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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004201-33 | EudraCT Number |
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The primary objective of this study is to assess and compare the efficacy and safety of sacituzumab govitecan-hzi versus treatment of physician's choice (TPC) in participants with hormonal receptor-positive (HR+) human epidermal growth factor receptor 2 (HER2-) negative metastatic breast cancer (MBC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sacituzumab Govitecan-hziy | Experimental | Participants will receive sacituzumab govitecan-hziy 10 mg/kg via intravenous (IV) injection administered on Day 1 and Day 8 of a 21-day cycle. |
|
| Treatment of Physician's Choice (TPC) | Active Comparator | Participants will receive TPC determined prior to randomization from one of the following single-agent treatment: Dosing per National Comprehensive Cancer Network (NCCN) guidelines (with dose modifications for if toxic)
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sacituzumab Govitecan-hziy | Drug | Administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) Assessment | PFS was defined as the time from the date of randomization to the date of the first documentation of disease progression or death (whichever occurred first) according to BICR using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Disease progression was defined as an increase of greater than 20% in the sum of the longest diameter (LD) of target lesions and a 5 mm absolute increase, taking as a reference the smallest sum LD recorded since the baseline assessment or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate. | Up to 42.8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the time from the date of randomization to the date of death from any cause. OS was estimated using Kaplan-Meier estimate. Participants without documentation of death were censored on the date they were last known to be alive. | Up to 42.8 months |
| Objective Response Rate (ORR) by BICR and Local Investigator Review (LIR) Assessment |
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Key Inclusion Criteria:
Documented evidence of hormone receptor-positive human epidermal growth factor receptor 2 negative (HER2-negative) (hormonal receptor-positive (HR+)/HER2-) metastatic breast cancer (MBC) confirmed.
Refractory to or relapsed after at least 2, and no more than 4, prior systemic chemotherapy regimens for metastatic disease:
Eligible for one of the chemotherapy options listed in the TPC arm.
Documented disease progression after the most recent therapy.
Adequate bone marrow function (hemoglobin ≥ 9 g/dL, absolute neutrophil count (ANC) ≥ 1,500 per mm^3, platelets ≥ 100,000 per mm^3).
Adequate renal function: calculated creatinine clearance ≥ 30 mL/minute according to the Cockcroft and Gault formula .
Adequate liver function (bilirubin ≤ 1.5 institutional upper limit of normal (IULN), or ≤ 3 IULN for individuals with documented Gilbert's syndrome, aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x IULN (in the case of liver metastases ≤ 5.0 x IULN)).
Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative beta human chorionic gonadotropin (ß-hCG)).
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth Research Institute | Avondale | Arizona | 85392 | United States | ||
| Arizona Oncology Associates, PC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37633306 | Background | Rugo HS, Bardia A, Marme F, Cortes J, Schmid P, Loirat D, Tredan O, Ciruelos E, Dalenc F, Gomez Pardo P, Jhaveri KL, Delaney R, Valdez T, Wang H, Motwani M, Yoon OK, Verret W, Tolaney SM. Overall survival with sacituzumab govitecan in hormone receptor-positive and human epidermal growth factor receptor 2-negative metastatic breast cancer (TROPiCS-02): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2023 Oct 21;402(10411):1423-1433. doi: 10.1016/S0140-6736(23)01245-X. Epub 2023 Aug 23. | |
| 36027558 |
| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy#Commitment
18 months after study completion
A secured external environment with username, password, and RSA code.
776 participants were screened.
