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| Name | Class |
|---|---|
| Center for International Blood and Marrow Transplant Research | NETWORK |
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This is a study for the outcome and safety of individualized busulfan dosing with cyclophosphamide and etoposide for patients preparing for a stem cell transplant to treat Non-Hodgkin or Hodgkin's Lymphoma.
Evaluation of progression-free survival, transplant related mortality, overall survival, and overall response rate, in subjects with NHL and HL receiving an IV busulfan-based conditioning regimen with PK-guided IV busulfan dosing, followed by autologous HSCT as well as comparison to those receiving carmustine, etoposide, cytarabine, and melphalan (BEAM) conditioning regimen (and its variants) obtained from registry data in the Center for International Blood and Marrow Transplant Research (CIBMTR) Assessment of the safety profile of a BuCyE conditioning regimen with PK-directed dosing of IV busulfan will also be completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV Busulfan | Experimental | Pk-directed IV Busulfan (based on test dose method) for 4 days followed by Etoposide 1400mg/m2 QD for one day and Cyclophosphamide 2.5 g/m2 QD for two days followed by autologous stem cell transplant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV Busulfan, Cyclophosphamide and Etoposide (BuCyE Regimen) | Drug | Pk-directed IV Busulfan (based on test dose method) for 4 days followed by Etoposide 1400mg/m2 QD for one day and Cyclophosphamide 2.5 g/m2 QD for two days followed by autologous stem cell transplant. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Progression Events in 2 Years. | The time of Progression-Free Survival (PFS) was defined as the time from transplantation to the occurrence of the event that was death or first recurrence of progressive disease. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Death Events in 2 Years. | The time of overall survival was defined as the time from transplantation to death of all causes. | 2 years |
| Number of Transplant-related Death Events Until Day 100. |
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Inclusion Criteria:
Subjects with NHL to be included:
Subjects with HL to be included:
Exclusion Criteria:
Excluded will also be subjects with existing or active central nervous system lymphoma or human immunodeficiency virus related lymphoma, unacceptable organ function, or uncontrolled infections.
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| Name | Affiliation | Role |
|---|---|---|
| Agnes Elekes, MD | Otsuka Pharmaceutical Development and commercialization | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama in Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Arizona Cancer Center |
Test dose of 0.8 mg/kg of IV busulfan was administered (2-hour continuous infusion) 1 day between Days -14 and -11 for PK analysis to inform subsequent dosing. The conditioning regimen consisted of IV busulfan on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0.
A multicenter (43 trial sites in United States and Canada), single-arm, open-label, phase 2 exploratory trial to evaluate clinical outcomes following pharmacokinetic (PK)-directed intravenous (IV) busulfan therapy in 207 participants with Non-Hodgkin's and Hodgkin's lymphoma were evaluated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hodgkin's Lymphoma (≤ 65 Years) | Participants with Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Transplant-related mortality was defined as death due to any cause other than disease relapse/progression up until Day 100.
| Day 100 |
| Overall Response Rate | The overall response status is complete response and not complete response (partial remission, primary refractory/primary induction failure, stable disease, progressive disease, and relapse) at Baseline and each of the scheduled follow-up time points. | Baseline, Day 100, Month 6, 12, 24, Early termination and End of Trial (within 30 days of the trial termination) |
| Tucson |
| Arizona |
| 85719 |
| United States |
| Alta Bates Summit Medical Center | Berkeley | California | 94704 | United States |
| Scripps Clinic | La Jolla | California | 92037 | United States |
| UCSD Medical Center BMT Program | La Jolla | California | 92093 | United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Sutter Cancer Center | Sacramento | California | 95816 | United States |
| University of California, Davis Medical Center | Sacramento | California | 95817 | United States |
| University of California San Francisco Medical Center | San Francisco | California | 94143 | United States |
| Rocky Mountain Cancer Centers | Denver | Colorado | 80218 | United States |
| Florida Hospital Cancer Institute | Orlando | Florida | 32804 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| University of Illinois Cancer Center | Chicago | Illinois | 60612 | United States |
| The University of Chicago | Chicago | Illinois | 60637 | United States |
| Loyola University Chicago | Maywood | Illinois | 60153 | United States |
| Bone Marrow and Stem Cell Transplant Program | Indianapolis | Indiana | 46202 | United States |
| University of Kansas Medical Center | Westwood | Kansas | 66205 | United States |
| LSU Health Sciences Center at Shreveport/Feist Weiller Cancer Center | Shreveport | Louisiana | 71103 | United States |
| University of Maryland Medical Center - Marlene & Stewart Greenebaum Cancer Center | Baltimore | Maryland | 21201 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Weill Cornell Medical College | New York | New York | 10065 | United States |
| Montefiore-Einstein Cancer Center | The Bronx | New York | 10467 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| The Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | 15224 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| South Texas Veterans Health Care System | San Antonio | Texas | 78229 | United States |
| Texas Transplant Physician Group, PLLC | San Antonio | Texas | 78229 | United States |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | United States |
| West Virginia University Hospital | Morgantown | West Virginia | 26506 | United States |
| Saint John Regional Hospital | Saint John | New Brunswick | E2L 4L2 | Canada |
| Queen Elizabeth II Health Sciences Centre - VG Site | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| The Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| Royal Victoria Hospital MUHC | Montreal | Quebec | H3A 1A1 | Canada |
| Saskatoon Cancer Centre | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| FG001 |
| Hodgkin's Lymphoma (> 65 Years) |
Participants with Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0. |
| FG002 | Non-Hodgkin's Lymphoma (≤ 65 Years) | Participants with Non-Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0. |
