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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-142455 | Registry Identifier | JapicCTI |
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The purpose of this study is to evaluate the safety of brentuximab vedotin (recombinant) for intravenous (IV) infusion (ADCETRIS IV Infusion 50 mg) in patients with relapsed/refractory CD30+ Hodgkin's lymphoma or anaplastic large cell lymphoma in the routine clinical setting, as well as to collect efficacy information for reference.
The present survey was designed to evaluate the safety of brentuximab vedotin (recombinant) for IV infusion (ADCETRIS IV Infusion 50 mg) in patients with relapsed/refractory CD30+ Hodgkin's lymphoma or anaplastic large cell lymphoma in the routine clinical setting.
The usual adult dosage is 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) infused intravenously once every three weeks. The dose should be adjusted depending on the participant's condition. See the "PRECAUTIONS" section of the package insert.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| brentuximab vedotin (recombinant) Intravenous infusion | Intravenous infusion of 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) administered once every three weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brentuximab vedotin (recombinant) | Drug | Brentuximab vedotin (recombinant) for IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE) | Up to Week 48 or until discontinuation of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieve or Maintain Any Best Response | Best response is defined as the cumulative numbers of participants who achieve each level of best response including partial response (PR), complete response uncertain (CRu) (when no positron emission tomography [PET] data are available), and complete response (CR) after each cycle of treatment. Reported data are divided into 4 populations; Hodgkin's lymphoma (HL) participants with PET data, HL participants without PET data, anaplastic large cell lymphoma (ALCL) participants with PET data, and ALCL participants without PET data. PET is used in cancer diagnosis and treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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Relapsed or refractory CD30+ Hodgkin's lymphoma or anaplastic large cell lymphoma
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osaka | Japan |
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Participants with a historical diagnosis of relapsed/refractory CD30+ Hodgkin's lymphoma (HL) or anaplastic large cell lymphoma (ALCL) were enrolled. Participants received interventions as part of routine medical care.
Participants took part in the study at 198 investigative sites in Japan, from 17 April 2014 to 30 June 2017. Registration period for patients was from 17 April 2014 to 30 September 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brentuximab Vedotin Infusion | Intravenous infusion of 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) administered once every three weeks. Participants received interventions as part of routine medical care. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 2, 2017 | Feb 1, 2019 |
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| Up to Week 48 or until discontinuation of treatment |
| Overall Survival (OS) | OS is defined as the period from the start of therapy in standard medical care to the time when death (regardless of the cause of death) is confirmed. Reported data as OS was point estimates of 1 year survival rate for HL and ALCL participants. | Up to Week 48 or until discontinuation of treatment |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Analysis Set; The safety analysis set was defined as all participants who had the safety data defined on the protocol.
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| ID | Title | Description |
|---|---|---|
| BG000 | Brentuximab Vedotin Infusion | Intravenous infusion of 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) administered once every three weeks. Participants received interventions as part of routine medical care. |
| 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 |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number | Participants |
| ||||||||||||||||||
| Duration of Diagnosis of Hodgkin's Lymphoma (HL) or Anaplastic Large Cell Lymphoma (ALCL) | Mean duration between start of study and first time of diagnosis of HL or ALCL was reported. | Count of Participants | Participants |
| |||||||||||||||||
| Diagnosis | Count of Participants | Participants |
| ||||||||||||||||||
| Recurrent and Refractory or Primary | Count of Participants | Participants |
| ||||||||||||||||||
| Number of participants with CD30 Positive | Count of Participants | Participants |
| ||||||||||||||||||
| ALK Positive or Negative | This baseline characteristic was analyzed only in participants who had been diagnosed with ALCL. | Count of Participants | Participants |
| |||||||||||||||||
