Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003621-28 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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The purpose of this study is to determine whether Nivolumab is effective in the treatment of DLBCL in patients that have failed or are ineligible for ASCT
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nivolumab (3 mg/kg) | Experimental | Nivolumab 3 mg/kg solution intravenously every 2 weeks until progression or unacceptable toxicity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) Per Independent Radiologic Review Committee (IRRC) Assessment | ORR is defined as the percentage of participants with a Best Overall Response (BOR) of Complete Remission (CR) or Partial Remission (PR), according to the 2007 revised International Working Group (IWG) Criteria for Malignant Lymphoma, , based on IRRC assessment. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measurable disease and no emergence of new sites | From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assesed up to April 2016, approximately 25 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) | DOR is defined as the time from first response (Complete Response (CR) or Partial Response (PR)) to the date of initial objectively documented progression as determined using the 2007 revised IWG Criteria for Malignant Lymphoma, based on Independent Radiology Review Committee (IRRC) assessment, or death due to any cause, whichever occurs first. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measurable disease and no emergence of new sites. |
Not provided
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Not provided
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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 |
|---|---|---|---|
| 30620669 | Derived | Ansell SM, Minnema MC, Johnson P, Timmerman JM, Armand P, Shipp MA, Rodig SJ, Ligon AH, Roemer MGM, Reddy N, Cohen JB, Assouline S, Poon M, Sharma M, Kato K, Samakoglu S, Sumbul A, Grigg A. Nivolumab for Relapsed/Refractory Diffuse Large B-Cell Lymphoma in Patients Ineligible for or Having Failed Autologous Transplantation: A Single-Arm, Phase II Study. J Clin Oncol. 2019 Feb 20;37(6):481-489. doi: 10.1200/JCO.18.00766. Epub 2019 Jan 8. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
Not provided
121 participants entered the treatment period.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Nivolumab 3mg/kg | Nivolumab 3mg/kg IV Q2W for participants who failed autologous stem cell transplant (ASCT) or who were ineligible for ASCT |
| 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 | Sep 15, 2021 |
Not provided
Not provided
Not provided
Not provided
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| From date of first response to the date of documented disease progression or death, whichever occurs first (up to approximately 18 months) |
| Complete Remission Rate | Complete Remission Rate is defined as the percentage of participants with a Best Overall Response (BOR) of Complete Response (CR) according to the 2007 revised IWG Criteria for Malignant Lymphoma, based on Independent Radiology Review Committee (IRRC) assessment. CR= Disappearance of all evidence of disease, confirmed by PET scan. | From date of first dose to study completion (up to approximately 78 months) |
| Duration of Complete Remission | The duration of Complete Remission is defined as the time from first documentation of Complete Response (CR) (which is the date of first negative FDG-PET scan or the date of first documentation of no disease involvement in the bone marrow [if required], whichever occurs later) to the date of initial objectively documented progression as determined using the 2007 IWG criteria, based on Independent Radiology Review Committee (IRRC) assessment, or death due to any cause, whichever occurs first. CR= Disappearance of all evidence of disease, confirmed by PET scan. | From time of first documentation of CR to the date of initial documented disease progression or death due to any cause, whichever occurs first (up approximately 14 months) |
| Partial Remission Rate | Partial Remission rate is defined as the percentage of participants with a Best Overall Response (BOR) of Partial Response (PR) according to the 2007 revised IWG Criteria for Malignant Lymphoma, based on Independent Radiology Review Committee (IRRC) assessment. PR= Regression of measurable disease and no emergence of new sites. | From date of first dose to study completion (up to approximately 78 months) |
| Duration of Partial Remission | Duration of Partial Remission is defined as the time from first documentation of Partial Response (PR) to the date of initial objectively documented progression as determined using the 2007 IWG criteria, based on Independent Radiology Review Committee (IRRC) assessment, or death due to any cause, whichever occurs first. PR= Regression of measurable disease and no emergence of new sites. | From date of first documentation of PR to date of disease progression or death due to any cause, whichever occurs first (up to approximately 12 months) |
| Progression Free Survival | Progression Free Survival (PFS) is defined as the time from first dosing date to the date of the first documented progression, as determined by an Independent Radiology Review Committee (IRRC) according to the 2007 revised IWG Criteria for Malignant Lymphoma, or death due to any cause, whichever occurs first. | From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (up to approximately 2 months) |
