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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000128-16 | EudraCT Number |
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The primary objective of this study was to compare progression-free survival in patients with multiple myeloma who relapsed after 1 to 3 prior therapies treated with carfilzomib plus dexamethasone or bortezomib plus dexamethasone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carfilzomib plus Dexamethasone | Experimental | Participants received 20 mg/m² carfilzomib administered by intravenous (IV) infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle. |
|
| Bortezomib plus Dexamethasone | Active Comparator | Participants received bortezomib 1.3 mg/m² administered IV or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carfilzomib | Drug | Carfilzomib is administered over 30 minutes as an infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Progression-free survival (PFS) was defined as the time from randomization to the earlier of disease progression or death due to any cause. Participants were evaluated for disease response and progression according to the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC) as assessed by an Independent Review Committee (IRC). Median PFS was estimated using the Kaplan-Meier method. Participants with no baseline disease assessments, starting a new anticancer therapy before documentation of disease progression or death, death or disease progression immediately after more than 1 consecutively missed disease assessment visit, or alive without documentation of disease progression before the data cut-off date were censored. | From randomization until the data cut-off date of 10 November 2014; median follow-up time for PFS was 11.1.and 11.9 months in the bortezomib and carfilzomib arms respectively |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival (OS) is defined as the time from randomization to the date of death (whatever the cause). Participants who were alive or lost to follow-up as of the data analysis cut-off date were censored at the patient's date of last contact (last known to be alive). Median overall survival was estimated using the Kaplan-Meier method. | From randomization until the data cut-off date of 03 January 2017; median follow-up time for OS was 36.9 and 37.5 months for each treatment group respectively. |
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Inclusion Criteria:
Multiple myeloma with relapsing or progressing disease at study entry.
Patients must have evaluable multiple myeloma with, at least one of the following (assessed within 21 days prior to randomization):
Patients must have documented at least partial response (PR) to at least 1 line of prior therapy. PR documentation can be based on Investigator assessment.
Received 1, but no more than 3 prior treatment regimens or lines of therapy for multiple myeloma. (Induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as one line of therapy).
Prior therapy with Velcade is allowed as long as the patient had at least a PR to prior Velcade therapy, was not removed from Velcade therapy due to toxicity, and will have at least a 6 month Velcade treatment-free interval from last dose received until first study treatment. (Patients may receive maintenance therapy with drugs that are not in the proteasome inhibitor class during this 6 month Velcade treatment-free interval).
Prior therapy with carfilzomib is allowed as long as the patient had at least a PR to prior carfilzomib therapy, was not removed from carfilzomib therapy due to toxicity, and had at least a 6-month carfilzomib treatment-free interval from last dose received until first study treatment. (Patients may receive maintenance therapy with drugs that are not in the proteasome inhibitor class during this 6 month carfilzomib treatment-free interval). The exception to this is patients randomized or previously randomized in any other Onyx-Sponsored Phase 3 trial.
Males and females ≥ 18 years of age.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
Adequate hepatic function within 21 days prior to randomization, with bilirubin < 1.5 times the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times the ULN.
Left ventricular ejection fraction (LVEF) ≥ 40%.
Absolute neutrophil count (ANC) ≥ 1000/mm³ within 21 days prior to randomization. Screening ANC should be independent of growth factor support for ≥ 1 week.
Hemoglobin ≥ 8.0 g/dL within 21 days prior to randomization. Use of erythropoietic stimulating factors and red blood cell (RBC) transfusions per institutional guidelines is allowed, however most recent RBC transfusion may not have been done within 7 days prior to obtaining screening hemoglobin.
Platelet count ≥ 50,000/mm³ (≥ 30,000/mm³ if myeloma involvement in the bone marrow is > 50%) within 21 days prior to randomization. Patients should not have received platelet transfusions for at least 1 week prior to obtaining the screening platelet count.
Calculated or measured creatinine clearance (CrCl) of ≥ 15 mL/min within 21 days prior to randomization. Calculation should be based on standard formula such as the Cockcroft and Gault:
[(140 - Age) x Mass (kg) / (72 x Creatinine mg/dL)]; multiply result by 0.85 if female.
Written informed consent in accordance with federal, local, and institutional guidelines.
Female patients of child-bearing potential (FCBP) must have a negative serum pregnancy test within 21 days prior to randomization and agree to use an effective method of contraception during and for 3 months following last dose of drug (more frequent pregnancy tests may be conducted if required per local regulations). FCBP is defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
Male patients must use an effective barrier method of contraception during study and for 3 months following the last dose if sexually active with a FCBP.
Exclusion Criteria:
Multiple Myeloma of IgM subtype.
Glucocorticoid therapy (prednisone > 30 mg/day or equivalent) within 14 days prior to randomization.
POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
Plasma cell leukemia or circulating plasma cells ≥ 2 × 10^9/L.
Waldenstrom's Macroglobulinemia.
Patients with known amyloidosis.
Chemotherapy with approved or investigational anticancer therapeutics within 21 days prior to randomization.
Patients randomized or previously randomized in any other Onyx-Sponsored Phase 3 trial.
Focal radiation therapy within 7 days prior to randomization. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to randomization (i.e., prior radiation must have been to less than 30% of the bone marrow).
Immunotherapy within 21 days prior to randomization.
Major surgery (excluding kyphoplasty) within 28 days prior to randomization.
Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within four months prior to randomization.
Acute active infection requiring systemic antibiotics, antiviral (except antiviral therapy directed at hepatitis B) or antifungal agents within 14 days prior to randomization.
Known human immunodeficiency (HIV) seropositive, hepatitis C infection, and/or hepatitis B (except for patients with hepatitis B surface antigen [SAg] or core antibody receiving and responding to antiviral therapy directed at hepatitis B: these patients are allowed).
Patients with known cirrhosis.
Second malignancy within the past 3 years except:
Patients with myelodysplastic syndrome.
Significant neuropathy (Grades 3 to 4, or Grade 2 with pain) within 14 days prior to randomization.
Female patients who are pregnant or lactating.
Known history of allergy to Captisol(a cyclodextrin derivative used to solubilize carfilzomib).
Patients with hypersensitivity to carfilzomib, Velcade, boron, or mannitol.
Patients with contraindication to dexamethasone.
Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment.
Ongoing graft-vs-host disease.
Patients with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to randomization.
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence St. Joseph Medical Center | Burbank | California | United States | |||
| UCSD Moore Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27491641 | Background | Moreau P, Joshua D, Chng WJ, Palumbo A, Goldschmidt H, Hajek R, Facon T, Ludwig H, Pour L, Niesvizky R, Oriol A, Rosinol L, Suvorov A, Gaidano G, Pika T, Weisel K, Goranova-Marinova V, Gillenwater HH, Mohamed N, Aggarwal S, Feng S, Dimopoulos MA. Impact of prior treatment on patients with relapsed multiple myeloma treated with carfilzomib and dexamethasone vs bortezomib and dexamethasone in the phase 3 ENDEAVOR study. Leukemia. 2017 Jan;31(1):115-122. doi: 10.1038/leu.2016.186. Epub 2016 Jul 4. | |
| 28025582 |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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Randomization was stratified by previous proteasome inhibitor therapy (yes vs no), previous lines of treatment (1 vs 2 or 3), International Staging System stage (I vs II-III), and planned route of bortezomib administration (intravenous vs subcutaneous) if randomly assigned to the bortezomib group.
