Prostate Cancer Clinical Trial
— CheckMate 7DXOfficial title:
A Phase 3, Randomized, Double-Blind Study of Nivolumab or Placebo in Combination With Docetaxel, in Men With Metastatic Castration-resistant Prostate Cancer
| Verified date | May 2024 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to assess the safety and effectiveness of nivolumab with docetaxel in men with advanced castration resistant prostate cancer who have progressed after second-generation hormonal manipulation.
| Status | Active, not recruiting |
| Enrollment | 1095 |
| Est. completion date | June 27, 2024 |
| Est. primary completion date | June 1, 2023 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Histologic confirmation of adenocarcinoma of the prostate without small cell features - Current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computerized tomography/magnetic resonance imaging (CT/MRI) - Eastern Cooperative Oncology Group (ECOG) performance status 0-1 - Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy - Documented prostate cancer progression per Prostate Cancer Working Group (PCWG3) criteria within 6 months prior to screening - Chemotherapy-naïve for metastatic castration-resistant prostate cancer (mCRPC), with 1 to 2 prior second generation hormonal therapies in the recurrent non-metastatic setting and/or metastatic setting, and no more than 1 second generation hormonal therapy in the mCRPC setting. Must have progressed during or after second generation hormonal therapy or have documented intolerance to second generation hormonal therapy - Participants must meet one of the following criteria regarding tissue submission: Sufficient tumor samples from a newly obtained ("fresh") biopsy (obtained during screening); or archival tumor tissue in the form of formalin-fixed paraffin-embedded (FFPE) block or unstained tumor tissue slides. For participants with bone-only disease or inaccessible soft tissue lesions or if the biopsy procedure would pose an unacceptable clinical risk for the participant, submission of tumor tissue obtained from a fresh biopsy is not required. - Men must agree to follow specific methods of contraception, if applicable Exclusion Criteria: - Active brain metastases - Active, known, or suspected autoimmune disease - Condition requiring systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids or adrenal replacement steroid doses are permitted in the absence of active autoimmune disease - Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways - Prior treatment with docetaxel or other chemotherapy for mCRPC. Prior docetaxel for metastatic castration-sensitive prostate cancer is permitted if at least 12 months have elapsed from last dose of docetaxel Other protocol-defined inclusion/exclusion criteria apply |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Local Institution - 0077 | Buenos Aires | |
| Argentina | Local Institution - 0178 | Buenos Aires | |
| Argentina | Local Institution - 0185 | Buenos Aires | |
| Argentina | Local Institution - 0369 | La Rioja | |
| Argentina | Local Institution - 0129 | Mar del Plata | Buenos Aires |
| Argentina | Local Institution - 0153 | Parana | Cordoba |
| Argentina | Local Institution - 0061 | Pergamino | Buenos Aires |
| Argentina | Local Institution - 0393 | Rio Cuarto | Cordoba |
| Argentina | Local Institution - 0394 | San Juan | |
| Argentina | Local Institution - 0083 | Viedma | RIO Negro |
| Australia | Local Institution - 0379 | Ballarat | Victoria |
| Australia | Local Institution - 0040 | Frankston | Victoria |
| Australia | Local Institution - 0152 | Gosford | New South Wales |
| Australia | Local Institution - 0091 | Lismore | New South Wales |
| Australia | Local Institution - 0032 | Malvern | Victoria |
| Australia | Local Institution - 0010 | North Adelaide | South Australia |
| Australia | Local Institution - 0006 | South Brisbane | Queensland |
| Australia | Local Institution - 0132 | Wahroonga | New South Wales |