| Objective Response Rate (ORR) Per Investigator Assessment | ORR is defined as the percentage of participants with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR), according to investigator assessment. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measurable disease and no emergence of new sites. | From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (up to approximately 30 months) |
| Los Angeles |
| California |
| 90095 |
| United States |
| Winship Cancer Center | Atlanta | Georgia | 30322 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Columbia University Medical Center (Cumc) | New York | New York | 10019 | United States |
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| Local Institution | Waratah | New South Wales | NSW 2298 | Australia |
| Local Institution | Woodville | South Australia | 5011 | Australia |
| Local Institution | Heidelberg | Victoria | 3084 | Australia |
| Local Institution | B-leuven | 3000 | Belgium |
| Local Institution | Brussels | 1200 | Belgium |
| Local Institution | Ghent | 9000 | Belgium |
| Local Institution | Montreal | Quebec | H3T 1E2 | Canada |
| Local Institution | Montreal | H2X 3E4 | Canada |
| Local Institution | Créteil | 94010 | France |
| Hopital Saint Eloi | Montpellier | 34295 | France |
| Local Institution | Pierre-Bénite | 69495 | France |
| Local Institution | Rennes | 35033 | France |
| Local Institution | Erlangen | 91054 | Germany |
| Local Institution | Essen | 45147 | Germany |
| Local Institution | Homburg | 66424 | Germany |
| Local Institution | 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 | Amsterdam | 1066 CX | Netherlands |
| Local Institution | Rotterdam | 3000 CA | Netherlands |
| Local Institution | Rotterdam | 3075 EA | Netherlands |
| Local Institution | Utrecht | 3584 CX | Netherlands |
| Local Institution | Singapore | 119228 | Singapore |
| Local Institution | Singapore | 169608 | Singapore |
| Local Institution | Hospitalet Llobregat- Barcelona | 9908 | Spain |
| Local Institution | Madrid | 28009 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Local Institution | Salamanca | 37007 | Spain |
| Local Institution | Gothenburg | 413 45 | Sweden |
| Local Institution | Lund | 221 85 | 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 |
|
| NOT COMPLETED |
|
|
All treated participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ASCT-failed | Participants who failed Autologous stem cell transplant (ASCT), treated with Nivolumab 3 mg/Kg Q2W |
| BG001 | ASCT-ineligible | Participants who were ineligible for Autologous stem cell transplant (ASCT), treated with Nivolumab 3 mg/Kg Q2W |
| 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 | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | 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 | Objective Response Rate (ORR) Per Independent Radiologic Review Committee (IRRC) Assessment | ORR is defined as the percentage of participants with a Best Overall Response (BOR) of Complete Remission (CR) or Partial Remission (PR), according to the 2007 revised International Working Group (IWG) Criteria for Malignant Lymphoma, , based on IRRC assessment. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measurable disease and no emergence of new sites | All treated participants | Posted | Number | 95% Confidence Interval | Percent of participants | From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assesed up to April 2016, approximately 25 months) |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | DOR is defined as the time from first response (Complete Response (CR) or Partial Response (PR)) to the date of initial objectively documented progression as determined using the 2007 revised IWG Criteria for Malignant Lymphoma, based on Independent Radiology Review Committee (IRRC) assessment, or death due to any cause, whichever occurs first. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measurable disease and no emergence of new sites. | All participants with CR or PR | Posted | Median | 95% Confidence Interval | Months | From date of first response to the date of documented disease progression or death, whichever occurs first (up to approximately 18 months) |
|
| |||||||||||||||||||||||||||||
| Secondary | Complete Remission Rate | Complete Remission Rate is defined as the percentage of participants with a Best Overall Response (BOR) of Complete Response (CR) according to the 2007 revised IWG Criteria for Malignant Lymphoma, based on Independent Radiology Review Committee (IRRC) assessment. CR= Disappearance of all evidence of disease, confirmed by PET scan. | All treated participants | Posted | Number | 95% Confidence Interval | Percent of participants | From date of first dose to study completion (up to approximately 78 months) |
|
| |||||||||||||||||||||||||||||
| Secondary | Duration of Complete Remission | The duration of Complete Remission is defined as the time from first documentation of Complete Response (CR) (which is the date of first negative FDG-PET scan or the date of first documentation of no disease involvement in the bone marrow [if required], whichever occurs later) to the date of initial objectively documented progression as determined using the 2007 IWG criteria, based on Independent Radiology Review Committee (IRRC) assessment, or death due to any cause, whichever occurs first. CR= Disappearance of all evidence of disease, confirmed by PET scan. | All participants with CR | Posted | Median | 95% Confidence Interval | Months | From time of first documentation of CR to the date of initial documented disease progression or death due to any cause, whichever occurs first (up approximately 14 months) |
|
| |||||||||||||||||||||||||||||
