Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004128-39 | EudraCT Number | ||
| U1111-1154-9784 | Registry Identifier | WHO | |
| REec-2014-0649 | Registry Identifier | REec | |
| 13/NI/0072 | Registry Identifier | NRES |
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| Name | Class |
|---|---|
| Takeda Development Center Americas, Inc. | INDUSTRY |
Not provided
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The purpose of this study is to assess the antitumor efficacy of single-agent brentuximab vedotin 1.8 mg/kg administered intravenously (IV) every 3 weeks, as measured by the overall objective response rate (ORR) in patients with r/r sALCL following at least 1 multiagent chemotherapy regimen (cyclophosphamide, doxorubicin hydrochloride [hydroxydaunorubicin], vincristine sulfate [Oncovin], and prednisone [CHOP] or equivalent multiagent chemotherapy regimens with curative intent).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brentuximab Vedotin 1.8 mg/kg | Experimental | Participants received brentuximab vedotin 1.8 mg/kg as a 30 minute intravenous (IV) infusion on Day 1 of each 3 week cycle. Participants with stable disease or better and without unacceptable toxicity were to receive a minimum of 8 cycles with the opportunity to receive a maximum of 16 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brentuximab vedotin | Drug | Brentuximab vedotin IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR was defined as the percentage of participants with a complete remission (CR) or partial remission (PR) by Independent Review Facility (IRF) response assessment according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites. | Up to data cut-off date: 04 May 2021 (Up to approximately 7 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) Per IRF | DOR was defined as the time between initial response and documented tumor progression in the subset of participants who achieved an objective response, either CR or PR. DOR per IRF was based upon the radiological assessment of measured lesions from an independent review facility. DOR was censored on the date of the last disease assessment documenting absence of progressive disease (PD) for participants who were lost to follow-up, withdrew consent, started a new anticancer therapy other than stem cell transplant (SCT), or discontinued treatment due to undocumented PD after the last adequate disease assessment. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZNA Stuivenberg | Antwerp | 2060 | Belgium | |||
| Cliniques Universitaires Saint-Luc |
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Not provided
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Participants with a diagnosis of relapsed or refractory systemic anaplastic large cell lymphoma were enrolled to receive brentuximab vedotin 1.8 milligrams per kilogram (mg/kg).
Participants took part in the study at various investigative sites globally from 23 January 2014 to 29 August 2024.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Brentuximab Vedotin 1.8 mg/kg | Participants received brentuximab vedotin 1.8 mg/kg as a 30 minute intravenous (IV) infusion on Day 1 of each 3 week cycle. Participants with stable disease or better and without unacceptable toxicity were to receive a minimum of 8 cycles with the opportunity to receive a maximum of 16 cycles. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 27, 2021 | Apr 27, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years) |
| Progression-free Survival (PFS) Per IRF | PFS is defined as the time from start of study treatment to first documentation of objective tumor progression or to death due to any cause, whichever comes first. PFS per IRF is based upon the radiological assessment from an independent review facility. | Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years) |
| Complete Remission Rate (CRR) Per IRF | CRR is defined as percentage of participants with CR. CR is defined as the disappearance of all evidence of disease. | Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years) |
| Overall Survival (OS) | OS is defined as the time from start of study treatment to date of death due to any cause. | Until disease progression, death, or end of study (Up to approximately 10.7 years) |
| Percentage of Participants Receiving Hematopoietic Stem Cell Transplant (SCT) Following Treatment With Brentuximab Vedotin | Until disease progression, death, or end of study (Up to approximately 10.7 years) |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Related TEAEs and TEAEs by Severity (Grade 3 or Higher) | An adverse event (AE): any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to medicinal product. TEAE was defined as any AE that started after the first administration of study drug in this continuation study. Serious TEAEs: defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect, or is a medically important event. | From first dose up to 30 days post last dose of study drug (Up to approximately 1 year) |
| Concentration of Serum Antibody-drug Conjugate (ADC) at the End of Infusion | Cycle 1, Day 1 and Cycle 3, Day 1 at the end of infusion |
| Concentration of Serum Total Antibody (TAb) Conjugate Plus Free Total Antibody | Cycle 1, Day 1 and Cycle 3, Day 1 at the end of infusion |
| Maximum Concentration for Unconjugated Drug- Monomethyl Auristatin E (MMAE) | Cycle 1, Day 1 and Cycle 3, Day 1 at the end of infusion |
| Percentage of Participants With Presence of Anti-Therapeutic Antibodies (ATA) and Neutralizing Antibodies (NAb) to Brentuximab Vedotin | Up to 16 cycles (each cycle = 21 days) |