| Australia | Local Institution - 0127 | Westmead | New South Wales |
| Australia | Local Institution - 0084 | Woolloongabba | Queensland |
| Austria | Local Institution - 0118 | Linz | Upper Austria |
| Austria | Local Institution - 0038 | Salzburg | |
| Austria | Local Institution - 0131 | Wien | |
| Austria | Local Institution - 0157 | Wien | |
| Belgium | Local Institution - 0122 | Anderlecht | Brussel |
| Belgium | Local Institution - 0121 | Brugge | |
| Belgium | Local Institution - 0114 | Gent | |
| Belgium | Local Institution - 0162 | Gent | |
| Belgium | Local Institution - 0137 | Turnhout | |
| Belgium | Local Institution - 0029 | Wilrijk | |
| Brazil | Local Institution - 0022 | Belo Horizonte | Minas Gerais |
| Brazil | Local Institution - 0097 | Belo Horizonte | Minas Gerais |
| Brazil | Local Institution - 0086 | Campinas | SAO Paulo |
| Brazil | Local Institution - 0082 | Curitiba | Parana |
| Brazil | Local Institution - 0100 | Curitiba | Parana |
| Brazil | Local Institution - 0058 | Ijui | Rio Grande Do Sul |
| Brazil | Local Institution - 0321 | Natal | Rio Grande Do Norte |
| Brazil | Local Institution - 0056 | Porto Alegre | RIO Grande DO SUL |
| Brazil | Local Institution - 0057 | Porto Alegre | Rio Grande Do Sul |
| Brazil | Local Institution - 0063 | Porto Alegre | RS |
| Brazil | Local Institution - 0060 | Rio de Janeiro | |
| Brazil | Local Institution - 0189 | Rio de Janeiro | |
| Brazil | Local Institution - 0059 | Santo Andre | SP |
| Brazil | Local Institution - 0096 | Sao Jose Do Rio Preto | Sao Paulo |
| Brazil | Local Institution - 0080 | Sao Paulo | |
| Brazil | Local Institution - 0273 | Sao Paulo | |
| Brazil | Local Institution - 0328 | Sao Paulo | |
| Canada | Local Institution - 0151 | Brampton | Ontario |
| Canada | Local Institution - 0143 | Montreal | Quebec |
| Canada | Local Institution - 0191 | Toronto | Ontario |
| Chile | Local Institution - 0378 | Providencia | Metropolitana |
| Chile | Local Institution - 0026 | Santiago | RM |
| Chile | Local Institution - 0025 | Santiago de Chile | Metropolitana |
| Chile | Local Institution - 0377 | Santiago de Chile | Metropolitana |
| Chile | Local Institution - 0027 | Vina del Mar | Valparaiso |
| China | Local Institution - 0320 | Baoding Shi | Hebei |
| China | Local Institution - 0245 | Beijing | Beijing |
| China | Local Institution - 0254 | Beijing | Beijing |
| China | Local Institution - 0312 | Beijing | Bei |
| China | Local Institution - 0337 | Beijing | Beijing |
| China | Local Institution - 0345 | Beijing | Beijing |
| China | Local Institution - 0140 | Beijing Shi | Beijing |
| China | Local Institution - 0168 | Changsha | Hunan |
| China | Local Institution - 0253 | Chengdu | Sichuan |
| China | Local Institution - 0256 | Fuzhou | Fujian |
| China | Local Institution - 0319 | Guangzhou | Guangdong |
| China | Local Institution - 0316 | Hangzhou | Zhejiang |
| China | Local Institution - 0344 | Hangzhou | Zhejiang |
| China | Local Institution - 0224 | Harbin Shi | Heilongjiang |
| China | Local Institution - 0314 | Henan Sheng | Henan |
| China | Local Institution - 0326 | Jinan | Shandong |
| China | Local Institution - 0330 | Nanchang | Jiangxi |
| China | Local Institution - 0347 | Nanchang | Jiangxi |
| China | Local Institution - 0165 | Nanjing | Jiangsu |
| China | Local Institution - 0317 | Nanjing | Jiangsu |
| China | Local Institution - 0325 | Nanjing | Jiangsu |
| China | Local Institution - 0155 | Shanghai | Shanghai |
| China | Local Institution - 0161 | Shenyang | Liaoning |
| China | Local Institution - 0310 | Urumqi | Xinjiang |
| China | Local Institution - 0313 | Wu Han | Hubei |
| China | Local Institution - 0353 | Xian | Shannxi |
| China | Local Institution - 0275 | Zhengzhou | Henan |
| Czechia | Local Institution - 0093 | Brno | |
| Czechia | Local Institution - 0108 | Brno | |
| Czechia | Local Institution - 0049 | Olomouc | |
