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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-005872-29 | EudraCT Number |
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Lack of efficacy
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| Name | Class |
|---|---|
| Eisai Europe Ltd. (United Kingdom) | INDUSTRY |
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This research is being done to find out if Carboplatin and Taxane works better alone or when given with an experimental drug called MORAb-003(farletuzumab) in subjects with first platinum sensitive relapsed ovarian cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Farletuzumab (1.25 mg/kg) | Active Comparator | Participants will receive farletuzumab 1.25 milligram per kilogram (mg/kg) administer as an intravenous (IV) infusion weekly, followed by taxane (paclitaxel [175 milligram per meter square {mg/m^2}] or docetaxel [75 mg/m^2]), administer as IV infusion and followed by carboplatin (to maintain area under curve [AUC] 5-6 milligram per milliliter per minute [mg/mL/minute]), administer as IV infusion, every three weeks, on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg, administer as IV infusion, weekly is given until disease progression. |
|
| Farletuzumab (2.5 mg/kg) | Active Comparator | Participants will receive farletuzumab 2.5 mg/kg administer as an IV infusion weekly, followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]), administer as IV infusion and followed by carboplatin (to maintain AUC 5-6 mg/mL/minute), administer as IV infusion, every three weeks on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg, administer as IV infusion, weekly is given until disease progression. |
|
| Placebo | Placebo Comparator | Participants will receive farletuzumab-matched placebo (0.9 percent [%] saline) administer as an IV infusion weekly, followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]), administer as IV infusion and followed by carboplatin (to maintain AUC 5-6 mg/mL/minute), administer as IV infusion, every three weeks on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo (0.9% saline), administer as IV infusion, weekly is given until disease progression. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Farletuzumab | Drug | Farletuzumab IV infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | PFS was defined as the time (in months) from the date of randomization to the date of the first observation of progression based on the independent radiologic assessment (modified response evaluation criteria in solid tumors [RECIST]), or date of death, whatever the cause. As per RECIST, disease progression was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions. If progression or death was not observed for a participant, the PFS time was censored at the date of the last tumor assessment without evidence of progression before the date of initiation of further antitumor treatment, or the cutoff date (whichever was earlier). | From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the time (in months) from the date of randomization to the date of death, due to any cause. If death was not observed for a participant, the survival time was censored on the last date the participant was known to be alive or the cutoff date, whichever was earlier. | From the date of randomization until date of death from any cause, or study termination by sponsor, whichever came first (up to 48 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Of Alabama At Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Oncology Specialties, PC |
A total of 1100 participants were randomized and enrolled, out of which 1091 participants received study treatment. Study was terminated early due to lack of efficacy based on the results for progression-free survival (PFS).
Participants took part in the study at 274 investigative sites in North America, Europe, Asia Pacific, Latin America, and Japan from 16 April 2009 to 12 April 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin | Participants received farletuzumab 1.25 milligram per kilogram (mg/kg) as an intravenous (IV) infusion, weekly followed by taxane (paclitaxel [175 milligram per meter square {mg/m^2}] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve area under curve (AUC) 5 or 6 milligram per minute per milliliter (mg/min/mL) (carboplatin dose [milligram {mg}] = Target AUC [mg*min/mL]*glomerular filtration rate [GFR] milliliter per minute [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Carboplatin | Drug | Carboplatin IV infusion. |
|
| Taxane | Drug | Taxane (Paclitaxel or Docetaxel) IV infusion. |
|
| Farletuzumab-matched placebo | Drug | Farletuzumab-matched placebo IV infusion. |
|
| Cancer Antigen-125 (CA-125) Progression-Free Survival | CA-125 PFS was defined as the time (in months) from the date of randomization until the date of the first observation of progression based on the Rustin criteria, or date of death, whatever the cause. If progression or death was not observed for a participant, the CA-125 PFS time was censored at the date of the last CA-125 assessment without evidence of progression before the date of initiation of further antitumor treatment or the "primary analysis cut off" date, whichever was earlier. Based on Rustin criteria, progressive disease (PD) was a rise in CA125 since beginning of consolidation or previously normal CA125 that rises to greater than or equal to (>=) 2 multiple (*) ULN with either event documented on two occasions or CA-125 >=2*nadir value with either event documented on two occasions. | From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months) |
| Progression-Free Survival Based on Gynecologic Cancer InterGroup (GCIG) Criteria | PFS using GCIG criteria was defined as time (in months) from date of randomization until date of first observation of progression based on GCIG criteria, or date of death, whatever the cause. If progression or death was not observed for a participant, GCIG PFS time was censored at later date of last tumor assessment or CA-125 assessment without evidence of progression before date of initiation of further antitumor treatment or the "primary analysis cut off" date, whichever was earlier. Disease progression per GCIG: Participants with elevated CA-125 pretreatment and normalisation of CA-125 must show evidence of CA-125 >=two times ULN on two occasions at least one week apart or participants with elevated CA-125 pretreatment, which never normalises must show evidence of CA-125 >=two times nadir value on two occasions at least one week apart or participants with CA-125 in normal range pretreatment must show evidence of CA-125 >=two times ULN on two occasions at least one week apart. | From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months) |
| Percentage of Participants With Length of Second Remission Greater Than First Remission | Length of first remission was defined as a.) the period of time (in months) from the date of completion of previous platinum-based chemotherapy until date of first relapse (that is, first observation of progression). It was assumed that the date of first relapse was the earlier of progression by CA-125 or progression by radiologic assessment, as judged by the investigator using GCIG criteria. b.) the period of time (in months) from the date of completion of previous platinum-based chemotherapy (used prior to study entry) until date of randomization. The length of the second remission was defined as the period of time (in months) from the date of completion of platinum-based chemotherapy until the first observation of progression based on GCIG criteria. Based on GCIG criteria, disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions. | From the date of last dose of platinum-based chemotherapy to date of relapse and date of last dose of platinum-based chemotherapy to first observation of progression (up to 48 months) |
| Percentage of Participants With Objective Response | Objective response was defined as either a confirmed complete response (CR) or confirmed partial response (PR) as assessed by investigator based on response evaluation criteria in solid tumors version 1.1 (RECIST version 1.1). CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis less than (<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. | From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 48 months) |
| Duration of Tumor Response | Duration of response was defined as the time (in months) from first documentation of objective response (confirmed CR or PR) to the first documentation of objective tumor progression or death due to any cause. Duration of response was derived only for those participants with objective evidence of confirmed CR or PR. | From the first date of confirmed objective response (CR or PR) to first date of progression or death due to any cause (up to 48 months) |
