the reference population mean and a score of 60 is one standard deviation higher than the reference population mean. Higher scores for this scale are indicative of worse symptoms. | Baseline |
| Patient-reported Health Status Related to Fatigue of Patients at 6 Months (After Stopping Tyrosine Kinase Inhibitors (TKIs) | Patient-reported health status of fatigue using the Patient-Reported Outcomes Measurement Information System (PROMIS) scales. The research team used five questions. The responses are in a Likert -style scale numbered one to five -- 1 (not at all) and 5 (very much). PROMIS scales use a T-score metric for interpretation of results. The mean score for a relevant reference population (United States general population in this case) is 50 and 10 is the standard deviation of that population. T-score range is 20 to 80. Thus, a score of 40 is one standard deviation lower than the reference population mean and a score of 60 is one standard deviation higher than the reference population mean. Higher scores for this scale are indicative of worse symptoms. | Six months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ehab Atallah, MD | Medical College of Wisconsin | Principal Investigator |
| Kathryn Flynn, PhD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helen Diller Family Comprehensive Cancer Center University of California | San Francisco | California | 94143 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29609532 | Result | Atallah E, Schiffer CA, Weinfurt KP, Zhang MJ, Radich JP, Oehler VG, Pinilla-Ibarz J, Deininger MWN, Lin L, Larson RA, Mauro MJ, Moore JO, Ritchie EK, Shah NP, Silver RT, Wadleigh M, Cortes J, Thompson J, Guhl J, Horowitz MM, Flynn KE. Design and rationale for the life after stopping tyrosine kinase inhibitors (LAST) study, a prospective, single-group longitudinal study in patients with chronic myeloid leukemia. BMC Cancer. 2018 Apr 2;18(1):359. doi: 10.1186/s12885-018-4273-1. | |
| 33180106 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Discontinuation of TKI Medication | Patients with CML on treatment with imatinib, dasatinib, nilotinib, or bosutinib and are in confirmed deep molecular response will stop their TKI. Confirmed deep (> 4 log reduction) molecular response (>MR4) defined as p210 (bcr-abl) fusion protein (BCR-ABL) < 0.01%, for at least two years. Concurrently, the study will assess a wide range of PROs before stopping TKIs and after discontinuation in conjunction with polymerase chain reaction (PCR) testing, though at fewer time points, utilizing online and/or phone questionnaires. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 23, 2017 |
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| OTHER |
| Emory University | OTHER |
| Barbara Ann Karmanos Cancer Institute | OTHER |
| Duke Cancer Institute | OTHER |
| Fred Hutchinson Cancer Center | OTHER |
| Memorial Sloan Kettering Cancer Center | OTHER |
| Weill Medical College of Cornell University | OTHER |
| H. Lee Moffitt Cancer Center and Research Institute | OTHER |
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|
|
| Dasatinib (Stopping their TKI) | Drug | Patients with CML on treatment with dasatinib and are in confirmed deep molecular response will stop their TKI. Confirmed deep (> 4 log reduction) molecular response (>MR4) defined as p210 (bcr-abl) fusion protein (BCR-ABL) < 0.01%, for at least two years. Concurrently, the study will assess a wide range of PROs before stopping TKIs and after discontinuation in conjunction with PCR testing, though at fewer time points, utilizing online and/or phone questionnaires. |
|
|
| Nilotinib (Stopping their TKI) | Drug | Patients with CML on treatment with nilotinib and are in confirmed deep molecular response will stop their TKI. Confirmed deep (> 4 log reduction) molecular response (>MR4) defined as p210 (bcr-abl) fusion protein (BCR-ABL) < 0.01%, for at least two years. Concurrently, the study will assess a wide range of PROs before stopping TKIs and after discontinuation in conjunction with PCR testing, though at fewer time points, utilizing online and/or phone questionnaires. |
|
|
| Bosutinib (Stopping their TKI) | Drug | Patients with CML on treatment with bosutinib and are in confirmed deep molecular response will stop their TKI. Confirmed deep (> 4 log reduction) molecular response (>MR4) defined as p210 (bcr-abl) fusion protein (BCR-ABL) < 0.01%, for at least two years. Concurrently, the study will assess a wide range of PROs before stopping TKIs and after discontinuation in conjunction with PCR testing, though at fewer time points, utilizing online and/or phone questionnaires. |
|
|
| Patient-reported Health Status Related to Diarrhea of Patients at Baseline (Before Stopping Tyrosine Kinase Inhibitors (TKIs) |