| Czechia | Local Institution - 0088 | Ostrava | |
| Czechia | Local Institution - 0361 | Prague | |
| Czechia | Local Institution - 0050 | Praha | |
| France | Local Institution - 0107 | Angers Cedex 02 | |
| France | Local Institution - 0202 | Brest | |
| France | Local Institution - 0398 | Dijon | |
| France | Local Institution - 0030 | Hyeres | |
| France | Local Institution - 0167 | Le Mans | Sarthe |
| France | Local Institution - 0079 | Lille | Nord |
| France | Local Institution - 0109 | Montpellier | |
| France | Local Institution - 0395 | Montpellier | |
| France | Local Institution - 0384 | Nice cedex 2 | |
| France | Local Institution - 0068 | Nimes Cedex 9 | |
| France | Local Institution - 0071 | Paris | |
| France | Local Institution - 0106 | Paris | |
| France | Local Institution - 0381 | Paris | |
| France | Local Institution - 0133 | Pierre-Benite | |
| France | Local Institution - 0399 | Reims | |
| France | Local Institution - 0380 | Rennes | |
| France | Local Institution - 0105 | Strasbourg | Alsace |
| France | Local Institution - 0387 | Strasbourg | |
| France | Local Institution - 0271 | Villejuif Cedex | |
| Germany | Local Institution - 0089 | Bonn | |
| Germany | Local Institution - 0090 | Dresden | Saxony |
| Germany | Local Institution - 0376 | Duesseldorf | |
| Germany | Local Institution - 0172 | Emmendingen | |
| Germany | Local Institution - 0142 | Erlangen | |
| Germany | Local Institution - 0018 | Frankfurt am Main | |
| Germany | Local Institution - 0064 | Hamburg | |
| Germany | Local Institution - 0069 | Hamburg | |
| Germany | Local Institution - 0389 | Heidelberg | |
| Germany | Local Institution - 0014 | Koblenz | Rheinland Pfa |
| Germany | Local Institution - 0004 | Magdeburg | |
| Germany | Local Institution - 0372 | Marburg | |
| Germany | Local Institution - 0204 | Muenchen | |
| Germany | Local Institution - 0036 | Muenster | |
| Germany | Local Institution - 0023 | Nuertingen | Baden-Wuerttemberg |
| Germany | Local Institution - 0169 | Tuebingen | |
| Hong Kong | Local Institution - 0045 | Hong Kong | |
| Hong Kong | Local Institution - 0145 | Hong Kong | |
| Hong Kong | Local Institution - 0146 | Hong Kong | |
| Israel | Local Institution - 0072 | Haifa | |
| Israel | Local Institution - 0388 | Jerusalem | |
| Israel | Local Institution - 0368 | Kfar Saba | |
| Israel | Local Institution - 0128 | Petach tikva | |
| Israel | Local Institution - 0135 | Ramat Gan | |
| Israel | Local Institution - 0138 | Tel Aviv | |
| Italy | Local Institution - 0099 | Benevento | |
| Italy | Local Institution - 0001 | Bergamo | |
| Italy | Local Institution - 0111 | Bologna | |
| Italy | Local Institution - 0039 | Brescia | |
| Italy | Local Institution - 0053 | Cremona | |
| Italy | Local Institution - 0066 | Milan | |
| Italy | Local Institution - 0120 | Napoli | |
| Italy | Local Institution - 0070 | Orbassano | |
| Italy | Local Institution - 0037 | Parma | |
| Italy | Local Institution - 0199 | Pisa | |
| Italy | Local Institution - 0046 | Rome | |
| Italy | Local Institution - 0385 | Rome | |
| Italy | Local Institution - 0067 | Trento | |
| Japan | Local Institution - 0340 | Akita-shi | Akita |
| Japan | Local Institution - 0346 | Chiba-shi | Chiba |
| Japan | Local Institution - 0280 | Fukuoka-shi | Fukuoka |
| Japan | Local Institution - 0309 | Hamamatsu | Shizuoka |
| Japan | Local Institution - 0358 | Hirosaki-shi | Aomori |
| Japan | Local Institution - 0342 | Kamigyo-ku | Kyoto |
| Japan | Local Institution - 0355 | Kashihara-shi | Nara |
| Japan | Local Institution - 0324 | Kumamoto-Shi | Kumamoto |
| Japan | Local Institution - 0307 | Matsuyama-shi | Ehime |
| Japan | Local Institution - 0341 | Nagasaki | |
| Japan | Local Institution - 0362 | Nagoya-shi | Aichi |
| Japan | Local Institution - 0327 | Niigata | |
| Japan | Local Institution - 0354 | Okayama | |
| Japan | Local Institution - 0338 | Osaka | |
| Japan | Local Institution - 0323 | Osaka Sayama | Osaka |
