Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000136-15 | EudraCT Number |
Not provided
Not provided
Trial terminated because of lack of efficacy in the short term acute phase
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether the combination of Ulocuplumab and Nivolumab is safe and effective in the treatment of pancreatic cancer and small cell lung cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-936564 (Ulocuplumab) + Nivolumab, Tumor type arm (SCLC) | Active Comparator | Small cell lung cancer (SCLC) |
|
| BMS-936564 (Ulocuplumab) + Nivolumab, Tumor type arm (PAC) | Active Comparator | Pancreatic cancer (PAC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ulocuplumab | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Immune-mediated AEs | The number participants who experienced on-study AEs, SAEs, and AEs requiring immune modulating medication is reported. | From first dose until date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2017, approximately 18 months) |
| Objective Response Rate (ORR) Per RECIST 1.1 Criteria | ORR is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of treated participants. BOR is defined as the best response designation recorded between the first dose date and the date of progression per RECIST 1.1, or the date of subsequent anti-cancer therapy, whichever occurs first. CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD)=At least a 20% increase in the sum of diameters of target lesions, referencing the smallest sum on study, and an absolute increase of at least 5 mm, or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referencing the smallest sum diameters while on study. | From first dose until disease progression or treatment discontinuation (assessed up to January 2017, approximately 18 months) |
| Overall Survival (OS) | If a Phase 2 comparative study is initiated and, for PAC only: Overall Survival is defined as the time from randomization to date of death due to any cause. | From date of randomization to date of death (assessed up to study completion, approximately 18 months) |
| Number of Participants With Laboratory Abnormalities | The number of participants who experienced on-study Grade 3 or 4 laboratory abnormalities (without Grade 3 or 4 abnormality at baseline) was reported for each arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | Progression-free survival is defined as the time from first dosing date to the date of the first documented tumor progression, as determined by the investigator according to RECIST 1.1 criteria, or death due to any cause, whichever occurs first. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. PFS was not assessed for this study due to the small number of participants. |
Not provided
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Of Colorado Hosp | Aurora | Colorado | 80045 | United States | ||
| Indiana University Health |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
Not provided
61 participants were enrolled; 41 participants entered the treatment period.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | PAC DL1 (DLT) | Pancreatic Adenocarcinoma (PAC) Dose level 1, 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W |
| FG001 | PAC DL-1 (Tot) | Pancreatic Adenocarcinoma (PAC) Dose level -1, 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W |
| FG002 | SCLC (Tot) | All Small Cell Lung Cancer (SCLC) subjects in study, 1 subject received 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W and 7 subjects received 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All treated participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PAC DL1 (DLT) | Pancreatic Adenocarcinoma (PAC) Dose level 1, 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W |
| BG001 | PAC DL-1 (Tot) | Pancreatic Adenocarcinoma (PAC) Dose level -1, 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W |
| 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 |
| 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 | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Immune-mediated AEs | The number participants who experienced on-study AEs, SAEs, and AEs requiring immune modulating medication is reported. | All treated participants. Participants in the SCLC (Tot) Arm were not evaluated for Immune-mediated AEs | Posted | Number | Participants | From first dose until date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2017, approximately 18 months) |
|
From first dose to date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2018, approximately 18 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 | PAC DL1 (DLT) | Pancreatic Adenocarcinoma (PAC) Dose level 1, 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ascites | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com | Clinical.Trials@bms.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 13, 2016 | Jan 26, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jan 13, 2016 | Mar 1, 2018 | Prot_001.pdf |
| ID | Term |
|---|---|
| C581980 | ulocuplumab |
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Nivolumab | Drug |
|
| From first dose until date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2017, approximately 18 months) |
| Number of Participants With Electrocardiogram Abnormalities | The number of participants experiencing electrocardiogram abnormalities was reported for each arm | From first dose to date of last dose plus 30 days |
