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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-01123 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| EA9131 | Other Identifier | ECOG-ACRIN Cancer Research Group | |
| EA9131 | Other Identifier | CTEP | |
| UG1CA189828 | U.S. NIH Grant/Contract | View source | |
| U10CA037403 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial studies how well simplified patient care strategy works in decreasing early death in patients with acute promyelocytic leukemia. Implementing simplified acute promyelocytic leukemia guidelines along with support from acute promyelocytic leukemia experts may decrease deaths and improve survival.
PRIMARY OBJECTIVES:
I. To evaluate if the proposed patient care strategy, that includes use of simplified guidelines along with acute promyelocytic leukemia (APL) expert support, decreases the one-month induction mortality rate from 30% to under 15%.
SECONDARY OBJECTIVES:
I. To assess the overall survival 1 year after accrual is completed. II. To assess incidence and severity of differentiation syndrome. III. To correlate outcomes with time to initiation of all-trans retinoic acid (ATRA) from diagnosis or suspicion of diagnosis.
IV. To compare outcomes between academic and community centers separately. V. To evaluate factors associated with outcome.
OUTLINE:
Patients receive standard of care treatment for APL. Patients and doctors regularly discuss with an APL expert to identify and mange treatment.
After diagnosis, patients are followed up for 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simplified Patient Care Strategy plus APL Expert Support | Experimental | Patients receive standard of care treatment for APL. Treating physicians regularly discuss with an APL expert to identify and mange treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simplified Patient Care Strategy | Other | Treatment per Acute Promyelocytic Leukemia (APL) Treatment Guidelines plus discussion between doctors and APL expert |
|
| Measure | Description | Time Frame |
|---|---|---|
| One-month Mortality Rate | Proportion of patients died within one month from the first date of induction therapy. | Assessed at one month |
| Measure | Description | Time Frame |
|---|---|---|
| Survival Rate at One Year | Overall survival is defined as the time from the first date of induction therapy to death or date last known alive. Proportion of patients alive at one year was estimated using the method of Kaplan and Meier. | Assessed at one year |
| One-month Survival Rate by Lead Academic Sites and Community Sites |
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Inclusion Criteria:
Confirmed to have a diagnosis of APL, which is defined as:
Patients must accept treatment and supportive care guidelines
Referrals must be made as early as possible but no later than 5 calendar days after ATRA therapy is initiated; consent can be obtained up till day 7 or earlier
Co-management can be started as soon as referral is made including weekends; the physician at the outlying facility should make every effort to call the APL expert at the first suspicion of APL
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| Name | Affiliation | Role |
|---|---|---|
| Anand Jillella | ECOG-ACRIN Cancer Research Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fairbanks Memorial Hospital | Fairbanks | Alaska | 99701 | United States | ||
| Kaiser Permanente-Anaheim |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40014329 | Derived | Jillella AP, Lee SJ, Altman JK, Luger SM, Tallman MS, Foran JM, Bradshaw D, Law LY, Bryan LJ, Abou Zahr A, Begna KH, Perl AE, Vadakara JJL, Qamar R, Bergan RC, Fisch MJ, Carlos RC, Wagner LI, Kota VK, Litzow MR. Academic Community Partnership in Acute Promyelocytic Leukemia and Early Mortality: The ECOG-ACRIN EA9131 Trial. JAMA Oncol. 2025 Feb 27;11(4):400-7. doi: 10.1001/jamaoncol.2024.7033. Online ahead of print. |
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Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.