Participants were enrolled at study sites in Belgium, Canada, France, Germany, Italy, the Netherlands, Spain, the United Kingdom, and the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sacituzumab Govitecan | Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow intravenous (IV) infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, occurrence of unacceptable adverse events (AEs), or another treatment discontinuation criterion was met (up to 40.1 months). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 23, 2021 | Jun 14, 2024 |
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| Eribulin | Drug | Administered intravenously per NCCN guidelines |
|
| Capecitabine | Drug | Administered orally per NCCN guidelines |
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| Gemcitabine | Drug | Administered intravenously per NCCN guidelines |
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| Vinorelbine | Drug | Administered intravenously per NCCN guidelines |
|
ORR was defined as the percentage of participants who had the best overall response of either complete response (CR) or partial response (PR) that was confirmed at 4 weeks or later after initial response by BICR and LIR using RECIST 1.1. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. |
| Up to 42.8 months |
| Duration of Response (DOR) by BICR and LIR Assessment | DOR was defined as the time from the date a response of CR or PR was first documented until the date of the first documentation of disease progression or date of death (whichever occurred first). DOR was analyzed based on both BICR and LIR assessments. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Disease progression was defined as an increase of greater than 20% in the sum of the LD of target lesions and a 5 mm absolute increase, taking as a reference the smallest sum LD recorded since the baseline assessment or the appearance of new non-target lesions. DOR was estimated using Kaplan-Meier estimate. | Up to 42.8 months |
| Clinical Benefit Rate (CBR) by BICR and LIR Assessment | CBR was defined as the percentage of participants with the best overall response of CR, PR, or durable stable disease (duration of SD ≥ 6 months after randomization). CBR was analyzed based on both BICR and LIR assessments. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started. PD: Disease progression was defined as an increase of greater than 20% in the sum of the LD of target lesions and a 5 mm absolute increase, taking as a reference the smallest sum LD recorded since the baseline assessment or the appearance of new non-target lesions. | Up to 42.8 months |
| PFS by LIR Assessment | PFS was defined as the time from the date of randomization to the date of the first documentation of disease progression or death (whichever occurred first) according to LIR using RECIST 1.1. Disease progression was defined as an increase of greater than 20% in the sum of the LD of target lesions and a 5 mm absolute increase, taking as a reference the smallest sum LD recorded since the baseline assessment or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate. | Up to 42.8 months |
| Time to Deterioration (TTD) of Global Health Status/Quality of Life (QoL) Scale as Measured by European Organization for Research and Treatment of Cancer Quality of Life for Cancer Patients, Core Questionnaire Version 3.0 (EORTC QLQ-C30) | TTD was defined as the time from randomization to the first date a subject achieves 10-point deterioration from baseline in the global health status/QoL scale.The EORTC QLQ-C30 is a 30-item questionnaire to assess QoL of cancer patients. It has 5 functional scales(physical,role,emotional,cognitive, social)1 global health status scale,3 symptom scales (fatigue, nausea and vomiting, pain),and 6 single items(dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties). Participant responses to global health status,'How would you rate your overall health during the past week?' (Item 29)and the QoL 'How would you rate your overall quality of life during the past week?'(Item 30)questions were scored on 7-point scale (1=very poor; 7=excellent). All scales and single-item measures range in score from 0 to 100. Summed raw scores were standardized by linear transformation so that scores ranged from 0 to 100. Higher scores for GHS show a better level of functioning. | Up to 37.8 months |
| TTD of Pain Score as Measured by EORTC QLQ-C30 | TTD was defined as the time from randomization to the first date a subject achieves 10-point deterioration from baseline in the pain score.The EORTC QLQ-C30 is a questionnaire to assess quality of life, it is composed of 30 questions(items) resulting in 5 functional scales(physical, role, emotional, cognitive, social),1 global health status scale,3 symptom scales (fatigue, nausea and vomiting, pain),and 6 single items(dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties). All of the scales and single-item measures range in score from 0 to 100. Participant responses to 2 questions about pain, 'Have you had pain' and 'Did pain interfere with your daily activities' were scored on 4-point scale (1=not at all;4=very much). Summed raw scores were standardized by linear transformation so that scores ranges from 0 to 100. Higher scores on the symptom scales indicate a higher level of symptoms (i.e. a worse state of the participant). | Up to 37.8 months |