| Brussels |
| 1200 |
| Belgium |
| Universitair Ziekenhuis Gent | Ghent | 9000 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| Clinical Hospital Centre Rijeka | Rijeka | 51000 | Croatia |
| Clinical Hospital Centre Zagreb | Zagreb | 10000 | Croatia |
| Clinical Hospital Dubrava | Zagreb | 10000 | Croatia |
| Fakultni nemocnice Brno | Brno | 625 00 | Czechia |
| Fakultni nemocnice Olomouc | Olomouc | 779 00 | Czechia |
| Fakultni nemocnice Kralovske Vinohrady | Prague | 100 34 | Czechia |
| Vseobecna fakultni nemocnice v Praze | Prague | 128 08 | Czechia |
| Semmelweis Egyetem | Budapest | 1083 | Hungary |
| Debreceni Egyetem Klinikai Kozpont | Debrecen | 4032 | Hungary |
| Pecsi Tudomanyegyetem | Pécs | 7624 | Hungary |
| Uniwersyteckie Centrum Kliniczne | Gdansk | 80-952 | Poland |
| Malopolskie Centrum Medyczne s.c. | Krakow | 30-510 | Poland |
| SPZOZ MSW zWarminsko-MazurskimCen.Onko.wOlsztynie | Olsztyn | 10-228 | Poland |
| Centrum Onkologii-Instytut im. M. Sklodowskiej Curie | Warsaw | 02-781 | Poland |
| Hospital de Braga | Braga | 4710-243 | Portugal |
| Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria | Lisbon | 1649-035 | Portugal |
| Centro Hospitalar do Porto, E.P.E. - Hospital de Santo Antonio | Porto | 4099-001 | Portugal |
| Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE | Porto | 4200-072 | Portugal |
| Policlinica de Diagnostic Rapid SA | Brasov | 500152 | Romania |
| Spitalul Clinic Colentina | Bucharest | 020125 | Romania |
| Spitalul Clinic Coltea | Bucharest | 030171 | Romania |
| Spitalul Clinic Judetean de Urgenta Targu Mures | Târgu Mureş | 540042 | Romania |
| ICO lHospitalet Hospital Duran i Reynals | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital Universitario Marques de Valdecilla | Santander | Cantabria | 39008 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario de Salamanca | Salamanca | 37007 | Spain |
| Ankara University Medical Faculty | Ankara | 06340 | Turkey (Türkiye) |
| Pamukkale Uni. Med. Fac. | Denizli | 20070 | Turkey (Türkiye) |
| Istanbul Bilim University Medical Fac. | Istanbul | 34200 | Turkey (Türkiye) |
| Ege University Medical Faculty | Izmir | 35040 | Turkey (Türkiye) |
| Dokuz Eylul University Faculty of Medicine | Izmir | 35340 | Turkey (Türkiye) |
| Erciyes University Medical Faculty | Kayseri | 38039 | Turkey (Türkiye) |
| Royal Cornwall Hospital | Truro | Cornwall | TR1 3LJ | United Kingdom |
| The Christie | Manchester | Greater Manchester | M20 4BX | United Kingdom |
| Birmingham Heartlands Hospital | Birmingham | West Midlands | B9 5SS | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Brentuximab Vedotin 1.8 mg/kg | Participants received brentuximab vedotin 1.8 mg/kg as a 30 minute IV infusion on Day 1 of each 3 week cycle. Participants with stable disease or better and without unacceptable toxicity were to receive a minimum of 8 cycles with the opportunity to receive a maximum of 16 cycles. |
| 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 |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| |||||||||||||||||||||||
| Height | Mean | Standard Deviation | centimeters (cm) |
| ||||||||||||||||||||||
| Weight | Mean | Standard Deviation | kilograms (kg) |
| ||||||||||||||||||||||
| Body Mass Index (BMI) | BMI= weight/height^2, where weight is in kilograms and height in meters. | Mean | Standard Deviation | kilograms per meter squared (kg/m^2) |
|
| 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 | Objective Response Rate (ORR) | ORR was defined as the percentage of participants with a complete remission (CR) or partial remission (PR) by Independent Review Facility (IRF) response assessment according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites. | Intent-to-Treat Population included all participants enrolled in the study. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to data cut-off date: 04 May 2021 (Up to approximately 7 years) |
|
|
| |||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) Per IRF | DOR was defined as the time between initial response and documented tumor progression in the subset of participants who achieved an objective response, either CR or PR. DOR per IRF was based upon the radiological assessment of measured lesions from an independent review facility. DOR was censored on the date of the last disease assessment documenting absence of progressive disease (PD) for participants who were lost to follow-up, withdrew consent, started a new anticancer therapy other than stem cell transplant (SCT), or discontinued treatment due to undocumented PD after the last adequate disease assessment. | Intent-to-Treat Population included all participants enrolled in the study. Only responders were analyzed for this outcome measure. | Posted | Median | 95% Confidence Interval | months | Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years) |
|
| ||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) Per IRF | PFS is defined as the time from start of study treatment to first documentation of objective tumor progression or to death due to any cause, whichever comes first. PFS per IRF is based upon the radiological assessment from an independent review facility. | Intent-to-Treat Population included all participants enrolled in the study. | Posted | Median | 95% Confidence Interval | months | Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years) |
|
| ||||||||||||||||||||||||||