| Japan | Local Institution - 0343 | Osaka shi | Osaka |
| Japan | Local Institution - 0339 | Sakura-Shi | Chiba |
| Japan | Local Institution - 0281 | Sapporo | Hokkaido |
| Japan | Local Institution - 0296 | Sapporo-shi | Hokkaido |
| Japan | Local Institution - 0308 | Tokyo | |
| Japan | Local Institution - 0279 | Toyama-shi | Toyama |
| Japan | Local Institution - 0282 | Ube shi | Yamaguchi |
| Japan | Local Institution - 0278 | Wakayama | |
| Japan | Local Institution - 0283 | Yokohama-shi | Kanagawa |
| Korea, Republic of | Local Institution - 0391 | Daegu | |
| Korea, Republic of | Local Institution - 0298 | Incheon | |
| Korea, Republic of | Local Institution - 0375 | Jeollanam-do | |
| Korea, Republic of | Local Institution - 0297 | Jung-gu | Daejeon |
| Korea, Republic of | Local Institution - 0374 | Seodaemun-Gu | |
| Korea, Republic of | Local Institution - 0171 | Seoul | |
| Korea, Republic of | Local Institution - 0187 | Seoul | |
| Korea, Republic of | Local Institution - 0193 | Seoul | |
| Korea, Republic of | Local Institution - 0370 | Seoul | |
| Korea, Republic of | Local Institution - 0373 | Seoul | |
| Korea, Republic of | Local Institution - 0186 | Songnam-si | Gyeonggi-do |
| Korea, Republic of | Local Institution - 0158 | Yangsan Si | |
| Mexico | Local Institution - 0017 | Mexico City | D.f. |
| Mexico | Local Institution - 0062 | Morelia | Michoacan |
| Mexico | Local Institution - 0015 | Zapopan | Jalisco |
| Mexico | Local Institution - 0016 | Zapopan | Jalisco |
| New Zealand | Local Institution - 0101 | Hamilton | |
| New Zealand | Local Institution - 0184 | Palmerston North | Manawatu-Wanganui |
| New Zealand | Local Institution - 0102 | Tauranga | |
| Poland | Local Institution - 0383 | Bydgoszcz | |
| Poland | Local Institution - 0136 | Koszalin | |
| Poland | Local Institution - 0009 | Lodz | |
| Poland | Local Institution - 0013 | Lublin | |
| Poland | Local Institution - 0065 | Poznan | |
| Poland | Local Institution | Warsaw | |
| Poland | Local Institution - 0095 | Warszawa | |
| Puerto Rico | Local Institution - 0329 | Rio Piedras | |
| Puerto Rico | Local Institution - 0359 | San Juan | |
| Romania | Local Institution - 0042 | Bucharest | |
| Romania | Local Institution - 0041 | Cluj | Cluj-Napoca |
| Romania | Local Institution - 0043 | Cluj Napoca | |
| Romania | Local Institution - 0020 | Constanta | |
| Romania | Local Institution - 0052 | Craiova | |
| Romania | Local Institution - 0035 | Timisoara | |
| Russian Federation | SBHI Arkhangelsk Region - Arkhangelsk Clinical Oncological Dispensary | Arkhangelsk | |
| Russian Federation | SAHI Republican Clinical Oncology Dispensary of MoH of RT | Kazan | |
| Russian Federation | Clinical Hospital MEDSI in Otradnoye | Krasnogorsk Moscow Region | |
| Russian Federation | Federal State Budgetary Institution N.N. Blokhin National Medical Research Center of Oncology of the | Moscow | |
| Russian Federation | P.A. Herzen Moscow Oncology Research Institute | Moscow | |
| Russian Federation | Sechenov University | Moscow | |
| Russian Federation | FSBI National Medical Research Radiology Center NMRRC - A. Tsyb Medical Radiological Research Centre | Obninsk | |
| Russian Federation | Budgetary Healthcare Institution of Omsk Region ",Clinical Oncological Dispensary", | Omsk | |
| Russian Federation | Andros Clinic LLC | Saint-Petersburg | |
| Russian Federation | Russian Scientific Centre of Radiology and Surgical Technologies n.a. acad. M.A. | Saint-Petersburg | |
| Singapore | Local Institution - 0005 | Singapore | |
| Singapore | Local Institution - 0116 | Singapore | |
| Singapore | Local Institution - 0170 | Singapore | |
| Spain | Local Institution - 0073 | Barcelona | |
| Spain | Local Institution - 0123 | Barcelona | |
| Spain | Local Institution - 0360 | Cordoba | |
| Spain | Local Institution - 0044 | Girona | |
| Spain | Local Institution - 0034 | Lugo | |
| Spain | Local Institution - 0003 | Madrid | |
