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The purpose of this study is to further quantify the risk of cerebrovascular events (CVEs) following sipuleucel-T (PROVENGE®) therapy, and to follow all subjects for survival.
Subjects will receive product as described in the sipuleucel-T approved label. The registry will be strictly observational and thus no additional clinical visits or laboratory tests will be conducted beyond normal clinical practice. Investigators will be asked to record information that becomes available in the normal course of clinical management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sipuleucel-T |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sipuleucel-T | Biological | Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals. |
| Measure | Description | Time Frame |
|---|---|---|
| To Further Quantify the Risk of Cerebrovascular Events Following Sipuleucel-T Therapy for All Subjects | The incidence rate of CVEs (cardiovascular events) was estimated as the number of new events per 100 patient years of follow-up in the overall sample of men with advanced-stage or metastatic prostate cancer and in men with or without castration. | Every 3 months for a minimum of 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | To quantify survival by estimating the median time of survival in all subjects using the Kaplan-Meier method. | Every 3 months for a minimum of 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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Men at least 18 years of age that have advanced prostate cancer that is treated with sipuleucel-T
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Brown, MD | Dendreon Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Hematology and Oncology Associates, LLC | Bessemer | Alabama | 35022 | United States | ||
| Birmingham Hematology and Oncology Associates, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35145218 | Derived | Wei XX, Kwak L, Hamid A, He M, Sweeney C, Flanders SC, Harmon M, Choudhury AD. Outcomes in men with metastatic castration-resistant prostate cancer who received sipuleucel-T and no immediate subsequent therapy: experience at Dana Farber and in the PROCEED Registry. Prostate Cancer Prostatic Dis. 2022 Feb;25(2):314-319. doi: 10.1038/s41391-022-00493-x. Epub 2022 Feb 10. | |
| 32111923 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sipuleucel-T | sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Birmingham |
| Alabama |
| 35205 |
| United States |
| Birmingham Hematology and Oncology Associates, LLC | Birmingham | Alabama | 35211 | United States |
| Birmingham Hematology and Oncology Associates, LLC | Birmingham | Alabama | 35213 | United States |
| Birmingham Hematology and Oncology Associates, LLC | Birmingham | Alabama | 35235 | United States |
| Clearview Cancer Institute | Huntsville | Alabama | 35805 | United States |
| Ironwood Cancer and Research | Chandler | Arizona | 85224-5665 | United States |
| Palo Verde Cancer Specialists | Glendale | Arizona | 85304 | United States |
| Weatern Regional Medical Center / Cancer Treatment Centers of America | Goodyear | Arizona | 85338 | United States |
| 21st Century Oncology | Scottsdale | Arizona | 85251 | United States |
| Pinnacle Oncology Hematology, Oncology Research Associates, PLLC | Scottsdale | Arizona | 85258 | United States |
| Arizona Oncology Associates, PC - HOPE | Tucson | Arizona | 85704 | United States |
| Arizona Oncology Associates, PC - HOPE | Tucson | Arizona | 85710 | United States |
| Arizona Oncology Associates, PC - HOPE | Tucson | Arizona | 85712 | United States |
| El Dorado Research | Tucson | Arizona | 85715 | United States |
| Urological Associates of Southern Arizona, P.C. | Tucson | Arizona | 85715 | United States |
| Little Rock Hematology Oncology: A Division of CARTI | Little Rock | Arkansas | 72205 | United States |
| South County Hematology/Oncology | Chula Vista | California | 91911 | United States |
| Wilshire Oncology Medical Group, Inc. | Corona | California | 92879 | United States |
| Urology Specialists of Southern California | Encino | California | 91436-2140 | United States |
| Robert A. Moss, M.D., F.A.C.P., Inc | Fountain Valley | California | 92708 | United States |
| Pacific Shores Medical Group | Glendale | California | 91204 | United States |
| Wilshire Oncology Medical Group, Inc. | Glendora | California | 91741 | United States |
| Pacific Shores Medical Group | Huntington Beach | California | 92648 | United States |
| UCSD Medical Center - La Jolla | La Jolla | California | 92037 | United States |
| UCSD Moores Cancer Center | La Jolla | California | 92093-0820 | United States |
| Moores UCSD Cancer Center | La Jolla | California | 92093 | United States |
| Cancer Center Oncology Medical Group | La Mesa | California | 91942 | United States |
| Wilshire Oncology Medical Group, Inc. | La Verne | California | 91750 | United States |
