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The purpose of this study is to assess the safety of Ipilimumab monotherapy in Japanese subjects with advanced melanoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Ipilimumab | Experimental | Ipilimumab Intravenous Injection 3 mg/kg for every 3 weeks upto 4 doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ipilimumab | Biological |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) at Primary Endpoint - All Treated Participants | AEs graded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Related=relationship to study drug reported as certain, probable, possible, or missing. Immune-related AEs (irAEs) characterized by potential association with inflammation and considered by investigator as drug related. Primary endpoint (PE) includes results from Day 1 to 12 weeks after initial dose of last participant. Data evaluated at PE last patient, last visit (LPLV). | Day 1 to 90 Days after the last dose, up to May 2014 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) - All Treated Participants | AEs graded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Related=relationship to study drug reported as certain, probable, possible, or missing. Immune-related AEs (irAEs) characterized by potential association with inflammation and considered by investigator as drug related. |
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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 |
|---|---|---|---|---|---|---|
| Local Institution | Fukuoka | Fukuoka | 8128582 | Japan | ||
| Local Institution |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26410424 | Derived | Yamazaki N, Kiyohara Y, Uhara H, Fukushima S, Uchi H, Shibagaki N, Tsutsumida A, Yoshikawa S, Okuyama R, Ito Y, Tokudome T. Phase II study of ipilimumab monotherapy in Japanese patients with advanced melanoma. Cancer Chemother Pharmacol. 2015 Nov;76(5):997-1004. doi: 10.1007/s00280-015-2873-x. Epub 2015 Sep 26. |
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26 participants were enrolled and 20 were treated with study drug. Of the 6 participants not treated: 5 no longer met study criteria, 1 withdrew consent.
Study initiated 12 December 2013 and completed February 2015. Previously treated or untreated patients with Stage III (unresectable) or Stage IV melanoma were recruited. Previously untreated defined as: patients without treatment for metastatic disease but who may have received treatment in the adjuvant setting.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ipilimumab | During treatment, participants received Ipilimumab intravenous (IV) injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease(PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment (4 Doses Over 12 Weeks) |
|
| ||||||||||||||||||
| Week 12 to Week 24 Post Dosing Follow Up |
| |||||||||||||||||||
| 90 Day Follow Up for All Participants |
|
All participants in the study who received at least one dose of treatment with ipilimumab were summarized.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ipilimumab | Participants received Ipilimumab intravenous (IV) injection 3 mg/kg every 3 weeks, up to 4 doses. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) at Primary Endpoint - All Treated Participants | AEs graded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Related=relationship to study drug reported as certain, probable, possible, or missing. Immune-related AEs (irAEs) characterized by potential association with inflammation and considered by investigator as drug related. Primary endpoint (PE) includes results from Day 1 to 12 weeks after initial dose of last participant. Data evaluated at PE last patient, last visit (LPLV). | All participants in the study who received at least one dose of treatment with ipilimumab were summarized. Data up to May 2014 included. | Posted | Number | participants | Day 1 to 90 Days after the last dose, up to May 2014 |
Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)
Study initiated: December 2013; Study Completion: February 2015
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ipilimumab | During treatment, participants received Ipilimumab IV injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease (PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| C-reactive protein increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000074324 | Ipilimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Day 1 to 90 Days after the last dose, up to July 2014 |
| Number of Participants Who Died - All Treated Participants | Total number of deaths that occurred in all treated participants by study completion are reported. | Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years) |
| Number of Participants With Hematology Laboratory Abnormalities | Abnormal laboratory results were reported after the induction period start and within 90 days after induction period end date. Induction Period was 1 dose every 3 weeks for 4 doses (12 weeks). Common Terminology Criteria (CTC) version 3.0 was used in this study; Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Hematology parameters included: White Blood Cell Count (WBC), Absolute Neutrophil Count, Platelet Count, Hemoglobin, and Lymphocyte Count (absolute). The most recent assessment on or before Day 1 of study medication was taken as baseline (in addition, baseline laboratory must have been collected no earlier than Day -28). | Baseline to 90 days post last dose, up to July 2014 |
| Number of Participants With Liver Function Laboratory Abnormalities | Abnormal laboratory results were reported after the induction period start and within 90 days after induction period end date. Induction Period was 1 dose every 3 weeks for 4 doses (12 weeks). Common Terminology Criteria (CTC) version 3.0 was used in this study; Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Liver Function parameters included: alanine aminotransaminase (ALT), aspartate aminotransferase (AST), Total Bilirubin, and Alkaline Phosphatase (Alk Phos). The most recent assessment on or before Day 1 of study medication was taken as baseline (in addition, baseline laboratory must have been collected no earlier than Day -28). | Baseline to 90 days post last dose, up to July 2014 |