| Time to Tumor Response (TTR) | Time to tumor response was defined as the time (in months) from the date of randomization to first documentation of objective tumor response. Time to tumor response was derived for those participants with objective evidence of CR or PR. | From the date of randomization to first documentation of objective response (up to 48 months) |
| Percentage of Participants With Serologic Response (SR) | SR was defined as either normalization, 75% response, or 50% response using the Rustin criteria. Percentage of participants with 50% SR, 75% SR and SR leading to normalization were reported. A 50% response according to CA-125 was defined as a 50% decrease in serum CA-125 levels, as determined through a series of four CA-125 samples (one baseline sample with an elevated level, the sample that showed a 50% decrease, and a confirmatory sample at the decreased level). A 75% response was established if there had a serial decrease in serum CA-125 levels of 75% over three samples. In both the 50% and 75% response definitions, the final sample was analyzed at least 28 days after the previous sample. | Up to 48 months |
| Duration of 50% Serologic Response | Duration of SR was defined as the time (in months) from first documentation of response to the first documentation of 50% serologic progression or death due to any cause. For responding participants who did not have serologic progression or did not die and who 1) were either still on study at the time of an analysis, 2) were given antitumor treatment other than study treatment, or 3) were withdrawn from study follow-up before documentation of serologic progression, the duration of SR was censored at the last date the participant was known to be without serologic progression. A 50% response according to CA-125 was defined as a 50% decrease in serum CA-125 levels, as determined through a series of three CA-125 samples (one baseline sample with an elevated level, the sample that showed a 50% decrease, and a confirmatory sample at the decreased level). | From the first date of documentation of response to first documentation of serologic progression or death due to any cause (up to 48 months) |
| Time to 50% Serologic Response (TSR) | TSR was defined as the time (in months) from the date of randomization to first documentation of 50% SR. A 50% response according to CA-125 was defined as a 50% decrease in serum CA-125 levels, as determined through a series of three CA-125 samples (one baseline sample with an elevated level, the sample that showed a 50% decrease, and a confirmatory sample at the decreased level). | From the date of randomization to first documentation of 50% SR (up to 48 months) |
| Percentage of Participants With Clinical Benefit | Clinical benefit was defined as a confirmed CR or a confirmed PR, or stable disease (SD) using RECIST 1.0 criteria. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis <10 mm. PR was defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non target lesions. | Up to 48 months |
| Cmax: Maximum Observed Plasma Concentration of Total Carboplatin and Total Paclitaxel | Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days) |
| Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of Total Carboplatin and Total Paclitaxel | Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days) |
| AUC (0-inf): Area Under the Concentration-time Curve From Zero (Pre-dose) Extrapolated to Infinite Time of Total Carboplatin and Total Paclitaxel | Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days) |
| T1/2: Terminal Half-life of Total Carboplatin and Total Paclitaxel | Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days) |
| CL: Clearance of Total Carboplatin and Total Paclitaxel | Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days) |
| Vd: Volume of Distribution of Total Carboplatin and Total Paclitaxel | Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days) |
| Mean Functional Assessment of Cancer Therapy-Ovarian Treatment Outcome Index (FACT-O TOI) Scores | Participant-reported Quality of Life (QoL) was measured using the Functional Assessment of Cancer Therapy-Ovarian (FACT-O), version 4 and reported in the Treatment Outcome Index (TOI) format. TOI is a 26-item subset of the FACT-O questionnaire composed of the raw sum of the physical well-being subscale (7 items), the functional well-being subscale (7 items), and the ovarian cancer subscale (12 items). Each item was scored on a scale of 0 (not at all) to 4 (very much). Some items were reversed scored. Scores from each subsection were summed into one composite score, termed the FACT-O TOI score which ranged from 0 to 104 and a higher score reflected better QoL. As per planned analysis, farletuzumab treatment groups 1.25 mg/kg and 2.5 mg/kg were pooled for the QoL assessment. | Cycle 3, Cycle 6, Cycle 12 (each cycle length=21 days) |
| Huntsville |
| Alabama |
| 35801 |
| United States |
| Arizona Hematology & Oncology Associates | Phoenix | Arizona | 85012 | United States |
| St. Joseph's Hospital, Barrow Neurology Clinics | Phoenix | Arizona | 85013 | United States |
| Arizona Oncology Associates | Tucson | Arizona | 85712 | United States |
| Arizona Cancer Center | Tucson | Arizona | 85724 | United States |
| Providence St. Joseph Medical Center | Burbank | California | 91505 | United States |
| California Cancer Care, Inc. | Greenbrae | California | 94904 | United States |
| University of California San Diego | La Jolla | California | 92093-0698 | United States |
| University of California Los Angeles Medical Center | Los Angeles | California | 90095 | United States |
| Gynecologic Oncology Associates | Newport Beach | California | 92663 | United States |
| University of California Davis Cancer Center | Sacramento | California | 95817 | United States |
| Stanford University | Stanford | California | 94305 | United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| Catholic Health Initiatives | Colorado Springs | Colorado | 80907 | United States |
| Denver Health and Hospital Authority | Denver | Colorado | 80204 | United States |
| Hematology Oncology P.C. | Stamford | Connecticut | 06902 | United States |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Palm Beach Institute of Hematology and Oncology | Boynton Beach | Florida | 33435 | United States |
| University Cancer Institute | Boynton Beach | Florida | 33435 | United States |
| Gainsville Hematology Oncology Associates | Gainesville | Florida | 32605 | United States |
| Baptist Cancer Institute | Jacksonville | Florida | 32207 | United States |
| Jupiter Medical center Physician's Group | Jupiter | Florida | 33458 | United States |
| Hematology/Oncology Associates | Lake Worth | Florida | 33461 | United States |
| Lakeland Regional Cancer Center | Lakeland | Florida | 33805 | United States |
| Florida Hospital | Orlando | Florida | 32804 | United States |
| Sarasota Memorial Healthcare System | Sarasota | Florida | 34239 | United States |
| Gulfcoast Oncology | St. Petersburg | Florida | 33705 | United States |
| Oncology-Hematology Associates of W. Broward P.A. | Tamarac | Florida | 33321 | United States |
| Palm Beach Cancer Institute | West Palm Beach | Florida | 33401 | United States |
| Medical College of Georgia | Augusta | Georgia | 30912 | United States |
| Memorial Health University Medical Center | Savannah | Georgia | 31404 | United States |
| Kaiser Permanente - Moanalua Medical Center | Honolulu | Hawaii | 96819 | United States |
| Kapi'olani Medical Center for Women and Children | Honolulu | Hawaii | 96826 | United States |
| Medical & Surgical Specialists, LLC | Galesburg | Illinois | 61401 | United States |
| Ingalls Memorial Hospital | Harvey | Illinois | 60425 | United States |
| Loyola University Chicago | Maywood | Illinois | 60153 | United States |
| Midwest Cancer Research Group | Skokie | Illinois | 60625 | United States |
| Central DuPage Hospital | Winfield | Illinois | 60190 | United States |
| St. Francis Hospital & Health Centers | Indianapolis | Indiana | 46237 | United States |
| St. Vincent Gynecologic Oncology | Indianapolis | Indiana | 46260 | United States |
| Central Baptist Hospital | Lexington | Kentucky | 40503 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| Norton Healthcare | Louisville | Kentucky | 40207 | United States |
| Hematology & Oncology Specialists | Metairie | Louisiana | 70006 | United States |
| Mercy Medical Center | Baltimore | Maryland | 21202 | United States |
| Greater Baltimore Medical Center | Baltimore | Maryland | 21204 | United States |
| John Hopkins University | Baltimore | Maryland | 21231 | United States |