Adults with relapsed multiple myeloma were enrolled between 20 June 2012 and 30 June 2014 at 198 centers in 27 countries in Europe, North America, South America, and the Asia-Pacific region.
Results are reported as of the data cut-off date of 03 January 2017, the pre-specified 2nd interim analysis of the secondary endpoint of overall survival.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bortezomib + DEX | Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle. |
| FG001 | Carfilzomib + DEX |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Bortezomib | Drug | Bortezomib is administered as a 3-5 second bolus IV injection or SC injection (in accordance with regulatory approval) |
|
|
| Dexamethasone | Drug | Tablet for oral administration; On days when carfilzomib or bortezomib was administered, the dexamethasone was to be given 30 minutes to 4 hours prior to the carfilzomib or bortezomib dose. |
|
| Overall Response | Disease response was evaluated according to the IMWG-URC by the IRC. Overall response was defined as the percentage of participants with a best overall response of partial response (PR), very good PR (VGPR), complete response (CR) or stringent CR (sCR). sCR: As for CR, normal serum free light chain (SFLC) ratio and no clonal cells in bone marrow (BM). CR: No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and < 5% plasma cells in BM biopsy; VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% reduction in serum M-protein with urine M-protein <100 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline. PR: ≥ 50% reduction of serum M-protein and reduction in urine M-protein by ≥ 90% or to < 200 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline. | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 10 November 2014; median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group. |
| Duration of Response | Duration of response (DOR) was calculated for participants who achieved an sCR, CR, VGPR, or PR. Duration of response is defined as the time from first evidence of PR or better to confirmation of disease progression or death due to any cause. Median duration of response was estimated using the Kaplan-Meier method. Participants with no baseline disease assessments, starting a new anticancer therapy before documentation of disease progression or death, death or disease progression immediately after more than 1 consecutively missed disease assessment visit, or alive without documentation of disease progression before the data cut-off date were censored. | From randomization until the data cut-off date of 10 November 2014; median follow-up time for DOR was 9.4 and 10.4 months for each treatment group respectively. |
| Percentage of Participants With ≥ Grade 2 Peripheral Neuropathy | Neuropathy events were defined as Grade 2 or higher peripheral neuropathy as specified by peripheral neuropathy Standardised Medical Dictionary for Regulatory Activities (MedDRA) Query, narrow (scope) (SMQN) terms. Peripheral neuropathy was assessed by neurologic exam and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03: Grade 1: Asymptomatic; Grade 2: Moderate symptoms, limiting instrumental activities of daily living (ADL) Grade 3: Severe symptoms; limiting self-care ADL; Grade 4: Life-threatening consequences, urgent intervention indicated; Grade 5: Death. | From the first dose of study drug up to 30 days after the last dose of study drug as of the data cut-off date of 10 November 2014; median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group. |
| Percentage of Participants With a Significant Reduction in Left Ventricular Ejection Fraction (LVEF) | A significant reduction in LVEF was defined as a ≥ 10% decrease (absolute change) from baseline in participants whose baseline LVEF is ≤ 55%. For participants with LVEF > 55% at baseline, a significant change was defined as a decrease in LVEF to < 45%. | Baseline and 24 weeks |
| Change From Baseline in Right Ventricular Fractional Area Change (FAC) | Right ventricular function was assessed by measuring fractional area change (FAC) on echocardiogram. | Baseline and Weeks 12, 24 and 36 and at end of treatment (median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group). |
| Change From Baseline in Pulmonary Artery Systolic Pressure (PASP) | Pulmonary artery pressure was measured using transthoracic echocardiogram. | Baseline and Weeks 12, 24 and 36 and at end of treatment (median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group). |
| La Jolla |
| California |
| United States |
| UCLA Medical Center | Los Angeles | California | United States |
| Central Coast Medical Oncology Group | Santa Maria | California | United States |
| Colorado Blood Cancer Institute | Denver | Colorado | United States |
| MAB Oncology/Hematology | Melbourne | Florida | United States |
| Palm Beach Cancer Institute | West Palm Beach | Florida | United States |
| Winship Cancer Institute | Atlanta | Georgia | United States |
| Hematology Oncology of Indiana, PC | Indianapolis | Indiana | United States |
| Center for Cancer and Blood Disorders | Bethesda | Maryland | United States |
| Associates in Oncology/Hematology PC | Rockville | Maryland | United States |
| University of Michigan | Ann Arbor | Michigan | United States |
| University of Kansas | Kansas City | Missouri | United States |
| Hackensack University Medical Ctr | Hackensack | New Jersey | United States |
| Clinical Research Alliance Inc. | New York | New York | United States |
| Weill Cornell Medical College | New York | New York | United States |
| Montefiore Medical Center | The Bronx | New York | United States |
| Wake Forest University Health Sciences, Section on Hematology and Oncology | Winston-Salem | North Carolina | United States |
| Gabrail Cancer Center | Canton | Ohio | United States |
| The Christ Hospital | Cincinnati | Ohio | United States |
| Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | United States |
| Hematology/Oncology Associates of SC | Greenville | South Carolina | United States |
| Vanderbilt Ingram Cancer Center | Nashville | Tennessee | United States |
| MD Anderson | Houston | Texas | United States |
| The Methodist Cancer Center | Houston | Texas | United States |
| Scott & White Memorial Hospital | Temple | Texas | United States |
| University of Utah School of Medicine | Salt Lake City | Utah | United States |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | Australia |
| St. Vincent's Public Hospital Sydney | Darlinghurst | New South Wales | Australia |
| Saint George Hospital | Kogarah | New South Wales | Australia |
| Liverpool Hospital | Liverpool | New South Wales | Australia |
| Royal North Shore Hospital | Saint Leonards | New South Wales | Australia |
| Calvary Mater Newcastle | Waratah | New South Wales | Australia |
| Westmead Hospital | Westmead | New South Wales | Australia |
| Royal Brisbane and Women's Hospital | Herston | Queensland | Australia |
| Haematology & Oncology Clinics of Australia | South Brisbane | Queensland | Australia |
| Haematology and Oncology Clinics of Australia at Chermside | South Brisbane | Queensland | Australia |
| Haematology and Oncology Clinics of Australia at Wesley | South Brisbane | Queensland | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | Australia |
| The Queen Elizabeth Hospital | Woodville | South Australia | Australia |
| Box Hill Hospital | Box Hill | Victoria | Australia |
| Monash Medical Centre | Clayton | Victoria | Australia |
| Saint Vincent's Hospital | East Melbourne | Victoria | Australia |
| Western Hospital | Footscray | Victoria | Australia |
| The Alfred Hospital | Melbourne | Victoria | Australia |
| Sunshine Hospital | St Albans | Victoria | Australia |
| Fremantle Hospital | Fremantle | Western Australia | Australia |
| Royal Perth Hospital | Perth | Western Australia | Australia |