| Spain | Local Institution - 0024 | Madrid | |
| Spain | Local Institution - 0031 | Madrid | |
| Spain | Local Institution - 0076 | Madrid | |
| Spain | Local Institution - 0364 | Madrid | |
| Spain | Local Institution - 0141 | Manresa | Barcelona |
| Spain | Local Institution - 0124 | Sabadell (Barcelona) | |
| Spain | Local Institution - 0363 | Sevilla | |
| Taiwan | Local Institution - 0192 | Niaosng | Kaohsiung |
| Taiwan | Local Institution - 0194 | Taichung | |
| Taiwan | Local Institution - 0371 | Taichung | |
| Taiwan | Local Institution - 0386 | Tainan | |
| Taiwan | Local Institution - 0175 | Taipei | |
| Taiwan | Local Institution - 0188 | Taipei | |
| Turkey | Local Institution - 0094 | Adana | |
| Turkey | Local Institution - 0119 | Ankara | |
| Turkey | Local Institution - 0130 | Ankara | |
| Turkey | Local Institution - 0113 | Istanbul | |
| Turkey | Local Institution - 0104 | Izmir | |
| Turkey | Local Institution - 0112 | Malatya | |
| United Kingdom | Local Institution - 0048 | Guildford | Surrey |
| United Kingdom | Local Institution - 0154 | London | |
| United Kingdom | Local Institution - 0173 | London | Greater London |
| United Kingdom | Local Institution - 0098 | Manchester | Lancashire |
| United Kingdom | Local Institution - 0008 | Northwood | Middlesex |
| United Kingdom | Local Institution - 0051 | Nottingham | Nottinghamshire |
| United Kingdom | Local Institution - 0265 | Oxford | Oxfordshire |
| United States | Local Institution - 0300 | Albany | New York |
| United States | Local Institution - 0180 | Allentown | Pennsylvania |
| United States | Local Institution - 0012 | Anchorage | Alaska |
| United States | Local Institution - 0117 | Atlanta | Georgia |
| United States | Local Institution - 0286 | Austin | Texas |
| United States | Local Institution - 0074 | Bala-Cynwyd | Pennsylvania |
| United States | Local Institution - 0150 | Baltimore | Maryland |
| United States | Local Institution - 0332 | Brandywine | Maryland |
| United States | Local Institution - 0233 | Charleston | South Carolina |
| United States | Local Institution - 0333 | Columbus | Ohio |
| United States | Local Institution - 0303 | Dallas | Texas |
| United States | Local Institution - 0087 | Denver | Colorado |
| United States | Local Institution - 0365 | East Brunswick | New Jersey |
| United States | Local Institution - 0139 | Florham Park | New Jersey |
| United States | Local Institution - 0183 | Fort Wayne | Indiana |
| United States | Local Institution - 0149 | Germantown | Tennessee |
| United States | Local Institution - 0196 | Hollywood | Florida |
| United States | Local Institution - 0195 | Houston | Texas |
| United States | Local Institution - 0284 | Houston | Texas |
| United States | Local Institution - 0397 | Jacksonville | Florida |
| United States | Local Institution - 0269 | Jonesboro | Arkansas |
| United States | Local Institution - 0164 | Lakeland | Florida |
| United States | Local Institution - 0302 | Louisville | Kentucky |
| United States | Local Institution - 0126 | Marietta | Georgia |
| United States | Local Institution - 0305 | Mobile | Alabama |
| United States | Local Institution - 0115 | Myrtle Beach | South Carolina |
| United States | Local Institution - 0287 | Niles | Illinois |
| United States | Local Institution - 0299 | Omaha | Nebraska |
| United States | Local Institution - 0179 | Orange | California |
| United States | Local Institution - 0181 | Orlando | Florida |
| United States | Local Institution - 0285 | Pensacola | Florida |
| United States | Local Institution - 0292 | Pittsburgh | Pennsylvania |
| United States | Local Institution - 0028 | Port Jefferson Station | New York |
| United States | Local Institution - 0055 | Rancho Mirage | California |
| United States | Local Institution - 0260 | Redondo Beach | California |
| United States | Local Institution - 0011 | San Antonio | Texas |
| United States | Local Institution - 0081 | Santa Monica | California |
