Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003645-42 | EudraCT Number |
Not provided
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The purpose of this study is to assess the clinical benefit of Nivolumab, as measured by independent radiologic review committee (IRRC)-assessed objective response rate (ORR) in subjects with FL lymphoma who have failed therapy with both CD20 antibody and an alkylating agent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Nivolumab | Experimental | Nivolumab 3 mg/kg injection by Intravenous for every 2 weeks until disease progression or discontinuation due to toxicity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) as Determined by IRRC | ORR is determined by an independent radiologic review committee (IRRC) according to the revised International Working Group Criteria for non-Hodgkin Lymphoma. ORR is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) and expressed as a percentage of all treated participants. CR=Disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of spleen, liver, and bone marrow involvement. PR=Regression of measurable disease and no new sites; no increase in size of liver or spleen. >=50% decrease in SPD of up to 6 largest dominant masses (index lesions); no increase in size of other nodes (non-index lesions) | From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) Based on IRRC Assessments | DOR is defined as the time from first remission (CR or PR) to the date of initial objectively documented progression as determined using the revised International Working Group Criteria for non-Hodgkin Lymphoma, or death due to any cause, whichever occurs first. CR definition includes the complete disappearance of all evidence of disease, the definition of PR includes at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses, and PD is defined as any new lesion or increase by >50% of previously involved sites from nadir, as described in the IWG response criteria |
Not provided
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | United States | ||
| Division Of Hematology & Oncology Ctr. For Health Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32870269 | Derived | Armand P, Janssens A, Gritti G, Radford J, Timmerman J, Pinto A, Mercadal Vilchez S, Johnson P, Cunningham D, Leonard JP, Rodig SJ, Martin-Regueira P, Sumbul A, Samakoglu S, Tang H, Ansell SM. Efficacy and safety results from CheckMate 140, a phase 2 study of nivolumab for relapsed/refractory follicular lymphoma. Blood. 2021 Feb 4;137(5):637-645. doi: 10.1182/blood.2019004753. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
Not provided
116 participants were enrolled; 92 received study treatment. Participants were enrolled but not treated because they no longer met study criteria (n=20), withdrew consent (n=1), or for other reasons (n=3).
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Nivolumab | Nivolumab 3mg/kg intravenously every 2 weeks until disease progression or discontinuation due to toxicity |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 21, 2016 | Dec 13, 2021 |
Not provided
Not provided
Not provided
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| From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months) |
| Complete Remission Rate (CRR) Based on IRRC Assessment | CRR is defined as the number of subjects with a BOR of CR according to the revised International Working Group Criteria for non-Hodgkin Lymphoma, divided by the number of treated participants and expressed as a percentage. CR=Disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of spleen, liver, and bone marrow involvement. | From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months) |
| Partial Remission (PR) Rate Based on IRRC Assessment | PR rate is defined as the number of participants with a best overall response (BOR) of PR according to the 2007 International Working Group (IWG) criteria, based on IRRC assessment, divided by the number of treated participants and expressed as a percentage. PR=Regression of measurable disease and no new sites; no increase in size of liver or spleen. >=50% decrease in SPD of up to 6 largest dominant masses (index lesions); no increase in size of other nodes (non-index lesions) | From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months) |
| Progression Free Survival (PFS) Based on IRRC Assessment | PFS was summarized descriptively using the Kaplan-Meier (KM) product-limit method. Median values of PFS, along with the two-sided 95% CIs were calculated using a method based on log-log transformation. | From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months) |
| Overall Response Rate (ORR) Based on Investigator Assessments | ORR is determined by investigator assessments according to the revised International Working Group Criteria for non-Hodgkin Lymphoma. ORR is defined as the number of subjects with a best overall response (BOR) of complete response (CR) or partial response (PR) and is expressed as a percentage of all treated participants. CR=Disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of spleen, liver, and bone marrow involvement. PR=Regression of measurable disease and no new sites; no increase in size of liver or spleen. >=50% decrease in SPD of up to 6 largest dominant masses (index lesions); no increase in size of other nodes (non-index lesions) | From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months) |
| Los Angeles |
| California |
| 90095 |
| United States |
| Winship Cancer Institute. | Atlanta | Georgia | 30322 | United States |
| Beth Israel Deaconess Medical Center (BIDMC) | Boston | Massachusetts | 02215 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02215 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| Local Institution | Woodville | South Australia | 5011 | Australia |
| Local Institution | Parkville | Victoria | 3050 | Australia |
| Local Institution | B-leuven | 3000 | Belgium |
| Local Institution | Brussels | 1200 | Belgium |
| Local Institution | Ghent | 9000 | Belgium |
| Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| CISSS du Bas-Saint-Laurent Hopital Regional de Rimouski | Rimouski | Quebec | G5L 5T1 | Canada |
| Local Institution | Créteil | 94010 | France |
| Local Institution | Montpellier | 34295 | France |
| Local Institution | Pierre-Bénite | 69495 | France |
| Local Institution | Rennes | 35033 | France |
| Universitaetsklinikum Essen | Essen | 45147 | Germany |
| Universitaetsklinikum d. Saarlandes | Homburg | 66424 | Germany |
| Universitaetsklinikum Des Saarlandes | Homburg | 66424 | Germany |
| Local Institution | Regensburg | 93053 | Germany |
| Universitaetsklinikum Ulm | Ulm | 89081 | Germany |
| Local Institution | Bergamo | 24127 | Italy |
| Local Institution | Bologna | 40138 | Italy |
| Local Institution | Milan | 20133 | Italy |
| Local Institution | Naples | 80131 | Italy |
| Local Institution | Roma | 00161 | Italy |
| Local Institution | Oslo | 0424 | Norway |
| Local Institution | Singapore | 169865 | Singapore |
| Local Institution | Singapore | 308433 | Singapore |
| Hospital Duran I Reynals | Hospitalet Llobregat- Barcelona | 9908 | Spain |
| Local Institution | Madrid | 28009 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Local Institution | Salamanca | 37007 | Spain |
| Local Institution | Gothenberg | 413 45 | Sweden |