| Wilhelminenspital der Stadt Wien | Vienna | State of Vienna | Austria |
| Medizinische Universität Innsbruck | Innsbruck | Tyrol | Austria |
| Krankenhaus der Elisabethinen Linz, I Interne Abteilung | Linz | Upper Austria | Austria |
| Universitair Ziekenhuis Leuven | Leuven | Flemish Brabant | Belgium |
| Cliniques Universitaires UCL de Mont-Godinne | Yvoir | Namur | Belgium |
| Universitair Ziekenhuis Gent | Ghent | Oost-vlaanderen | Belgium |
| Ziekenhuis Netwerk Antwerpen | Antwerp | Belgium |
| Cliniques Universitaires Saint Luc | Brussels | Belgium |
| Universitair Ziekenhuis Brussel | Brussels | Belgium |
| Liga Norte Riograndense Contra o Câncer | Natal | Rio Grande do Norte | Brazil |
| Clínica de Oncologia de Porto Alegre | Porto Alegre | Rio Grande do Sul | Brazil |
| Hospital de Clínicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | Brazil |
| Hospital São Lucas da PUCRS | Porto Alegre | Rio Grande do Sul | Brazil |
| Hemocentro Campinas-Unicamp | Campinas | São Paulo | Brazil |
| Hospital Universitário Clementino Fraga Filho da Universidade Federal do Rio de Janeiro | Rio de Janeiro | Brazil |
| Instituto Centros Oncológicos Integrados de Educação e Pesquisa | Rio de Janeiro | Brazil |
| Instituto Nacional do Câncer-INCA | Rio de Janeiro | Brazil |
| Irmandade da Santa Casa de Misericórdia de São Paulo | São Paulo | Brazil |
| Military Medical Academy Hospital for Active Treatment | Sofia | Sofia | Bulgaria |
| Shato, Ead | Sofia | Sofia | Bulgaria |
| University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD | Plovdiv | Bulgaria |
| Multiprofile Hospital for Active Treatment, "Sveta Marina'' | Varna | Bulgaria |
| University of Alberta Hospital | Edmonton | Alberta | Canada |
| British Columbia Cancer Agency | Kelowna | British Columbia | Canada |
| Saint John Regional Hospital | Saint John | New Brunswick | Canada |
| Queen Elizabeth II Health Science Centre | Halifax | Nova Scotia | Canada |
| London Health Sciences Centre | London | Ontario | Canada |
| The Ottawa Hospital Regional Cancer Centre | Ottawa | Ontario | Canada |
| Windsor Regional Hospital | Windsor | Ontario | Canada |
| Hopital Maisonneuve-Rosemont | Montreal | Quebec | Canada |
| Fakultní nemocnice Královské Vinohrady | Prague | Prague | Czechia |
| Fakultní nemocnice Olomouc | Olomouc | Severomoravsky KRAJ | Czechia |
| FN Ostrava | Ostrava | Severomoravsky KRAJ | Czechia |
| Fakultní nemocnice Hradec Králové | Hradec Kralové | Vychodocesky KRAJ | Czechia |
| Fakultní nemocnice Brno | Brno | Czechia |
| Všeobecná fakultní nemocnice v Praze | Prague | Czechia |
| Centre Hospitalier de la Cote Basque | Bayonne | Aquitaine | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | Auvergne-Rhône-Alpes | France |
| Centre Hospitalier Universitaire Brest | Brest | Brittany Region | France |
| Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou | Rennes | Brittany Region | France |
| Hopital Hotel-Dieu - Service d'Hematologie | Nantes | Cedex 1 | France |
| Centre Henri-Becquerel | Rouen | Haute-normandie | France |
| Hôpital Claude Huriez | Lille | Hauts-de-France | France |
| Hôpital Hôtel-Dieu | Nantes | Pays de la Loire Region | France |
| Institut Paoli Calmettes | Marseille | Provence-Alpes-Côte d'Azur Region | France |
| Centre Hospitalier de Versailles | Le Chesnay | Île-de-France Region | France |
| Hôpital Saint Louis | Paris | Île-de-France Region | France |
| Hôpital Saint-Antoine | Paris | Île-de-France Region | France |
| Universitätsklinik Heidelberg | Heidelberg | Baden-Wurttemberg | Germany |
| Universitätsklinikum Tübingen | Tübingen | Baden-Wurttemberg | Germany |
| Universitätsklinikum Ulm | Ulm | Baden-Wurttemberg | Germany |
| Medizinische Klinik der Universität Würzburg | Würzburg | Bavaria | Germany |
| Medizinische Hochschule Hannover | Hanover | Lower Saxony | Germany |
| Universitätsklinikum Aachen | Aachen | North Rhine-Westphalia | Germany |
| Universitätsklinikum Münster | Münster | North Rhine-Westphalia | Germany |
| Universitätsmedizin der Johannes Gutenberg Universität | Mainz | Rhineland-Palatinate | Germany |
| Universitätsklinikum des Saarlandes | Homburg / Saar | Saarland | Germany |
| Klinikum Chemnitz gGmbH | Chemnitz | Saxony | Germany |
| Universitätsklinikum Carl Gustav Carus, Med. Klinik und Poliklinik I | Dresden | Saxony | Germany |
| Universitätsklinikum Leipzig | Leipzig | Saxony | Germany |
| Universitätsklinikum Jena | Jena | Thuringia | Germany |
| Universitatsklinikum Freiburg | Freiburg im Breisgau | Germany |
| Universitätsklinikum Hamburg Eppendorf | Hamburg | Germany |
| Alexandra General Hospital | Athens | Attica | Greece |
| Pécsi Tudományegyetem | Pécs | Baranya | Hungary |
| Bács-Kiskun Megyei Kórház Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza | Kecskemét | Bács-Kiskun county | Hungary |
| Szegedi Tudományegyetem | Szeged | Csongrád megye | Hungary |
| Debreceni Egyetem Klinikai Központ | Debrecen | Hajdú-Bihar | Hungary |
| Egyesített Szent István és Szent László Kórház-Rendelointézet | Budapest | Hungary |
| Somogy Megyei Kaposi Mac okato Korhoz | Kaposvár | Hungary |
| Somogy Megyei Kaposi Mór Oktató Kórház | Kaposvár | Hungary |
| Rambam Health Corp. | Haifa | Israel |
| Hadassah Medical Center | Jerusalem | Israel |
| Meir Medical Center | Kfar Saba | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | Israel |
| The Chaim Sheba Medical Center at Tel Hashomer | Tel Litwinsky | Israel |
| IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture | Rionero in Vulture | Potenza | Italy |
| Azienda Ospedaliero-Univesitaria San Luigi Gonzaga | Orbassano | Torino | Italy |
| Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona | Ancona | Italy |
| Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi | Bologna | Italy |
| Azienda Ospedaliera Spedali Civili di Brescia | Brescia | Italy |
| IRCCS Azienda Ospedaliera Universitaria San Martino | Genova | Italy |
| Azienda Ospedaliera Universitaria Maggiore della Carità | Novara | Italy |
| Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto | Piacenza | Italy |
| Azienda Ospedaliera Pisana Ospedale Santa Chiara | Pisa | Italy |
| Aienda Policknico Umberto I di Roma | Roma | Italy |
| Azienda Policknico Umberto l di Roma | Roma | Italy |
| Università Tor Vergata Ospedale Sant Eugenio | Roma | Italy |
| Azienda Ospedaliera Universitaria Senese - Policlinico S. Maria alle Scotte | Siena | Italy |
| Azienda Ospedaliera Città della Salute e della Scienza di Torino | Torino | Italy |
| Nagoya City University Hospital | Nagoya | Aichi-ken | Japan |
| Toyohashi Municipal Hospital | Toyohashi | Aichi-ken | Japan |
| National Hospital Organization Kyushu Cancer Center | Fukuoka | Fukuoka | Japan |
| Ogaki Municipal Hospital | Ōgaki | Gifu | Japan |
| Gunma University Hospital | Maebashi | Gunma | Japan |
| National Hospital Organization Nishigunma National Hospital | Shibukawa | Gunma | Japan |
| Sapporo Medical University Hospital | Sapporo | Hokkaido | Japan |
| Kobe City Medical Center General Hospital | Kobe | Hyōgo | Japan |
| Tokai University Hospital | Isehara | Kanagawa | Japan |
| Niigata Cancer Center Hospital | Niigata | Niigata | Japan |
| Osaka University Hospital | Suita | Osaka | Japan |
| Saitama Medical Center | Kawagoe | Saitama | Japan |
| Tochigi Cancer Center | Utsunomiya | Tochigi | Japan |
| National Cancer Center Hospital | Chuo-ku | Tokyo | Japan |
| The Cancer Institute Hospital Of Japanese Foundation For Cancer Research | Koto-ku | Tokyo | Japan |
| Toranornon Hospital | Shinagawa | Tokyo | Japan |
| Tokyo Medical University Hospital | Shinjuku | Tokyo | Japan |
| National Hospital Organization Disaster Medical Center | Tachikawa | Tokyo | Japan |
| Kyushu University Hospital | Fukuoka | Japan |
| Social Insurance Kyoto Hospital of All Japan Federation of Social Insurance Associations | Kyoto | Japan |