| Staging of Lymphoma | Lymphoma is classified with following stages. Stage 1; Lymphoma in only 1 group of lymph nodes. Stage 2; Lymphoma in 2 or more groups of lymph nodes. Stage 3; There are lymph nodes that contain lymphoma on both sides of the diaphragm. Stage 4; The most advanced stage of lymphoma and lymphoma cells have spread to at least 1 body organ outside the lymphatic system. | Count of Participants | Participants |
| |||||||||||||||||
| B Symptom | B symptom means participants have 1 or more these symptoms as following; Unintentional weight loss (more than 10% in the 6 months before you were diagnosed), Night sweats, Fevers (temperatures above 38 Celsius degrees). | Count of Participants | Participants |
| |||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status | Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. | Count of Participants | Participants |
| |||||||||||||||||
| Healthcare Category | Participants were categorized as outpatient and inpatient. | Count of Participants | Participants |
| |||||||||||||||||
| Predisposition to Hypersensitivity | The baseline characteristic was analyzed in participants who had a liability or tendency to suffer from hypersensitivity. | Count of Participants | Participants |
| |||||||||||||||||
| Hepatitis C Virus (HCV) Antibody Positive or Negative | Count of Participants | Participants |
| ||||||||||||||||||
| Hepatitis B Surface (HBs) Antigen Positive or Negative | Count of Participants | Participants |
| ||||||||||||||||||
| HBs Antibody Positive or Negative | Count of Participants | Participants |
| ||||||||||||||||||
| Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Positive or Negative | Count of Participants | Participants |
| ||||||||||||||||||
| Medical History of Lung Disorder | Medical history defined as a disease or a health condition for each participant before start of the study. Medical history was classified as congenital anomalies, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, GI disorders, hepatic and biliary disorders, renal disease and other medical history. Other medical history included all medical history except for those mentioned above. | Count of Participants | Participants |
| |||||||||||||||||
| Medical Complications of Lung Disorder | Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above. | Count of Participants | Participants |
| |||||||||||||||||
| Medical History of Malignant Tumor | Medical history defined as a disease or a health condition for each participant before start of the study. Medical history was classified as congenital anomalies, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, GI disorders, hepatic and biliary disorders, renal disease and other medical history. Other medical history included all medical history except for those mentioned above. | Count of Participants | Participants |
| |||||||||||||||||
| Medical Complications of Malignant Tumor | Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above. | Count of Participants | Participants |
| |||||||||||||||||
| Medical History (Other Than Lung Disorder or Malignant Tumor) | Medical history defined as a disease or a health condition for each participant before start of the study. Medical history was classified as congenital anomalies, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, GI disorders, hepatic and biliary disorders, renal disease and other medical history. Other medical history included all medical history except for those mentioned above. | Count of Participants | Participants |
| |||||||||||||||||
| Medical Complications (Other Than Lung Disorder or Malignant Tumor) | Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above. | Count of Participants | Participants |
| |||||||||||||||||
| Concomitant Hepatic Disorder | Count of Participants | Participants |
| ||||||||||||||||||
| Concomitant Renal Disorder | Count of Participants | Participants |
| ||||||||||||||||||
| Weight | Mean | Standard Deviation | Kilograms (kg) |
| |||||||||||||||||
| BMI | Body Mass Index = weight (kg)/[height (m)^2] | Mean | Standard Deviation | kg/meter (m)^2 |
| ||||||||||||||||
| Smoking Classification | Count of Participants | Participants |
| ||||||||||||||||||
| Drug Therapy before Start of Brentuximab Vedotin Administration | Count of Participants | Participants |
| ||||||||||||||||||
| Number of Regimens before Start of Brentuximab Vedotin Administration | Population Analysis Description: This baseline characteristic was analyzed only in participants who had drug therapy before start of Brentuximab Vedotin administration. | Mean | Standard Deviation | Number of Regimens |
| ||||||||||||||||
| Time in Days from Last Month of Previous Drug Therapy Regimen to First Cycle of Brentuximab Vendotin | Mean | Standard Deviation | Days |
| |||||||||||||||||
| Radiotherapy before Start of Brentuximab Vedotin Administration | Count of Participants | Participants |
| ||||||||||||||||||
| Time in Days from Last Month of Most Recent Radiotherapy to First Cycle of Brentuximab Vendotin | Population Analysis Description: This baseline characteristic was analyzed only in participants who had radiotherapy before start of Brentuximab Vedotin administration. The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Days |