| Pacific Shores Medical Group | Long Beach | California | 90813 | United States |
| Pacific Shores Medical Group | Los Alamitos | California | 90720 | United States |
| UCLA Institute of Urologic Oncology, UCLA Medical Center | Los Angeles | California | 90024 | United States |
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
| Tower Urology | Los Angeles | California | 90048 | United States |
| Prostate Oncology Speciality Inc. | Marina del Rey | California | 90292 | United States |
| Tri Valley Urology Medical Group | Murrieta | California | 92562 | United States |
| North County Oncology Medical Group, Inc. | Oceanside | California | 92056 | United States |
| Hematology-Oncology Medical Group of Orange County, Inc. | Orange | California | 92868 | United States |
| Medical Oncology Care Associates (MOCA) | Orange | California | 92868 | United States |
| The Center for Cancer Prevention and Treatment, St. Joseph Hospital | Orange | California | 92868 | United States |
| PMK Medical Group, Inc., DBA Ventura County Hematology Oncology Specialists | Oxnard | California | 93030 | United States |
| Wilshire Oncology Medical Group, Inc. | Pasadena | California | 91105 | United States |
| Wilshire Oncology Medical Group, Inc. | Pomona | California | 91767 | United States |
| Wilshire Oncology Medical Group, Inc. | Rancho Cucamonga | California | 91730 | United States |
| Sutter Roseville Medical Center | Roseville | California | 95677 | United States |
| Sutter Cancer Center / Sacramento Center for Hematology and Medical Oncology | Sacramento | California | 95816 | United States |
| Sutter Memorial Hospital | Sacramento | California | 95819-3223 | United States |
| UCSD Medical Center - Hillcrest | San Diego | California | 92103 | United States |
| Genesis Research | San Diego | California | 92123 | United States |
| Medical Oncology Associates | San Diego | California | 92123 | United States |
| Sharp Clinical Oncology Research | San Diego | California | 92123 | United States |
| Sharp Rees-Stealy | San Diego | California | 92123 | United States |
| Edward Alexson, MD, Inc. | Santa Ana | California | 92705 | United States |
| Stockton Hematology Oncology Medical Group | Stockton | California | 95204 | United States |
| Contra Costa Oncology | Walnut Creek | California | 94598 | United States |
| Wilshire Oncology Medical Group, Inc. | West Covina | California | 91790 | United States |
| Rocky Mountain Cancer Centers | Aurora | Colorado | 80012 | United States |
| Rocky Mountain Cancer Centers | Boulder | Colorado | 80303 | United States |
| Rocky Mountain Cancer Centers | Colorado Springs | Colorado | 80907 | United States |
| Rocky Mountain Cancer Centers | Colorado Springs | Colorado | 80909 | United States |
| The Urology Center of Colorado | Denver | Colorado | 80211 | United States |
| Rocky Mountain Cancer Centers | Denver | Colorado | 80218 | United States |
| Rocky Mountain Cancer Centers | Denver | Colorado | 80220 | United States |
| Western Oncology/Hematology Associates, PC | Golden | Colorado | 80401 | United States |
| Rocky Mountain Cancer Centers | Lakewood | Colorado | 80228 | United States |
| Rocky Mountain Cancer Centers | Littleton | Colorado | 80120-4413 | United States |
| Rocky Mountain Cancer Centers | Lone Tree | Colorado | 80124 | United States |
| Rocky Mountain Cancer Centers | Longmont | Colorado | 80501 | United States |
| Advanced Urology, PC | Parker | Colorado | 80134 | United States |
| Rocky Mountain Cancer Centers | Parker | Colorado | 80138 | United States |
| Rocky Mountain Cancer Centers | Pueblo | Colorado | 81008 | United States |
| Rocky Mountain Cancer Centers | Thornton | Colorado | 80260 | United States |
| Grove Hill Clinical Research, Grove Hill Medical Center, Urology Center of Grove Hill | New Britain | Connecticut | 06052 | United States |
| Yale Urology | New Haven | Connecticut | 06511 | United States |
| Norwalk Hospital | Norwalk | Connecticut | 06856 | United States |
| Eastern Connecticut Hematology and Oncology Associates | Norwich | Connecticut | 06360 | United States |
| The Stamford Hospital | Stamford | Connecticut | 06902 | United States |
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
| Howard University Cancer Center & Howeard University Hospital | Washington D.C. | District of Columbia | 20060 | United States |
| Mount Sinai Comprehensive Cancer Center | Aventura | Florida | 33180 | United States |
| Manatee Medical Research Institute, LLC | Bradenton | Florida | 34205 | United States |
| 21st Century Oncology | Crestview | Florida | 32539 | United States |
| Integrated Community Oncology Network | Fleming Island | Florida | 32003 | United States |
| 21st Century Oncology | Fort Myers | Florida | 33907 | United States |
| Florida Cancer Specialists, PL | Hudson | Florida | 34667 | United States |
| Integrated Community Oncology Network | Jacksonville | Florida | 32204 | United States |