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This study was activated on August 16, 2017, and closed to accrual on July 2, 2021. A total of 202 patients were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Simplified Patient Care Strategy Plus APL Expert Support | All evaluable patients are included in this analysis. |
| 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 | May 25, 2018 |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
|
Proportion of patients who are alive at one month since the first date of induction therapy by lead academic sites and community sites |
| Assessed at one month |
| Differentiation Syndrome Rate | The proportion of patients with differentiation syndrome (measured based on the CTC version 4.0) will be evaluated. | Assessed up to 1 year |
| Association Between One-month Mortality Rate and Time From Diagnosis to Initiation of All-trans Retinoic Acid (ATRA) | The time from diagnosis and initiation of ATRA will be assessed and dichotomized as "short' vs. "long" using the median value. One-month mortality rate will be compared in these two groups (short vs. long) using the Fisher's exact test. | Assessed at one month |
| Association Between One-month Survival and Baseline Factors | The associations between one-month survival and baseline factors will be evaluated. | Assessed at baseline and one month |
| Anaheim |
| California |
| 92806 |
| United States |
| Kaiser Permanente-Deer Valley Medical Center | Antioch | California | 94531 | United States |
| Kaiser Permanente-Baldwin Park | Baldwin Park | California | 91706 | United States |
| Kaiser Permanente-Bellflower | Bellflower | California | 90706 | United States |
| Kaiser Permanente-Fontana | Fontana | California | 92335 | United States |
| Kaiser Permanente-Fremont | Fremont | California | 94538 | United States |
| Fresno Cancer Center | Fresno | California | 93720 | United States |
| Kaiser Permanente-Fresno | Fresno | California | 93720 | United States |
| Kaiser Permanente - Harbor City | Harbor City | California | 90710 | United States |
| Kaiser Permanente-Irvine | Irvine | California | 92618 | United States |
| Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | 90027 | United States |
| Kaiser Permanente-Cadillac | Los Angeles | California | 90034 | United States |
| Kaiser Permanente-Modesto | Modesto | California | 95356 | United States |
| Kaiser Permanente Oakland-Broadway | Oakland | California | 94611 | United States |
| Kaiser Permanente-Oakland | Oakland | California | 94611 | United States |
| Kaiser Permanente-Ontario | Ontario | California | 91761 | United States |
| Kaiser Permanente - Panorama City | Panorama City | California | 91402 | United States |
| Kaiser Permanente-Rancho Cordova Cancer Center | Rancho Cordova | California | 95670 | United States |
| Kaiser Permanente-Redwood City | Redwood City | California | 94063 | United States |
| Kaiser Permanente-Richmond | Richmond | California | 94801 | United States |
| Kaiser Permanente-Riverside | Riverside | California | 92505 | United States |
| Rohnert Park Cancer Center | Rohnert Park | California | 94928 | United States |
| Kaiser Permanente-Roseville | Roseville | California | 95661 | United States |
| The Permanente Medical Group-Roseville Radiation Oncology | Roseville | California | 95678 | United States |
| Kaiser Permanente Downtown Commons | Sacramento | California | 95814 | United States |
| Kaiser Permanente-South Sacramento | Sacramento | California | 95823 | United States |
| South Sacramento Cancer Center | Sacramento | California | 95823 | United States |
| Kaiser Permanente - Sacramento | Sacramento | California | 95825 | United States |
| Kaiser Permanente-San Diego Mission | San Diego | California | 92108 | United States |
| Kaiser Permanente-San Diego Zion | San Diego | California | 92120 | United States |
| Kaiser Permanente-San Francisco | San Francisco | California | 94115 | United States |
| Kaiser Permanente-Santa Teresa-San Jose | San Jose | California | 95119 | United States |
| Kaiser Permanente San Leandro | San Leandro | California | 94577 | United States |
| Kaiser Permanente-San Marcos | San Marcos | California | 92078 | United States |
| Kaiser San Rafael-Gallinas | San Rafael | California | 94903 | United States |