| Local Institution | Gothenburg | 413 45 | Sweden |
| Local Institution | Southampton | Hampshire | SO16 6YD | United Kingdom |
| Local Institution | Withington | Manchester | M20 4BX | United Kingdom |
| Local Institution | Sutton | Surrey | SM2 5PT | United Kingdom |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls | View source |
| COMPLETED | Completed = Participants continuing in the Follow-up period |
|
| NOT COMPLETED |
|
|
All treated participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: Nivolumab | Nivolumab 3mg/kg intravenously every 2 weeks until disease progression or discontinuation due to toxicity |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | All treated participants | Mean | Standard Deviation | years |
| ||||||||||||||||
| Sex: Female, Male | All treated participants | Count of Participants | Participants |
| |||||||||||||||||
| Ethnicity (NIH/OMB) | All treated participants | Count of Participants | Participants |
| |||||||||||||||||
| Race (NIH/OMB) | All treated participants | 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 | Overall Response Rate (ORR) as Determined by IRRC | ORR is determined by an independent radiologic review committee (IRRC) according to the revised International Working Group Criteria for non-Hodgkin Lymphoma. ORR is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) and expressed as a percentage of all treated participants. CR=Disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of spleen, liver, and bone marrow involvement. PR=Regression of measurable disease and no new sites; no increase in size of liver or spleen. >=50% decrease in SPD of up to 6 largest dominant masses (index lesions); no increase in size of other nodes (non-index lesions) | All treated participants | Posted | Number | 95% Confidence Interval | Percentage of participants | From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months) |
|
|
| |||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) Based on IRRC Assessments | DOR is defined as the time from first remission (CR or PR) to the date of initial objectively documented progression as determined using the revised International Working Group Criteria for non-Hodgkin Lymphoma, or death due to any cause, whichever occurs first. CR definition includes the complete disappearance of all evidence of disease, the definition of PR includes at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses, and PD is defined as any new lesion or increase by >50% of previously involved sites from nadir, as described in the IWG response criteria | All treated participants | Posted | Median | 95% Confidence Interval | months | From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Complete Remission Rate (CRR) Based on IRRC Assessment | CRR is defined as the number of subjects with a BOR of CR according to the revised International Working Group Criteria for non-Hodgkin Lymphoma, divided by the number of treated participants and expressed as a percentage. CR=Disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of spleen, liver, and bone marrow involvement. | All treated participants | Posted | Number | 95% Confidence Interval | Percentage of participants | From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Partial Remission (PR) Rate Based on IRRC Assessment | PR rate is defined as the number of participants with a best overall response (BOR) of PR according to the 2007 International Working Group (IWG) criteria, based on IRRC assessment, divided by the number of treated participants and expressed as a percentage. PR=Regression of measurable disease and no new sites; no increase in size of liver or spleen. >=50% decrease in SPD of up to 6 largest dominant masses (index lesions); no increase in size of other nodes (non-index lesions) | All treated participants | Posted | Number | 95% Confidence Interval | Percentage of participants | From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) Based on IRRC Assessment | PFS was summarized descriptively using the Kaplan-Meier (KM) product-limit method. Median values of PFS, along with the two-sided 95% CIs were calculated using a method based on log-log transformation. | All treated participants | Posted | Median | 95% Confidence Interval | months | From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) Based on Investigator Assessments | ORR is determined by investigator assessments according to the revised International Working Group Criteria for non-Hodgkin Lymphoma. ORR is defined as the number of subjects with a best overall response (BOR) of complete response (CR) or partial response (PR) and is expressed as a percentage of all treated participants. CR=Disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of spleen, liver, and bone marrow involvement. PR=Regression of measurable disease and no new sites; no increase in size of liver or spleen. >=50% decrease in SPD of up to 6 largest dominant masses (index lesions); no increase in size of other nodes (non-index lesions) | All treated participants | Posted | Number | 95% Confidence Interval | Percentage of participants | From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months) |
|
|
AEs collected were reported between first dose and 100 days after last dose of study therapy (up to approximately 6 years 9 months)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nivolumab 3 mg/kg | Nivolumab 3mg/kg intravenously every 2 weeks until disease progression or discontinuation due to toxicity | 36 | 92 | 46 | 92 | 89 | 92 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Autoimmune haemolytic anaemia | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
| |
| Cytopenia | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | 23.1 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | 23.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | 23.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | 23.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Asthenia | General disorders | 23.1 | Systematic Assessment |
| |
| Fatigue | General disorders | 23.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | 23.1 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | 23.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 23.1 | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | 23.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | 23.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
| |
| Influenza B virus test positive | Investigations | 23.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | 23.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | 23.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 23.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Immune-mediated pneumonitis | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Toxic epidermal necrolysis | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Asthenia | General disorders | 23.1 | Systematic Assessment |
| |
| Fatigue | General disorders | 23.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 23.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 23.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please Email | Clinical.Trials@bms.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 27, 2017 | May 16, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|