| Weinberg Cancer Institute at Franklin Square | Baltimore | Maryland | 21237-3998 | United States |
| Center for Cancer and Blood Disorders | Bethesda | Maryland | 20817 | United States |
| Frederick Memorial Hospital | Frederick | Maryland | 21701 | United States |
| Barbara Ann Kamanos Cancer Center | Detroit | Michigan | 48201 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Saint Mary's Health Care | Grand Rapids | Michigan | 49503 | United States |
| Sparrow Regional Cancer Center | Lansing | Michigan | 48909 | United States |
| Park Nicollet Institute | Saint Louis Park | Minnesota | 55426 | United States |
| Saint Francis Memorial Health Center | Grand Island | Nebraska | 68803 | United States |
| Good Samaritan Hospital Cancer Center | Kearney | Nebraska | 68847 | United States |
| The Center for Cancer and Hematologic Disease | Camden | New Jersey | 08003 | United States |
| Hematology-Oncolgy Associates of NNJ-PA | Denville | New Jersey | 07834 | United States |
| John Theurer Cancer Center at Hackensack University MC | Hackensack | New Jersey | 07601 | United States |
| Morristown Memorial Hospital | Morristown | New Jersey | 07962 | United States |
| Cooper Cancer Institute | Voorhees Township | New Jersey | 08043 | United States |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87106 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Arena Oncology Associates | Lake Success | New York | 11042 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28204 | United States |
| Presbyterian Hospital | Charlotte | North Carolina | 28204 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Piedmont Hematology & Oncology | Winston-Salem | North Carolina | 27103 | United States |
| Catholic Health Initiatives | Cincinnati | Ohio | 45220 | United States |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | United States |
| MetroHealth Medical Center | Cleveland | Ohio | 44195 | United States |
| Miami Valley Hospital | Dayton | Ohio | 45409 | United States |
| Kettering Medical Center | Kettering | Ohio | 45429 | United States |
| Signal Point Clinical Research Center, LLC | Middletown | Ohio | 45042 | United States |
| Cancer Care Associates | Tulsa | Oklahoma | 74136 | United States |
| Providence Oncology & Hematology Care | Portland | Oregon | 95213 | United States |
| Kaiser Permanente Northwest | Portland | Oregon | 97227 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Willamette Valley Cancer Center | Springfield | Oregon | 97477 | United States |
| Abington Memorial Hospital | Abington | Pennsylvania | 19001 | United States |
| St. Luke's Hospital | Bethlehem | Pennsylvania | 18015 | United States |
| Oncology Hematology Associates | DuBois | Pennsylvania | 15801 | United States |
| Gettysburg Cancer Center | Gettysburg | Pennsylvania | 17325 | United States |
| Magee-Womens Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
| Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | 15224 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Chattanooga's Program in Women's Oncology | Chattanooga | Tennessee | 37403 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Texas Oncology, PA | Austin | Texas | 78705 | United States |
| Texas Oncology, P.A. | Bedford | Texas | 76022 | United States |
| Texas Oncology, PA | Dallas | Texas | 75231 | United States |
| Baylor Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| International Beneficence Clinical Research, L.L.C. | Harlingen | Texas | 78550 | United States |
| University of Texas Health Science Center at Houston Medical School | Houston | Texas | 77030 | United States |
| South Texas Oncology and Hematology, PA | San Antonio | Texas | 78229 | United States |
| Scott and White Memorial Hospital | Temple | Texas | 76508 | United States |
| US Oncology Research | Wichita Falls | Texas | 76310 | United States |
| Northern Utah Associates | Ogden | Utah | 84403 | United States |
| Utah Cancer Specialists | Salt Lake City | Utah | 84106 | United States |
| Northern Virginia Pelvic Surgery Associates | Annandale | Virginia | 22003 | United States |
| Peninsula Cancer Institute - Riverside Gynecology Oncology | Newport News | Virginia | 23601 | United States |
| Harrison Bremerton Hematology and Oncology | Bremerton | Washington | 98310 | United States |
| Providence Everett Medical Center | Everett | Washington | 98201 | United States |
| Cancer Care Northwest-South | Spokane | Washington | 99202 | United States |
| Northwest Cancer Specialists, PC | Vancouver | Washington | 98684 | United States |
| Aurora Health Care | West Allis | Wisconsin | 53227 | United States |
| Hospital Zonal Especializado en Oncología de Lanús | Buenos Aires | 1824 | Argentina |
| Consultorios Medicos Privados SA | Buenos Aries | 1704 | Argentina |
| Fundación Sanatorio Güemes | CABA | 1180 | Argentina |
| Clinica Universitaria Reina Fabiola | Códoba | 5004 | Argentina |
| Instituto Medico Platense | La Plata | 1900 | Argentina |
| Centro Oncologico Riojano Integral (CORI) | La Rioja | F5300COE | Argentina |
| Hospital Bocalandro | Loma Hermosa | 1657 | Argentina |
| Centro Oncologico Integral | Mar del Plata | B7600LTO | Argentina |
| CER Instituto Medico | Quilmes | B1878DVB | Argentina |
| Centro Médico San Roque | San Miguel de Tucumán | 4000 | Argentina |
| Centro Medico de Alta Complejidad Cemac | San Salvador de Jujuy | 4600 | Argentina |
| ISIS Centro Especializado de LUCE SA | Santa Fe | S3000FFU | Argentina |
| Tweed Hospital | Tweed Heads | New South Wales | 2485 | Australia |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| The Royal Brisbane and Women's Hospital | Herston | Queensland | 4029 | Australia |
| Mater Adult Hospital | South Brisbane | Queensland | 4101 | Australia |
| North Adelaide Oncology Clinical Trials | North Adelaide | South Australia | 5006 | Australia |
| Sir Charles Gairdner Hospital | Nedlands | Western Australia | 6009 | Australia |
| Kaiser-Franz-Josef Spital | Vienna | 1100 | Austria |
| Krankenhaus Wien-Hietzing | Vienna | 1130 | Austria |
| Landeskrankenhaus Villach | Villach | 9500 | Austria |
| Institut Jules Bordet | Brussels | 1000 | Belgium |
| Cliniques Universitaires Saint-Luc | Brussels | 1200 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| AZ Groeninge - Campus Maria's Voorzienigheid | Kortrijk | 8500 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| CHU de Liège | Liège | 4000 | Belgium |
| Sint-Augustinuskliniek | Wilrijk | 2610 | Belgium |
| Fundação Pio XII - Hospital de Câncer de Barretos | Barretos | 14784-400 | Brazil |
| Instituto de Pesquisas Clínicas para Estudos Multicêntricos | Caxias do Sul | 95070-560 | Brazil |
| Santa Casa da Misericórdia de Curitiba | Curitiba | 80010-030 | Brazil |
| Instituto do Câncer do Ceará - ICC | Fortaleza | 60430-230 | Brazil |
| Hosp. Araujo Jorge | Goiânia | 74605-160 | Brazil |
| Associação Hospital de Caridade Ijuí | Ijuí | 98700-000 | Brazil |
| Clinica de Neoplasias Litoral | Itajaí | 88301-220 | Brazil |
| Hospital Amaral Carvalho | Jaú | 17210-120 | Brazil |
| Liga Norte-Riograndense Contra o Câncer | Natal | 59062-000 | Brazil |
| Irmandade Santa Casa de Misericórdia de Porto Alegre | Porto Alegre | 90050-170 | Brazil |
| Clínica de Oncologia de Porto Alegre S/S Ltda | Porto Alegre | 90430-090 | Brazil |
| Instituto Ribeirãopretano de Combate ao Câncer | Ribeirão Preto | 14015-130 | Brazil |
| Clínica Oncologistas Associados | Rio de Janeiro | 22260-020 | Brazil |
| INCA - Instituto Nacional do Câncer | Rio de Janeiro - RJ | 20220-410 | Brazil |
| Hospital Santa Izabel - Santa Casa de Misericordia da Bahia | Salvador | 40050-410 | Brazil |
| Clínica AMO - Assistência Multidiciplinar em Oncologia | Salvador | 41825-010 | Brazil |
| Centro de Estudos de Oncologia da FMABC | Santo André | 09060-650 | Brazil |
| Saúde ABC Serviços Médicos Hospitalares Ltda | Santo André | 09090-780 | Brazil |
| Instituto do Câncer Arnaldo Vieira de Carvalho | São Paulo | 01209-000 | Brazil |
| Certo Oncologia | São Paulo | 04551-010 | Brazil |
| Hospital Premier | São Paulo | 04583-100 | Brazil |
| Tom Baker Cancer Centre | Calgary | Alberta | T2N-4N2 | Canada |
| Cancer Center For The Southern Interior | Kelowna | British Columbia | V1Y5L3 | Canada |
| British Columbia Cancer Agency | Surrey | British Columbia | V3V 1Z2 | Canada |
| BCCA | Vancouver | British Columbia | V5Z 4E6 | Canada |
| The Moncton Hospital | Moncton | New Brunswick | E1C6Z8 | Canada |
| Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| Instituto de Terapias Oncologicas | Santiago | 7501088 | Chile |
| Instituto Clínico Oncológico del Sur | Temuco | 4810469 | Chile |
| Instituto Oncologico Ltda. | Viña del Mar | Chile |
| Centre Régional de lutte contre le cancer Paul Papin | Angers | 49933 | France |