| Kaiser Permanente Medical Center - Santa Clara | Santa Clara | California | 95051 | United States |
| Kaiser Permanente-Santa Rosa | Santa Rosa | California | 95403 | United States |
| Kaiser Permanente Cancer Treatment Center | South San Francisco | California | 94080 | United States |
| Kaiser Permanente-South San Francisco | South San Francisco | California | 94080 | United States |
| Kaiser Permanente-Stockton | Stockton | California | 95210 | United States |
| Kaiser Permanente Medical Center-Vacaville | Vacaville | California | 95688 | United States |
| Kaiser Permanente-Vallejo | Vallejo | California | 94589 | United States |
| Kaiser Permanente-Walnut Creek | Walnut Creek | California | 94596 | United States |
| Kaiser Permanente-Woodland Hills | Woodland Hills | California | 91367 | United States |
| Rocky Mountain Cancer Centers-Aurora | Aurora | Colorado | 80012 | United States |
| The Medical Center of Aurora | Aurora | Colorado | 80012 | United States |
| Boulder Community Hospital | Boulder | Colorado | 80301 | United States |
| Rocky Mountain Cancer Centers-Boulder | Boulder | Colorado | 80304 | United States |
| Rocky Mountain Cancer Centers - Centennial | Centennial | Colorado | 80112 | United States |
| Cancer Center of Colorado at Sloan's Lake | Denver | Colorado | 80204 | United States |
| Denver Health Medical Center | Denver | Colorado | 80204 | United States |
| National Jewish Health-Main Campus | Denver | Colorado | 80206 | United States |
| The Women's Imaging Center | Denver | Colorado | 80209 | United States |
| Colorado Blood Cancer Institute | Denver | Colorado | 80218 | United States |
| Presbyterian - Saint Lukes Medical Center - Health One | Denver | Colorado | 80218 | United States |
| Rocky Mountain Cancer Centers-Midtown | Denver | Colorado | 80218 | United States |
| SCL Health Saint Joseph Hospital | Denver | Colorado | 80218 | United States |
| Rocky Mountain Cancer Centers-Rose | Denver | Colorado | 80220 | United States |
| Rose Medical Center | Denver | Colorado | 80220 | United States |
| Mountain Blue Cancer Care Center - Swedish | Englewood | Colorado | 80113 | United States |
| Swedish Medical Center | Englewood | Colorado | 80113 | United States |
| National Jewish Health-Western Hematology Oncology | Golden | Colorado | 80401 | United States |
| Saint Mary's Hospital and Regional Medical Center | Grand Junction | Colorado | 81501 | United States |
| North Colorado Medical Center | Greeley | Colorado | 80631 | United States |
| Rocky Mountain Cancer Centers-Greenwood Village | Greenwood Village | Colorado | 80111 | United States |
| Good Samaritan Medical Center | Lafayette | Colorado | 80026 | United States |
| Rocky Mountain Cancer Centers-Littleton | Littleton | Colorado | 80120 | United States |
| Rocky Mountain Cancer Centers-Sky Ridge | Lone Tree | Colorado | 80124 | United States |
| Sky Ridge Medical Center | Lone Tree | Colorado | 80124 | United States |
| McKee Medical Center | Loveland | Colorado | 80539 | United States |
| National Jewish Health-Northern Hematology Oncology | Thornton | Colorado | 80260 | United States |
| SCL Health Lutheran Medical Center | Wheat Ridge | Colorado | 80033 | United States |
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | United States |
| Phoebe Putney Memorial Hospital | Albany | Georgia | 31701 | United States |
| University Cancer and Blood Center LLC | Athens | Georgia | 30607 | United States |
| Augusta University Medical Center | Augusta | Georgia | 30912 | United States |
| Dekalb Medical Center | Decatur | Georgia | 30033 | United States |
| Lewis Cancer and Research Pavilion at Saint Joseph's/Candler | Savannah | Georgia | 31405 | United States |
| Low Country Cancer Care Associates PC | Savannah | Georgia | 31405 | United States |
| Summit Cancer Care-Candler | Savannah | Georgia | 31405 | United States |
| Kaiser Permanente Moanalua Medical Center | Honolulu | Hawaii | 96819 | United States |
| Illinois CancerCare-Bloomington | Bloomington | Illinois | 61704 | United States |
| Illinois CancerCare-Canton | Canton | Illinois | 61520 | United States |
| Memorial Hospital of Carbondale | Carbondale | Illinois | 62902 | United States |
| SIH Cancer Institute | Carterville | Illinois | 62918 | United States |
| Illinois CancerCare-Carthage | Carthage | Illinois | 62321 | United States |