Patient-reported health status of diarrhea using the Patient-Reported Outcomes Measurement Information System (PROMIS) scales. There are two unrelated questions. Question no. 1 focuses on loose or watery stool and asks how many days the subject experienced this. O is no days and 4 is six to seven days. Question no. 2 asks if the subject often feels the need to empty the bowel right away. Responses are 0 (never) to 4 (more than once a day). Responses are a Likert -style scale numbered one to five -- 1 (not at all) and 5 (very much). PROMIS scales use a T-score metric interpret results. The mean score for a relevant reference population (United States general population) is 50 and 10 is the standard deviation of the population. T-score range is 20 to 80. A score of 40 is one standard deviation lower than the reference population mean and 60 is one standard deviation higher than the reference population mean. Higher scores indicate worse symptoms. |
| Baseline |
| Patient-reported Health Status Related to Diarrhea of Patients at 6 Months (After Stopping Tyrosine Kinase Inhibitors (TKIs) | Patient-reported health status of diarrhea using the Patient-Reported Outcomes Measurement Information System (PROMIS) scales. There are two unrelated questions. Question no. 1 focuses on loose or watery stool and asks how many days the subject experienced this. O is no days and 4 is six to seven days. Question no. 2 asks if the subject often feels the need to empty the bowel right away. Responses are 0 (never) to 4 (more than once a day). Responses are a Likert -style scale numbered one to five -- 1 (not at all) and 5 (very much). PROMIS scales use a T-score metric interpret results. The mean score for a relevant reference population (United States general population) is 50 and 10 is the standard deviation of the population. T-score range is 20 to 80. A score of 40 is one standard deviation lower than the reference population mean and 60 is one standard deviation higher than the reference population mean. Higher scores indicate worse symptoms. | Six months |
| Patient-reported Health Status Related to Sleep Status of Patients at Baseline (Before Stopping Tyrosine Kinase Inhibitors (TKIs) | Patient-reported health status of sleep using the Patient-Reported Outcomes Measurement Information System (PROMIS) scales. There are four questions. The responses are in a Likert Scale numbered one to five. All questions are regarding the quality of sleep. The answers are one (not at all) to 5 (very much). PROMIS scales use a T-score metric interpret results. The mean score for a relevant reference population (United States general population) is 50 and 10 is the standard deviation of the population. T-score range is 20 to 80. A score of 40 is one standard deviation lower than the reference population mean and 60 is one standard deviation higher than the reference population mean. Higher scores indicate worse symptoms. | Baseline |
| Patient-reported Health Status Related to Sleep Status of Patients at 6 Months (After Stopping Tyrosine Kinase Inhibitors (TKIs) | Patient-reported health status of sleep using the Patient-Reported Outcomes Measurement Information System (PROMIS) scales. There are four questions. The responses are in a Likert Scale numbered one to five. All questions are regarding the quality of sleep. The answers are one (not at all) to 5 (very much). PROMIS scales use a T-score metric interpret results. The mean score for a relevant reference population (United States general population) is 50 and 10 is the standard deviation of the population. T-score range is 20 to 80. A score of 40 is one standard deviation lower than the reference population mean and 60 is one standard deviation higher than the reference population mean. Higher scores indicate worse symptoms. | Six months |
| Moffit Cancer Center |
| Tampa |
| Florida |
| 33612 |
| United States |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30322 | United States |
| The University of Chicago | Chicago | Illinois | 60637 | United States |
| The University of Chicago Medicine Comprehensive Cancer Center at Silver Cross | New Lenox | Illinois | 60451 | United States |
| Beth Israel Deaconess Medical Center (Satellite site of Dana Farber) | Boston | Massachusetts | 02215 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Karmanos Cancer Institute of Wayne State University | Detroit | Michigan | 48201 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Weill Medical College of Cornell University | New York | New York | 10021 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77054 | United States |
| University of Utah Huntsman Cancer Institute | Salt Lake City | Utah | 84132-2408 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109-1024 | United States |
| Froedtert Hospital & Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Result |
