Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Protocol 26083 | Other Identifier | EORTC | |
| 2009-010576-21 | EudraCT Number |
Not provided
Not provided
Not provided
Inability to meet protocol objectives
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| European Organisation for Research and Treatment of Cancer - EORTC | NETWORK |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To determine whether dasatinib plus lomustine are effective for treatment of recurrent glioblastoma
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dasatinib | Active Comparator |
| |
| Lomustine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dasatinib | Drug | Tablets, Oral, 100 mg, Once or Twice daily (depending on safety cohort), Until progression or toxicity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | SAE=any untoward medical event that results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires inpatient hospitalization or prolongation. AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. Treatment-related(Tx-R)=certainly, probably, possibly related and unknown relationship to study drug. AE grades(Gr) 1=Mild; 2=Moderate; 3=Severe; 4=Life-threatening. | Assessed at baseline, every 2 weeks during cycles 1-6 (6-week cycles), and every 6 weeks after cycle 6. Median number of cycles = 1.0 (range: 1.0 - 7.0). |
| Number of Participants With Dose-limiting Toxicities (DLTs) | Grades (gr) according to National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. DLTs were defined as adverse drug reactions as follows: absolute neutrophil counts <0.5x10^9/L (gr4) lasting for 7 consecutive days; febrile neutropenia (neutrophil count <1x10^9/L and fever of >=38.5°C); thrombocytopenia (gr4); any gr3/4 nonhematological toxicity except nausea, vomiting and fever which could be rapidly controlled with appropriate measures; any toxicity which did not allow administering at least 70% of the intended dose intensity for both agents. | The duration for observation of DLT was 2 6-week cycles in participants with escalated dose (QD to BID) and 1 6 -week cycle for participants starting with BID regime. For participants receiving dasatinib at 150 mg, DLTs were only documented over cycle 1. |
| Deaths Within 30 Days of Protocol Treatment Discontinuation | From time of randomization through within 30 days after protocol treatment discontinuation. Median (full range) number of 6-week treatment cycles was 1.0 (1.0-7.0). | |
| Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Disease Progression at 12 Months | As measured by brain magnetic resonance imaging. | 12 months |
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 |
|---|---|---|---|---|---|---|
| Local Institution | Paris | 75013 | France | |||
| Local Institution |
Of 28 participants enrolled in this study, 26 received treatment.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2. |
| FG001 | Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m^2. |
| FG002 | Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m^2 |
| FG003 | Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m^2 |
| FG004 | Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | Dose Level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dose Level 1A | Dasatinib: 100 mg once daily (QD) cycle 1 / 100 mg twice daily (BID) cycle 2 + lomustine (CCNU): 110 mg/m² |
| BG001 | Dose Level 1B | Dasatinib: 100 mg QD / 100mg BID + CCNU: 90 mg/m² |
| 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 Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs | SAE=any untoward medical event that results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires inpatient hospitalization or prolongation. AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. Treatment-related(Tx-R)=certainly, probably, possibly related and unknown relationship to study drug. AE grades(Gr) 1=Mild; 2=Moderate; 3=Severe; 4=Life-threatening. | All treated participants | Posted | Number | participants | Assessed at baseline, every 2 weeks during cycles 1-6 (6-week cycles), and every 6 weeks after cycle 6. Median number of cycles = 1.0 (range: 1.0 - 7.0). |
|
Not provided
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 | Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 | Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agitation | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| BMS Study Director | Bristol-Myers Squibb | clinical.trials@bms.com |
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069439 | Dasatinib |
| D008130 | Lomustine |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Lomustine | Drug | Tablets, Oral, 110 mg/m², Every 6 weeks, until progression or toxicity |
|
Neutrophils (neutropenia): Grade (gr)1 \
| Assessed at baseline, every 2 weeks during cycles 1-6 (6-week cycles), and every 6 weeks after cycle 6. Median number of cycles = 1.0 (range: 1.0 - 7.0). |
| Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | Grades (gr) 1=mild; gr2=moderate; gr3=severe; gr4=life-threatening. For details of NCI CTCAE laboratory values for each grade, please refer to http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm#ctc\_30. Low Potassium=Hypokalemia, High Potassium=Hyperkalemia, Low Sodium=Hyponatremia, Low Calcium=Hypocalcemia, High Bilirubin=Hyperbilirubinemia, low phosphatase=Hypophosphatemia, Low Potassium=Hypokalemia. | Assessed at baseline, every 2 weeks during cycles 1-6 (6-week cycles), and every 6 weeks after 6 cycles. Median number of cycles = 1.0 (range: 1.0 - 7.0). |
| Bologna |
| 40139 |
| Italy |
| Local Institution | Nijmegen | 6525 GA | Netherlands |
| Local Institution | Rotterdam | 3075 EA | Netherlands |
| Local Institution | Lausanne | 1011 | Switzerland |
| Thrombocytopenia, Grade 4 |
|
| Both Progression and Toxicity |
|
| BG002 | Dose Level 2 | Dasatinib: 100 mg BID + CCNU: 90 mg/m² |
| BG003 | Dose Level 3A | Dasatinib: 150 mg/day (100 mg AM and 50 mg PM) + CCNU: 90 mg/m² |
| BG004 | Dose Level 3B | Dasatinib: 100 mg/day (QD) + CCNU: 90 mg/m² |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Histological Diagnosis of Primary Disease | by local pathologist | Number | participants |
