Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003965-16 | EudraCT Number |
Not provided
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The purpose of the study is to assess the objective response rate (change in tumor size from baseline) in patients with advanced or metastatic squamous cell nonsmall-cell lung cancer treated with Nivolumab (BMS-936558) after failure of 2 prior systemic regimens
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nivolumab, 3 mg/kg | Experimental | Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) as Assessed by Independent Radiology Review Committee (IRC) | ORR is defined as the percentage of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) divided by the number of participants who received treatment. The IRC-assessed ORR (using RECIST v1.1, to confirm response and based on the IRC global radiology review after incorporation of on-study clinical data) was estimated using a binomial response rate and its corresponding 2-sided 95% exact confidence intervals using the Clopper-Pearson method. | Day 1 of treatment up to approximately 14 months |
| Duration of Response (DOR) as Assessed by Independent Radiology Review Committee (IRC) | DOR is defined as the time from first confirmed response (CR or PR) per IRC assessment to the date of the first documented tumor progression as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Participants who start subsequent therapy without a prior reported progression will be censored at the last evaluable tumor assessments prior to initiation of the subsequent anticancer therapy. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. Median values of DOR, along with two-sided 95% CI in each treatment group will be computed based on a log-log transformation method. | From the first treatment to the date of the first documented tumor progression or death. Approximately up to 14 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) as Assessed by Investigator | ORR is defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on investigator assessment. The investigator-assessed ORR is summarized by a binomial response rate and its corresponding two-sided 95% exact CIs using Clopper-Pearson method. | Day 1 of treatment to approximately 101 months |
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 |
|---|---|---|---|---|---|---|
| University Of California Davis Medical Center | Sacramento | California | 95817 | United States | ||
| Va San Diego Healthcare System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32198149 | Derived | Dercle L, Fronheiser M, Lu L, Du S, Hayes W, Leung DK, Roy A, Wilkerson J, Guo P, Fojo AT, Schwartz LH, Zhao B. Identification of Non-Small Cell Lung Cancer Sensitive to Systemic Cancer Therapies Using Radiomics. Clin Cancer Res. 2020 May 1;26(9):2151-2162. doi: 10.1158/1078-0432.CCR-19-2942. Epub 2020 Mar 20. | |
| 25704439 | Derived |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
Not provided
117 participants treated.
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Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Nivolumab, 3 mg/kg | Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Treatment Period |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Duration of Response (DOR) as Assessed by Investigator | DOR is defined as the time from first confirmed response (CR or PR) per investigator assessment to the date of the first documented tumor progression as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Participants who start subsequent therapy without a prior reported progression will be censored at the last evaluable tumor assessments prior to initiation of the subsequent anticancer therapy. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. Median values of DOR, along with two-sided 95% CI in each treatment group will be computed based on a log-log transformation method. | From the first treatment to the date of the first documented tumor progression or death. Approximately up to 101 months |
| San Diego |
| California |
| 92161 |
| United States |
| H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida | 33612 | United States |
| Winship Cancer Institute. | Atlanta | Georgia | 30322 | United States |
| Local Institution | Metairie | Louisiana | 70006 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Providence Cancer Institute | Southfield | Michigan | 48075 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Beth Israel Comprehensive Cancer Center | New York | New York | 10011 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| University Of North Carolina At Chapel Hill | Chapel Hill | North Carolina | 27599-7305 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Providence Oncology And Hematology | Portland | Oregon | 97213 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Network Office of Research and Innovation | Allentown | Pennsylvania | 18103 | United States |
| University Of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Henry-Joyce Cancer Center | Nashville | Tennessee | 37232 | United States |
| Oncology Consultants, Pa | Houston | Texas | 77024 | United States |
| Local Institution | Caen | 14000 | France |
| Local Institution | Créteil | 94010 | France |
| Local Institution | Pierre-Bénite | 69495 | France |
| Local Institution | Rennes | 35033 | France |
| Local Institution | Strasbourg | 67090 | France |
| Local Institution | Toulouse | 31059 | France |
| Local Institution | Villejuif | 94800 | France |
| Local Institution | Berlin | 13125 | Germany |
| Local Institution | Cologne | 50937 | Germany |
| Local Institution | München | 80336 | Germany |
| Local Institution | Livorno | 57100 | Italy |
| Local Institution | Lucca | 55100 | Italy |
| Local Institution | Terni | 05100 | Italy |
| Rizvi NA, Mazieres J, Planchard D, Stinchcombe TE, Dy GK, Antonia SJ, Horn L, Lena H, Minenza E, Mennecier B, Otterson GA, Campos LT, Gandara DR, Levy BP, Nair SG, Zalcman G, Wolf J, Souquet PJ, Baldini E, Cappuzzo F, Chouaid C, Dowlati A, Sanborn R, Lopez-Chavez A, Grohe C, Huber RM, Harbison CT, Baudelet C, Lestini BJ, Ramalingam SS. Activity and safety of nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (CheckMate 063): a phase 2, single-arm trial. Lancet Oncol. 2015 Mar;16(3):257-65. doi: 10.1016/S1470-2045(15)70054-9. Epub 2015 Feb 20. |
| BMS Clinical Trial Patient Recruiting | View source |
| FDA Safety Alerts and Recalls | View source |
|
| COMPLETED | = Continuing in the treatment period |
|
| NOT COMPLETED |
|
|
| End of Study Period |
|
|
Participants who received at least 1 dose of study drug
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Nivolumab, 3 mg/kg | Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle. |
| 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 |
| |||||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Disease stage | Non-Small Cell Lung Cancer is categorized in 4 Stages (I-IV). I: Cancer located only in lungs and has not spread to any lymph nodes. II: Cancer in the lung and nearby lymph nodes. III: Cancer in the lung and lymph nodes in the middle of the chest. Stage III has two subtypes, IIIA (cancer has spread only to lymph nodes on the same side of the chest where the cancer started) and IIIB (cancer has spread to the lymph nodes on the opposite side of the chest, or above the collar bone). IV: Cancer has spread to both lungs, to fluid in the area around the lungs, or to another part of the body | Count of Participants | Participants |
| |||||||||||||||||
| Cell type | Count of Participants | Participants |