| Atallah E, Schiffer CA, Radich JP, Weinfurt KP, Zhang MJ, Pinilla-Ibarz J, Kota V, Larson RA, Moore JO, Mauro MJ, Deininger MWN, Thompson JE, Oehler VG, Wadleigh M, Shah NP, Ritchie EK, Silver RT, Cortes J, Lin L, Visotcky A, Baim A, Harrell J, Helton B, Horowitz M, Flynn KE. Assessment of Outcomes After Stopping Tyrosine Kinase Inhibitors Among Patients With Chronic Myeloid Leukemia: A Nonrandomized Clinical Trial. JAMA Oncol. 2021 Jan 1;7(1):42-50. doi: 10.1001/jamaoncol.2020.5774. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Discontinuation of TKI Medication | Patients with CML on treatment with imatinib, dasatinib, nilotinib, or bosutinib and are in confirmed deep molecular response will stop their TKI. Confirmed deep (> 4 log reduction) molecular response (>MR4) defined as p210 (bcr-abl) fusion protein (BCR-ABL) < 0.01%, for at least two years. Concurrently, the study will assess a wide range of PROs before stopping TKIs and after discontinuation in conjunction with PCR testing, though at fewer time points, utilizing online and/or phone questionnaires. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | 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 | Number of Patients With Chronic Myeloid Leukemia (CML) Who Develop Molecular Recurrence After Discontinuing TKIs. | The number of patients who develop molecular recurrence after discontinuing TKIs. This will be reported as the number of new occurrences from the end of the prior time frame. | One subject expired after the 10th month visit. | Posted | Count of Participants | Participants | 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 27, 30, 33, 36 months |
|
|
| ||||||||||||||||||||||||||||
| Primary | Patient-reported Health Status Related to Fatigue of Patients at Baseline (Before Stopping Tyrosine Kinase Inhibitors (TKIs) | Patient-reported health status of fatigue using the Patient-Reported Outcomes Measurement Information System (PROMIS) scales. The research team used five questions. The responses are in a Likert -style scale numbered one to five -- 1 (not at all) and 5 (very much). PROMIS scales use a T-score metric for interpretation of results. The mean score for a relevant reference population (United States general population in this case) is 50 and 10 is the standard deviation of that population. T-score range is 20 to 80. Thus, a score of 40 is one standard deviation lower than the reference population mean and a score of 60 is one standard deviation higher than the reference population mean. Higher scores for this scale are indicative of worse symptoms. | Posted | Mean | Standard Deviation | T-Score | Baseline |
|
| |||||||||||||||||||||||||||||
| Primary | Patient-reported Health Status Related to Fatigue of Patients at 6 Months (After Stopping Tyrosine Kinase Inhibitors (TKIs) | Patient-reported health status of fatigue using the Patient-Reported Outcomes Measurement Information System (PROMIS) scales. The research team used five questions. The responses are in a Likert -style scale numbered one to five -- 1 (not at all) and 5 (very much). PROMIS scales use a T-score metric for interpretation of results. The mean score for a relevant reference population (United States general population in this case) is 50 and 10 is the standard deviation of that population. T-score range is 20 to 80. Thus, a score of 40 is one standard deviation lower than the reference population mean and a score of 60 is one standard deviation higher than the reference population mean. Higher scores for this scale are indicative of worse symptoms. | Posted | Mean | Standard Deviation | T-Score | Six months |
|
| |||||||||||||||||||||||||||||
| Primary | Patient-reported Health Status Related to Diarrhea of Patients at Baseline (Before Stopping Tyrosine Kinase Inhibitors (TKIs) | Patient-reported health status of diarrhea using the Patient-Reported Outcomes Measurement Information System (PROMIS) scales. There are two unrelated questions. Question no. 1 focuses on loose or watery stool and asks how many days the subject experienced this. O is no days and 4 is six to seven days. Question no. 2 asks if the subject often feels the need to empty the bowel right away. Responses are 0 (never) to 4 (more than once a day). Responses are a Likert -style scale numbered one to five -- 1 (not at all) and 5 (very much). PROMIS scales use a T-score metric interpret results. The mean score for a relevant reference population (United States general population) is 50 and 10 is the standard deviation of the population. T-score range is 20 to 80. A score of 40 is one standard deviation lower than the reference population mean and 60 is one standard deviation higher than the reference population mean. Higher scores indicate worse symptoms. | Posted | Mean | Standard Deviation | T-Score | Baseline |
| ||||||||||||||||||||||||||||||