| Number of Participants With Renal Laboratory Abnormalities | Abnormal laboratory results were reported after the induction period start and within 90 days after induction period end date. Induction Period was 1 dose every 3 weeks for 4 doses (12 weeks). Common Terminology Criteria (CTC) version 3.0 was used in this study; Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Renal parameter=Creatinine. The most recent assessment on or before Day 1 of study medication was taken as baseline (in addition, baseline laboratory must have been collected no earlier than Day -28). | Baseline to 90 days post last dose, up to July 2014 |
| Number of Participants With Complete Response, Partial Response, Stable Disease, or Progressive Disease as the Best Overall Response | Overall response (OR) was determined using modified World Health Organization (mWHO) criteria. Complete response (CR): complete disappearance of all index and non-index lesions, and no new lesions. Partial response (PR): decrease in index lesions of 50% or greater in a sum of the products of diameters (SPD) relative to baseline, and no new lesions. Stable Disease (SD): Does not meet criteria for CR or PR, in the absence of PD in index lesions and no change or any change with persistence of one or more non-index lesions, and no new lesions. Progressive Disease (PD): At least 25% increase in SPD relative to nadir in index lesions and unequivocal progression of non-index lesions, along with new lesions or no new lesions; or PD: new lesions with any response with index or non-index lesions. Not Evaluable: Response cannot be determined. | Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years) |
| Percent of Participants With Best Overall Response (BOR) of Complete Response or Partial Response | Best Overall Response Rate (BORR) was defined as the total number of participants whose Best Overall Response (BOR) is Complete Response (CR) or Partial Response (PR) divided by the total number of treated participants (%). A two-sided, exact 95% Confidence Interval (Clopper and Pearson) for the BORR was calculated. Overall response (OR) was determined using modified World Health Organization (mWHO) criteria: Complete Response = complete disappearance of all index and non-index lesions, and no new lesions. Partial Response = decrease in index lesions of 50% or greater in a SPD relative to baseline, and no new lesions. BOR=an overall response of CR or PR at Week 12 or after Week 12. | Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years) |
| Kumamoto |
| Kumamoto |
| 8608556 |
| Japan |
| Local Institution | Matsumoto-shi | Nagano | 3908621 | Japan |
| Local Institution | Sunto-gun | Shizuoka | 4118777 | Japan |
| Local Institution | Chuo-ku | Tokyo | 1040045 | Japan |
| Local Institution | Chuo-shi | Yamanashi | 4093898 | Japan |
|
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| M-Stage at Study Entry | Melanoma Tumor Staging: Metastasis (M) classification (M1a versus M1b versus M1c). M1a: Distant skin, subcutaneous tissue, or nodal metastases with normal lactic dehydrogenase (LDH); M1b: Lung metastases with normal LDH; M1c: All other visceral metastases with normal LDH; Any distant metastasis with elevated LDH. Final Version of the American Joint Committee on Cancer Staging System for Cutaneous melanoma. Journal of Clinical Oncology, 2001. (Vol. 19 No.16): p. 3635-3648. | Number | participants |
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) | ECOG PS, is a 6-item scale to assess disease progression, daily functioning, and appropriate treatment and prognosis. Scale: 0-5 with 0=Fully active; 1= restricted in physically strenuous activity; 2= ambulatory; 3=limited self care; 4= completely disabled; 5=dead. | Number | participants |
|
| Height in centimeters (cm) | Median | Full Range | cm |
|
| Weight in kilograms (kg) | Median | Full Range | kg |
|
| Baseline Lactate Dehydrogenase (LDH) | Elevation defined as greater than (>) Upper Limit of Normal (ULN) limit. | Number | participants |
|
| Baseline LDH Greater than 2 Times Upper Limit of Normal | Elevation in this baseline characteristic was defined as greater than (>) 2 Times the Upper Limit of Normal | Number | participants |
|
| Prior Systemic Anti-Cancer Therapy | Number | participants |
|
|
|
|
| Secondary | Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) - All Treated Participants | AEs graded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Related=relationship to study drug reported as certain, probable, possible, or missing. Immune-related AEs (irAEs) characterized by potential association with inflammation and considered by investigator as drug related. | All participants in the study who received at least one dose of treatment with ipilimumab were summarized. | Posted | Number | participants | Day 1 to 90 Days after the last dose, up to July 2014 |
|
|
|
| Secondary | Number of Participants Who Died - All Treated Participants | Total number of deaths that occurred in all treated participants by study completion are reported. | All participants in the study who received at least one dose of treatment with ipilimumab were summarized. | Posted | Number | participants | Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years) |
|
|
|
| Secondary | Number of Participants With Hematology Laboratory Abnormalities | Abnormal laboratory results were reported after the induction period start and within 90 days after induction period end date. Induction Period was 1 dose every 3 weeks for 4 doses (12 weeks). Common Terminology Criteria (CTC) version 3.0 was used in this study; Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Hematology parameters included: White Blood Cell Count (WBC), Absolute Neutrophil Count, Platelet Count, Hemoglobin, and Lymphocyte Count (absolute). The most recent assessment on or before Day 1 of study medication was taken as baseline (in addition, baseline laboratory must have been collected no earlier than Day -28). | All participants in the study who received at least one dose of treatment with ipilimumab and had laboratory data were summarized. Data included up to July 2014. | Posted | Number | participants | Baseline to 90 days post last dose, up to July 2014 |