| Centre Hospitalier Louis Pasteur | Le Coudray | 28630 | France |
| Institut Paoli Calmettes | Marseille | 13273 | France |
| Hôpital Saint Louis | Paris | 75475 | France |
| Institut Jean Godinot - Centre de lutte contre le cancer | Reims | 51056 | France |
| Charité - Universitätsmedizin Berlin | Berlin | 13353 | Germany |
| Helios Klinikum Berlin-Buch | Buch | 13125 | Germany |
| Klinikum Chemnitz gGmbH | Chemnitz | 09116 | Germany |
| Marien-Hospital Akademisches Lehrkrankenhaus | Düsseldorf | 40479 | Germany |
| Frauenarztpraxis Dr. med. Gröll de Rivera | Ebersberg | 85560 | Germany |
| Universitätsklinikum Essen | Essen | 45122 | Germany |
| Krankenhaus Nordwest | Frankfurt | 60488 | Germany |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Kath. Marienkrankenhaus gGmbH | Hamburg | 22087 | Germany |
| Universität Heidelberg | Heidelberg | 69120 | Germany |
| St. Vincentius Kliniken Karlsruhe | Karlsruhe | 76135 | Germany |
| Universitätsklinik Magdeburg | Magdeburg | 39108 | Germany |
| Universitätsmedizin der Johannes Gutenberg-Universität Mainz | Mainz | 55131 | Germany |
| Klinikum der Universität München - Innenstadt | München | 80337 | Germany |
| Rotkreuzklinikum München | München | 80637 | Germany |
| Klinikum Südstadt Rostock | Rostock | 18059 | Germany |
| Klinikum Traunstein | Traunstein | 83278 | Germany |
| University General Hospital of Heraklion | Heraklion | Crete | 71110 | Greece |
| Alexandra Hospital | Athens | 115 28 | Greece |
| General Oncology Hospital Kifissias "Oi Agioi Anargyroi" | Athens | 145 64 | Greece |
| University General Hospital of Patras | Pátrai | 26500 | Greece |
| Papageorgiou General Hospital | Thessaloniki | 564 29 | Greece |
| Queen Mary Hospital | Pokfulam | Islands | Hong Kong |
| Tuen Mun Hospital | Tuenmen | Hong Kong |
| Semmelweis Egyetem | Budapest | 1082 | Hungary |
| Semmelweis Egyetem | Budapest | 1088 | Hungary |
| Petz Aladár Megyei Oktató Kórház | Győr | 9024 | Hungary |
| Bács-Kiskun Megyei Önkormányzat Kórháza | Kecskemét | 6000 | Hungary |
| Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház | Miskolc | 3526 | Hungary |
| Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelöintézet | Szolnok | 5004 | Hungary |
| Veszprém Megyei Önkormányzat Csolnoky Ferenc Kórház-Rendelöintézet | Veszprém | 8200 | Hungary |
| Apollo Hospitals International Limited | Gandhinagar | Gujarat | 382428 | India |
| Kidwai Memorial Institute of Oncology | Bangalore | Karnataka | 560032 | India |
| Jawaharlal Nehru Cancer Hospital & Research Centre | Bhopal | Madhya Pradesh | 462001 | India |
| Jehangir, Clinical Development Centre | Pune | Maharashtra | 411001 | India |
| Ruby Hall Clinic | Pune | Maharashtra | 411001 | India |
| Dr. Kamakshi Memorial Hospital | Chennai | Tamil Nadu | 600100 | India |
| Chittaranjan National Cancer Institute | Kolkata | West Bengal | 700026 | India |
| M.S Ramaiah Medical College and Teaching Hospital Ethical Review Board | Bangalore | 560054 | India |
| MNJ Institute of Oncology and Regional Cancer Centre | Hyderabaad | 500004 | India |
| SK Soni Hospital | Jaipur | 302013 | India |
| Bhagwan Mahaveer Cancer Hospital and Research Centre | Jaipur | 302017 | India |
| Amrita Institute of Medical Sciences and Research Centre | Kochi | 682026 | India |
| Lakeshore Hospital | Kochi | 682304 | India |
| Tata Memorial Hospital | Mumbai | 400012 | India |
| Curie Manavata Cancer Centre | Nashik | 422004 | India |
| Shatabdi Superspeciality Hospital | Nashik | 422005 | India |
| All India Institute of Medical Sciences | New Delhi | 110029 | India |
| Regional Cancer Centre | Trivandrum | 695011 | India |
| Rambam Medical Center | Haifa | 31096 | Israel |
| Linn Medical Center, Clalit Health Services | Haifa | 35152 | Israel |
| Wolfson Centre | Holon | 58100 | Israel |
| Shaare Zedek Medical Center | Jerusalem | 91031 | Israel |
| Hadassah University Hospital Ein Kerem | Jerusalem | 91120 | Israel |
| Meir Medical Center | Kfar Saba | 44281 | Israel |
| Rabin Medical Center | Petah Tikva | 49100 | Israel |
| The Chaim Sheba Medical Center | Ramat Gan | 52621 | Israel |
| Kaplan Medical Center | Rehovot | 76100 | Israel |
| Assaf Harofe Medical Center | Ẕerifin | 70300 | Israel |
| Centro di Riferimento Oncologico | Aviano | Pordenone | 33081 | Italy |
| Azienda Ospedaliera Santi Antonio, Biagio e Cesare Arrigo | Alessandria | 15100 | Italy |
| Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi | Bologna | 40138 | Italy |
| Istituto Ospedaliero Fondazione Poliambulanza | Brescia | 25124 | Italy |
| Centro di Ricerca e Formazione ad Alta Tecnologia nelle Scienze Biomediche | Campobasso | 86100 | Italy |
| Azienda Ospedaliera Cannizzaro | Catania | 95126 | Italy |
| Humanitas Centro Catanese di Oncologia | Catania | 95126 | Italy |
| Azienda Ospedaliera Sant'Anna | Como | 22100 | Italy |
| Ospedale di Faenza | Faenza | 48018 | Italy |
| Azienda Ospedaliera Universitaria San Martino | Genova | 16132 | Italy |
| Presidio Ospedaliero Vito Fazzi | Lecce | 73044 | Italy |
| Ospedale Mater Salutis ULSS 21 della regione Veneto | Legnago | 37045 | Italy |
| Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST | Meldola | 47014 | Italy |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico | Milan | 20122 | Italy |
| Fondazione Centro San Raffaele del Monte Tabor | Milan | 20132 | Italy |
| Istituto Nazionale dei Tumori | Milan | 20133 | Italy |
| Azienda Ospedaliera Niguarda Cà Granda | Milan | 20162 | Italy |
| Istituto Nazionale per lo studio e la cura dei tumori "Fondazione Giovanni Pascale" | Naples | 80131 | Italy |
| Ospedale Sacro Cuore Don Calabria | Negrar | 37024 | Italy |
| Istituto Oncologico Veneto | Padova | 35128 | Italy |
| Ospedale Santa Maria della Misericordia di Perugia | Perugia | 06132 | Italy |
| Ospedale Santa Maria delle Croci | Ravenna | 48100 | Italy |
| Arcispedale Santa Maria Nuova | Reggio Emilia | 42100 | Italy |
| Azienda Policlinico Umberto I | Roma | 00161 | Italy |
| Policlinico Universitario "A. Gemelli" | Roma | 00168 | Italy |
| Azienda Ospedaliero-Universitaria di Udine | Udine | 33100 | Italy |
| Akashi | Japan |
| Amagasaki | Japan |
| Chiba | Japan |
| Fukuoka | Japan |
| Hidaka | Japan |
| Hiroshima | Japan |
| Kagoshima | Japan |
| Kashiwa | Japan |
| Kawasaki | Japan |
| Kōtoku | Japan |
| Kumamoto | Japan |
| Kure | Japan |
| Kurume | Japan |
| Matsuyama | Japan |
| Minatoku | Japan |
| Morioka | Japan |
| Nagoya | Japan |
| Nakano | Japan |
| Niigata | Japan |
| Okayama | Japan |
| Osaka | Japan |
| Sapporo | Japan |
| Sayama | Japan |
| Sendai | Japan |
| Shinjuku-Ku | Japan |
| Sunto-Gun | Japan |
| Tsu | Japan |
| Tsukuba | Japan |
| Yamagata | Japan |
| Yonago | Japan |
| Union Medica Quirurgica de Colima | Colima | 3402 | Mexico |
| Triva Investigaciones Medicas Sociedad Anónima de Capital Variable | Morelia | 58000 | Mexico |
| Hospital Regional de Veracruz | Veracruz | 91700 | Mexico |
| VU Medisch Centrum | Amsterdam | 1081 HV | Netherlands |
| Albert Schweitzer Ziekenhuis | Dordrecht | 3318 AT | Netherlands |
| Academisch Ziekenhuis Maastricht | Maastricht | 6229 HX | Netherlands |
| Orbis Medisch Centrum | Sittard-Geleen | 6162 BG | Netherlands |
| Perpetual Succour Hospital | Cebu City | Cebu | 6000 | Philippines |
| Cebu Gynecologic Cancer Care Clinic | Cebu | 6000 | Philippines |
| Manila Doctors Hospital | Manila | 1000 | Philippines |
| San Juan de Dios Hospital | Pasay | 1300 | Philippines |
| St. Luke's Medical Center | Quezon City | 1102 | Philippines |
| National Kidney and Transplant Institute | Quezon City | 1112 | Philippines |
| Bialostockie Centrum Onkologii | Bialystok | 15-027 | Poland |
| Wojewodzkie Centrum Onkologii | Gdansk | 80-219 | Poland |
| Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie oddzial w Gliwicach | Gliwice | 44-100 | Poland |
| Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi | Lodz | 93-509 | Poland |
| Centrum Onkologii Ziemi Lubelskiej | Lublin | 20-090 | Poland |
| Zaklad Opieki Zdrowotnej MSWiA z Warminsko-Mazurskim Centrum Onkologii | Olsztyn | 10-228 | Poland |
| Olsztynski Osrodek Onkologiczny "Kopernik" Sp. z o.o. | Olsztyn | 10-513 | Poland |
| Wielkopolskie Centrum Onkologii | Poznan | 61-866 | Poland |
| Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Pozna | Poznan | 61-878 | Poland |
| SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 | Rybnik | 44-200 | Poland |
| Samodzielny Publiczny Szpital Kliniczny nr 2 PAM w Szczecinie | Szczecin | 70-111 | Poland |
| Wojskowy Instytut Medyczny | Warsaw | 04-141 | Poland |
| Hospitais da Universidade de Coimbra | Coimbra | 3000-075 | Portugal |
| Instituto Português de Oncologia Francisco Gentil, Centro Regional de Oncologia de Coimbra, EPE | Coimbra | 3000-075 | Portugal |
