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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000232-10 | EudraCT Number | ||
| U1111-1154-2250 | Registry Identifier | WHO | |
| NMRR-13-1246-18099 | Registry Identifier | NMRR | |
| REec-2014-0619 | Registry Identifier | REec |
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This phase 4, single-arm, open-label, multicenter study is designed to evaluate the efficacy and safety of brentuximab vedotin as a single agent in adult participants with histologically confirmed CD30+ relapsed or refractory classical Hodgkin Lymphoma who have not received a prior stem cell transplantation (SCT) and are considered to be not suitable for SCT or multiagent chemotherapy at the time of study entry.
The drug being tested in this study is called brentuximab vedotin. Brentuximab vedotin is being tested to treat people who have relapsed or refractory Hodgkin Lymphoma. This study will look at the overall response of people who took brentuximab vedotin.
The study will enroll 60 patients. Participants received:
• Brentuximab vedotin 1.8 mg/kg
This multicenter trial is being conducted worldwide. The overall time to participate in this study is approximately 6 to 7 years. Participants will make multiple visits to the clinic, and will be contacted by telephone every 3 months for 18 months after the end of treatment (EOT) for follow-up assessment of overall survival and then every 6 months until death, study closure, or 5 years after enrollment of the last participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brentuximab Vedotin 1.8 mg/kg | Experimental | Brentuximab vedotin 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 in every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose could be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic, hematologic toxicity or peripheral neuropathy to brentuximab vedotin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brentuximab Vedotin | Drug | Brentuximab vedotin IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Objective response rate is defined as the percentage of participants with complete remission (CR) or partial remission (PR) as assessed by an independent review facility (IRF) using 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. | Baseline until disease progression, death or end of study (EOS) (Up to 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) | DOR is defined as the time in months from the date of first documentation of a CR or PR response to the date of first documentation of tumor progression or progressive disease (PD) per IRF assessment according to IWG criteria. CR is defined as the disappearance of all evidence of disease. PR is defined as regression of measurable disease and no new sites. PD is defined as any new lesion or increase by >50% of previously involved sites from nadir. |
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Inclusion Criteria:
Each participant must meet all of the following inclusion criteria to be enrolled in the study:
Male or female participants 18 years or older, with relapsed or refractory classical Hodgkin lymphoma (HL), who have previously received at least 1 prior systemic chemotherapeutic regimen
Not suitable for stem cell transplantation (SCT) or multiagent chemotherapy, according to 1 of the following criteria:
Bidimensional measurable disease
An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Female participants who are postmenopausal for at least 1 year before the screening visit, surgically sterile, or agree to practice 2 effective methods of contraception at the same time, or agree to practice true abstinence.
Male participants who agree to practice effective barrier contraception during the entire study treatment period through 6 months after the last dose of study drug or agree to practice true abstinence.
Clinical laboratory values as specified in the study protocol.
Exclusion Criteria:
Participants who meet any of the following exclusion criteria are not to be enrolled in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Millennium Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prague | Prague | Czechia | ||||
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.
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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 Hodgkin Lymphoma were enrolled in 1 treatment group to receive brentuximab vedotin 1.8 mg/kg, 30-minute intravenous (IV) infusion on Day 1 of every 3-week cycle and were followed for progression free survival (PFS) and overall survival (OS) up to the End of study (approximately 6 years).