| Centralia Oncology Clinic | Centralia | Illinois | 62801 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| John H Stroger Jr Hospital of Cook County | Chicago | Illinois | 60612 | United States |
| Cancer Care Specialists of Illinois - Decatur | Decatur | Illinois | 62526 | United States |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | United States |
| Illinois CancerCare-Dixon | Dixon | Illinois | 61021 | United States |
| Crossroads Cancer Center | Effingham | Illinois | 62401 | United States |
| Illinois CancerCare-Eureka | Eureka | Illinois | 61530 | United States |
| Illinois CancerCare-Galesburg | Galesburg | Illinois | 61401 | United States |
| Western Illinois Cancer Treatment Center | Galesburg | Illinois | 61401 | United States |
| Illinois CancerCare-Kewanee Clinic | Kewanee | Illinois | 61443 | United States |
| Illinois CancerCare-Macomb | Macomb | Illinois | 61455 | United States |
| Cancer Care Center of O'Fallon | O'Fallon | Illinois | 62269 | United States |
| Illinois CancerCare-Ottawa Clinic | Ottawa | Illinois | 61350 | United States |
| Illinois CancerCare-Pekin | Pekin | Illinois | 61554 | United States |
| OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center | Pekin | Illinois | 61554 | United States |
| Illinois CancerCare-Peoria | Peoria | Illinois | 61615 | United States |
| OSF Saint Francis Radiation Oncology at Peoria Cancer Center | Peoria | Illinois | 61615 | United States |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61636 | United States |
| OSF Saint Francis Medical Center | Peoria | Illinois | 61637 | United States |
| Illinois CancerCare-Peru | Peru | Illinois | 61354 | United States |
| Valley Radiation Oncology | Peru | Illinois | 61354 | United States |
| Illinois CancerCare-Princeton | Princeton | Illinois | 61356 | United States |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62702 | United States |
| Springfield Clinic | Springfield | Illinois | 62702 | United States |
| Memorial Medical Center | Springfield | Illinois | 62781 | United States |
| Southwest Illinois Health Services LLP | Swansea | Illinois | 62226 | United States |
| Mary Greeley Medical Center | Ames | Iowa | 50010 | United States |
| McFarland Clinic PC - Ames | Ames | Iowa | 50010 | United States |
| McFarland Clinic PC-Boone | Boone | Iowa | 50036 | United States |
| McFarland Clinic PC-Trinity Cancer Center | Fort Dodge | Iowa | 50501 | United States |
| McFarland Clinic PC-Jefferson | Jefferson | Iowa | 50129 | United States |
| McFarland Clinic PC-Marshalltown | Marshalltown | Iowa | 50158 | United States |
| Siouxland Regional Cancer Center | Sioux City | Iowa | 51101 | United States |
| Cancer Center of Kansas - Chanute | Chanute | Kansas | 66720 | United States |
| Cancer Center of Kansas - Dodge City | Dodge City | Kansas | 67801 | United States |
| Cancer Center of Kansas - El Dorado | El Dorado | Kansas | 67042 | United States |
| Cancer Center of Kansas - Fort Scott | Fort Scott | Kansas | 66701 | United States |
| Central Care Cancer Center - Garden City | Garden City | Kansas | 67846 | United States |
| Central Care Cancer Center - Great Bend | Great Bend | Kansas | 67530 | United States |
| Cancer Center of Kansas-Independence | Independence | Kansas | 67301 | United States |
| Cancer Center of Kansas-Kingman | Kingman | Kansas | 67068 | United States |
| Lawrence Memorial Hospital | Lawrence | Kansas | 66044 | United States |
| Kansas Institute of Medicine Cancer and Blood Center | Lenexa | Kansas | 66219 | United States |
| Minimally Invasive Surgery Hospital | Lenexa | Kansas | 66219 | United States |
| Cancer Center of Kansas-Liberal | Liberal | Kansas | 67905 | United States |
| Cancer Center of Kansas-Manhattan | Manhattan | Kansas | 66502 | United States |
| Cancer Center of Kansas - McPherson | McPherson | Kansas | 67460 | United States |
| Cancer Center of Kansas - Newton | Newton | Kansas | 67114 | United States |
| Menorah Medical Center | Overland Park | Kansas | 66209 | United States |
| Cancer Center of Kansas - Parsons | Parsons | Kansas | 67357 | United States |
| Cancer Center of Kansas - Pratt | Pratt | Kansas | 67124 | United States |
| Cancer Center of Kansas - Salina | Salina | Kansas | 67401 | United States |