| TTD of Fatigue Score as Measured by EORTC QLQ-C30 | TTD was defined as the time from randomization to the first date a subject achieves 10-point deterioration from baseline in the fatigue score.The EORTC QLQ-C30 is a questionnaire to assess quality of life, it is composed of 30 questions(items) resulting in 5 functional scales(physical, role, emotional, cognitive, social),1 global health status scale,3 symptom scales (fatigue, nausea and vomiting, pain),and 6 single items(dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties).All of the scales and single-item measures range in score from 0 to 100.Participant responses to 3 questions about fatigue 'Did you need to rest', 'Have you felt weak' and 'Were you tired' were scored on a 4-point scale (1=not at all;4=very much).Summed raw scores were standardized by linear transformation so that scores ranged from 0 to 100. Higher scores on the symptom scales indicate a higher level of symptoms (i.e. a worse state of the participant). | Up to 37.8 months |
| Percentage of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) | An AE was defined as any untoward medical occurrence in a subject administered a medicinal product that does not necessarily have a causal relationship with this treatment. TEAEs were defined as any AEs that begin or worsen on or after the start of study drug through 30 days after the last dose of the study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5.0. | Up to 43.4 months |
| Percentage of Participants Who Experienced Treatment Emergent Serious Adverse Events (TESAEs) | Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5.0. An AE that met one or more of the following outcomes was classified as serious:
| Up to 43.4 months |
| Percentage of Participants Who Experienced the Worst Laboratory Abnormalities Grade 3 or 4 Post-Baseline | Blood samples were collected for hematology, serum chemistry, and the laboratory abnormalities were assessed. A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and including the date of last study drug dose plus 30 days.The most severe graded abnormality observed post-baseline for each graded test was counted for each participant. Safety as assessed by grading of laboratory values and AEs according to the National Cancer Institutes' Common Terminology Criteria for Adverse Events (NCI CTCAE) covering grades 0-5 (0=Normal, 1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening, 5=Death). The percentage of participants with worst postbaseline grades 3 or 4 are reported. | Up to 43.4 months |
| Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) - Shift From Baseline Value to Best Value During Treatment | ECOG performance status (PS) measured on-therapy assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease performance without restriction;1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature;2=Ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours;3=Capable of only limited self-care;confined to bed or chair more than 50% of waking hours;4=Completely disabled; cannot carry on any self-care; totally confined to bed or chair;5=Dead. Lower score indicated good performance status. Percentage of participants with Baseline ECOG PS score and corresponding changes to the best values post-baseline have been reported. | Up to 43.4 months |
| Tucson |
| Arizona |
| 85704 |
| United States |
| Highlands Oncology Group | Fayetteville | Arkansas | 72703 | United States |
| University of California, San Diego Moores Cancer Center | La Jolla | California | 92093 | United States |
| Los Angeles Hematology Oncology Medical Group | Los Angeles | California | 90017 | United States |
| UCLA Department of Medicine - Hematology/Oncology | Los Angeles | California | 90095 | United States |
| University of California, Irvine Medical Center-Chao Family Comprehensive Cancer Center | Orange | California | 92868 | United States |
| Southern California Permanente Medical Group | San Diego | California | 92120 | United States |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94115 | United States |
| Rocky Mountain Cancer Centers | Aurora | Colorado | 80012 | United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| Yale University Cancer Center | New Haven | Connecticut | 06520 | United States |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States |
| University of Miami - Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States |
| Miami Cancer Institute | Miami | Florida | 33176 | United States |
| Orlando Health, Inc. | Orlando | Florida | 32806 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Emory University - Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
| Northside Hospital, Inc. | Atlanta | Georgia | 30342 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| The University of Kansas Cancer Center | Westwood | Kansas | 66205 | United States |
| James Graham Brown Cancer Center | Louisville | Kentucky | 40202 | United States |
| Mercy Medical Center, Medical Oncology & Hematology | Baltimore | Maryland | 21202 | United States |