| From first dose to date of progression (assessed up to January 2017, approximately 18 months) |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins | Baltimore | Maryland | 21287 | United States |
| Columbia University Medical Center (Cumc) | New York | New York | 10032 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| Local Institution | Helsinki | 00029 | Finland |
| Study drug toxicity |
|
| Subject request to discontinue treatment |
|
| BG002 | SCLC (Tot) | All Small Cell Lung Cancer (SCLC) subjects in study, 1 subject received 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W and 7 subjects received 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W |
| BG003 | Total | Total of all reporting groups |
| 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 |
|
Pancreatic Adenocarcinoma (PAC) Dose level -1, 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W
| OG002 | SCLC (Tot) | All Small Cell Lung Cancer (SCLC) subjects in study, 1 subject received 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W and 7 subjects received 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W |
|
|
| Primary | Objective Response Rate (ORR) Per RECIST 1.1 Criteria | ORR is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of treated participants. BOR is defined as the best response designation recorded between the first dose date and the date of progression per RECIST 1.1, or the date of subsequent anti-cancer therapy, whichever occurs first. CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD)=At least a 20% increase in the sum of diameters of target lesions, referencing the smallest sum on study, and an absolute increase of at least 5 mm, or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referencing the smallest sum diameters while on study. | All treated participants in PAC arms. ORR data was not collected for SCLC arm. | Posted | Number | 90% Confidence Interval | Percentage of participants | From first dose until disease progression or treatment discontinuation (assessed up to January 2017, approximately 18 months) |
|
|
|
| Primary | Overall Survival (OS) | If a Phase 2 comparative study is initiated and, for PAC only: Overall Survival is defined as the time from randomization to date of death due to any cause. | OS data was not collected for any participants | Posted | From date of randomization to date of death (assessed up to study completion, approximately 18 months) |
|
|
| Primary | Number of Participants With Laboratory Abnormalities | The number of participants who experienced on-study Grade 3 or 4 laboratory abnormalities (without Grade 3 or 4 abnormality at baseline) was reported for each arm. | All treated participants in PAC arms. Lab abnormality data was not collected for SCLC arm. | Posted | Number | Participants | From first dose until date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2017, approximately 18 months) |
|
|
|
| Secondary | Progression-Free Survival (PFS) | Progression-free survival is defined as the time from first dosing date to the date of the first documented tumor progression, as determined by the investigator according to RECIST 1.1 criteria, or death due to any cause, whichever occurs first. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. PFS was not assessed for this study due to the small number of participants. | PFS data was not collected for any participants | Posted | From first dose to date of progression (assessed up to January 2017, approximately 18 months) |
|
|
| Primary | Number of Participants With Electrocardiogram Abnormalities | The number of participants experiencing electrocardiogram abnormalities was reported for each arm | Electrocardiogram data was not collected for any participants | Posted | From first dose to date of last dose plus 30 days |
|
|
| 3 |
| 6 |
| 3 |
| 6 |
| 6 |
| 6 |
| EG001 | PAC DL-1 (Tot) | Pancreatic Adenocarcinoma (PAC) Dose level -1, 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W | 16 | 27 | 21 | 27 | 26 | 27 |
| EG002 | SCLC (Tot) | All Small Cell Lung Cancer (SCLC) subjects in study, 1 subject received 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W and 7 subjects received 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W | 5 | 8 | 7 | 8 | 8 | 8 |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
|
| Biliary tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 19.1 | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 19.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 19.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
|
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| Lipase abnormal | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| Troponin increased | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
|
| Chromaturia | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 19.1 | 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.
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Hemoglobin |
|
| Leukocytes |
|
| Neutrophils |
|
| Platelet Count |
|
| Alanine Aminotransferase |
|
| Alkaline Phosphatase |
|
| Aspartate Aminotransferase |
|
| Bilirubin |
|
| Creatine |
|
| Hypernatremia |
|
| Hyponatremia |
|
| Hypermagnesemia |
|
| Hypomagnesemia |
|
| Hypercalcemia |
|
| Hypocalcemia |
|
| Hyperkalemia |
|
| Hypokalemia |
|
| Amylase |
|
| Lipase |
|