| Cancer Center of Kansas - Wellington | Wellington | Kansas | 67152 | United States |
| Associates In Womens Health | Wichita | Kansas | 67208 | United States |
| Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita | Kansas | 67208 | United States |
| Ascension Via Christi Hospitals Wichita | Wichita | Kansas | 67214 | United States |
| Cancer Center of Kansas - Wichita | Wichita | Kansas | 67214 | United States |
| Wesley Medical Center | Wichita | Kansas | 67214 | United States |
| Cancer Center of Kansas - Winfield | Winfield | Kansas | 67156 | United States |
| Ochsner Medical Center Jefferson | New Orleans | Louisiana | 70121 | United States |
| Riverwood Healthcare Center | Aitkin | Minnesota | 56431 | United States |
| Sanford Joe Lueken Cancer Center | Bemidji | Minnesota | 56601 | United States |
| Essentia Health Saint Joseph's Medical Center | Brainerd | Minnesota | 56401 | United States |
| Fairview Ridges Hospital | Burnsville | Minnesota | 55337 | United States |
| Minnesota Oncology - Burnsville | Burnsville | Minnesota | 55337 | United States |
| Cambridge Medical Center | Cambridge | Minnesota | 55008 | United States |
| Mercy Hospital | Coon Rapids | Minnesota | 55433 | United States |
| Essentia Health - Deer River Clinic | Deer River | Minnesota | 56636 | United States |
| Essentia Health Saint Mary's - Detroit Lakes Clinic | Detroit Lakes | Minnesota | 56501 | United States |
| Essentia Health Cancer Center | Duluth | Minnesota | 55805 | United States |
| Essentia Health Saint Mary's Medical Center | Duluth | Minnesota | 55805 | United States |
| Miller-Dwan Hospital | Duluth | Minnesota | 55805 | United States |
| Fairview Southdale Hospital | Edina | Minnesota | 55435 | United States |
| Lake Region Healthcare Corporation-Cancer Care | Fergus Falls | Minnesota | 56537 | United States |
| Essentia Health - Fosston | Fosston | Minnesota | 56542 | United States |
| Unity Hospital | Fridley | Minnesota | 55432 | United States |
| Essentia Health Hibbing Clinic | Hibbing | Minnesota | 55746 | United States |
| Fairview Clinics and Surgery Center Maple Grove | Maple Grove | Minnesota | 55369 | United States |
| Minnesota Oncology Hematology PA-Maplewood | Maplewood | Minnesota | 55109 | United States |
| Saint John's Hospital - Healtheast | Maplewood | Minnesota | 55109 | United States |
| Abbott-Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
| Health Partners Inc | Minneapolis | Minnesota | 55454 | United States |
| Monticello Cancer Center | Monticello | Minnesota | 55362 | United States |
| New Ulm Medical Center | New Ulm | Minnesota | 56073 | United States |
| Essentia Health - Park Rapids | Park Rapids | Minnesota | 56470 | United States |
| Fairview Northland Medical Center | Princeton | Minnesota | 55371 | United States |
| North Memorial Medical Health Center | Robbinsdale | Minnesota | 55422 | United States |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota | 55416 | United States |
| Regions Hospital | Saint Paul | Minnesota | 55101 | United States |
| United Hospital | Saint Paul | Minnesota | 55102 | United States |
| Essentia Health Sandstone | Sandstone | Minnesota | 55072 | United States |
| Saint Francis Regional Medical Center | Shakopee | Minnesota | 55379 | United States |
| Lakeview Hospital | Stillwater | Minnesota | 55082 | United States |
| Sanford Thief River Falls Medical Center | Thief River Falls | Minnesota | 56701 | United States |
| Essentia Health Virginia Clinic | Virginia | Minnesota | 55792 | United States |
| Ridgeview Medical Center | Waconia | Minnesota | 55387 | United States |
| Rice Memorial Hospital | Willmar | Minnesota | 56201 | United States |
| Minnesota Oncology Hematology PA-Woodbury | Woodbury | Minnesota | 55125 | United States |
| Sanford Cancer Center Worthington | Worthington | Minnesota | 56187 | United States |
| Fairview Lakes Medical Center | Wyoming | Minnesota | 55092 | United States |
| Central Care Cancer Center - Bolivar | Bolivar | Missouri | 65613 | United States |
| Parkland Health Center-Bonne Terre | Bonne Terre | Missouri | 63628 | United States |
| Saint Francis Medical Center | Cape Girardeau | Missouri | 63703 | United States |
| Southeast Cancer Center | Cape Girardeau | Missouri | 63703 | United States |
| Parkland Health Center - Farmington | Farmington | Missouri | 63640 | United States |