| Integrated Community Oncology Network | Jacksonville | Florida | 32207 | United States |
| Cancer Specialists of North Florida | Jacksonville | Florida | 32256 | United States |
| Integrated Community Oncology Network | Jacksonville | Florida | 32258 | United States |
| Integrated Community Oncology Network | Jacksonville Beach | Florida | 32250 | United States |
| Watson Clinic LLP, Center for Cancer Care & Research, Clark & Daughtrey Medical Group, PA | Lakeland | Florida | 33805 | United States |
| Northwest Florida Hematology Oncology PA | Lynn Haven | Florida | 32444 | United States |
| Advanced Medical Specialties | Miami | Florida | 33143 | United States |
| Advanced Medical Specialties | Miami | Florida | 33176 | United States |
| Mount Sinai Comprehensive Cancer Center | Miami Beach | Florida | 33140 | United States |
| 21st Century Oncology | Naples | Florida | 34102 | United States |
| Premier Oncology | Naples | Florida | 34102 | United States |
| Florida Cancer Specialists, PL | New Port Richey | Florida | 34655 | United States |
| Ocala Oncology Center | Ocala | Florida | 33471 | United States |
| Atlantic Urological Associates | Orange City | Florida | 32763 | United States |
| Integrated Community Oncology Network | Orange Park | Florida | 32073 | United States |
| Integrated Community Oncology Network | Palatka | Florida | 32177 | United States |
| Sacred Heart Medical Oncology Groupl | Pensacola | Florida | 32504 | United States |
| Integrated Community Oncology Network | Saint Augustine | Florida | 32086 | United States |
| Southeastern Research Group, Inc. | Tallahassee | Florida | 32308 | United States |
| Georgia Cancer Specialists - Alpharetta | Alpharetta | Georgia | 30005 | United States |
| Georgia Cancer Specialists - Athens | Athens | Georgia | 30606 | United States |
| Georgia Cancer Specialists - Emory Midtown | Atlanta | Georgia | 30308 | United States |
| Midtown Urology | Atlanta | Georgia | 30308 | United States |
| Atlanta Hematology Oncology Associates | Atlanta | Georgia | 30309-1710 | United States |
| Peachtree Hematology-Oncology Consultants, PC | Atlanta | Georgia | 30318 | United States |
| Piedmont West | Atlanta | Georgia | 30318 | United States |
| Emory University Hospital, The Emory Clinic, Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
| Georgia Urology, PA | Atlanta | Georgia | 30342 | United States |
| Augusta Oncology Associates, PC | Augusta | Georgia | 30901 | United States |
| Northwest Georgia Oncology Centers, P.C. | Austell | Georgia | 30106 | United States |
| Northwest Georgia Oncology Centers, P.C. | Carrollton | Georgia | 30117 | United States |
| Northwest Georgia Oncology Centers, P.C. | Cartersville | Georgia | 30121 | United States |
| John B. Amos Cancer Center | Columbus | Georgia | 31904 | United States |
| Georgia Cancer Specialists - Stemmer | Decatur | Georgia | 30033 | United States |
| Northwest Georgia Oncology Centers, P.C. | Douglasville | Georgia | 30134 | United States |
| Gwinnett Hospital System Inc. dba Center for Cancer Care | Duluth | Georgia | 30096 | United States |
| Georgia Cancer Specialists - Fayetteville | Fayetteville | Georgia | 30215 | United States |
| Gwinnett Hospital System Inc. dba Center for Cancer Care | Lawrenceville | Georgia | 30046 | United States |
| Georgia Cancer Specialists - Macon | Macon | Georgia | 31217 | United States |
| Georgia Cancer Specialists - Kennestone | Marietta | Georgia | 30060 | United States |
| Northwest Georgia Oncology Centers, P.C. | Marietta | Georgia | 30060 | United States |
| Urology Enterprises | Marietta | Georgia | 30060 | United States |
| Harbin Clinic | Rome | Georgia | 30165 | United States |
| Georgia Cancer Specialists - Northside | Sandy Springs | Georgia | 30342 | United States |
| Gwinnett Hospital System Inc. dba Center for Cancer Care | Snellville | Georgia | 30078 | United States |
| Georgia Cancer Specialists - Stockbridge | Stockbridge | Georgia | 30281 | United States |
| Joliet Oncology-Hematology Associates, Ltd. | Joliet | Illinois | 60435 | United States |
| Urological Surgeons of Illinois | Kankakee | Illinois | 60901 | United States |
| Oncology Specialists, S.C. | Niles | Illinois | 60714 | United States |
| Mid-Illinois Hematology & Oncology Associates, LTD | Normal | Illinois | 61761 | United States |
| Oncology Specialists, S.C. | Park Ridge | Illinois | 60068 | United States |
| Midwestern Regional Medical Center | Zion | Illinois | 60099 | United States |
| Elkhart Clinic | Elkhart | Indiana | 46514 | United States |
| Elkhart General Hospital | Elkhart | Indiana | 46514 | United States |
| Urological Associates, Inc. | Evansville | Indiana | 47714 | United States |
| Fort Wayne Medical Oncology and Hematology, Inc. | Fort Wayne | Indiana | 46845 | United States |
| Metropolitan Urology Clinical Research | Jeffersonville | Indiana | 47130 | United States |
| Indiana University Health La Porte Hospital | La Porte | Indiana | 46350 | United States |