| University Hospital, Kyoto Prefectural University of Medicine | Kyoto | Japan |
| National Hospital Organization Okayama Medical Center | Okayama | Japan |
| Tokushima Prefectural Central Hospital | Tokushima | Japan |
| Japanese Red Cross Medical Center | Tokyo | Japan |
| North Shore Hospital | North Shore | Auckland | New Zealand |
| Middlemore Hospital | Otahuhu | Auckland | New Zealand |
| Auckland City Hospital | Grafton | Aukland | New Zealand |
| Christchurch Hospital | Christchurch | New Zealand |
| Dunedin Hospital | Dunedin | New Zealand |
| Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K. Marcinkowskiego w Poznaniu | Poznan | Greater Poland Voivodeship | Poland |
| Specjalistyczny Szpital Miejski im. Mikolaja Kopernika | Torun | Kuyavian-Pomeranian Voivodeship | Poland |
| Szpital Uniwersytecki w Krakowie | Krakow | Lesser Poland Voivodeship | Poland |
| Zamojski Szpital Niepubliczny Sp. z o.o. | Zamość | Lublin Voivodeship | Poland |
| Instytut Hematologii i Transfuzjologii | Warsaw | Masovian Voivodeship | Poland |
| Uniwersyteckie Centrum Kliniczne | Gdansk | Pomeranian Voivodeship | Poland |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich | Chorzów | Silesian Voivodeship | Poland |
| Spitalul Universitar de Urgenta Bucuresti | Bucharest | Bucharest | Romania |
| Policlinica de Diagnostic Rapid SA, Compartiment Medical Oncologie-Hematologie | Brasov | Romania |
| Spitalul Clinic Judetean de Urgenta Brasov (Bumbea, Horia) | Brasov | Romania |
| Institutul Clinic Fundeni | Bucharest | Romania |
| Institutul Regional de Oncologie Iasi | Iași | Romania |
| Republican Clinical Hospital #1 | Izhevsk | Russia |
| City Clinical Hospital n.a. S. P. Botkin | Moscow | Russia |
| Non-state Healthcare Institution "N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway | Moscow | Russia |
| Ryazan Regional Clinical Hospital | Ryazan | Russia |
| Clinical Hospital Number 31 | Saint Petersburg | Russia |
| Federal Almazov Medical Research Centre | Saint Petersburg | Russia |
| FGU Russian Scientific Research Institute of Hematology and Transfusiology | Saint Petersburg | Russia |
| First Saint Petersburg I.P. Pavlov State Medical University | Saint Petersburg | Russia |
| GUZ Samara Regional Clinical Hospital n.a. M.I. Kalinin | Samara | Russia |
| National University Cancer Institute | Singapore | Singapore |
| Singapore General Hospital | Singapore | Singapore |
| Singapore Oncology Consultants | Singapore | Singapore |
| Univerzitná nemocnica Bratislava | Bratislava | Slovakia |
| Gachon University Gil Medical Center | Incheon | Gyeonggi-do | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | South Korea |
| Pusan National University Hospital | Pusan | Gyeongsangnam-do | South Korea |
| Kyungpook National University Hospital | Daegu | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Seoul Saint Mary's Hospital | Seoul | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | South Korea |
| Hospital Son Llàtzer | Palma de Mallorca | Balearic Islands | Spain |
| Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona | Spain |
| Hospital Clinic I Provincial de Barcelona | Barcelona | Spain |
| Institut Universitari Dexeus | Barcelona | Spain |
| Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro | Madrid | Spain |
| Hospital Universitario 12 de Octubre | Madrid | Spain |
| Hospital Universitario La Princesa | Madrid | Spain |
| Hospital Clínico Universitario de Salamanca | Salamanca | Spain |
| Hospital Universitario Virgen del Rocio | Seville | Spain |
| Hospital Universitari i Politecnic La Fé de Valencia | Valencia | Spain |
| Chang Gung Memorial Hospital | Kaohsiung City | Taiwan |
| China Medical University Hospital | Taichung | Taiwan |
| National Cheng-Kung University Hospital | Tainan | Taiwan |
| National Taiwan University Hospital | Taipei | Taiwan |
| Taipei Veterans General Hospital | Taipei | Taiwan |
| Chang Gung Medical Foundation-LinKou Branch | Taoyuan | Taiwan |
| King Chulalongkorn Memorial Hospital | Bangkok | Bangkok Metropolis | Thailand |
| Ramathibodi Hospital | Bangkok | Bangkok Metropolis | Thailand |
| Srinagarind Hospital | Khon Kaen | Thailand |
| City Hematology Center | Dnipro | Dnipropretrovsk | Ukraine |
| Municipal Institution of Health Protection "Clinical Hospital #8" | Kharkiv | Kharkiv Oblast | Ukraine |
| Cherkassy Regional Oncology Center | Cherkassy | Ukraine |
| MI "Dnipropetrovsk City Multifield Clinical Hospital #4" of Dnipropetrovsk Regional Council", City Hematology Center | Dnipropetrovsk | Ukraine |
| Institute of Urgent and Reparative Surgury of Ukraine Academy of Medical Sciences | Donetsk | Ukraine |
| Khmelnytsky Regional Clinical Hospital | Khmelnytsky | Ukraine |
| Khmelnytsky Regional Hospital, Department of Hematology | Khmelnytsky | Ukraine |
| National Institute of Cancer, Oncohematology Department | Kiev | Ukraine |
| Kyiv Bone Marrow Transplantation Center | Kyiv | Ukraine |
| Lviv Regional Oncology Dispensary | Lviv | Ukraine |
| Lviv State Oncology Regional Treatment-Prophylactic Center, Department of Chemotherapy | Lviv | Ukraine |
| Regional Clinical Hospital | Mykolayiv | Ukraine |
| Royal Free Hospital | London | England | United Kingdom |
| University College Hospital | London | England | United Kingdom |
| Manchester Royal Infirmary | Manchester | England | United Kingdom |
| Nottingham University Hospitals NHS Trust | Nottingham | England | United Kingdom |
| Churchill Hospital | Oxford | England | United Kingdom |
| Derriford Hospital | Plymouth | England | United Kingdom |
| Royal Hallamshire Hospital | Sheffield | England | United Kingdom |
| Royal Marsden Hospital | Surrey | England | United Kingdom |
| Royal Wolverhampton Hospitals Trust | Wolverhampton | England | United Kingdom |
| Background |
| Chng WJ, Goldschmidt H, Dimopoulos MA, Moreau P, Joshua D, Palumbo A, Facon T, Ludwig H, Pour L, Niesvizky R, Oriol A, Rosinol L, Suvorov A, Gaidano G, Pika T, Weisel K, Goranova-Marinova V, Gillenwater HH, Mohamed N, Feng S, Aggarwal S, Hajek R. Carfilzomib-dexamethasone vs bortezomib-dexamethasone in relapsed or refractory multiple myeloma by cytogenetic risk in the phase 3 study ENDEAVOR. Leukemia. 2017 Jun;31(6):1368-1374. doi: 10.1038/leu.2016.390. Epub 2016 Dec 27. |
| 28843768 | Background | Dimopoulos MA, Goldschmidt H, Niesvizky R, Joshua D, Chng WJ, Oriol A, Orlowski RZ, Ludwig H, Facon T, Hajek R, Weisel K, Hungria V, Minuk L, Feng S, Zahlten-Kumeli A, Kimball AS, Moreau P. Carfilzomib or bortezomib in relapsed or refractory multiple myeloma (ENDEAVOR): an interim overall survival analysis of an open-label, randomised, phase 3 trial. Lancet Oncol. 2017 Oct;18(10):1327-1337. doi: 10.1016/S1470-2045(17)30578-8. Epub 2017 Aug 23. |
| 28306371 | Background | Ludwig H, Dimopoulos MA, Moreau P, Chng WJ, Goldschmidt H, Hajek R, Facon T, Pour L, Niesvizky R, Oriol A, Rosinol L, Suvorov A, Gaidano G, Pika T, Weisel K, Goranova-Marinova V, Palumbo A, Gillenwater HH, Mohamed N, Aggarwal S, Feng S, Joshua D. Carfilzomib and dexamethasone vs bortezomib and dexamethasone in patients with relapsed multiple myeloma: results of the phase 3 study ENDEAVOR (NCT01568866) according to age subgroup. Leuk Lymphoma. 2017 Oct;58(10):2501-2504. doi: 10.1080/10428194.2017.1298755. Epub 2017 Mar 17. No abstract available. |
| 29991494 | Background | Chari A, Stewart AK, Russell SD, Moreau P, Herrmann J, Banchs J, Hajek R, Groarke J, Lyon AR, Batty GN, Ro S, Huang M, Iskander KS, Lenihan D. Analysis of carfilzomib cardiovascular safety profile across relapsed and/or refractory multiple myeloma clinical trials. Blood Adv. 2018 Jul 10;2(13):1633-1644. doi: 10.1182/bloodadvances.2017015545. |