| Centerpoint Medical Center LLC | Independence | Missouri | 64057 | United States |
| Capital Region Southwest Campus | Jefferson City | Missouri | 65109 | United States |
| Research Medical Center | Kansas City | Missouri | 64132 | United States |
| Sainte Genevieve County Memorial Hospital | Sainte Genevieve | Missouri | 63670 | United States |
| Missouri Baptist Medical Center | St Louis | Missouri | 63131 | United States |
| Missouri Baptist Sullivan Hospital | Sullivan | Missouri | 63080 | United States |
| Missouri Baptist Outpatient Center-Sunset Hills | Sunset Hills | Missouri | 63127 | United States |
| Saint Vincent Healthcare | Billings | Montana | 59101 | United States |
| Saint Vincent Frontier Cancer Center | Billings | Montana | 59102 | United States |
| Saint James Community Hospital and Cancer Treatment Center | Butte | Montana | 59701 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| AdventHealth Infusion Center Asheville | Asheville | North Carolina | 28803 | United States |
| AdventHealth Infusion Center Haywood | Clyde | North Carolina | 28721 | United States |
| AdventHealth Hendersonville | Hendersonville | North Carolina | 28792 | United States |
| Sanford Bismarck Medical Center | Bismarck | North Dakota | 58501 | United States |
| Essentia Health Cancer Center-South University Clinic | Fargo | North Dakota | 58103 | United States |
| Sanford South University Medical Center | Fargo | North Dakota | 58103 | United States |
| Sanford Broadway Medical Center | Fargo | North Dakota | 58122 | United States |
| Sanford Roger Maris Cancer Center | Fargo | North Dakota | 58122 | United States |
| Essentia Health - Jamestown Clinic | Jamestown | North Dakota | 58401 | United States |
| Bryn Mawr Hospital | Bryn Mawr | Pennsylvania | 19010 | United States |
| Main Line Health Center-Collegeville | Collegeville | Pennsylvania | 19426 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Main Line Health Center-Exton | Exton | Pennsylvania | 19341 | United States |
| Riddle Memorial Hospital | Media | Pennsylvania | 19063 | United States |
| Paoli Memorial Hospital | Paoli | Pennsylvania | 19301 | United States |
| University of Pennsylvania/Abramson Cancer Center | Philadelphia | Pennsylvania | 19104 | United States |
| Lankenau Medical Center | Wynnewood | Pennsylvania | 19096 | United States |
| Gibbs Cancer Center-Gaffney | Gaffney | South Carolina | 29341 | United States |
| Saint Francis Hospital | Greenville | South Carolina | 29601 | United States |
| Saint Francis Cancer Center | Greenville | South Carolina | 29607 | United States |
| Gibbs Cancer Center-Pelham | Greer | South Carolina | 29651 | United States |
| Spartanburg Medical Center | Spartanburg | South Carolina | 29303 | United States |
| MGC Hematology Oncology-Union | Union | South Carolina | 29379 | United States |
| Sanford Cancer Center Oncology Clinic | Sioux Falls | South Dakota | 57104 | United States |
| Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | 57117-5134 | United States |
| Baptist Memorial Hospital and Cancer Center-Memphis | Memphis | Tennessee | 38120 | United States |
| American Fork Hospital / Huntsman Intermountain Cancer Center | American Fork | Utah | 84003 | United States |
| Sandra L Maxwell Cancer Center | Cedar City | Utah | 84720 | United States |
| Logan Regional Hospital | Logan | Utah | 84321 | United States |
| Intermountain Medical Center | Murray | Utah | 84107 | United States |
| McKay-Dee Hospital Center | Ogden | Utah | 84403 | United States |
| Utah Valley Regional Medical Center | Provo | Utah | 84604 | United States |
| Riverton Hospital | Riverton | Utah | 84065 | United States |
| Utah Cancer Specialists-Salt Lake City | Salt Lake City | Utah | 84106 | United States |
| LDS Hospital | Salt Lake City | Utah | 84143 | United States |
| Dixie Medical Center Regional Cancer Center | St. George | Utah | 84770 | United States |
| MultiCare Auburn Medical Center | Auburn | Washington | 98001 | United States |
| MultiCare Gig Harbor Medical Park | Gig Harbor | Washington | 98335 | United States |
| Jefferson Healthcare | Port Townsend | Washington | 98368 | United States |
| MultiCare Good Samaritan Hospital | Puyallup | Washington | 98372 | United States |