Participants took part in the study at 18 investigative sites in Czech Republic, Germany, Malaysia, Poland, Spain, Thailand and Turkey, from 14 March 2014 to 12 March 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brentuximab Vedotin 1.8 mg/kg | Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose could be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin. |
| 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 | Jul 11, 2013 | Mar 10, 2021 |
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| From first documented complete or partial remission until disease progression (Up to 24 months) |
| Progression Free Survival (PFS) | PFS is defined as time in months from start of study treatment to first documentation of objective tumor progression per IRF assessment or up to death due to any cause, whichever occurs first. | Baseline until disease progression, death or end of treatment (EOT), and then every 3 months up to approximately 6 years |
| Complete Remission Rate | Complete remission rate is defined as percentage of participants with CR per IRF response assessment based on IWG criteria are reported. CR is defined as the disappearance of all evidence of disease. | Baseline until disease progression, death or EOS (Up to approximately 6 years) |
| Duration of Complete Remission | Duration of CR is defined as the time from the date of first documentation of a CR or to the date of first documentation of tumor progression or progressive disease (PD) per IRF assessment according to IWG criteria. CR is defined as the disappearance of all evidence of disease and PD is defined as any new lesion or increase by >50% of previously involved sites from nadir. | From first documented complete remission until disease progression (up to approximately 6 years) |
| Overall Survival (OS) | OS is the time in months from start of study treatment to date of death due to any cause. | Every 3 months for 18 months after EOT, thereafter, every 6 months until the sooner of death, study closure, or 5 years after enrollment of the last participant (up to approximately 6 years) |
| Percentage of Participants Who Received Hematopoietic SCT | Baseline up to EOS (up to approximately 6 years) |
| Number of Participants With Adverse Events (AEs), Drug-Related AEs, Grade 3 or Higher AEs, Serious Adverse Events (SAEs), Drug-Related SAEs and Grade 3 or Higher SAEs | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE a serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. AE severity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. AEs Grade 3 and higher are severe. | From first dose through 30 days after the last dose of study medication (Up to 24 months) |
| Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs | Abnormal clinical laboratory values (serum chemistry and hematology) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention. | From the first dose through 30 days after the last dose of study medication (Up to 24 months) |
| Antibody-drug Conjugate (ADC) Serum Concentrations | Blood samples were collected and tested for serum concentrations of brentuximab vedotin antibody-drug conjugate. | Cycle 1 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 2 pre-dose and 10 minutes post-dose; Cycle 3 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 4 to 16 pre-dose and 10 minutes post-dose; EOT (Up to 24 months) |
| Serum Concentration of Total Antibodies (Conjugated and Unconjugated) | Blood samples were collected and tested for conjugated and unconjugated antibodies. | Cycle 1 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 2 pre-dose and 10 minutes post-dose; Cycle 3 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 4 to 16 pre-dose and 10 minutes post-dose; EOT (Up to 24 months) |
| Monomethyl Auristatin E (MMAE) Serum Concentrations | Blood samples were collected and tested for MMAE serum concentrations. | Cycle 1 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 2 pre-dose and 10 minutes post-dose; Cycle 3 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 4 to 16 pre-dose and 10 minutes post-dose; EOT (Up to 24 months) |
| Number of Participants With Antitherapeutic Antibodies (ATA) | Blood samples were collected to assess the immunogenicity of brentuximab vedotin (ATA development) using a laboratory test. Confirmed ATA-positive response was categorized as transient (defined as 1 or 2 post-Baseline confirmed ATA-positive responses) and persistent (defined as more than 2 post-Baseline confirmed ATA positive responses) and neutralizing ATA (nATA) status. The confirmed ATA-positive samples were assessed for ATA titer and delineated into having high or low titers. | Day 1 of every 3-week cycle up to 16 cycles and EOT (Up to 24 months) |
| Brno |
| Czechia |
| Heidelberg | Baden-Wurttemberg | Germany |
| Cologne | Germany |
| George Town | Pulau Pinang | Malaysia |
| Ampang | Selangor | Malaysia |
| Kuala Lumpur | Malaysia |
| Gdansk | Poland |
| Krakow | Poland |
| Warsaw | Poland |
| Pamplona | Navarre | Spain |
| Madrid | Spain |
| Bangkoknoi | Bangkok | Thailand |
| Patumwan | Bangkok | Thailand |
| Ratchathewi | Bangkok | Thailand |
| Izmir | Bornova | Turkey (Türkiye) |
| Ankara | Turkey (Türkiye) |
| Izmir | Turkey (Türkiye) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Population included all enrolled participants who received at least 1 dose of brentuximab vedotin.