| 30478094 | Background | Dimopoulos M, Siegel D, White DJ, Boccia R, Iskander KS, Yang Z, Kimball AS, Mezzi K, Ludwig H, Niesvizky R. Carfilzomib vs bortezomib in patients with multiple myeloma and renal failure: a subgroup analysis of ENDEAVOR. Blood. 2019 Jan 10;133(2):147-155. doi: 10.1182/blood-2018-06-860015. Epub 2018 Nov 26. |
| 33166401 | Background | Facon T, Niesvizky R, Mateos MV, Siegel D, Rosenbaum C, Bringhen S, Weisel K, Ho PJ, Ludwig H, Kumar S, Wang K, Obreja M, Yang Z, Klippel Z, Mezzi K, Goldrick A, Tekle C, Dimopoulos MA. Efficacy and safety of carfilzomib-based regimens in frail patients with relapsed and/or refractory multiple myeloma. Blood Adv. 2020 Nov 10;4(21):5449-5459. doi: 10.1182/bloodadvances.2020001965. |
| 28439109 | Background | Hari P, Mateos MV, Abonour R, Knop S, Bensinger W, Ludwig H, Song K, Hajek R, Moreau P, Siegel DS, Feng S, Obreja M, Aggarwal SK, Iskander K, Goldschmidt H. Efficacy and safety of carfilzomib regimens in multiple myeloma patients relapsing after autologous stem cell transplant: ASPIRE and ENDEAVOR outcomes. Leukemia. 2017 Dec;31(12):2630-2641. doi: 10.1038/leu.2017.122. Epub 2017 Apr 25. |
| 30287200 | Background | Leleu X, Martin TG, Einsele H, Lyons RM, Durie BGM, Iskander KS, Ailawadhi S. Role of Proteasome Inhibitors in Relapsed and/or Refractory Multiple Myeloma. Clin Lymphoma Myeloma Leuk. 2019 Jan;19(1):9-22. doi: 10.1016/j.clml.2018.08.016. Epub 2018 Sep 5. |
| 30796199 | Background | Ludwig H, Moreau P, Dimopoulos MA, Mateos MV, Kaiser M, Hajek R, Feng S, Cocks K, Buchanan J, Weisel K. Health-related quality of life in the ENDEAVOR study: carfilzomib-dexamethasone vs bortezomib-dexamethasone in relapsed/refractory multiple myeloma. Blood Cancer J. 2019 Feb 22;9(3):23. doi: 10.1038/s41408-019-0181-0. |
| 29446103 | Background | Mateos MV, Goldschmidt H, San-Miguel J, Mikhael J, DeCosta L, Zhou L, Obreja M, Blaedel J, Szabo Z, Leleu X. Carfilzomib in relapsed or refractory multiple myeloma patients with early or late relapse following prior therapy: A subgroup analysis of the randomized phase 3 ASPIRE and ENDEAVOR trials. Hematol Oncol. 2018 Apr;36(2):463-470. doi: 10.1002/hon.2499. Epub 2018 Feb 15. |
| 32108443 | Background | Moreau P, Stewart KA, Dimopoulos M, Siegel D, Facon T, Berenson J, Raje N, Berdeja JG, Orlowski RZ, Yang H, Ma H, Klippel Z, Zahlten-Kumeli A, Mezzi K, Iskander K, Mateos MV. Once-weekly (70 mg/m2 ) vs twice-weekly (56 mg/m2 ) dosing of carfilzomib in patients with relapsed or refractory multiple myeloma: A post hoc analysis of the ENDEAVOR, A.R.R.O.W., and CHAMPION-1 trials. Cancer Med. 2020 May;9(9):2989-2996. doi: 10.1002/cam4.2945. Epub 2020 Feb 28. |
| 31388932 | Background | Dimopoulos MA, Moreau P, Iida S, Huang SY, Takezako N, Chng WJ, Zahlten-Kumeli A, Sersch MA, Li J, Huang M, Lee JH. Outcomes for Asian patients with multiple myeloma receiving once- or twice-weekly carfilzomib-based therapy: a subgroup analysis of the randomized phase 3 ENDEAVOR and A.R.R.O.W. Trials. Int J Hematol. 2019 Oct;110(4):466-473. doi: 10.1007/s12185-019-02704-z. Epub 2019 Aug 6. |
| 28937327 | Background | Goldschmidt H, Moreau P, Ludwig H, Niesvizky R, Chng WJ, Joshua D, Weisel K, Spencer A, Orlowski RZ, Feng S, Iskander KS, Dimopoulos MA. Carfilzomib-dexamethasone versus subcutaneous or intravenous bortezomib in relapsed or refractory multiple myeloma: secondary analysis of the phase 3 ENDEAVOR study. Leuk Lymphoma. 2018 Jun;59(6):1364-1374. doi: 10.1080/10428194.2017.1376743. Epub 2017 Sep 22. |
| 29027825 | Background | Jakubowiak AJ, Houisse I, Majer I, Benedict A, Campioni M, Panjabi S, Ailawadhi S. Cost-effectiveness of carfilzomib plus dexamethasone compared with bortezomib plus dexamethasone for patients with relapsed or refractory multiple myeloma in the United States. Expert Rev Hematol. 2017 Dec;10(12):1107-1119. doi: 10.1080/17474086.2017.1391088. |
| 33067574 | Background | Weisel K, Mateos MV, Gay F, Delforge M, Cook G, Szabo Z, Desgraz R, DeCosta L, Moreau P. Efficacy and safety profile of deep responders to carfilzomib-based therapy: a subgroup analysis from ASPIRE and ENDEAVOR. Leukemia. 2021 Jun;35(6):1732-1744. doi: 10.1038/s41375-020-01049-5. Epub 2020 Oct 16. |
| 31640435 | Background | Weisel K, Majer I, DeCosta L, Oriol A, Goldschmidt H, Ludwig H, Campioni M, Szabo Z, Dimopoulos M. Carfilzomib and dexamethasone versus eight cycles of bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma: an indirect comparison using data from the phase 3 ENDEAVOR and CASTOR trials. Leuk Lymphoma. 2020 Jan;61(1):37-46. doi: 10.1080/10428194.2019.1648806. Epub 2019 Oct 22. |
| 31160237 | Background | Orlowski RZ, Moreau P, Niesvizky R, Ludwig H, Oriol A, Chng WJ, Goldschmidt H, Yang Z, Kimball AS, Dimopoulos M. Carfilzomib-Dexamethasone Versus Bortezomib-Dexamethasone in Relapsed or Refractory Multiple Myeloma: Updated Overall Survival, Safety, and Subgroups. Clin Lymphoma Myeloma Leuk. 2019 Aug;19(8):522-530.e1. doi: 10.1016/j.clml.2019.04.018. Epub 2019 May 2. |
| 30610657 | Derived | Majer IM, Castaigne JG, Palmer S, DeCosta L, Campioni M. Modeling Covariate-Adjusted Survival for Economic Evaluations in Oncology. Pharmacoeconomics. 2019 May;37(5):727-737. doi: 10.1007/s40273-018-0759-6. |
| 26771810 | Derived | Rosenthal A, Luthi J, Belohlavek M, Kortum KM, Mookadam F, Mayo A, Fonseca R, Bergsagel PL, Reeder CB, Mikhael JR, Stewart AK. Carfilzomib and the cardiorenal system in myeloma: an endothelial effect? Blood Cancer J. 2016 Jan 15;6(1):e384. doi: 10.1038/bcj.2015.112. |
| 26671818 | Derived | Dimopoulos MA, Moreau P, Palumbo A, Joshua D, Pour L, Hajek R, Facon T, Ludwig H, Oriol A, Goldschmidt H, Rosinol L, Straub J, Suvorov A, Araujo C, Rimashevskaya E, Pika T, Gaidano G, Weisel K, Goranova-Marinova V, Schwarer A, Minuk L, Masszi T, Karamanesht I, Offidani M, Hungria V, Spencer A, Orlowski RZ, Gillenwater HH, Mohamed N, Feng S, Chng WJ; ENDEAVOR Investigators. Carfilzomib and dexamethasone versus bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma (ENDEAVOR): a randomised, phase 3, open-label, multicentre study. Lancet Oncol. 2016 Jan;17(1):27-38. doi: 10.1016/S1470-2045(15)00464-7. Epub 2015 Dec 5. |
Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle. |
| Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat population (all randomized participants)
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bortezomib + DEX | Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle. |
| BG001 | Carfilzomib + DEX | Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status | Eastern Cooperative Oncology Group (ECOG) Performance Status is used by doctors and researchers to assess how a participants disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis. 0 = Fully Active; 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, no self-care, confined to bed or chair; 5 = Dead. | Count of Participants | Participants |
| |||||||||||||||
| Stratification Factor: Prior Proteasome Inhibitor Treatment | Count of Participants | Participants |
| ||||||||||||||||
| Stratification Factor: Lines of Prior Treatment | Count of Participants | Participants |
| ||||||||||||||||
| Stratification Factor: International Staging System (ISS) Stage | The International Staging System (ISS) for myeloma was published by the International Myeloma Working Group:
| Count of Participants | Participants |
| |||||||||||||||