| MultiCare Deaconess Cancer and Blood Specialty Center - Downtown | Spokane | Washington | 99204 | United States |
| MultiCare Deaconess Cancer and Blood Specialty Center - North | Spokane | Washington | 99218 | United States |
| MultiCare Deaconess Cancer and Blood Specialty Center - Valley | Spokane Valley | Washington | 99216 | United States |
| Mary Bridge Children's Hospital and Health Center | Tacoma | Washington | 98405 | United States |
| MultiCare Tacoma General Hospital | Tacoma | Washington | 98405 | United States |
| ThedaCare Regional Cancer Center | Appleton | Wisconsin | 54911 | United States |
| Duluth Clinic Ashland | Ashland | Wisconsin | 54806 | United States |
| Northwest Wisconsin Cancer Center | Ashland | Wisconsin | 54806 | United States |
| Aurora Cancer Care-Southern Lakes VLCC | Burlington | Wisconsin | 53105 | United States |
| Aurora Saint Luke's South Shore | Cudahy | Wisconsin | 53110 | United States |
| Marshfield Medical Center-EC Cancer Center | Eau Claire | Wisconsin | 54701 | United States |
| Aurora Health Center-Fond du Lac | Fond du Lac | Wisconsin | 54937 | United States |
| Aurora Health Care Germantown Health Center | Germantown | Wisconsin | 53022 | United States |
| Aurora Cancer Care-Grafton | Grafton | Wisconsin | 53024 | United States |
| Aurora BayCare Medical Center | Green Bay | Wisconsin | 54311 | United States |
| Aurora Cancer Care-Kenosha South | Kenosha | Wisconsin | 53142 | United States |
| Gundersen Lutheran Medical Center | La Crosse | Wisconsin | 54601 | United States |
| Aurora Bay Area Medical Group-Marinette | Marinette | Wisconsin | 54143 | United States |
| Marshfield Medical Center-Marshfield | Marshfield | Wisconsin | 54449 | United States |
| Aurora Cancer Care-Milwaukee | Milwaukee | Wisconsin | 53209 | United States |
| Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
| Aurora Sinai Medical Center | Milwaukee | Wisconsin | 53233 | United States |
| Marshfield Clinic-Minocqua Center | Minocqua | Wisconsin | 54548 | United States |
| Cancer Center of Western Wisconsin | New Richmond | Wisconsin | 54017 | United States |
| Vince Lombardi Cancer Clinic - Oshkosh | Oshkosh | Wisconsin | 54904 | United States |
| Aurora Cancer Care-Racine | Racine | Wisconsin | 53406 | United States |
| Lakeview Medical Center-Marshfield Clinic | Rice Lake | Wisconsin | 54868 | United States |
| Marshfield Medical Center-Rice Lake | Rice Lake | Wisconsin | 54868 | United States |
| Vince Lombardi Cancer Clinic-Sheboygan | Sheboygan | Wisconsin | 53081 | United States |
| Marshfield Clinic Stevens Point Center | Stevens Point | Wisconsin | 54482 | United States |
| Aurora Medical Center in Summit | Summit | Wisconsin | 53066 | United States |
| Vince Lombardi Cancer Clinic-Two Rivers | Two Rivers | Wisconsin | 54241 | United States |
| Aurora Cancer Care-Milwaukee West | Wauwatosa | Wisconsin | 53226 | United States |
| Aurora West Allis Medical Center | West Allis | Wisconsin | 53227 | United States |
| Marshfield Medical Center - Weston | Weston | Wisconsin | 54476 | United States |
| Cheyenne Regional Medical Center-West | Cheyenne | Wyoming | 82001 | United States |
| Advance Oncology Center | Aguadilla | 00603 | Puerto Rico |
| Doctor's Cancer Center-Arecibo | Arecibo | 00614 | Puerto Rico |
| Cancer Center-Metro Medical Center Bayamon | Bayamón | 00959-5060 | Puerto Rico |
| Hematologia Oncologia San Pablo | Bayamón | 00961 | Puerto Rico |
| HIMA San Pablo Oncologic Hospital | Caguas | 00726 | Puerto Rico |
| Doctors Cancer Center | Manati | 00674 | Puerto Rico |
| Instituto Oncologia Moderna Ponce | Ponce | 00716 | Puerto Rico |
| San Juan Community Oncology Group | San Juan | 00917 | Puerto Rico |
| Primary Care Physician Group | San Juan | 00920 | Puerto Rico |
| Centro Comprensivo de Cancer de UPR | San Juan | 00927 | Puerto Rico |
| San Juan City Hospital | San Juan | 00936 | Puerto Rico |
| Centro de Hematologia y Oncologia del Sur | Santa Isabel | 00757 | Puerto Rico |
| Evaluable patients |
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| Evaluable patients with toxicity data |
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| COMPLETED |
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| NOT COMPLETED |
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All evaluable patients are included...