| Saint Joseph Regional Medical Center | Mishawaka | Indiana | 46545 | United States |
| Michiana Hematology Oncology, P. C. | Plymouth | Indiana | 46563 | United States |
| Memorial Hospital of South Bend | South Bend | Indiana | 46601 | United States |
| Northern Indiana Cancer Research Consortium, Michiana Hematology Oncology, P.C. | South Bend | Indiana | 46601 | United States |
| Michiana Hematology Oncology, P. C. | Westville | Indiana | 46391 | United States |
| McFarland Clinic, PC | Ames | Iowa | 50010 | United States |
| Physician's Clinic of Iowa, P.C. | Cedar Rapids | Iowa | 52401 | United States |
| Heartland Oncology & Hematology, PLLC | Council Bluffs | Iowa | 51503 | United States |
| Kansas City Urology Care | Overland Park | Kansas | 66211 | United States |
| University of Kansas Cancer Center | Westwood | Kansas | 66205 | United States |
| Cancer Center of Kansas | Wichita | Kansas | 67214 | United States |
| Wichita Urology Group P.A | Wichita | Kansas | 67226 | United States |
| Jewish Hospital & St. Mary's Healthcare | Louisville | Kentucky | 40245 | United States |
| Louisiana Oncology Associates | Crowley | Louisiana | 70526 | United States |
| Louisiana Oncology Associates | Lafayette | Louisiana | 70508 | United States |
| Louisiana Oncology Associates | New Iberia | Louisiana | 70560 | United States |
| Tulane University Health Sciences Center | New Orleans | Louisiana | 70112 | United States |
| Louisiana Oncology Associates | Opelousas | Louisiana | 70570 | United States |
| Northwest Louisiana Oncology Associates Of Highland Clinic | Shreveport | Louisiana | 71105 | United States |
| Regional Urology, LLC | Shreveport | Louisiana | 71106 | United States |
| Chesapeake Urology Research Associates | Baltimore | Maryland | 21204 | United States |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | United States |
| Myron I Murdock MD LLC | Greenbelt | Maryland | 20770 | United States |
| MedStar Montgomery Medical Center | Olney | Maryland | 20832 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Steward Sr. Elizabeth's Medical Center of Boston Inc. | Boston | Massachusetts | 02135 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Henry Ford Medical Center - Woodhaven | Brownstown | Michigan | 48183 | United States |
| Henry Ford Medical Center - Fairlane | Dearborn | Michigan | 48126 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Karmanos Cancer Institute at Farmington Hills | Farmington Hills | Michigan | 48334 | United States |
| Lakeland Hospital | Niles | Michigan | 49120 | United States |
| Henry Ford Medical Center - Columbus Center | Novi | Michigan | 48377 | United States |
| Michgan Institute of Urology, PC | Saint Clair Shores | Michigan | 48081 | United States |
| Lakeland Hospital | Saint Joseph | Michigan | 49085-2158 | United States |
| Marie Yeager Cancer Center | Saint Joseph | Michigan | 49085 | United States |
| Michigan Institute of Urology, PC | Troy | Michigan | 48084 | United States |
| Michigan Institute of Urology, PC | Utica | Michigan | 48317 | United States |
| Henry Ford Medical Center- West Bloomfield | West Bloomfield | Michigan | 48322 | United States |
| Minnesota Oncology Hematology, P.A. | Burnsville | Minnesota | 55337 | United States |
| Minnesota Oncology Hematology, P.A. | Coon Rapids | Minnesota | 55433 | United States |
| Minnesota Oncology Hematology, P.A. | Edina | Minnesota | 55435-2150 | United States |
| Minnesota Oncology Hematology, P.A. | Fridley | Minnesota | 55432 | United States |
| Minnesota Oncology Hematology, P.A. | Maplewood | Minnesota | 55109 | United States |
| Minnesota Oncology Hematology, P.A. | Minneapolis | Minnesota | 55404 | United States |
| University Of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Hubert H. Humphrey Cancer Center | Robbinsdale | Minnesota | 55422 | United States |
| Minnesota Oncology Hematology, P.A. | Saint Paul | Minnesota | 55102-2389 | United States |
| Adult and Pediatric Urology | Sartell | Minnesota | 56377 | United States |
| Minnesota Oncology Hematology, P.A. | Woodbury | Minnesota | 55125 | United States |
| The Jones Clinic, PC | New Albany | Mississippi | 38652 | United States |
| Family Cancer Center Foundation, Inc. | Oxford | Mississippi | 38655 | United States |
| Family Cancer Center Foundation, Inc. | Southaven | Mississippi | 38671 | United States |
| St. Louis Cancer Care, LLP | Bridgeton | Missouri | 63044 | United States |
| St. Louis Cancer Care, LLP | Chesterfield | Missouri | 63017 | United States |
| Ellis Fischel Cancer Center - University of Missouri Health Care | Columbia | Missouri | 65203 | United States |
| Saint Luke's Cancer Institute, Saint Luke's Hospital | Kansas City | Missouri | 64111 | United States |
| St. Louis Cancer Care, LLP | St Louis | Missouri | 63127 | United States |
| Comprehensive Cancer Care | St Louis | Missouri | 63141 | United States |
| Nebraska Hematology-Oncology, PC | Lincoln | Nebraska | 68506 | United States |