| Secondary | Complete Remission Rate (CRR) Per IRF | CRR is defined as percentage of participants with CR. CR is defined as the disappearance of all evidence of disease. | Intent-to-Treat Population included all participants enrolled in the study. | Posted | Number | 95% Confidence Interval | percentage of participants | Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years) |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS is defined as the time from start of study treatment to date of death due to any cause. | Intent-to-Treat Population included all participants enrolled in the study. | Posted | Median | 95% Confidence Interval | months | Until disease progression, death, or end of study (Up to approximately 10.7 years) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Receiving Hematopoietic Stem Cell Transplant (SCT) Following Treatment With Brentuximab Vedotin | Intent-to-Treat Population included all participants enrolled in the study. | Posted | Number | percentage of participants | Until disease progression, death, or end of study (Up to approximately 10.7 years) |
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Related TEAEs and TEAEs by Severity (Grade 3 or Higher) | An adverse event (AE): any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to medicinal product. TEAE was defined as any AE that started after the first administration of study drug in this continuation study. Serious TEAEs: defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect, or is a medically important event. | Safety Population included all participants who received at least 1 dose of brentuximab vedotin. | Posted | Number | percentage of participants | From first dose up to 30 days post last dose of study drug (Up to approximately 1 year) |
| ||||||||||||||||||||||||||||
| Secondary | Concentration of Serum Antibody-drug Conjugate (ADC) at the End of Infusion | Pharmacokinetic (PK) Population included participants who received at least 1 dose of brentuximab vedotin and have PK concentration data available. Number analyzed are participants with data available for analyses at the given timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per liter (µg/L) | Cycle 1, Day 1 and Cycle 3, Day 1 at the end of infusion |
|
| |||||||||||||||||||||||||||
| Secondary | Concentration of Serum Total Antibody (TAb) Conjugate Plus Free Total Antibody | PK Population included participants who received at least 1 dose of brentuximab vedotin and have PK concentration data available. Number analyzed are participants with data available for analyses at the given timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/L | Cycle 1, Day 1 and Cycle 3, Day 1 at the end of infusion |
|
| |||||||||||||||||||||||||||
| Secondary | Maximum Concentration for Unconjugated Drug- Monomethyl Auristatin E (MMAE) | PK Population included participants who received at least 1 dose of brentuximab vedotin and have PK concentration data available. Number analyzed are participants with data available for analyses at the given timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/ml) | Cycle 1, Day 1 and Cycle 3, Day 1 at the end of infusion |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Presence of Anti-Therapeutic Antibodies (ATA) and Neutralizing Antibodies (NAb) to Brentuximab Vedotin | Immunogenicity-evaluable Population included all participants who received at least 1 dose of brentuximab vedotin and had a baseline and at least 1 post-baseline sample available for evaluation for the presence of ATA and NAb. Overall number analyzed are participants with data available for analyses at the given timepoint. | Posted | Number | percentage of participants | Up to 16 cycles (each cycle = 21 days) |
|
|
All-cause mortality: Throughout the study (Up to approximately 10.7 years); Serious and other adverse events: From first dose up to 30 days post last dose of study drug (up to approximately 1 year)
The Safety Population included all participants who received at least 1 dose of brentuximab vedotin.
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 | Brentuximab Vedotin 1.8 mg/kg | Participants received brentuximab vedotin 1.8 mg/kg as a 30 minute IV infusion on Day 1 of each 3 week cycle. Participants with stable disease or better and without unacceptable toxicity were to receive a minimum of 8 cycles with the opportunity to receive a maximum of 16 cycles. | 25 | 50 | 16 | 50 | 37 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal incarcerated hernia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Anaplastic large cell lymphoma T- and null-cell types | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Autonomic neuropathy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Central nervous system haemorrhage | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Epididymitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Invasive lobular breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Large intestinal haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | 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 | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 18, 2021 | Apr 27, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D012008 | Recurrence |
| D008228 | Lymphoma, Non-Hodgkin |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| D006402 | Hematologic Diseases |
| 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 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016399 | Lymphoma, T-Cell |
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
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Czech Republic |
|
| Hungary |
|
| Poland |
|
| Portugal |
|
| Romania |
|
| Spain |
|
| Turkey |
|
| United Kingdom |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|