| Maryland Oncology Hematology, P.A. | Rockville | Maryland | 20850 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Allina Health, Virginia Piper Cancer Institute | Minneapolis | Minnesota | 55407 | United States |
| Masonic Cancer Center, University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Saint Luke's Cancer Institute | Kansas City | Missouri | 64111 | United States |
| Washington University School of Medicine - Siteman Cancer Center | St Louis | Missouri | 63110 | United States |
| St. Vincent Frontier Cancer Center | Billings | Montana | 59102 | United States |
| Summit Medical Group | Florham Park | New Jersey | 07932 | United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States |
| New York Oncology Hematology, P.C. | Albany | New York | 12206 | United States |
| Laura and Isaac Perlmutter Cancer Center/NYU Langone Health | New York | New York | 10016 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Magee-Womens Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
| The West Clinic, PC dba West Cancer Center | Germantown | Tennessee | 38138 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37203 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Texas Oncology-Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| University of Texas Southwestern Harold C. Simmons Comprehensive Cancer Center | Dallas | Texas | 75390 | United States |
| Texas Oncology-Denton South | Denton | Texas | 76210 | United States |
| Houston Methodist Hospital/Houston Methodist Cancer Center | Houston | Texas | 77030 | United States |
| Texas Oncology-Longview Cancer Center | Longview | Texas | 75601 | United States |
| UT Health San Antonio - Mays Cancer Center | San Antonio | Texas | 78229 | United States |
| Virginia Cancer Specialists | Arlington | Virginia | 22205 | United States |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | United States |
| Oncology & Hematology Associates of Southwest Virginia, Inc. DBA Blue Ridge Cancer Care | Salem | Virginia | 24153 | United States |
| Northwest Medical Specialties, PLLC | Tacoma | Washington | 98405 | United States |
| Chirec Cancer Institute | Brussels | Belgium |
| Institut Jules Bordet | Brussels | Belgium |
| Universitair Ziekenhuis Leuven | Leuven | Belgium |
| CHU UCL Namur/Site Sainte Elisabeth | Namur | Belgium |
| Nova Scotia Cancer Centre | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Centre Hospitalier de L'Universite de Montreal - Hôpital Notre-Dame | Montreal | Canada |
| Centre Hospitalier Universitaire de Sherbrooke - Fleurimont | Sherbrooke | Canada |
| Hopital de Mercy | Ars-Laquenexy | 57245 | France |
| Institut Sainte Catherine | Avignon | 84918 | France |
| Hôpital Jean-Minjoz | Besançon | 25030 | France |
| Centre Georges-Francois Leclerc | Dijon | 21000 | France |
| Centre Leon Berard | Lyon | 69008 | France |
| Institut Régional du Cancer de Montpellier | Montpellier | 34298 | France |
| Institut Curie | Paris | 75005 | France |
| Hospices Civils de Lyon | Pierre-Bénite | 69310 | France |
| Institut de Cancérologie Lucien Neuwirth | Saint-Priest-en-Jarez | 42271 | France |
| Institut Claudius Regaud | Toulouse | 31300 | France |
| HELIOS Klinikum Berlin-Buch | Berlin | 13125 | Germany |
| Gynakologisches Zentrum Bonn | Bonn | 53111 | Germany |
| Marienhospital Bottrop | Bottrop | 46236 | Germany |
| Städtisches Klinikum Dessau | Dessau | 06847 | Germany |
| Universitätsklinikum Erlangen | Erlangen | 91054 | Germany |
| Kliniken Essen-Mitte | Essen | 45136 | Germany |
| Centrum für Hämatologie und Onkologie Bethanien | Frankfurt | 60389 | Germany |
| Onkologische Schwerpunktpraxis Eppendorf | Hamburg | 20249 | Germany |
| Gynakologisch-Onkologische Praxis Hannover | Hanover | 30177 | Germany |
| DIAKOVERE Krankenhaus gGmbH Henriettenstift - Standort Kirchrode | Hanover | Germany |
| Nationales Centrum für Tumorerkrankungen - Heidelberg | Heidelberg | 69120 | Germany |
| Praxisklinik für Hämatologie und Onkologie Koblenz | Koblenz | 56068 | Germany |
| Universitätsmedizin Mannheim | Mannheim | 68167 | Germany |
| Klinikum Mutterhaus der Borromäerinnen | Trier | Germany |
| Azienda Ospedaliera Spedali Civili di Brescia | Brescia | Italy |
| Ospedale di Desio | Desio | 20832 | Italy |
| Ospedale Vito Fazzi di Lecce | Lecce | Italy |
| Ospedale San Raffaele | Milan | 20132 | Italy |
| Azienda Ospedaliera San Gerardo di Monza | Monza | Italy |
| Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto | Piacenza | 29121 | Italy |
| IFO Istituto Nazionale dei Tumori Regina Elena | Rome | 00144 | Italy |
| Antoni van Leeuwenhoekziekenhuis | Amsterdam | 1066 | Netherlands |
| Medisch Centrum Haaglanden Antoniushove | Leidschendam | Netherlands |
| Maastricht UMC+ | Maastricht | 6229 | Netherlands |
| Complejo Hospitalario Universitario A Coruna | A Coruña | 15006 | Spain |
| Hospital Quirónsalud Barcelona Instituto Oncologico Baselga | Barcelona | 08023 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital de la Santa Creu I Sant Pau | Barcelona | 08041 | Spain |
| Hospital Provincial de Castellón | Castillón | 12002 | Spain |
| Hospital Universitari Arnau de Vilanova | Lleida | 25198 | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | 28007 | Spain |