| ||||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status | ECOG is a 6-item scale used to assess disease progression, daily functioning, and appropriate treatment and prognosis. Performance status is scored on a scale ranging from 0-5, with (best score) 0=fully active and able to carry on all predisease performance without restriction and (worst score) 5=death. | Count of Participants | Participants |
| |||||||||||||||||
| Central nervous system metastasis | 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) as Assessed by Independent Radiology Review Committee (IRC) | ORR is defined as the percentage of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) divided by the number of participants who received treatment. The IRC-assessed ORR (using RECIST v1.1, to confirm response and based on the IRC global radiology review after incorporation of on-study clinical data) was estimated using a binomial response rate and its corresponding 2-sided 95% exact confidence intervals using the Clopper-Pearson method. | All Treated Participants | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 1 of treatment up to approximately 14 months |
|
|
| |||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) as Assessed by Investigator | ORR is defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on investigator assessment. The investigator-assessed ORR is summarized by a binomial response rate and its corresponding two-sided 95% exact CIs using Clopper-Pearson method. | All Treated Participants | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 1 of treatment to approximately 101 months |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) as Assessed by Investigator | DOR is defined as the time from first confirmed response (CR or PR) per investigator assessment to the date of the first documented tumor progression as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Participants who start subsequent therapy without a prior reported progression will be censored at the last evaluable tumor assessments prior to initiation of the subsequent anticancer therapy. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. Median values of DOR, along with two-sided 95% CI in each treatment group will be computed based on a log-log transformation method. | All treated participants who responded | Posted | Median | 95% Confidence Interval | Months | From the first treatment to the date of the first documented tumor progression or death. Approximately up to 101 months |
|
| ||||||||||||||||||||||||||
| Primary | Duration of Response (DOR) as Assessed by Independent Radiology Review Committee (IRC) | DOR is defined as the time from first confirmed response (CR or PR) per IRC assessment to the date of the first documented tumor progression as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Participants who start subsequent therapy without a prior reported progression will be censored at the last evaluable tumor assessments prior to initiation of the subsequent anticancer therapy. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. Median values of DOR, along with two-sided 95% CI in each treatment group will be computed based on a log-log transformation method. | All confirmed responders per IRC | Posted | Median | 95% Confidence Interval | Months | From the first treatment to the date of the first documented tumor progression or death. Approximately up to 14 months |
|
| ||||||||||||||||||||||||||
| Post-Hoc | Duration of Response (DOR) as Assessed by Independent Radiology Review Committee (IRC) | DOR is defined as the time from first confirmed response (CR or PR) per IRC assessment to the date of the first documented tumor progression as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Participants who start subsequent therapy without a prior reported progression will be censored at the last evaluable tumor assessments prior to initiation of the subsequent anticancer therapy. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. Median values of DOR, along with two-sided 95% CI in each treatment group will be computed based on a log-log transformation method. | All confirmed responders per IRC | Posted | Median | 95% Confidence Interval | Months | From the first treatment to the date of the first documented tumor progression or death. Approximately up to 21 months |
|
|
From the first visit to 100 days after last treatment. Approximately up to 101 months
101 deaths occurred on or before the last disposition date; 7 deaths occurred after the last disposition date
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 | Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle. | 108 | 117 | 88 | 117 | 110 | 117 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | 24.0 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | 24.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | 24.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | 24.0 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | 24.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | 24.0 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | 24.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Large intestinal ulcer | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Chest pain | General disorders | 24.0 | Systematic Assessment |
| |
| Pain | General disorders | 24.0 | Systematic Assessment |
| |
| Performance status decreased | General disorders | 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 24.0 | Systematic Assessment |
| |
| Sudden death | General disorders | 24.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | 24.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | 24.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | 24.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Motor dysfunction | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Peripheral nerve paresis | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | 24.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 24.0 | Systematic Assessment |
| |
| Urinary tract disorder | Renal and urinary disorders | 24.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Laryngeal haemorrhage | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Aortic aneurysm rupture | Vascular disorders | 24.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | 24.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | 24.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 24.0 | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Asthenia | General disorders | 24.0 | Systematic Assessment |
| |
| Chest pain | General disorders | 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 24.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | 24.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 24.0 | Systematic Assessment |
| |
| Pain | General disorders | 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 24.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 24.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | 24.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 24.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 24.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 24.0 | 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 | Clinical.Trials@bms.com |
| 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
| Other Reasons |
|
| 75 years and older |
|
| Unknown or Not Reported |
|
| American Indian or Alaska Native |
|
| Asian |
|
| Native Hawaiian or other Pacific Islander |
|
| Other |
|
| 2 |
|
| 3 |
|
| 4 |
|
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|