| Stratification Factor: Route of Bortezomib Administration | The route of bortezomib administration (IV versus SC) was made in accordance with local regulatory approved route of administration. The value for this variable was selected for all participants prior to randomization to treatment group in order to balance the baseline characteristics that led to the choice of the particular route of bortezomib administration between the 2 arms. | 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 | Progression-free survival (PFS) was defined as the time from randomization to the earlier of disease progression or death due to any cause. Participants were evaluated for disease response and progression according to the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC) as assessed by an Independent Review Committee (IRC). Median PFS was estimated using the Kaplan-Meier method. Participants with no baseline disease assessments, starting a new anticancer therapy before documentation of disease progression or death, death or disease progression immediately after more than 1 consecutively missed disease assessment visit, or alive without documentation of disease progression before the data cut-off date were censored. | Intent-to-treat population | Posted | Median | 95% Confidence Interval | months | From randomization until the data cut-off date of 10 November 2014; median follow-up time for PFS was 11.1.and 11.9 months in the bortezomib and carfilzomib arms respectively |
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| Secondary | Overall Survival | Overall survival (OS) is defined as the time from randomization to the date of death (whatever the cause). Participants who were alive or lost to follow-up as of the data analysis cut-off date were censored at the patient's date of last contact (last known to be alive). Median overall survival was estimated using the Kaplan-Meier method. | Intent-to-treat population | Posted | Median | 95% Confidence Interval | months | From randomization until the data cut-off date of 03 January 2017; median follow-up time for OS was 36.9 and 37.5 months for each treatment group respectively. |
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| Secondary | Overall Response | Disease response was evaluated according to the IMWG-URC by the IRC. Overall response was defined as the percentage of participants with a best overall response of partial response (PR), very good PR (VGPR), complete response (CR) or stringent CR (sCR). sCR: As for CR, normal serum free light chain (SFLC) ratio and no clonal cells in bone marrow (BM). CR: No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and < 5% plasma cells in BM biopsy; VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% reduction in serum M-protein with urine M-protein <100 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline. PR: ≥ 50% reduction of serum M-protein and reduction in urine M-protein by ≥ 90% or to < 200 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline. | Intent-to-treat population | Posted | Number | 95% Confidence Interval | percentage of participants | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 10 November 2014; median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group. |
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| Secondary | Duration of Response | Duration of response (DOR) was calculated for participants who achieved an sCR, CR, VGPR, or PR. Duration of response is defined as the time from first evidence of PR or better to confirmation of disease progression or death due to any cause. Median duration of response was estimated using the Kaplan-Meier method. Participants with no baseline disease assessments, starting a new anticancer therapy before documentation of disease progression or death, death or disease progression immediately after more than 1 consecutively missed disease assessment visit, or alive without documentation of disease progression before the data cut-off date were censored. | Intent-to-treat population with an overall response | Posted | Median | 95% Confidence Interval | months | From randomization until the data cut-off date of 10 November 2014; median follow-up time for DOR was 9.4 and 10.4 months for each treatment group respectively. |
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| Secondary | Percentage of Participants With ≥ Grade 2 Peripheral Neuropathy | Neuropathy events were defined as Grade 2 or higher peripheral neuropathy as specified by peripheral neuropathy Standardised Medical Dictionary for Regulatory Activities (MedDRA) Query, narrow (scope) (SMQN) terms. Peripheral neuropathy was assessed by neurologic exam and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03: Grade 1: Asymptomatic; Grade 2: Moderate symptoms, limiting instrumental activities of daily living (ADL) Grade 3: Severe symptoms; limiting self-care ADL; Grade 4: Life-threatening consequences, urgent intervention indicated; Grade 5: Death. | Safety population (all participants who received at least 1 dose of study treatment) | Posted | Number | 95% Confidence Interval | percentage of participants | From the first dose of study drug up to 30 days after the last dose of study drug as of the data cut-off date of 10 November 2014; median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group. |
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| Secondary | Percentage of Participants With a Significant Reduction in Left Ventricular Ejection Fraction (LVEF) | A significant reduction in LVEF was defined as a ≥ 10% decrease (absolute change) from baseline in participants whose baseline LVEF is ≤ 55%. For participants with LVEF > 55% at baseline, a significant change was defined as a decrease in LVEF to < 45%. | Cardiopulmonary Safety Evaluable subgroup (all randomized participants who enrolled in the cardiopulmonary substudy with evaluable baseline echocardiogram scans per the central laboratory) and with both baseline and at least one post-baseline LVEF measurement within 24 weeks. | Posted | Number | percentage of participants | Baseline and 24 weeks |
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| Secondary | Change From Baseline in Right Ventricular Fractional Area Change (FAC) | Right ventricular function was assessed by measuring fractional area change (FAC) on echocardiogram. | Cardiopulmonary Safety Evaluable subgroup with available FAC data at baseline; "n" indicates participants whose results were available at both the baseline and the specified post-baseline visit. | Posted | Mean | Standard Deviation | percent fractional area change | Baseline and Weeks 12, 24 and 36 and at end of treatment (median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group). |
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| Secondary | Change From Baseline in Pulmonary Artery Systolic Pressure (PASP) | Pulmonary artery pressure was measured using transthoracic echocardiogram. | Cardiopulmonary Safety Evaluable subgroup with available PASP data at baseline; "n" indicates participants whose results were available at both the baseline and the specified post-baseline visit. | Posted | Mean | Standard Deviation | mmHg | Baseline and Weeks 12, 24 and 36 and at end of treatment (median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group). |
|
|
From the first dose of study drug up to 30 days after the last dose of study drug as of the data cut-off date of 03 January 2017; median duration of treatment was 27 weeks in the bortezomib group and 48 weeks in the carfilzomib treatment group.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
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 | Bortezomib | 182 | 456 | 435 | 456 | |||