| Southeast Nebraska Hematology & Oncology Consultants, PC / Southeast Nebraska Cancer Center | Lincoln | Nebraska | 68510 | United States |
| Southeast Nebraska Hematology & Oncology Consultants, PC / Southeast Nebraska Cancer Center | Lincoln | Nebraska | 68516 | United States |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists | Omaha | Nebraska | 68130 | United States |
| Urology Cancer Center & GU Research Network | Omaha | Nebraska | 68130 | United States |
| Comprehensive Cancer Centers of Nevada | Henderson | Nevada | 89014 | United States |
| Comprehensive Cancer Centers of Nevada | Henderson | Nevada | 89052 | United States |
| Comprehensive Cancer Centers of Nevada | Henderson | Nevada | 89074 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89128 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89148 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | United States |
| Dartmouth Hitchcock Medical Center, Norris Cotton Cancer Center | Lebanon | New Hampshire | 03756 | United States |
| New Jersey Urology, LLC | Bloomfield | New Jersey | 07003 | United States |
| Oncology and Hematology Specialists, P.A. | Denville | New Jersey | 07830 | United States |
| Hematology-Oncology Associates of Northern NJ, PA; Carol G. Simon Cancer Center | Morristown | New Jersey | 07962 | United States |
| Delaware Valley Urology, LLC | Mount Laurel | New Jersey | 08054 | United States |
| Sparta Cancer Center | Sparta | New Jersey | 07871 | United States |
| Urology Group of New Jersey | West Orange | New Jersey | 07052 | United States |
| New Mexico Oncology Hematology Consultants, LTD | Albuquerque | New Mexico | 87109 | United States |
| New Mexico Cancer Care Associates | Santa Fe | New Mexico | 87505 | United States |
| New York Oncology Hematology, P.C. | Albany | New York | 12206 | United States |
| New York Oncology Hematology, P.C. | Albany | New York | 12208 | United States |
| The Jonah Center | Buffalo | New York | 14215 | United States |
| Zale P. Bernstein, MD, PC | Buffalo | New York | 14215 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
| North Shore Hematology/Oncology Associates | East Setauket | New York | 11733 | United States |
| Queens Medical Associates | Fresh Meadows | New York | 11366 | United States |
| NYU Clinical Cancer Center | New York | New York | 10016 | United States |
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| Integrated Medical Professionals | North Hills | New York | 11042 | United States |
| Premier Medical Group of the Hudson Valley | Poughkeepsie | New York | 12601 | United States |
| James P. Wilmot Cancer Center | Rochester | New York | 14642 | United States |
| Staten Island Urological Research, PC | Staten Island | New York | 10304 | United States |
| Associated Medical Professionals of New York, PLLC | Syracuse | New York | 13210 | United States |
| Albert Einstein Cancer Center at the Montefiore Medical Park | The Bronx | New York | 10461 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Eastchester Center for Cancer Care | The Bronx | New York | 10469 | United States |
| Asheville Hematology & Oncology | Asheville | North Carolina | 28803 | United States |
| Raleigh Hematology Oncology Associates, D.B.A., Cancer Centers of North Carolina | Cary | North Carolina | 27518 | United States |
| Presbyterian Hospital Cancer Center | Charlotte | North Carolina | 28204 | United States |
| Regional Cancer Care, P.A. | Durham | North Carolina | 27704 | United States |
| Duke University Medical Center - Duke South Clinics | Durham | North Carolina | 27710 | United States |
| Cape Fear Valley Health System | Fayetteville | North Carolina | 28304 | United States |
| Carolina Urology Partners | Gastonia | North Carolina | 28054-3456 | United States |
| Presbyterian Hospital Huntersville | Huntersville | North Carolina | 28078 | United States |
| Matthews Hematology Oncology Associates | Matthews | North Carolina | 28105 | United States |
| Presbyterian Hospital Matthews | Matthews | North Carolina | 28105 | United States |
| Lake Norman Hematology Oncology Specialists | Mooresville | North Carolina | 28117 | United States |
| Coastal Carolina Health Care, PA, dba New Bern Cancer Care | New Bern | North Carolina | 28562 | United States |
| Raleigh Hematology Oncology Associates, D.B.A., Cancer Centers of North Carolina | Raleigh | North Carolina | 27607 | United States |
| Raleigh Hematology Oncology Associates, D.B.A., Cancer Centers of North Carolina | Raleigh | North Carolina | 27614 | United States |
| TriState Urologic Services PSC, Inc. dba TUG Research | Cincinnati | Ohio | 45212 | United States |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210-1280 | United States |
| SouthWest Urology | Middleburg Heights | Ohio | 44130 | United States |
| Cancer Centers of Southwest Oklahoma | Altus | Oklahoma | 73521 | United States |
| Cancer Centers of Southwest Oklahoma | Duncan | Oklahoma | 73533 | United States |