|
|
|
| Secondary | Number of Participants With Liver Function Laboratory Abnormalities | Abnormal laboratory results were reported after the induction period start and within 90 days after induction period end date. Induction Period was 1 dose every 3 weeks for 4 doses (12 weeks). Common Terminology Criteria (CTC) version 3.0 was used in this study; Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Liver Function parameters included: alanine aminotransaminase (ALT), aspartate aminotransferase (AST), Total Bilirubin, and Alkaline Phosphatase (Alk Phos). The most recent assessment on or before Day 1 of study medication was taken as baseline (in addition, baseline laboratory must have been collected no earlier than Day -28). | All participants in the study who received at least one dose of treatment with ipilimumab and had laboratory data were summarized. Data included up to July 2014. | Posted | Number | participants | Baseline to 90 days post last dose, up to July 2014 |
|
|
|
| Secondary | Number of Participants With Renal Laboratory Abnormalities | Abnormal laboratory results were reported after the induction period start and within 90 days after induction period end date. Induction Period was 1 dose every 3 weeks for 4 doses (12 weeks). Common Terminology Criteria (CTC) version 3.0 was used in this study; Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Renal parameter=Creatinine. The most recent assessment on or before Day 1 of study medication was taken as baseline (in addition, baseline laboratory must have been collected no earlier than Day -28). | All participants in the study who received at least one dose of treatment with ipilimumab and had laboratory data were summarized. Data included up to July 2014. | Posted | Number | participants | Baseline to 90 days post last dose, up to July 2014 |
|
|
|
| Secondary | Number of Participants With Complete Response, Partial Response, Stable Disease, or Progressive Disease as the Best Overall Response | Overall response (OR) was determined using modified World Health Organization (mWHO) criteria. Complete response (CR): complete disappearance of all index and non-index lesions, and no new lesions. Partial response (PR): decrease in index lesions of 50% or greater in a sum of the products of diameters (SPD) relative to baseline, and no new lesions. Stable Disease (SD): Does not meet criteria for CR or PR, in the absence of PD in index lesions and no change or any change with persistence of one or more non-index lesions, and no new lesions. Progressive Disease (PD): At least 25% increase in SPD relative to nadir in index lesions and unequivocal progression of non-index lesions, along with new lesions or no new lesions; or PD: new lesions with any response with index or non-index lesions. Not Evaluable: Response cannot be determined. | All participants in the study who received at least one dose of treatment with ipilimumab were summarized. | Posted | Number | participants | Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years) |
|
|
|
| Secondary | Percent of Participants With Best Overall Response (BOR) of Complete Response or Partial Response | Best Overall Response Rate (BORR) was defined as the total number of participants whose Best Overall Response (BOR) is Complete Response (CR) or Partial Response (PR) divided by the total number of treated participants (%). A two-sided, exact 95% Confidence Interval (Clopper and Pearson) for the BORR was calculated. Overall response (OR) was determined using modified World Health Organization (mWHO) criteria: Complete Response = complete disappearance of all index and non-index lesions, and no new lesions. Partial Response = decrease in index lesions of 50% or greater in a SPD relative to baseline, and no new lesions. BOR=an overall response of CR or PR at Week 12 or after Week 12. | All participants in the study who received at least one dose of treatment with ipilimumab were summarized. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years) |
|
|
|
| 11 |
| 20 |
| 19 |
| 20 |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
|
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Metastatic pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
|
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Anaphylactic shock | Immune system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Brain oedema | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
| Lymphoedema | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA 17.1 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Blood sodium decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| VIth nerve paralysis | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Radiation skin injury | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | 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.
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Title | Measurements |
|---|---|
|
| Treatment-Related SAEs |
|
| AEs Leading to Discontinuation of Study Drug |
|
| Grade 3/4 AEs |
|
| Treatment-Related AEs |
|
| Grade 3/4 Related AEs |
|
| irAEs |
|
| Grade 3/4 irAEs |
|
| Title | Measurements |
|---|---|
|
| Absolute Neutophil Grade 4-4 |
|
| Platelet Count Grade 1-4 |
|
| Platelet Count Grade 3-4 |
|
| Hemoglobin Grade 1-4 |
|
| Hemoglobin Grade 3-4 |
|
| Lymphocytes Grade 1-4 |
|
| Lymphocytes Grade 3-4 |
|
| Title | Measurements |
|---|---|
|
| AST Grade 3-4 |
|
| Total Bilirubin Grade 1-4 |
|
| Total Bilirubin Grade 3-4 |
|
| Alk Phos Grade 1-4 |
|
| Alk Phos Grade 3-4 |
|
| Title | Measurements |
|---|---|
|
| Not Evaluable |
|