| Secondary | Partial Remission Rate | Partial Remission rate is defined as the percentage of participants with a Best Overall Response (BOR) of Partial Response (PR) according to the 2007 revised IWG Criteria for Malignant Lymphoma, based on Independent Radiology Review Committee (IRRC) assessment. PR= Regression of measurable disease and no emergence of new sites. | All treated participants | Posted | Number | 95% Confidence Interval | Percent of participants | From date of first dose to study completion (up to approximately 78 months) |
|
| |||||||||||||||||||||||||||||
| Secondary | Duration of Partial Remission | Duration of Partial Remission is defined as the time from first documentation of Partial Response (PR) to the date of initial objectively documented progression as determined using the 2007 IWG criteria, based on Independent Radiology Review Committee (IRRC) assessment, or death due to any cause, whichever occurs first. PR= Regression of measurable disease and no emergence of new sites. | All participants with PR | Posted | Median | Full Range | Months | From date of first documentation of PR to date of disease progression or death due to any cause, whichever occurs first (up to approximately 12 months) |
|
| |||||||||||||||||||||||||||||
| Secondary | Progression Free Survival | Progression Free Survival (PFS) is defined as the time from first dosing date to the date of the first documented progression, as determined by an Independent Radiology Review Committee (IRRC) according to the 2007 revised IWG Criteria for Malignant Lymphoma, or death due to any cause, whichever occurs first. | All treated participants | Posted | Median | 95% Confidence Interval | Months | From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (up to approximately 2 months) |
|
| |||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) Per Investigator Assessment | ORR is defined as the percentage of participants with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR), according to investigator assessment. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measurable disease and no emergence of new sites. | All treated participants | Posted | Number | 95% Confidence Interval | Percent of participants | From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (up to approximately 30 months) |
|
|
All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 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 | 98 | 121 | 83 | 121 | 109 | 121 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal lymphadenopathy | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | 23.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | 23.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | 23.1 | Systematic Assessment |
| |
| Eye swelling | Eye disorders | 23.1 | Systematic Assessment |
| |
| Uveitis | Eye disorders | 23.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Gastrointestinal perforation | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Oesophageal perforation | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Asthenia | General disorders | 23.1 | Systematic Assessment |
| |
| Facial pain | General disorders | 23.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | 23.1 | Systematic Assessment |
| |
| Localised oedema | General disorders | 23.1 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | 23.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 23.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 23.1 | Systematic Assessment |
| |
| Swelling face | General disorders | 23.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | 23.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | 23.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Bone lesion | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Morphoea | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
| |
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
| |
| Lung adenocarcinoma | 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 |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| IIIrd nerve paralysis | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | 23.1 | Systematic Assessment |
| |
| Hallucination, visual | Psychiatric disorders | 23.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 23.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | 23.1 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | 23.1 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Obstructive airways disorder | 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 |
| |
| Stridor | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Hypotension | Vascular 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 |
| |
| Dry mouth | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Stomatitis | 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 |
| |
| Upper respiratory tract infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 23.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 23.1 | Systematic Assessment |
| |
| Decreased appetite | 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 |
| |
| Hypomagnesaemia | 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 |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | 23.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric 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 |
| |
| Night sweats | Skin and subcutaneous tissue 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 |
|
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_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 20, 2017 | Sep 15, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| 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
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
| Participants |
|
|
|
|
|
|