| Cancer Centers of Southwest Oklahoma | Lawton | Oklahoma | 73505 | United States |
| Urologic Specialists of Oklahoma | Tulsa | Oklahoma | 74146 | United States |
| Northwest Cancer Specialists, P.C. | Portland | Oregon | 97213-2982 | United States |
| Providence Cancer Center Oncology and Hematology Care | Portland | Oregon | 97213 | United States |
| Northwest Cancer Specialists, P.C. | Portland | Oregon | 97225 | United States |
| Northwest Cancer Specialists, P.C. | Portland | Oregon | 97227 | United States |
| Oregon Urology Institute | Springfield | Oregon | 97477 | United States |
| Northwest Cancer Specialists, P.C. | Tualatin | Oregon | 97062 | United States |
| Urologic Consultants of SE PA | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| Urology Health Specialists, LLC | Bryn Mawr | Pennsylvania | 19010 | United States |
| The Regional Cancer Center | Erie | Pennsylvania | 16505 | United States |
| Gettysburg Cancer Center | Gettysburg | Pennsylvania | 17325 | United States |
| Urological Associates of Lancaster | Lancaster | Pennsylvania | 17604 | United States |
| UPMC Cancer Center / Hillman Cancer Centerl | Pittsburgh | Pennsylvania | 15232 | United States |
| Scranton Hematology Oncology | Scranton | Pennsylvania | 18510 | United States |
| Cancer Care Associates of York | York | Pennsylvania | 17403 | United States |
| Charleston Hematology Oncology Associates, PA | Charleston | South Carolina | 29414 | United States |
| South Carolina Oncology Associates, PA | Columbia | South Carolina | 29210 | United States |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | United States |
| Urology Center of Spartanburg | Spartanburg | South Carolina | 29303 | United States |
| Lexington Oncology Associates, LLC | West Columbia | South Carolina | 29169 | United States |
| Avera Cancer Institute, Avera Medical Group Oncology and Hematology | Sioux Falls | South Dakota | 57105 | United States |
| Family Cancer Center Foundation, Inc. | Bartlett | Tennessee | 38133 | United States |
| The Jones Clinic, PC | Germantown | Tennessee | 38138 | United States |
| Family Cancer Center Foundation, Inc. | Memphis | Tennessee | 38119 | United States |
| Family Cancer Center Foundation, Inc. | Memphis | Tennessee | 38120 | United States |
| The West Clinic | Memphis | Tennessee | 38120 | United States |
| Tennessee Oncology, Centennial Medical Center | Nashville | Tennessee | 37203 | United States |
| Urology Associates, P.C. | Nashville | Tennessee | 37209 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Hendrick Medical Center / Hendrick Cancer Center | Abilene | Texas | 79601 | United States |
| Texas Oncology-Abilene | Abilene | Texas | 79606-5208 | United States |
| Texas Oncology - Austin Midtown | Austin | Texas | 78705 | United States |
| Texas Oncolocy - South Austin | Austin | Texas | 78745 | United States |
| Texas Oncology - Austin North | Austin | Texas | 78758 | United States |
| Texas Oncology - Beaumont, Mamie McFaddin Ward Cancer Center | Beaumont | Texas | 77702-1449 | United States |
| Texas Oncology - Cedar Park | Cedar Park | Texas | 78613 | United States |
| Cancer Specialists of South Texas, PA | Corpus Christi | Texas | 78412 | United States |
| Urology Clinics of North Texas, PLLC | Dallas | Texas | 75231-4482 | United States |
| Texas Oncology - Dallas Presbyterian Hospital | Dallas | Texas | 75231 | United States |
| Texas Oncology - Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| Texas Oncology - Denton South | Denton | Texas | 76210 | United States |
| Texas Oncology - El Paso Cancer Treatment Center Grandview | El Paso | Texas | 79902 | United States |
| Texas Oncology - El Paso Cancer Treatment Center Gateway | El Paso | Texas | 79915 | United States |
| Texas Oncology - El Paso Cancer Treatment Center Joe Battle | El Paso | Texas | 79939 | United States |
| Texas Oncology - Fort Worth 12th Avenue | Fort Worth | Texas | 76104 | United States |
| Texas Oncology - Southwest Fort Worth | Fort Worth | Texas | 76132 | United States |
| UTHealth Oncology, Memorial Hermann Cancer Center | Houston | Texas | 77030 | United States |
| Memorial Hennann Hosptial - Southwest Cancer Center | Houston | Texas | 77074 | United States |
| Memorial Hennann Hospital - Northeast Cancer Center | Humble | Texas | 77338 | United States |
| Texas Oncology - Kyle | Kyle | Texas | 78640 | United States |
| Texas Oncology - Lewisville | Lewisville | Texas | 75067 | United States |
| Texas Oncology - Seton-Williamson | Round Rock | Texas | 78665 | United States |
| Texas Oncology - Round Rock | Round Rock | Texas | 78681 | United States |
| Urology San Antonio Research | San Antonio | Texas | 78229 | United States |
| Oncology San Antonio Research, LLC | San Antonio | Texas | 78240 | United States |
| Texas Oncology - San Marcos | San Marcos | Texas | 78666 | United States |
| Blood and Cancer Center of East Texas | Tyler | Texas | 75701 | United States |