| EG001 | Carfilzomib | 272 | 463 | 446 | 463 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| HAEMORRHAGIC ANAEMIA | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| PLASMACYTOSIS | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| THROMBOTIC MICROANGIOPATHY | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| THROMBOTIC THROMBOCYTOPENIC PURPURA | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ACUTE CORONARY SYNDROME | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ACUTE LEFT VENTRICULAR FAILURE | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| AORTIC VALVE INCOMPETENCE | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ATRIAL FLUTTER | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| BIFASCICULAR BLOCK | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| CARDIAC ARREST | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| CARDIAC FAILURE ACUTE | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| CARDIAC HYPERTROPHY | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| CARDIOMYOPATHY | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| LEFT VENTRICULAR DYSFUNCTION | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| LEFT VENTRICULAR FAILURE | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| PERICARDIAL EFFUSION | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| PLEUROPERICARDITIS | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| RIGHT VENTRICULAR FAILURE | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| SINUS TACHYCARDIA | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| STRESS CARDIOMYOPATHY | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| HEARING IMPAIRED | Ear and labyrinth disorders | MedDRA 15.1 | Systematic Assessment |
| |
| INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION | Endocrine disorders | MedDRA 15.1 | Systematic Assessment |
| |
| CATARACT | Eye disorders | MedDRA 15.1 | Systematic Assessment |
| |
| RETINAL TEAR | Eye disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ABDOMINAL STRANGULATED HERNIA | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| DIVERTICULUM | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ENTEROCOLITIS | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| GASTRIC HAEMORRHAGE | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| GASTROINTESTINAL DISORDER | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ILEUS | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ILEUS PARALYTIC | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| INTESTINAL POLYP HAEMORRHAGE | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| LARGE INTESTINE PERFORATION | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| LOWER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| MELAENA | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| PANCREATITIS | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| PARAESTHESIA ORAL | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| SUBILEUS | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| CARDIAC DEATH | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| DEATH | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| DEVICE OCCLUSION | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| DISEASE PROGRESSION | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| GENERALISED OEDEMA | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| HYPERPYREXIA | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| HYPERTHERMIA | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| MALAISE | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| SUDDEN DEATH | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| THROMBOSIS IN DEVICE | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| BILE DUCT STONE | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| HEPATIC FAILURE | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| HEPATOCELLULAR INJURY | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| JAUNDICE CHOLESTATIC | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| LIVER DISORDER | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| HYPERSENSITIVITY | Immune system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| HYPOGAMMAGLOBULINAEMIA | Immune system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ABDOMINAL INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| ABSCESS LIMB | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| ACUTE SINUSITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| APPENDICITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| BACTERAEMIA | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| BACTERIAL DIARRHOEA | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| BACTERIAL INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| BREAST ABSCESS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| BRONCHIOLITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| BRONCHOPNEUMONIA | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| BRONCHOPULMONARY ASPERGILLOSIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| BURSITIS INFECTIVE | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| CATHETER SITE INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| CLOSTRIDIAL INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| CLOSTRIDIUM DIFFICILE SEPSIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| CORONA VIRUS INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| DEVICE RELATED INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| ENCEPHALITIC INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| ENCEPHALITIS HERPES | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| ENTERITIS INFECTIOUS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| ERYSIPELAS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| ESCHERICHIA BACTERAEMIA | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| ESCHERICHIA URINARY TRACT INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| FEBRILE INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| H1N1 INFLUENZA | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| HAEMOPHILUS SEPSIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| INFECTIOUS PLEURAL EFFUSION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| LISTERIOSIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| LOBAR PNEUMONIA | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION VIRAL | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| LUNG INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| NECROTISING ULCERATIVE PERIODONTITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| ORAL FUNGAL INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| OSTEOMYELITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| PARAINFLUENZAE VIRUS INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| PNEUMOCOCCAL INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| PNEUMOCYSTIS JIROVECI PNEUMONIA | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| PNEUMONIA BACTERIAL | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| PNEUMONIA INFLUENZAL | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| PNEUMONIA MORAXELLA | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| PNEUMONIA PNEUMOCOCCAL | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| PSEUDOMEMBRANOUS COLITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| PULMONARY SEPSIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| PYELONEPHRITIS ACUTE | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| RESPIRATORY SYNCYTIAL VIRUS INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION VIRAL | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| STREPTOCOCCAL BACTERAEMIA | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| TRACHEOBRONCHITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| UROSEPSIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| VIRAL INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| CHEST INJURY | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| FACIAL BONES FRACTURE | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| FEMORAL NECK FRACTURE | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| FOOT FRACTURE | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| FRACTURE | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| HEAD INJURY | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| LIGAMENT SPRAIN | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| OPEN WOUND | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| PUBIS FRACTURE | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| ULNA FRACTURE | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| UPPER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| BLOOD CORTISOL DECREASED | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| INFLUENZA B VIRUS TEST POSITIVE | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| LYMPHOCYTE COUNT DECREASED | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| TROPONIN T INCREASED | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| DIABETES MELLITUS INADEQUATE CONTROL | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| HYPERCALCAEMIA | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| HYPOVOLAEMIA | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| TUMOUR LYSIS SYNDROME | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| FLANK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| LUMBAR SPINAL STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| MOBILITY DECREASED | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| OSTEONECROSIS OF JAW | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| PATHOLOGICAL FRACTURE | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| RHABDOMYOLYSIS | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ACUTE MYELOID LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| BLADDER TRANSITIONAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| CANCER PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| CARCINOMA IN SITU | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| COLON CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| MENINGEAL NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| METASTASES TO SPINE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| MULTIPLE MYELOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| OESOPHAGEAL SQUAMOUS CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| PLASMACYTOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| PLEURAL MESOTHELIOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| RECTAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| ACQUIRED EPILEPTIC APHASIA | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| CENTRAL NERVOUS SYSTEM LESION | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| COGNITIVE DISORDER | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| CONVULSION | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| DEPRESSED LEVEL OF CONSCIOUSNESS | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ENCEPHALOPATHY | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| HYPERCAPNIC COMA | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| HYPERTENSIVE ENCEPHALOPATHY | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ISCHAEMIC STROKE | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| LETHARGY | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| LOSS OF CONSCIOUSNESS | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| METABOLIC ENCEPHALOPATHY | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| NEURALGIA | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| PARAPARESIS | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| PARAPLEGIA | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| POLYNEUROPATHY | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| RADICULITIS BRACHIAL | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| RADICULOPATHY | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| SCIATICA | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| SPINAL CORD COMPRESSION | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| COMPLETED SUICIDE | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| DYSTHYMIC DISORDER | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| MENTAL DISORDER | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| PSYCHOTIC DISORDER | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ALBUMINURIA | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ANURIA | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| NEPHROPATHY | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| NEPHROTIC SYNDROME | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| PROTEINURIA | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| RENAL IMPAIRMENT | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| PROSTATOMEGALY | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
| |
| UTERINE HAEMORRHAGE | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ACUTE PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ACUTE RESPIRATORY DISTRESS SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| BRONCHOPNEUMOPATHY | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| LUNG DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| PULMONARY ARTERIAL HYPERTENSION | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| PULMONARY HYPERTENSION | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| DRUG ERUPTION | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ERYTHEMA MULTIFORME | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| PRURITUS GENERALISED | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| PURPURA | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| COLOSTOMY CLOSURE | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
| |
| HAEMORRHOID OPERATION | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
| |
| REMOVAL OF INTERNAL FIXATION | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
| |
| AORTIC ANEURYSM | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| AORTIC EMBOLUS | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| CIRCULATORY COLLAPSE | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| HAEMATOMA | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| HYPERTENSIVE CRISIS | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| MALIGNANT HYPERTENSION | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ORTHOSTATIC HYPOTENSION | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| THROMBOPHLEBITIS | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| VENA CAVA THROMBOSIS | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| VENOUS THROMBOSIS LIMB | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| CATARACT | Eye disorders | MedDRA 15.1 | Systematic Assessment |
| |
| CONJUNCTIVITIS | Eye disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| MALAISE | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| RHINITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| CREATININE RENAL CLEARANCE DECREASED | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| LYMPHOCYTE COUNT DECREASED | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| HYPERURICAEMIA | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| HYPOPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| HYPOAESTHESIA | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| NEURALGIA | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| POLYNEUROPATHY | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| TREMOR | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| FLUSHING | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C524865 | carfilzomib |
| D000069286 | Bortezomib |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided
| 65 -74 years |
|
| ≥ 75 years |
|
| Male |
|
| Black |
|
| Asian |
|
| Native Hawaiian/Other Pacific Islander |
|
| Not Reported |
|
| Multiple |
|
| 1 (Restrictive but ambulatory) |
|
| 2 (Ambulatory but unable to work) |
|
| No prior carfilzomib or bortezomib |
|
| 2 or 3 lines |
|
| Stage II or III |
|
| Subcutaneous |
|
| Superiority or Other (legacy) |
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle. |
|
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|
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|
|
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| Units | Counts |
|---|---|
| Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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| Participants |
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