| ||||||||||||||||
| Hematopoietic Stem Cell Transplantation before Start of Brentuximab Vedotin Administration | Count of Participants | Participants |
| ||||||||||||||||||
| Number of Participants Who Were Not Pregnant | This baseline characteristic was analyzed only in female participants. | 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 Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE) | Safety Analysis Set; The safety analysis set was defined as all participants who had the safety data defined on the protocol. | Posted | Count of Participants | Participants | Up to Week 48 or until discontinuation of treatment |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieve or Maintain Any Best Response | Best response is defined as the cumulative numbers of participants who achieve each level of best response including partial response (PR), complete response uncertain (CRu) (when no positron emission tomography [PET] data are available), and complete response (CR) after each cycle of treatment. Reported data are divided into 4 populations; Hodgkin's lymphoma (HL) participants with PET data, HL participants without PET data, anaplastic large cell lymphoma (ALCL) participants with PET data, and ALCL participants without PET data. PET is used in cancer diagnosis and treatment. | Efficacy assessment population; The efficacy assessment population was defined as participants who met the requirement of this study and had efficacy data available for analysis. The number analyzed is the number of participants with data available for analysis in the given timeframe. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to Week 48 or until discontinuation of treatment |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS is defined as the period from the start of therapy in standard medical care to the time when death (regardless of the cause of death) is confirmed. Reported data as OS was point estimates of 1 year survival rate for HL and ALCL participants. | Efficacy assessment population; The efficacy assessment population was defined as participants who met the requirement of this study and had efficacy data available for analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to Week 48 or until discontinuation of treatment |
|
|
Up to Week 48 or until discontinuation of treatment
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.
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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 | Brentuximab Vedotin Infusion | Intravenous infusion of 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) administered once every three weeks. Participants received interventions as part of routine medical care. | 51 | 284 | 97 | 284 | 238 | 284 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacteraemia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Epstein-Barr virus infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Meningitis aseptic | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Systemic candida | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Herpes zoster disseminated | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Peripheral T-cell lymphoma unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Gingival cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Anaplastic large-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Graft versus host disease | Immune system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Acute graft versus host disease | Immune system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Altered state of consciousness | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Clonic convulsion | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cardiomegaly | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Generalised erythema | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Renal disorder | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Brain herniation | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 27, 2017 | Feb 1, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| 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 |
|---|---|
| D000079963 | Brentuximab Vedotin |
| ID | Term |
|---|---|
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| >= 1 Year and < 3 Years |
|
| >= 3 Years and < 5 Years |
|
| >= 5 Years |
|
| Unknown |
|
| Others |
|
|
| ALK-Negative |
|
| Unknown |
|
| Stage 2 |
|
| Stage 3 |
|
| Stage 4 |
|
| Unknown |
|
| Had No B symptom |
|
| 1 |
|
| 2 |
|
| 3 |
|
| 4 |
|
| Inpatient |
|
| Unknown |
|
| Had No Predisposition to Hypersensitivity |
|
| Unknown |
|
|
| Unknown |
|
|
| Unknown |
|
|
| Unknown |
|
|
| Unknown |
|
| Had No Medical History |
|
| Had No Presence of Medical Complications |
|
| Had No Presence of Medical History |
|
| Had No Presence of Medical Complications |
|
| Had No Presence of Medical History |
|
| Had No Presence of Medical Complications |
|
|
|
|
| Ex-Smoker |
|
| Unknown |
|
|
|
| Had Autologous Transplantation |
|
| Had Allogeneic Transplantation |
|
| Had Autologous and Allogeneic Transplantation |
|
| Unknown |
|
|
|
|