| Instituto Oncologico Bureau (IOB) | Madrid | 28034 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Clinico Universitario de Santiago de Compostela | Santiago de Compostela | 15706 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| Royal Cornwall Hospital NHS Trust | Cornwell | United Kingdom |
| Royal Surrey County Hospital | Guildford | GU2 7XX | United Kingdom |
| Leicester Royal Infirmary | Leicester | LE1 5WW | United Kingdom |
| Barts Health NHS Trust | London | EC1A 7BE | United Kingdom |
| The Royal Marsden NHS Foundation Trust | London | SW3 6JJ | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | United Kingdom |
| Background |
| Rugo HS, Bardia A, Marme F, Cortes J, Schmid P, Loirat D, Tredan O, Ciruelos E, Dalenc F, Pardo PG, Jhaveri KL, Delaney R, Fu O, Lin L, Verret W, Tolaney SM. Sacituzumab Govitecan in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer. J Clin Oncol. 2022 Oct 10;40(29):3365-3376. doi: 10.1200/JCO.22.01002. Epub 2022 Aug 26. |
| 32223649 | Background | Rugo HS, Bardia A, Tolaney SM, Arteaga C, Cortes J, Sohn J, Marme F, Hong Q, Delaney RJ, Hafeez A, Andre F, Schmid P. TROPiCS-02: A Phase III study investigating sacituzumab govitecan in the treatment of HR+/HER2- metastatic breast cancer. Future Oncol. 2020 Apr;16(12):705-715. doi: 10.2217/fon-2020-0163. Epub 2020 Mar 30. |
| 38748596 | Background | Rugo HS, Schmid P, Tolaney SM, Dalenc F, Marme F, Shi L, Verret W, Shah A, Gharaibeh M, Bardia A, Cortes J. Health-related quality of life with sacituzumab govitecan in HR+/HER2- metastatic breast cancer in the phase III TROPiCS-02 trial. Oncologist. 2024 Sep 6;29(9):768-779. doi: 10.1093/oncolo/oyae088. |
| 38270051 | Background | Rugo HS, Bardia A, Marme F, Cortes J, Schmid P, Spears PA, Tolaney SM. A plain language summary of the TROPiCS-02 study in patients with breast cancer (HR-positive/HER2-negative). Future Oncol. 2024 Apr;20(11):635-651. doi: 10.2217/fon-2023-0845. Epub 2024 Jan 25. |
| 39067902 | Background | Rugo HS, Bardia A, Tolaney S. Sacituzumab govitecan for metastatic breast cancer: the TROPiCS-02 trial - Authors' reply. Lancet. 2024 Jul 27;404(10450):339-340. doi: 10.1016/S0140-6736(24)01049-3. No abstract available. |
| 33093337 | Derived | McCann KE, Hurvitz SA. Innovations in targeted therapies for triple negative breast cancer. Curr Opin Obstet Gynecol. 2021 Feb 1;33(1):34-47. doi: 10.1097/GCO.0000000000000671. |
| 32946924 | Derived | Kalinsky K, Diamond JR, Vahdat LT, Tolaney SM, Juric D, O'Shaughnessy J, Moroose RL, Mayer IA, Abramson VG, Goldenberg DM, Sharkey RM, Maliakal P, Hong Q, Goswami T, Wegener WA, Bardia A. Sacituzumab govitecan in previously treated hormone receptor-positive/HER2-negative metastatic breast cancer: final results from a phase I/II, single-arm, basket trial. Ann Oncol. 2020 Dec;31(12):1709-1718. doi: 10.1016/j.annonc.2020.09.004. Epub 2020 Sep 15. |
| FG001 |
| Treatment of Physician's Choice (TPC) |
Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent treatment that was determined by the investigator before participant randomization until progression of disease, occurrence of unacceptable adverse events (AEs), or another treatment discontinuation criterion was met. Dosing per National Comprehensive Cancer Network (NCCN) guidelines (with dose modifications for if toxic)
|
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Intent-to-Treat (ITT) Population included all participants who were randomized, regardless of whether they received study treatment or not.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sacituzumab Govitecan | Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met (up to 40.1 months). |
| BG001 | Treatment of Physician's Choice (TPC) | Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent treatment that was determined by the investigator before participant randomization until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met. Dosing per NCCN guidelines (with dose modifications for if toxic)
|
| BG002 | Total~(N=543) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) Assessment | PFS was defined as the time from the date of randomization to the date of the first documentation of disease progression or death (whichever occurred first) according to BICR using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Disease progression was defined as an increase of greater than 20% in the sum of the longest diameter (LD) of target lesions and a 5 mm absolute increase, taking as a reference the smallest sum LD recorded since the baseline assessment or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate. | The ITT Population included all participants who were randomized, regardless of whether they received study treatment or not. | Posted | Median | 95% Confidence Interval | months | Up to 42.8 months |
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| Secondary | Overall Survival (OS) | OS was defined as the time from the date of randomization to the date of death from any cause. OS was estimated using Kaplan-Meier estimate. Participants without documentation of death were censored on the date they were last known to be alive. | Participants in the ITT Population were analyzed. | Posted | Median | 95% Confidence Interval | months | Up to 42.8 months |