| United States | Local Institution - 0110 | Seattle | Washington |
| United States | Local Institution - 0289 | Spokane | Washington |
| United States | Local Institution - 0382 | Thomasville | Georgia |
| United States | Local Institution - 0293 | Tucson | Arizona |
| United States | The University of Texas Health Science Center at Tyler DBA UT Health East Texas Hope Cancer Center | Tyler | Texas |
| United States | Local Institution - 0366 | Washington | District of Columbia |
| United States | Local Institution - 0190 | West Haven | Connecticut |
| United States | Local Institution - 0177 | Weston | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, France, Germany, Hong Kong, Israel, Italy, Japan, Korea, Republic of, Mexico, New Zealand, Poland, Puerto Rico, Romania, Russian Federation, Singapore, Spain, Taiwan, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Radiographic progressive free survival (rPFS) assessed by Blinded Independent Central Review (BICR) per Prostate Cancer Working Group (PCWG3) | Up to 530 rPFS events | From the date of randomization to the first date of documented progression or death due to any cause, whichever occurs first, approximately 31 months | |
| Primary | Overall Survival (OS) | From the date of randomization to the date of death from any cause, approximately 51 months. For participants who are alive, their survival time will be censored at the last date that they were known to be alive | ||
| Secondary | Objective Response Rate (ORR) per PCWG3 | From the date of randomization to the date of objectively documented progression or the date of subsequent systemic cancer therapy, whichever occurs first, approximately 31 months | ||
| Secondary | Time to Response per PCWG3 (TTR-PCWG3) determined by BICR | From the date of randomization to the date of the first documented complete response (CR) or partial response (PR), approximately 31 months | ||
| Secondary | Duration of Response (DOR) per PCWG3 determined by BICR | From the date of first response (CR/PR) to the date of first documented radiographic progression, or death due to any cause, approximately 31 months | ||
| Secondary | Prostate-specific antigen (PSA) Response Rate (PSA-RR) | Approximately 31 months | ||
| Secondary | Time to PSA Progression (TTP-PSA) | From date of randomization to the date of PSA progression per PCWG3, approximately 31 months | ||
| Secondary | Incidence of Adverse Events (AEs) | Approximately 31 months | ||
| Secondary | Incidence of Serious Adverse Events (SAEs) | Approximately 31 months | ||
| Secondary | Incidence of AEs leading to discontinuation | Approximately 31 months | ||
| Secondary | Incidence of immune-mediated AEs | Approximately 31 months | ||
| Secondary | Incidence of deaths | Approximately 31 months | ||
| Secondary | Incidence of laboratory abnormalities: Clinical Chemistry Tests | Approximately 31 months | ||
| Secondary | Incidence of laboratory abnormalities: Hematology tests | Approximately 31 months | ||
| Secondary | Incidence of laboratory abnormalities: Serology tests | Approximately 31 months | ||
| Secondary | Median time to pain progression assessed by Brief Pain Inventory-Short Form (BPI-SF) | Approximately 31 months | ||
| Secondary | Incidence of changes from baseline in Physical Exam | Approximately 31 months | ||
| Secondary | Incidence of changes from baseline in vital signs: Respiratory rate | Approximately 31 months | ||
| Secondary | Incidence of changes from baseline in vital signs: Body temperature | Approximately 31 months | ||
| Secondary | Incidence of changes from baseline in vital signs: Blood pressure | Approximately 31 months | ||
| Secondary | Incidence of changes from baseline in vital signs: Heart Rate | Approximately 31 months | ||
| Secondary | Incidence of changes from baseline electrocardiogram (ECG) | Approximately 31 months |
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