| Texas Oncology - Deke Slayton Cancer Center | Webster | Texas | 77598-4420 | United States |
| Huntsman Cancer Hospital | Salt Lake City | Utah | 84112 | United States |
| Urology of Virginia / SMG | Norfolk | Virginia | 23502 | United States |
| Harrison Poulsbo Hematology & Oncology | Poulsbo | Washington | 98370 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| University of Washington | Seattle | Washington | 98109 | United States |
| Medical Oncology Associates, PS | Spokane | Washington | 99208 | United States |
| Northwest Cancer Specialists, P.C. | Vancouver | Washington | 98684 | United States |
| Northwest Cancer Specialists, P.C. | Vancouver | Washington | 98686 | United States |
| Wheaton Franciscan Healthcare - Elmbrook Memorial Hospital | Brookfield | Wisconsin | 53045 | United States |
| Wheaton Franciscan Healthcare - Reiman Cancer Center | Franklin | Wisconsin | 53132 | United States |
| Wheaton Franciscan Healthcare - St. Joseph's Hospital | Milwaukee | Wisconsin | 53210 | United States |
| Wheaton Franciscan Healthcare - St. Francis Hospital | Milwaukee | Wisconsin | 53215 | United States |
| Wheaton Franciscan Healthcare -Wauwatosa Cancer Care | Wauwatosa | Wisconsin | 53226 | United States |
| Derived |
| Sartor O, Armstrong AJ, Ahaghotu C, McLeod DG, Cooperberg MR, Penson DF, Kantoff PW, Vogelzang NJ, Hussain A, Pieczonka CM, Shore ND, Quinn DI, Small EJ, Heath EI, Tutrone RF, Schellhammer PF, Harmon M, Chang NN, Sheikh NA, Brown B, Freedland SJ, Higano CS. Survival of African-American and Caucasian men after sipuleucel-T immunotherapy: outcomes from the PROCEED registry. Prostate Cancer Prostatic Dis. 2020 Sep;23(3):517-526. doi: 10.1038/s41391-020-0213-7. Epub 2020 Feb 28. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The analysis population only includes subjects that received at least one partial infusion of Sip-T.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sipuleucel-T | sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals. |
| 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 |
| ||||||||||||||||||||
| Age, Continuous | Mean | Full Range | Years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||||
| Weight | Mean | Standard Deviation | kilogram |
| |||||||||||||||||||
| Height | Mean | Standard Deviation | Centimeters |
| |||||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status | ECOG Performance Status is a method used to assess the functional status of a patient. The scale ranges from 0-5. 0=Fully active, able to carry on all pre-disease performance without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out light or sedentary work; 2=Ambulatory, capable of all self-care but unable to carry out work activities. Up and about >50% of waking hour; 3=Capable of limited self-care, confined to bed or chair >50% of waking hours; 4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5=Dead | Count of Participants | Participants |
| |||||||||||||||||||
| Primary Gleason Score | Gleason score= prostate cancer grading system based on how tissue looks under a microscope. Scores range 2-10 and indicates how likely it is that a tumor will spread. A low score means the cancer tissue is similar to normal tissue and the tumor is less likely to spread. Gleason Score ≤ 6=the tumor is well differentiated, less aggressive and likely to grow more slowly;7=the tumor is moderately differentiated, moderately aggressive, and likely to grow but may not spread quickly;≥8=the tumor is poorly differentiated or undifferentiated, highly aggressive, and likely to grow faster and spread. | Count of Participants | Participants |
| |||||||||||||||||||
| Gleason Sum Reported | Gleason score= prostate cancer grading system based on how tissue looks under a microscope. Scores range 2-10 and indicates how likely it is that a tumor will spread. A low score means the cancer tissue is similar to normal tissue and the tumor is less likely to spread. Gleason Score ≤ 6=the tumor is well differentiated, less aggressive and likely to grow more slowly;7=the tumor is moderately differentiated, moderately aggressive, and likely to grow but may not spread quickly;≥8=the tumor is poorly differentiated or undifferentiated, highly aggressive, and likely to grow faster and spread. | Count of Participants | Participants |
| |||||||||||||||||||
| Comorbidity Score | The NCI Comorbidity Index was used for this study. It is a weighted index to predict risk of death within 1 year of hospitalization for patients with specific comorbid conditions. Nineteen conditions were included in the index. Each condition was assigned a weight from 1 to 6, based on the estimated 1-year mortality hazard ratio from a Cox proportional hazards model. These weights were summed and for this study, a score of 0-1 was classified as a LOW score and a score great than 2 was classified as a HIGH score. | Count of Participants | Participants |
| |||||||||||||||||||