| Instituto Portugues de Oncologia de Lisboa Francisco Gentil (IPOLFG, EPE) | Lisbon | 1099-023 | Portugal |
| Instituto Portugues de Oncologia do Porto Francisco Gentil (IPOPFG, EPE) | Porto | 4200-072 | Portugal |
| Hospital de São João | Porto | 4200-319 | Portugal |
| Kursk Regional Oncology Centre | Kursk | 305035 | Russia |
| Russian Oncology Research Center named after N.N. Blokhin | Moscow | 115478 | Russia |
| Russian Oncology Research Center | Moscow | 115478 | Russia |
| Moscow Research Oncology Institute n.a. P.A.Gertsen | Moscow | 125284 | Russia |
| Medical Radiology Research Center of RAMS | Obninsk | 249036 | Russia |
| Ryazan Regional Clinical Oncology Dispensary | Ryazan | 390011 | Russia |
| City Clinical Oncology Dispensary | Saint Petersburg | 198255 | Russia |
| Republican Clinical Oncology Center of Bashkortostan Republic Ministry of Healthcare | Ufa | 450054 | Russia |
| National University Hospital | Singapore | 119074 | Singapore |
| National Cancer Centre | Singapore | 169610 | Singapore |
| KK Women's and Children's Hospital | Singapore | 229899 | Singapore |
| National Cancer Center | Gyeonggi-do | 410-769 | South Korea |
| Gachon University Gil Medical Center | Incheon | 405760 | South Korea |
| Cheil General Hospital & Women's Healthcare Center | Seoul | 100380 | South Korea |
| Seoul national univercity hospital | Seoul | 110-744 | South Korea |
| Severance Hospital, Yonsei University College of Medicine | Seoul | 120752 | South Korea |
| Samsung Medical Center | Seoul | 135710 | South Korea |
| Asan Medical Center | Seoul | 138-736 | South Korea |
| Hospital Universitario Reina Sofia | Córdoba | Andalusia | 14004 | Spain |
| Hospital Virgen del Rocio | Seville | Andalusia | 41013 | Spain |
| Hospital Son Llatzer | Palma de Mallorca | Balearic Islands | 07198 | Spain |
| Hospital Universitario Vall D'Hebron | Barcelona | Catalonia | 08035 | Spain |
| Hospital Clinic i Provincial | Barcelona | Catalonia | 08036 | Spain |
| Hospital de Mataró | Mataró | Catalonia | 08034 | Spain |
| Corporació Sanitaria Parc Taulí | Sabadell | Catalonia | 08208 | Spain |
| Hospital Mutua de Terrassa | Terrassa | Catalonia | 08221 | Spain |
| Fundacion Hospital Alcorcon | Alcorcón | Madrid, Communidad de | 28922 | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | Madrid, Communidad de | 28007 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | Madrid, Communidad de | 28034 | Spain |
| Hospital 12 de Octubre | Madrid | Madrid, Communidad de | 28041 | Spain |
| Hospital General Universitario de Elche | Elche | Valencia | 03203 | Spain |
| Fundación Instituto Valenciano de Oncología | Valencia | Valencia | 46009 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Universität Zürich | Zurich | 8091 | Switzerland |
| National Cheng Kung University Hosptial | Tainan | 704 | Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| Mackay Memorial Hospital | Taipei | 104 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 112 | Taiwan |
| Tri-Service General Hospital | Taipei | 114 | Taiwan |
| Chang Gung Memorial Hospital | Taoyuan | 333 | Taiwan |
| Municipal Institution of Cherkasy Regional Counsil "Cherkasy Regional Oncology Dispensary" | Cherkasy | 18009 | Ukraine |
| Chernivtsi Regional Clinical Oncology Dispansery | Chernivtsi | 58013 | Ukraine |
| Kiev City Oncology Hospital | Kyiv | 03115 | Ukraine |
| Volyn Regional Oncology Dispensary | Lutsk | 43018 | Ukraine |
| Belfast City Hospital | Belfast | BT9 7AB | United Kingdom |
| Velindre Hospital | Cardiff | CF14 2TL | United Kingdom |
| University Hospital Coventry | Coventry | CV2 2DX | United Kingdom |
| Ninewells Hospital | Dundee | DD1 9SY | United Kingdom |
| Beatson Oncology Centre | Glasgow | G12 0YN | United Kingdom |
| Leicester Royal Infirmary | Leicester | LE1 5WW | United Kingdom |
| Royal Marsden Hospital | London | SW3 6JJ | United Kingdom |
| Hammersmith Hospital | London | W12 0HS | United Kingdom |
| Clatterbridge Centre For Oncology | Metropolitan Borough of Wirral | CH63 4JY | United Kingdom |
| Derriford Hospital | Plymouth | PL6 8DH | United Kingdom |
| Poole Hospital NHS Trust | Poole | BH15 2JB | United Kingdom |
| Weston Park Hospital | Sheffield | S10 2SJ | United Kingdom |
| New Cross Hospital | Wolverhampton | WV10 0QP | United Kingdom |
| FG001 | 2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin | Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days). |
| FG002 | Placebo Plus Taxane and Carboplatin | Participants received farletuzumab-matched placebo (0.9 percent [%] saline) as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days). |
| Safety Analysis Set |
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| COMPLETED |
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| NOT COMPLETED |
|
|
Intent-to-Treat (ITT) population included all participants randomly assigned to treatment, according to the treatment assigned by the interactive web or voice response randomization system (IWRS/IVRS).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin | Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days). |
| BG001 | 2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin | Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days). |
| BG002 | Placebo Plus Taxane and Carboplatin | Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days). |
| BG003 | Total | Total of all reporting groups |
| 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 | Mean | Standard Deviation | 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Progression-free Survival (PFS) | PFS was defined as the time (in months) from the date of randomization to the date of the first observation of progression based on the independent radiologic assessment (modified response evaluation criteria in solid tumors [RECIST]), or date of death, whatever the cause. As per RECIST, disease progression was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions. If progression or death was not observed for a participant, the PFS time was censored at the date of the last tumor assessment without evidence of progression before the date of initiation of further antitumor treatment, or the cutoff date (whichever was earlier). | ITT population included all participants randomly assigned to treatment, according to the treatment assigned by the IWRS/IVRS. | Posted | Median | 95% Confidence Interval | months | From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months) |
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| Secondary | Overall Survival (OS) | OS was defined as the time (in months) from the date of randomization to the date of death, due to any cause. If death was not observed for a participant, the survival time was censored on the last date the participant was known to be alive or the cutoff date, whichever was earlier. | ITT population included all participants randomly assigned to treatment, according to the treatment assigned by the IWRS/IVRS. | Posted | Median | 95% Confidence Interval | months | From the date of randomization until date of death from any cause, or study termination by sponsor, whichever came first (up to 48 months) |
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| Secondary | Cancer Antigen-125 (CA-125) Progression-Free Survival | CA-125 PFS was defined as the time (in months) from the date of randomization until the date of the first observation of progression based on the Rustin criteria, or date of death, whatever the cause. If progression or death was not observed for a participant, the CA-125 PFS time was censored at the date of the last CA-125 assessment without evidence of progression before the date of initiation of further antitumor treatment or the "primary analysis cut off" date, whichever was earlier. Based on Rustin criteria, progressive disease (PD) was a rise in CA125 since beginning of consolidation or previously normal CA125 that rises to greater than or equal to (>=) 2 multiple (*) ULN with either event documented on two occasions or CA-125 >=2*nadir value with either event documented on two occasions. | ITT population included all participants randomly assigned to treatment, according to the treatment assigned by the IWRS/IVRS. | Posted | Median | 95% Confidence Interval | months | From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months) |