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Simplified Patient Care Strategy Plus APL Expert Support | All evaluable patients are included in this analysis. |
| 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 | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | 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 | One-month Mortality Rate | Proportion of patients died within one month from the first date of induction therapy. | All evaluable patients are included in this analysis. | Posted | Number | 95% Confidence Interval | Proportion of participants | Assessed at one month |
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| Secondary | Survival Rate at One Year | Overall survival is defined as the time from the first date of induction therapy to death or date last known alive. Proportion of patients alive at one year was estimated using the method of Kaplan and Meier. | All evaluable patients are included in this analysis. | Posted | Number | 95% Confidence Interval | Proportion of participants | Assessed at one year |
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| Secondary | One-month Survival Rate by Lead Academic Sites and Community Sites | Proportion of patients who are alive at one month since the first date of induction therapy by lead academic sites and community sites | All evaluable patients are included in this analysis. | Posted | Number | 95% Confidence Interval | Proportion of participants | Assessed at one month |
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| Secondary | Differentiation Syndrome Rate | The proportion of patients with differentiation syndrome (measured based on the CTC version 4.0) will be evaluated. | Not Posted | Assessed up to 1 year | Participants | |||||||||||||||||||||||||||||||
| Secondary | Association Between One-month Mortality Rate and Time From Diagnosis to Initiation of All-trans Retinoic Acid (ATRA) | The time from diagnosis and initiation of ATRA will be assessed and dichotomized as "short' vs. "long" using the median value. One-month mortality rate will be compared in these two groups (short vs. long) using the Fisher's exact test. | Not Posted | Assessed at one month | Participants | |||||||||||||||||||||||||||||||
| Secondary | Association Between One-month Survival and Baseline Factors | The associations between one-month survival and baseline factors will be evaluated. | Not Posted | Assessed at baseline and one month | Participants |
Assessed while on treatment and for 30 days after the end of treatment, up to 1 year
All evaluable patients were included in the all-cause mortality analysis, while only patients with toxicity data were included in the adverse event analysis.
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 | Simplified Patient Care Strategy Plus APL Expert Support | Treatment per Acute Promyelocytic Leukemia (APL) Treatment Guidelines plus discussion between doctors and APL expert | 22 | 201 | 115 | 199 | 152 | 199 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE 4.0 | Systematic Assessment |
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| Disseminated intravascular coagulation | Blood and lymphatic system disorders | CTCAE 4.0 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE 4.0 | Systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | CTCAE 4.0 | Systematic Assessment |
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| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | CTCAE 4.0 | Systematic Assessment |
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| Ventricular arrhythmia | Cardiac disorders | CTCAE 4.0 | Systematic Assessment |
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| Death NOS | General disorders and administration site conditions | CTCAE 4.0 | Systematic Assessment |
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| Fatigue | General disorders and administration site conditions | CTCAE 4.0 | Systematic Assessment |
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| Multi-organ failure | General disorders and administration site conditions | CTCAE 4.0 | Systematic Assessment |
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| General disorders and administration site conditions - Other, specify | General disorders and administration site conditions | CTCAE 4.0 | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
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| Intra-abdominal hemorrhage | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Mucositis oral | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Immune system disorders - Other, specify | Immune system disorders | CTCAE 4.0 | Systematic Assessment |
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| Lung infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
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| Activated partial thromboplastin time prolonged | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Creatinine increased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Electrocardiogram QT corrected interval prolonged | Investigations | CTCAE 4.0 | Systematic Assessment |
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| INR increased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Lymphocyte count increased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Platelet count decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| White blood cell decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Hypertriglyceridemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Hyperuricemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
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| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
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| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
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| Edema cerebral | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
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| Mania | Psychiatric disorders | CTCAE 4.0 | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Retinoic acid syndrome | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | CTCAE 4.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | CTCAE 4.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | CTCAE 4.0 | Systematic Assessment |
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| Thromboembolic event | Vascular disorders | CTCAE 4.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders and administration site conditions | CTCAE 4.0 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders and administration site conditions | CTCAE 4.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Electrocardiogram QT corrected interval prolonged | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Hypocalcemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Retinoic acid syndrome | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | CTCAE 4.0 | Systematic Assessment |
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Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Statistician | ECOG-ACRIN Statistical Office | 617-632-3012 | eatrials@jimmy.harvard.edu |
| Feb 3, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015473 | Leukemia, Promyelocytic, Acute |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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