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| Secondary | Objective Response Rate (ORR) by BICR and Local Investigator Review (LIR) Assessment | ORR was defined as the percentage of participants who had the best overall response of either complete response (CR) or partial response (PR) that was confirmed at 4 weeks or later after initial response by BICR and LIR using RECIST 1.1. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. | Participants in the ITT Population with available data were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 42.8 months |
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| Secondary | Duration of Response (DOR) by BICR and LIR Assessment | DOR was defined as the time from the date a response of CR or PR was first documented until the date of the first documentation of disease progression or date of death (whichever occurred first). DOR was analyzed based on both BICR and LIR assessments. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Disease progression was defined as an increase of greater than 20% in the sum of the LD of target lesions and a 5 mm absolute increase, taking as a reference the smallest sum LD recorded since the baseline assessment or the appearance of new non-target lesions. DOR was estimated using Kaplan-Meier estimate. | Participants in the ITT Population with confirmed objective response were analyzed. | Posted | Median | 95% Confidence Interval | months | Up to 42.8 months |
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| Secondary | Clinical Benefit Rate (CBR) by BICR and LIR Assessment | CBR was defined as the percentage of participants with the best overall response of CR, PR, or durable stable disease (duration of SD ≥ 6 months after randomization). CBR was analyzed based on both BICR and LIR assessments. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started. PD: Disease progression was defined as an increase of greater than 20% in the sum of the LD of target lesions and a 5 mm absolute increase, taking as a reference the smallest sum LD recorded since the baseline assessment or the appearance of new non-target lesions. | Participants in the ITT Population with available data were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 42.8 months |
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| Secondary | PFS by LIR Assessment | PFS was defined as the time from the date of randomization to the date of the first documentation of disease progression or death (whichever occurred first) according to LIR using RECIST 1.1. Disease progression was defined as an increase of greater than 20% in the sum of the LD of target lesions and a 5 mm absolute increase, taking as a reference the smallest sum LD recorded since the baseline assessment or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate. | Participants in the ITT Population were analyzed. | Posted | Median | 95% Confidence Interval | months | Up to 42.8 months |
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| Secondary | Time to Deterioration (TTD) of Global Health Status/Quality of Life (QoL) Scale as Measured by European Organization for Research and Treatment of Cancer Quality of Life for Cancer Patients, Core Questionnaire Version 3.0 (EORTC QLQ-C30) | TTD was defined as the time from randomization to the first date a subject achieves 10-point deterioration from baseline in the global health status/QoL scale.The EORTC QLQ-C30 is a 30-item questionnaire to assess QoL of cancer patients. It has 5 functional scales(physical,role,emotional,cognitive, social)1 global health status scale,3 symptom scales (fatigue, nausea and vomiting, pain),and 6 single items(dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties). Participant responses to global health status,'How would you rate your overall health during the past week?' (Item 29)and the QoL 'How would you rate your overall quality of life during the past week?'(Item 30)questions were scored on 7-point scale (1=very poor; 7=excellent). All scales and single-item measures range in score from 0 to 100. Summed raw scores were standardized by linear transformation so that scores ranged from 0 to 100. Higher scores for GHS show a better level of functioning. | The HRQOL-Evaluable Population included all participants who had an evaluable assessment at baseline and at least 1 evaluable assessment at postbaseline visits. Participants with a baseline global health status/QOL score ≥ 10 were analyzed. | Posted | Median | 95% Confidence Interval | months | Up to 37.8 months |
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| Secondary | TTD of Pain Score as Measured by EORTC QLQ-C30 | TTD was defined as the time from randomization to the first date a subject achieves 10-point deterioration from baseline in the pain score.The EORTC QLQ-C30 is a questionnaire to assess quality of life, it is composed of 30 questions(items) resulting in 5 functional scales(physical, role, emotional, cognitive, social),1 global health status scale,3 symptom scales (fatigue, nausea and vomiting, pain),and 6 single items(dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties). All of the scales and single-item measures range in score from 0 to 100. Participant responses to 2 questions about pain, 'Have you had pain' and 'Did pain interfere with your daily activities' were scored on 4-point scale (1=not at all;4=very much). Summed raw scores were standardized by linear transformation so that scores ranges from 0 to 100. Higher scores on the symptom scales indicate a higher level of symptoms (i.e. a worse state of the participant). | Participants in the HRQOL-Evaluable Population with baseline pain score ≤ 90 were analyzed. | Posted | Median | 95% Confidence Interval | months | Up to 37.8 months |