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| Secondary | Progression-Free Survival Based on Gynecologic Cancer InterGroup (GCIG) Criteria | PFS using GCIG criteria was defined as time (in months) from date of randomization until date of first observation of progression based on GCIG criteria, or date of death, whatever the cause. If progression or death was not observed for a participant, GCIG PFS time was censored at later date of last tumor assessment or CA-125 assessment without evidence of progression before date of initiation of further antitumor treatment or the "primary analysis cut off" date, whichever was earlier. Disease progression per GCIG: Participants with elevated CA-125 pretreatment and normalisation of CA-125 must show evidence of CA-125 >=two times ULN on two occasions at least one week apart or participants with elevated CA-125 pretreatment, which never normalises must show evidence of CA-125 >=two times nadir value on two occasions at least one week apart or participants with CA-125 in normal range pretreatment must show evidence of CA-125 >=two times ULN on two occasions at least one week apart. | ITT population included all participants randomly assigned to treatment, according to the treatment assigned by the IWRS/IVRS. | Posted | Median | 95% Confidence Interval | months | From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months) |
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| Secondary | Percentage of Participants With Length of Second Remission Greater Than First Remission | Length of first remission was defined as a.) the period of time (in months) from the date of completion of previous platinum-based chemotherapy until date of first relapse (that is, first observation of progression). It was assumed that the date of first relapse was the earlier of progression by CA-125 or progression by radiologic assessment, as judged by the investigator using GCIG criteria. b.) the period of time (in months) from the date of completion of previous platinum-based chemotherapy (used prior to study entry) until date of randomization. The length of the second remission was defined as the period of time (in months) from the date of completion of platinum-based chemotherapy until the first observation of progression based on GCIG criteria. Based on GCIG criteria, disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions. | ITT population included all participants randomly assigned to treatment, according to the treatment assigned by the IWRS/IVRS. Here "N" overall number of participants analyzed included all participants with potential for second remission greater than first remission. | Posted | Number | 95% Confidence Interval | percentage of participants | From the date of last dose of platinum-based chemotherapy to date of relapse and date of last dose of platinum-based chemotherapy to first observation of progression (up to 48 months) |
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| Secondary | Percentage of Participants With Objective Response | Objective response was defined as either a confirmed complete response (CR) or confirmed partial response (PR) as assessed by investigator based on response evaluation criteria in solid tumors version 1.1 (RECIST version 1.1). CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis less than (<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. | ITT population included all participants randomly assigned to treatment, according to the treatment assigned by the IWRS/IVRS. | Posted | Number | 95% Confidence Interval | percentage of participants | From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 48 months) |
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| Secondary | Duration of Tumor Response | Duration of response was defined as the time (in months) from first documentation of objective response (confirmed CR or PR) to the first documentation of objective tumor progression or death due to any cause. Duration of response was derived only for those participants with objective evidence of confirmed CR or PR. | Analysis performed on a subset of participants who had objective response. | Posted | Median | 95% Confidence Interval | months | From the first date of confirmed objective response (CR or PR) to first date of progression or death due to any cause (up to 48 months) |
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| Secondary | Time to Tumor Response (TTR) | Time to tumor response was defined as the time (in months) from the date of randomization to first documentation of objective tumor response. Time to tumor response was derived for those participants with objective evidence of CR or PR. | Analysis performed on a subset of participants who had objective response. | Posted | Median | 95% Confidence Interval | months | From the date of randomization to first documentation of objective response (up to 48 months) |
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| Secondary | Percentage of Participants With Serologic Response (SR) | SR was defined as either normalization, 75% response, or 50% response using the Rustin criteria. Percentage of participants with 50% SR, 75% SR and SR leading to normalization were reported. A 50% response according to CA-125 was defined as a 50% decrease in serum CA-125 levels, as determined through a series of four CA-125 samples (one baseline sample with an elevated level, the sample that showed a 50% decrease, and a confirmatory sample at the decreased level). A 75% response was established if there had a serial decrease in serum CA-125 levels of 75% over three samples. In both the 50% and 75% response definitions, the final sample was analyzed at least 28 days after the previous sample. | SR Evaluable Populations included all randomized participants who received at least one dose of study drug and who had a baseline and at least one assessment during treatment, sufficient to assess the endpoint of interest. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 48 months |
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| Secondary | Duration of 50% Serologic Response | Duration of SR was defined as the time (in months) from first documentation of response to the first documentation of 50% serologic progression or death due to any cause. For responding participants who did not have serologic progression or did not die and who 1) were either still on study at the time of an analysis, 2) were given antitumor treatment other than study treatment, or 3) were withdrawn from study follow-up before documentation of serologic progression, the duration of SR was censored at the last date the participant was known to be without serologic progression. A 50% response according to CA-125 was defined as a 50% decrease in serum CA-125 levels, as determined through a series of three CA-125 samples (one baseline sample with an elevated level, the sample that showed a 50% decrease, and a confirmatory sample at the decreased level). | Analysis was performed on a subset of participants who had serologic response. | Posted | Median | 95% Confidence Interval | months | From the first date of documentation of response to first documentation of serologic progression or death due to any cause (up to 48 months) |
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| Secondary | Time to 50% Serologic Response (TSR) | TSR was defined as the time (in months) from the date of randomization to first documentation of 50% SR. A 50% response according to CA-125 was defined as a 50% decrease in serum CA-125 levels, as determined through a series of three CA-125 samples (one baseline sample with an elevated level, the sample that showed a 50% decrease, and a confirmatory sample at the decreased level). | Analysis was performed on a subset of participants who had serologic response. | Posted | Median | 95% Confidence Interval | months | From the date of randomization to first documentation of 50% SR (up to 48 months) |
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| Secondary | Percentage of Participants With Clinical Benefit | Clinical benefit was defined as a confirmed CR or a confirmed PR, or stable disease (SD) using RECIST 1.0 criteria. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis <10 mm. PR was defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non target lesions. | ITT population included all participants randomly assigned to treatment, according to the treatment assigned by the IWRS/IVRS. | Posted | Number | percentage of participants | Up to 48 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cmax: Maximum Observed Plasma Concentration of Total Carboplatin and Total Paclitaxel | Pharmacokinetic Analysis Set included all participants who have sufficient pharmacokinetic data to derive at least one pharmacokinetic parameter. Here "overall number of participants analyzed" signifies participants who were analyzed for this outcome measure. Pharmacokinetic data was collected and analyzed only for a maximum of 7 participants in this study. | Posted | Mean | Standard Deviation | microgram per milliliter (mcg/mL) | Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of Total Carboplatin and Total Paclitaxel | Pharmacokinetic Analysis Set included all participants who have sufficient pharmacokinetic data to derive at least one pharmacokinetic parameter. Here "overall number of participants analyzed" signifies participants who were analyzed for this outcome measure. Pharmacokinetic data was collected and analyzed only for a maximum of 7 participants in this study. | Posted | Median | Full Range | hours | Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days) |