| FG003 | Non-Hodgkin's Lymphoma (> 65 Years) | Participants with Non-Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hodgkin's/Non-Hodgkin's Lymphoma (≤ 65 Years) | Participants with Hodgkin's or Non-Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0. |
| BG001 | Hodgkin's/Non-Hodgkin's Lymphoma (> 65 Years) | Participants with Hodgkin's or Non-Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 Progression Events in 2 Years. | The time of Progression-Free Survival (PFS) was defined as the time from transplantation to the occurrence of the event that was death or first recurrence of progressive disease. | Participants receiving at least 1 PK-directed IV busulfan dose followed by autologous hematopoietic stem cell transplant are included in the Intent-to-treat (ITT) data set. Four participants (of 207) did not continue to the conditioning regimen after receiving the PK test dose and were excluded from ITT data set. | Posted | Number | Event | 2 years |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Death Events in 2 Years. | The time of overall survival was defined as the time from transplantation to death of all causes. | Participants receiving at least 1 PK-directed IV busulfan dose followed by autologous hematopoietic stem cell transplant are included in the ITT data set. Four participants (of 207) did not continue to the conditioning regimen after receiving the PK test dose and were excluded from ITT data set. | Posted | Number | Deaths | 2 years |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Transplant-related Death Events Until Day 100. | Transplant-related mortality was defined as death due to any cause other than disease relapse/progression up until Day 100. | Participants receiving at least 1 PK-directed IV busulfan dose followed by autologous hematopoietic stem cell transplant are included in the ITT data set. Four participants (of 207) did not continue to the conditioning regimen after receiving the PK test dose and were excluded from ITT data set. | Posted | Number | Transplant-related death | Day 100 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate | The overall response status is complete response and not complete response (partial remission, primary refractory/primary induction failure, stable disease, progressive disease, and relapse) at Baseline and each of the scheduled follow-up time points. | Participants receiving at least 1 PK-directed IV busulfan dose followed by autologous hematopoietic stem cell transplant are included in the ITT data set. Four participants (of 207) did not continue to the conditioning regimen after receiving the PK test dose and were excluded from ITT data set. | Posted | Number | Participants | Baseline, Day 100, Month 6, 12, 24, Early termination and End of Trial (within 30 days of the trial termination) |
|
Adverse events were reported during the entire trial period (from screening through Early Termination or End of Trial).
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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 | Hodgkin's/Non-Hodgkin's Lymphoma (≤ 65 Years or > 65 Years) | The safety data set consisted of all screened participants who had received at least 1 dose of IV busulfan (including PK test dose). | 90 | 207 | 190 | 207 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Lymphadenopathy mediastinal | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Normochromic normocytic anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Atrial thrombosis | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Diabetes insipidus | Endocrine disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Gastrointestinal toxicity | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cholecystits chronic | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hepatic vein occlusion | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Ischaemic hepatitis | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cytokine storm | Immune system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Acinetobacter bacteraemia | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Aspergillosis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| BK virus infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Clostridial infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Clostridium Difficile colitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cystitis viral | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cytomegalovirus viraemia | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pulmonary mycosis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Salmonella bacteraemia | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Syphilis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Urinary tract infection Enterococcal | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Viraemia | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Delayed engraftment | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Blood culture positive | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pulmonary physical examination abnormal | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
| |
| IIIrd nerve paralysis | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Vocal cord paralysis | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pleural haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Restrictive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Catheter site erythema | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dysguesia | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Affairs | Otsuka Pharmaceutical Development and Commercialization, Inc. | 800 562-3974 |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D006689 | Hodgkin Disease |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002066 | Busulfan |
| D003520 | Cyclophosphamide |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
Not provided
Not provided
| Male |
|
Participants with Non-Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0.
| OG003 | Non-Hodgkin's Lymphoma (> 65 Years) | Participants with Non-Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0. |
|
|
Participants with Non-Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0. |
| OG003 | Non-Hodgkin's Lymphoma (> 65 Years) | Participants with Non-Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0. |
|
|
| OG002 | Non-Hodgkin's Lymphoma (≤ 65 Years) | Participants with Non-Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0. |
| OG003 | Non-Hodgkin's Lymphoma (> 65 Years) | Participants with Non-Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days -14 and -11; and recieved conditioning regimen of IV busulfan once daily on Days -8 to -5, etoposide on Day -4, and cyclophosphamide on Days -3 and -2, followed by stem cell infusion on Day 0. |
|
|