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| Secondary | TTD of Fatigue Score as Measured by EORTC QLQ-C30 | TTD was defined as the time from randomization to the first date a subject achieves 10-point deterioration from baseline in the fatigue score.The EORTC QLQ-C30 is a questionnaire to assess quality of life, it is composed of 30 questions(items) resulting in 5 functional scales(physical, role, emotional, cognitive, social),1 global health status scale,3 symptom scales (fatigue, nausea and vomiting, pain),and 6 single items(dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties).All of the scales and single-item measures range in score from 0 to 100.Participant responses to 3 questions about fatigue 'Did you need to rest', 'Have you felt weak' and 'Were you tired' were scored on a 4-point scale (1=not at all;4=very much).Summed raw scores were standardized by linear transformation so that scores ranged from 0 to 100. Higher scores on the symptom scales indicate a higher level of symptoms (i.e. a worse state of the participant). | Participants in the HRQOL-Evaluable Population with baseline fatigue score ≤ 90 were analyzed. | Posted | Median | 95% Confidence Interval | months | Up to 37.8 months |
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| Secondary | Percentage of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) | An AE was defined as any untoward medical occurrence in a subject administered a medicinal product that does not necessarily have a causal relationship with this treatment. TEAEs were defined as any AEs that begin or worsen on or after the start of study drug through 30 days after the last dose of the study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5.0. | The Safety Population included all participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | Up to 43.4 months |
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| Secondary | Percentage of Participants Who Experienced Treatment Emergent Serious Adverse Events (TESAEs) | Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5.0. An AE that met one or more of the following outcomes was classified as serious:
| Participants in the Safety Population were analyzed. | Posted | Number | percentage of participants | Up to 43.4 months |
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| Secondary | Percentage of Participants Who Experienced the Worst Laboratory Abnormalities Grade 3 or 4 Post-Baseline | Blood samples were collected for hematology, serum chemistry, and the laboratory abnormalities were assessed. A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and including the date of last study drug dose plus 30 days.The most severe graded abnormality observed post-baseline for each graded test was counted for each participant. Safety as assessed by grading of laboratory values and AEs according to the National Cancer Institutes' Common Terminology Criteria for Adverse Events (NCI CTCAE) covering grades 0-5 (0=Normal, 1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening, 5=Death). The percentage of participants with worst postbaseline grades 3 or 4 are reported. | Participants in the Safety Population with post-baseline values were analyzed. 'Number Analyzed' indicates participants with post-baseline values with available data were analyzed. | Posted | Number | percentage of participants | Up to 43.4 months |
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| Secondary | Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) - Shift From Baseline Value to Best Value During Treatment | ECOG performance status (PS) measured on-therapy assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease performance without restriction;1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature;2=Ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours;3=Capable of only limited self-care;confined to bed or chair more than 50% of waking hours;4=Completely disabled; cannot carry on any self-care; totally confined to bed or chair;5=Dead. Lower score indicated good performance status. Percentage of participants with Baseline ECOG PS score and corresponding changes to the best values post-baseline have been reported. | Participants in the Safety Population were analyzed. | Posted | Number | percentage of participants | Up to 43.4 months |
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Adverse Events and All-Cause Mortality: Up to 43.4 months
Adverse Events: The Safety Population included all participants who received at least 1 dose of study drug; All-Cause Mortality: The ITT Population included all participants who were randomized, regardless of whether they received study treatment or not.