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| Secondary | AUC (0-inf): Area Under the Concentration-time Curve From Zero (Pre-dose) Extrapolated to Infinite Time of Total Carboplatin and Total Paclitaxel | Pharmacokinetic Analysis Set included all participants who have sufficient pharmacokinetic data to derive at least one pharmacokinetic parameter. Pharmacokinetic data was collected and analyzed only for a maximum of 7 participants in this study. Here "overall number of participants analyzed" signifies participants who were analyzed for this outcome measure. Here "number of participants analyzed" signifies participants who were analyzed for this outcome measure for given categories. | Posted | Mean | Standard Deviation | microgram hour per liter (mcg*h/L) | Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days) |
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| Secondary | T1/2: Terminal Half-life of Total Carboplatin and Total Paclitaxel | Pharmacokinetic Analysis Set included all participants who have sufficient pharmacokinetic data to derive at least one pharmacokinetic parameter. Pharmacokinetic data was collected and analyzed only for a maximum of 7 participants in this study. Here "overall number of participants analyzed" signifies participants who were analyzed for this outcome measure. Here "number of participants analyzed" signifies participants who were analyzed for this outcome measure for given categories. | Posted | Mean | Standard Deviation | hours | Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days) |
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| Secondary | CL: Clearance of Total Carboplatin and Total Paclitaxel | Pharmacokinetic Analysis Set included all participants who have sufficient pharmacokinetic data to derive at least one pharmacokinetic parameter. Pharmacokinetic data was collected and analyzed only for a maximum of 7 participants in this study. Here "overall number of participants analyzed" signifies participants who were analyzed for this outcome measure. Here "number of participants analyzed" signifies participants who were analyzed for this outcome measure for given categories. | Posted | Mean | Standard Deviation | liter per hour (L/h) | Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Vd: Volume of Distribution of Total Carboplatin and Total Paclitaxel | Pharmacokinetic Analysis Set included all participants who have sufficient pharmacokinetic data to derive at least one pharmacokinetic parameter. Pharmacokinetic data was collected and analyzed only for a maximum of 7 participants in this study. Here "overall number of participants analyzed" signifies participants who were analyzed for this outcome measure. Here "number of participants analyzed" signifies participants who were analyzed for this outcome measure for given categories. | Posted | Mean | Standard Deviation | liter | Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Functional Assessment of Cancer Therapy-Ovarian Treatment Outcome Index (FACT-O TOI) Scores | Participant-reported Quality of Life (QoL) was measured using the Functional Assessment of Cancer Therapy-Ovarian (FACT-O), version 4 and reported in the Treatment Outcome Index (TOI) format. TOI is a 26-item subset of the FACT-O questionnaire composed of the raw sum of the physical well-being subscale (7 items), the functional well-being subscale (7 items), and the ovarian cancer subscale (12 items). Each item was scored on a scale of 0 (not at all) to 4 (very much). Some items were reversed scored. Scores from each subsection were summed into one composite score, termed the FACT-O TOI score which ranged from 0 to 104 and a higher score reflected better QoL. As per planned analysis, farletuzumab treatment groups 1.25 mg/kg and 2.5 mg/kg were pooled for the QoL assessment. | The population comprised of all evaluable participants who received at least one dose of farletuzumab or placebo, with study treatment assignment designated according to the IWRS/IVRS, and who completed a baseline FACT-O assessment and at least one follow-up FACT-O assessment during the study. Here "overall number of participants analyzed" signifies participants who were analyzed for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Cycle 3, Cycle 6, Cycle 12 (each cycle length=21 days) |
|
Up to 48 months
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 | 1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin | Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days). | 143 | 376 | 140 | 376 | 373 | 376 |
| EG001 | 2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin | Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days). | 119 | 363 | 130 | 363 | 358 | 363 |
| EG002 | Placebo Plus Taxane and Carboplatin | Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days). | 121 | 352 | 112 | 352 | 347 | 352 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Small intestine obstruction | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Device failure | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Biliary tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Necrotising fasciitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
| |
| Pulmomary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Febrile Bone Marrow Aplasia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Atrial Flutter | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Myocardial Ischaemia | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Vertigo Positional | Ear and labyrinth disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Retinal Detachment | Eye disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Colonic Obstruction | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Abdominal Hernia | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Colitis Ischaemic | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Gastric Hypomotility | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Large Intestinal Obstruction | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Large Intestine Perforation | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Lower Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Mesenteric Panniculitis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Umbilical Hernia | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Catheter Site Inflammation | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Chest Discomfort | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hernia | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Feeling Hot | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Multi-Organ Disorder | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Ampulla Of Vater Stenosis | Hepatobiliary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Bile Duct Obstruction | Hepatobiliary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Bile Duct Stone | Hepatobiliary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hepatic Function Abnormal | Hepatobiliary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Jaundice Cholestatic | Hepatobiliary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Anaphylactic Reaction | Immune system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Anaphylactic Shock | Immune system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Abdominal Abscess | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Catheter Site Infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Clostridial Infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Clostridium Difficile Colitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Device Related Infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Escherichia Infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Infected Lymphocele | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Klebsiella Sepsis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Lobar Pneumonia | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Malaria | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Neutropenic Infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Psoas Abscess | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Staphylococcal Infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Subcutaneous Abscess | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Tooth Abscess | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Urinary Tract Infection Bacterial | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Herpes Zoster Oticus | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Infective Exacerbation Of Bronchiectasis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Pneumonia Cryptococcal | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Pyelonephritis Acute | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Pelvic Fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Rib Fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Vascular Access Complication | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Wrist Fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Joint Injury | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Post Procedural Discomfort | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Activated Partial Thromboplastin Time Prolonged | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| C-Reactive Protein Increased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Haemoglobin Decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| International Normalised Ratio Increased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| White Blood Cell Count Decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Blood Magnesium Decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Chest X-Ray Abnormal | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Clostridium Test Positive | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Failure To Thrive | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Electrolyte Imbalance | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
| |
| Metastases To Adrenals | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
| |
| Metastases To Lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
| |
| Metastases To Spleen | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
| |
| Ovarian Cancer Recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
| |
| Tumour Associated Fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Guillain-Barre Syndrome | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Petit Mal Epilepsy | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Transient Ischaemic Attack | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Mental Status Changes | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Panic Attack | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Renal Impairment | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Renal Vein Thrombosis | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Urogenital Haemorrhage | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Vaginal Haemorrhage | Reproductive system and breast disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Female Genital Tract Fistula | Reproductive system and breast disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pulmonary Artery Thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Lung Infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Obliterative Bronchiolitis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pleuritic Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pulmonary Fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Laryngospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Malignant Tumour Excision | Surgical and medical procedures | MedDRA 14.1 | Systematic Assessment |
| |
| Mass Excision | Surgical and medical procedures | MedDRA 14.1 | Systematic Assessment |
| |
| Ureteral Stent Insertion | Surgical and medical procedures | MedDRA 14.1 | Systematic Assessment |
| |
| Cytoreductive Surgery | Surgical and medical procedures | MedDRA 14.1 | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hot Flush | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Vena Cava Thrombosis | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Venous Thrombosis | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Peripheral Ischaemia | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Myaligia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 14.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN LOWER | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| FLATULENCE | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
|
Study termination was based on the primary analysis results for progression-free survival (PFS). Data collection and analyses of health care resource utilization were not performed due to the study being terminated early. Pharmacokinetic data was collected and analyzed for a maximum of only 7 participants in this study.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Medical Information | Eisai Inc. | 1-888-274-2378 | esi_oncmedinfo@eisai.com |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C527484 | farletuzumab |
| D016190 | Carboplatin |
| C080625 | taxane |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 0.0761 |
| Hazard Ratio (HR) |
| 0.86 |
| 2-Sided |
| 95 |
| 0.70 |
| 1.06 |
| Superiority |
Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).
| OG002 | Placebo Plus Taxane and Carboplatin | Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days). |
|
|
|
| OG001 | 2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin | Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days). |
| OG002 | Placebo Plus Taxane and Carboplatin | Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days). |
|
|
|
| OG001 | 2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin | Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days). |
| OG002 | Placebo Plus Taxane and Carboplatin | Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days). |
|
|
|
| OG001 | 2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin | Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days). |
| OG002 | Placebo Plus Taxane and Carboplatin | Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days). |
|
|
| OG001 | 2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin | Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days). |
| OG002 | Placebo Plus Taxane and Carboplatin | Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days). |
|
|
|
Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).
| OG002 | Placebo Plus Taxane and Carboplatin | Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days). |
|
|
| OG002 | Placebo Plus Taxane and Carboplatin | Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days). |
|
|
| OG001 | 2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin | Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days). |
| OG002 | Placebo Plus Taxane and Carboplatin | Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days). |
|
|
|
| OG001 | 2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin | Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days). |
| OG002 | Placebo Plus Taxane and Carboplatin | Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days). |
|
|
Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).
| OG002 | Placebo Plus Taxane and Carboplatin | Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days). |
|
|
| OG001 | 2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin | Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days). |
| OG002 | Placebo Plus Taxane and Carboplatin | Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days). |
|
|
| OG002 | Placebo Plus Taxane and Carboplatin | Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days). |
|
|
| OG002 | Placebo Plus Taxane and Carboplatin | Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days). |
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Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days). |
| OG002 | Placebo Plus Taxane and Carboplatin | Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days). |
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Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).
| OG002 | Placebo Plus Taxane and Carboplatin | Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days). |
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Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).
| OG002 | Placebo Plus Taxane and Carboplatin | Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days). |
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Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).
| OG002 | Placebo Plus Taxane and Carboplatin | Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days). |
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| OG001 | Placebo Plus Taxane and Carboplatin | Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose [mg] = Target AUC [mg*min/mL]*GFR [mL/min] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days). |
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