| Alkaline phosphatase | Mean | Standard Deviation | U/L |
| |||||||||||||||||||
| Hemoglobin | Mean | Standard Deviation | g/dL |
| |||||||||||||||||||
| Lactate dehydrogenase | Mean | Standard Deviation | U/L |
| |||||||||||||||||||
| Prostate-specific antigen (PSA) | Mean | Standard Deviation | ng/mL |
|
| 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 | To Further Quantify the Risk of Cerebrovascular Events Following Sipuleucel-T Therapy for All Subjects | The incidence rate of CVEs (cardiovascular events) was estimated as the number of new events per 100 patient years of follow-up in the overall sample of men with advanced-stage or metastatic prostate cancer and in men with or without castration. | Posted | Number | events per 100 patient years | Every 3 months for a minimum of 3 years |
|
|
| |||||||||||||||||||||||||||
| Secondary | Survival | To quantify survival by estimating the median time of survival in all subjects using the Kaplan-Meier method. | Posted | Median | 95% Confidence Interval | months | Every 3 months for a minimum of 3 years |
|
|
All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.
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 | Sipuleucel-T | sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals. | 1,223 | 1,976 | 260 | 1,902 | 12 | 1,902 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Retroperitoneal lymphadenopathy | Blood and lymphatic system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Papilloedema | Eye disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Colonic pseudo-obstruction | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Intestinal ulcer | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Endocarditis staphylococcal | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Ludwig angina | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Pneumococcal bacteraemia | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Salmonella sepsis | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Urinary tract infection staphylococcal | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Cystitis radiation | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
| |
| Post concussion syndrome | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
| |
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Blood pressure decreased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Non-systematic Assessment |
| |
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Non-systematic Assessment |
| |
| Prostate cancer stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Non-systematic Assessment |
| |
| Cauda equina syndrome | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Central nervous system haemorrhage | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Hemiplegia | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Hydromyelia | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Intracranial mass | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Paralysis | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Peroneal nerve palsy | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Thalamic infarction | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Acute psychosis | Psychiatric disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Bladder obstruction | Renal and urinary disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Nephropathy | Renal and urinary disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Obstructive uropathy | Renal and urinary disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Renal injury | Renal and urinary disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Urethral stenosis | Renal and urinary disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Prostatomegaly | Renal and urinary disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Cough | Reproductive system and breast disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Fracture reduction | Surgical and medical procedures | MedDRA 19.1 | Non-systematic Assessment |
| |
| Hip arthroplasty | Surgical and medical procedures | MedDRA 19.1 | Non-systematic Assessment |
| |
| Urethral stent insertion | Surgical and medical procedures | MedDRA 19.1 | Non-systematic Assessment |
| |
| Aneurysm | Vascular disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Blood pressure fluctuation | Vascular disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Ischaemia | Vascular disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Non-systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shabnam Vaziri | Dendreon | 206-455-2323 | svaziri@Dendreon.com |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C511774 | sipuleucel-T |
Not provided
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| ECOG 2= Capable of selfcare |
|
| ECOG 3= Capable of limited selfcare |
|
| ECOG Not Reported |
|
| Primary Gleason Score Data Not Recorded |
|
| Gleson Sum Data Not Recorded |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|