| Primary | Patient-reported Health Status Related to Diarrhea of Patients at 6 Months (After Stopping Tyrosine Kinase Inhibitors (TKIs) | Patient-reported health status of diarrhea using the Patient-Reported Outcomes Measurement Information System (PROMIS) scales. There are two unrelated questions. Question no. 1 focuses on loose or watery stool and asks how many days the subject experienced this. O is no days and 4 is six to seven days. Question no. 2 asks if the subject often feels the need to empty the bowel right away. Responses are 0 (never) to 4 (more than once a day). Responses are a Likert -style scale numbered one to five -- 1 (not at all) and 5 (very much). PROMIS scales use a T-score metric interpret results. The mean score for a relevant reference population (United States general population) is 50 and 10 is the standard deviation of the population. T-score range is 20 to 80. A score of 40 is one standard deviation lower than the reference population mean and 60 is one standard deviation higher than the reference population mean. Higher scores indicate worse symptoms. | Posted | Mean | Standard Deviation | T-Score | Six months |
| ||||||||||||||||||||||||||||||
| Primary | Patient-reported Health Status Related to Sleep Status of Patients at Baseline (Before Stopping Tyrosine Kinase Inhibitors (TKIs) | Patient-reported health status of sleep using the Patient-Reported Outcomes Measurement Information System (PROMIS) scales. There are four questions. The responses are in a Likert Scale numbered one to five. All questions are regarding the quality of sleep. The answers are one (not at all) to 5 (very much). PROMIS scales use a T-score metric interpret results. The mean score for a relevant reference population (United States general population) is 50 and 10 is the standard deviation of the population. T-score range is 20 to 80. A score of 40 is one standard deviation lower than the reference population mean and 60 is one standard deviation higher than the reference population mean. Higher scores indicate worse symptoms. | Posted | Mean | Standard Deviation | T-Score | Baseline |
|
| |||||||||||||||||||||||||||||
| Primary | Patient-reported Health Status Related to Sleep Status of Patients at 6 Months (After Stopping Tyrosine Kinase Inhibitors (TKIs) | Patient-reported health status of sleep using the Patient-Reported Outcomes Measurement Information System (PROMIS) scales. There are four questions. The responses are in a Likert Scale numbered one to five. All questions are regarding the quality of sleep. The answers are one (not at all) to 5 (very much). PROMIS scales use a T-score metric interpret results. The mean score for a relevant reference population (United States general population) is 50 and 10 is the standard deviation of the population. T-score range is 20 to 80. A score of 40 is one standard deviation lower than the reference population mean and 60 is one standard deviation higher than the reference population mean. Higher scores indicate worse symptoms. | Posted | Mean | Standard Deviation | T-Score | Six months |
|
|
4 years
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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 | Discontinuation of TKI Medication | Patients with CML on treatment with imatinib, dasatinib, nilotinib, or bosutinib and are in confirmed deep molecular response will stop their TKI. Confirmed deep (> 4 log reduction) molecular response (>MR4) defined as p210 (bcr-abl) fusion protein (BCR-ABL) < 0.01%, for at least two years. Concurrently, the study will assess a wide range of PROs before stopping TKIs and after discontinuation in conjunction with PCR testing, though at fewer time points, utilizing online and/or phone questionnaires. | 5 | 173 | 5 | 173 | 173 | 173 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide attempt | Psychiatric disorders | CTCAE v4.03 | Systematic Assessment |
| |
| Stroke | Nervous system disorders | CTCAE v4.03 | Systematic Assessment |
| |
| Death, cause not specified | General disorders | CTCAE v4.03 | Systematic Assessment |
| |
| Disease progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v4.03 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Eye disorders - Other, specify | Eye disorders | CTCAE 4.03 | Systematic Assessment | Eye "puffiness." bilateral |
|
| Eye disorders - Other, specify | Eye disorders | CTCAE 4.03 | Systematic Assessment | Increased difficulty reading |
|