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status | ECOG criteria is used to assess disease progression and affects on daily living abilities and to determine appropriate treatment and prognosis. Grade 0=normal activity; Grade 1=Restricted physical activity but ambulatory and capable of light work; Grade 2=Ambulatory, capable of self care, but unable to carry out any work activities; Grade 3=Capable of limited self care, confined to bed or chair 50% or more of waking hours; Grade 4=Completely disabled, totally confined to bed or chair. | Number | participants |
|
Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2. |
| OG001 | Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m^2 |
| OG002 | Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m^2 |
| OG003 | Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m^2 |
| OG004 | Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | Dose Level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2 |
|
|
| Primary | Number of Participants With Dose-limiting Toxicities (DLTs) | Grades (gr) according to National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. DLTs were defined as adverse drug reactions as follows: absolute neutrophil counts <0.5x10^9/L (gr4) lasting for 7 consecutive days; febrile neutropenia (neutrophil count <1x10^9/L and fever of >=38.5°C); thrombocytopenia (gr4); any gr3/4 nonhematological toxicity except nausea, vomiting and fever which could be rapidly controlled with appropriate measures; any toxicity which did not allow administering at least 70% of the intended dose intensity for both agents. | Evaluable Participants: subset of participants used to decide on dose escalations. Participants were assessable if they completed the period for DLT observation. | Posted | Number | participants | The duration for observation of DLT was 2 6-week cycles in participants with escalated dose (QD to BID) and 1 6 -week cycle for participants starting with BID regime. For participants receiving dasatinib at 150 mg, DLTs were only documented over cycle 1. |
|
|
|
| Primary | Deaths Within 30 Days of Protocol Treatment Discontinuation | Treated participants | Posted | Number | participants | From time of randomization through within 30 days after protocol treatment discontinuation. Median (full range) number of 6-week treatment cycles was 1.0 (1.0-7.0). |
|
|
|
| Primary | Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria | Neutrophils (neutropenia): Grade (gr)1 \ | Treated participants | Posted | Number | participants | Assessed at baseline, every 2 weeks during cycles 1-6 (6-week cycles), and every 6 weeks after cycle 6. Median number of cycles = 1.0 (range: 1.0 - 7.0). |
|
|
|
| Primary | Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria | Grades (gr) 1=mild; gr2=moderate; gr3=severe; gr4=life-threatening. For details of NCI CTCAE laboratory values for each grade, please refer to http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm#ctc\_30. Low Potassium=Hypokalemia, High Potassium=Hyperkalemia, Low Sodium=Hyponatremia, Low Calcium=Hypocalcemia, High Bilirubin=Hyperbilirubinemia, low phosphatase=Hypophosphatemia, Low Potassium=Hypokalemia. | Treated participants | Posted | Number | participants | Assessed at baseline, every 2 weeks during cycles 1-6 (6-week cycles), and every 6 weeks after 6 cycles. Median number of cycles = 1.0 (range: 1.0 - 7.0). |
|
|
|
| Other Pre-specified | Number of Participants With Disease Progression at 12 Months | As measured by brain magnetic resonance imaging. | Treated participants | Posted | Number | participants | 12 months |
|
|
|
| 5 |
| 6 |
| 6 |
| 6 |
| EG001 | Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 | Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m^2 | 1 | 3 | 3 | 3 |
| EG002 | Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 | Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m^2 | 4 | 7 | 7 | 7 |
| EG003 | Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 | Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m^2 | 3 | 9 | 9 | 9 |
| EG004 | Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 | Dose Level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2 | 0 | 1 | 1 | 1 |
| Convulsion | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Brain oedema | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Prostatism | Reproductive system and breast disorders | MedDRA 15.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Speech disorder | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 15.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Carbon monoxide diffusing capacity | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Ocular surface disease | Eye disorders | MedDRA 15.0 | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Conduction disorder | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hemianopia homonymous | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Peripheral coldness | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Urethral haemorrhage | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 15.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 15.0 | Systematic Assessment |
|
| Adverse event | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hemianopia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Optic neuropathy | Eye disorders | MedDRA 15.0 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Brain oedema | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hyperaesthesia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Neoplasm swelling | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Penile ulceration | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 15.0 | 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.
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009603 | Nitroso Compounds |
| At least 1 Grade 1-4 Leukopenia |
|
| At least 1 Grade 1-4 Lymphocytopenia |
|
| At least 1 Grade 1-4 Thrombocytopenia |
|
| At least 1 Grade 1-4 Anemia |
|
| At least 1 Grade 3-4 Neutropenia |
|
| At least 1 Grade 3-4 Leukopenia |
|
| At least 1 Grade 3-4 Lymphocytopenia |
|
| At least 1 Grade 3-4 Thrombocytopenia |
|
| At least 1 Grade 3-4 Anemia |
|
| At least 1 Gr 1-4 Hyperkalemia |
|
| At least 1 Gr 1-4 Hyponatremia |
|
| At least 1 Gr 1-4 Hypernatremia |
|
| At least 1 Gr 1-4 Creatinine |
|
| At least 1 Gr 1-4 Hypocalcemia |
|
| At least 1 Gr1-4 Hyperbilirubinemia |
|
| At least 1 Gr 1-4 Aspartate Aminotransferase / AST |
|
| At least 1 Gr 1-4 Hypophosphatemia |
|
| At least 1 Gr 3-4 Hypokalemia |
|