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 | Sacituzumab Govitecan | Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met (up to 40.1 months). | 234 | 272 | 74 | 268 | 264 | 268 |
| EG001 | Treatment of Physician's Choice (TPC) | Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent treatment that was determined by the investigator before participant randomization until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met. Dosing per NCCN guidelines (with dose modifications for if toxic)
| 238 | 271 | 48 | 249 | 234 | 249 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Thrombocytosis | Blood and lymphatic system disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Arrhythmia | Cardiac disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Myocardial ischaemia | Cardiac disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Secondary adrenocortical insufficiency | Endocrine disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Blepharospasm | Eye disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Enteritis | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Impaired gastric emptying | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Large intestine perforation | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Neutropenic colitis | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA Version 26.0 | Systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Mucosal inflammation | General disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Cholangitis | Hepatobiliary disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Cholangitis acute | Hepatobiliary disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Anal abscess | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
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| Clostridium difficile colitis | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
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| Clostridium difficile infection | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
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| Covid-19 | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
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| Covid-19 pneumonia | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
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| Device related infection | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
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| Escherichia bacteraemia | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
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| Herpes zoster disseminated | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
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| Lower respiratory tract infection viral | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
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| Mastitis | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
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| Peritonitis | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
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| Pneumocystis jirovecii infection | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
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| Tooth abscess | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
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| Vascular device infection | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
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| Wound infection | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
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| Compression fracture | Injury, poisoning and procedural complications | MedDRA Version 26.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA Version 26.0 | Systematic Assessment |
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| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA Version 26.0 | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA Version 26.0 | Systematic Assessment |
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| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA Version 26.0 | Systematic Assessment |
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| Procedural pneumothorax | Injury, poisoning and procedural complications | MedDRA Version 26.0 | Systematic Assessment |
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| Tibia fracture | Injury, poisoning and procedural complications | MedDRA Version 26.0 | Systematic Assessment |
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| Blood glucose decreased | Investigations | MedDRA Version 26.0 | Systematic Assessment |
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| Liver function test increased | Investigations | MedDRA Version 26.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.0 | Systematic Assessment |
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| Cerebral haemorrhage | Nervous system disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Cerebral ischaemia | Nervous system disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Nervous system disorder | Nervous system disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Device leakage | Product Issues | MedDRA Version 26.0 | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Hydronephrosis | Renal and urinary disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Urinary tract obstruction | Renal and urinary disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Embolism | Vascular disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA Version 26.0 | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA Version 26.0 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA Version 26.0 | Systematic Assessment |
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| Blood lactate dehydrogenase increased | Investigations | MedDRA Version 26.0 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA Version 26.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA Version 26.0 | Systematic Assessment |
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After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 7, 2022 | Jun 14, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000608132 | sacituzumab govitecan |
| C490954 | eribulin |
| D000069287 | Capecitabine |
| D000093542 | Gemcitabine |
| D000077235 | Vinorelbine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
Not provided
Not provided
| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Unknown or Not Reported |
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| Black or African American |
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| Asian |
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| Other or More Than One Race |
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| Native Hawaiian or Other Pacific Islander |
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| France |
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| Spain |
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| Germany |
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| Belgium |
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| Italy |
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| United Kingdom |
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| Netherlands |
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| Canada |
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Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent treatment that was determined by the investigator before participant randomization until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met. Dosing per NCCN guidelines (with dose modifications for if toxic)
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| OG001 | Treatment of Physician's Choice (TPC) | Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent treatment that was determined by the investigator before participant randomization until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met. Dosing per NCCN guidelines (with dose modifications for if toxic)
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Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent treatment that was determined by the investigator before participant randomization until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met. Dosing per NCCN guidelines (with dose modifications for if toxic)
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Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent treatment that was determined by the investigator before participant randomization until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met. Dosing per NCCN guidelines (with dose modifications for if toxic)
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Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent treatment that was determined by the investigator before participant randomization until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met. Dosing per NCCN guidelines (with dose modifications for if toxic)
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Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent treatment that was determined by the investigator before participant randomization until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met. Dosing per NCCN guidelines (with dose modifications for if toxic)
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