| Watering eyes | Eye disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Night sweats | General disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Gout | General disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Localized edema | General disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Malaise | General disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Pain | General disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Bladder infection | Infections and infestations | CTCAE 4.03 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | CTCAE 4.03 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | CTCAE 4.03 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE 4.03 | Systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | CTCAE 4.03 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE 4.03 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE 4.03 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE 4.03 | Systematic Assessment |
| |
| Cholesterol high | Investigations | CTCAE 4.03 | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE 4.03 | Systematic Assessment |
| |
| Investigations - Other, specify | Investigations | CTCAE 4.03 | Systematic Assessment | Increased BUN |
|
| Investigations - Other, specify | Investigations | CTCAE 4.03 | Systematic Assessment | Ferritin Increased |
|
| Platelet count decreased | Investigations | CTCAE 4.03 | Systematic Assessment |
| |
| Weight gain | Investigations | CTCAE 4.03 | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE 4.03 | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE 4.03 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Metabolism and nutrition disorders - Other, specify | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment | Hyperlipidemia |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | CTCAE 4.03 | Systematic Assessment | Arthralgia; bilateral shoulders |
|
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | CTCAE 4.03 | Systematic Assessment | Pain (Right Hip, Buttock) |
|
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | CTCAE 4.03 | Systematic Assessment | Hamstring Tear |
|
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | CTCAE 4.03 | Systematic Assessment | Right Shoulder Pain |
|
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | CTCAE 4.03 | Systematic Assessment | Muscle Aches |
|
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | CTCAE 4.03 | Systematic Assessment | Hand Cramping |
|
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | CTCAE 4.03 | Systematic Assessment | Muscle Pain |
|
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | CTCAE 4.03 | Systematic Assessment | Joint Stiffness |
|
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Concentration impairment | Nervous system disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Transient ischemic attacks | Nervous system disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Sleep apnea | Respiratory, thoracic and mediastinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Nail discoloration | Skin and subcutaneous tissue disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Periorbital edema | Skin and subcutaneous tissue disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE 4.03 | Systematic Assessment | Eczema |
|
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE 4.03 | Systematic Assessment | Skin discoloration |
|
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE 4.03 | Systematic Assessment | Hair coarsening |
|
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE 4.03 | Systematic Assessment | Knot on inner thigh |
|
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE 4.03 | Systematic Assessment | Hypersensitivity to right hip and right elbow |
|
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE 4.03 | Systematic Assessment | Itching |
|
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE 4.03 | Systematic Assessment | Rash |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Skin hypopigmentation | Skin and subcutaneous tissue disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE 4.03 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ehab Atallah, MD | Medical College of Wisconsin | 414-805-4600 | eatallah@mcw.edu |
| Dec 1, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| D000069439 | Dasatinib |
| C498826 | nilotinib |
| C471992 | bosutinib |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Two months to three months |
|
|
| Three months to four months |
|
|
| Four months to five months |
|
|
| Five months to six months |
|
|
| Six months to eight months |
|
|
| Eight months to 10 months |
|
|
| Ten months to 12 months |
|
|
| 12 months to 14 months |
|
|
| 14 months to 16 months |
|
|
| 16 months to 18 months |
|
|
| 18 months to 20 months |
|
|
| 20 months to 22 months |
|
|
| 22 months to 24 months |
|
|
| 24 months to 27 months |
|
|
| 27 months to 30 months |
|
|
| 30 months to 33 months |
|
|
| 33 months to 36 months |
|
|
| 36 months |
|
|
| Participants |
|
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| Participants |
|
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|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Participants |
|
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| Participants |
|
|