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| ID | Title | Description |
|---|---|---|
| BG000 | Brentuximab Vedotin 1.8 mg/kg | Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose could be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin. |
| 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 |
| |||||||||||||||||||||||
| Baseline Height | Mean | Standard Deviation | cm |
| ||||||||||||||||||||||
| Baseline Weight | Mean | Standard Deviation | kg |
| ||||||||||||||||||||||
| Body Mass Index (BMI) | BMI = weight (kg)/[height (m)^2] | Mean | Standard Deviation | 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) | Objective response rate is defined as the percentage of participants with complete remission (CR) or partial remission (PR) as assessed by an independent review facility (IRF) using 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 (ITT) Population included all participants who were enrolled in the study. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline until disease progression, death or end of study (EOS) (Up to 24 months) |
|
|
| |||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | DOR is defined as the time in months from the date of first documentation of a CR or PR response to the date of first documentation of tumor progression or progressive disease (PD) per IRF assessment according to IWG criteria. CR is defined as the disappearance of all evidence of disease. PR is defined as regression of measurable disease and no new sites. PD is defined as any new lesion or increase by >50% of previously involved sites from nadir. | ITT Population included all participants who were enrolled in the study. DOR was censored on the date of last disease assessment documenting absence of PD for those that were lost to follow-up, withdrew consent, started a new anticancer therapy other than stem cell transplantation (SCT), or discontinued treatment due to undocumented PD after last disease assessment. All responders were evaluated in this outcome measure. | Posted | Median | 95% Confidence Interval | months | From first documented complete or partial remission until disease progression (Up to 24 months) |
| |||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | PFS is defined as time in months from start of study treatment to first documentation of objective tumor progression per IRF assessment or up to death due to any cause, whichever occurs first. | ITT Population included all participants who were enrolled in the study. For a participant that has not progressed and has not died, PFS is censored at the last response assessment that is SD or better. | Posted | Median | 95% Confidence Interval | months | Baseline until disease progression, death or end of treatment (EOT), and then every 3 months up to approximately 6 years |
|
| ||||||||||||||||||||||||||
| Secondary | Complete Remission Rate | Complete remission rate is defined as percentage of participants with CR per IRF response assessment based on IWG criteria are reported. CR is defined as the disappearance of all evidence of disease. | ITT Population included all participants who were enrolled in the study. In the absence of confirmation of death, survival time is censored at the last date the participant is known to be alive, including study closure. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline until disease progression, death or EOS (Up to approximately 6 years) |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Complete Remission | Duration of CR is defined as the time from the date of first documentation of a CR or to the date of first documentation of tumor progression or progressive disease (PD) per IRF assessment according to IWG criteria. CR is defined as the disappearance of all evidence of disease and PD is defined as any new lesion or increase by >50% of previously involved sites from nadir. | ITT Population included all participants who were enrolled in the study. Duration of complete remission was censored on the date of last disease assessment documenting absence of PD for those that were lost to follow-up, withdrew consent, started a new anticancer therapy other than SCT, or discontinued treatment due to undocumented PD after last disease assessment. Only participants with CR were analyzed for this outcome measure. | Posted | Median | 95% Confidence Interval | months | From first documented complete remission until disease progression (up to approximately 6 years) |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS is the time in months from start of study treatment to date of death due to any cause. | ITT Population included all participants who were enrolled in the study. In the absence of confirmation of death, survival time is censored at the last date the participant is known to be alive, including study closure. | Posted | Median | 95% Confidence Interval | months | Every 3 months for 18 months after EOT, thereafter, every 6 months until the sooner of death, study closure, or 5 years after enrollment of the last participant (up to approximately 6 years) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Received Hematopoietic SCT | ITT Population included all participants who were enrolled in the study. | Posted | Number | percentage of participants | Baseline up to EOS (up to approximately 6 years) |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs), Drug-Related AEs, Grade 3 or Higher AEs, Serious Adverse Events (SAEs), Drug-Related SAEs and Grade 3 or Higher SAEs | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE a serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. AE severity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. AEs Grade 3 and higher are severe. | Safety Population was defined as all enrolled participants who received at least one dose of brentuximab vedotin. | Posted | Count of Participants | Participants | From first dose through 30 days after the last dose of study medication (Up to 24 months) |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs | Abnormal clinical laboratory values (serum chemistry and hematology) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention. | Safety Population was defined as all enrolled participants who received at least one dose of brentuximab vedotin. | Posted | Count of Participants | Participants | From the first dose through 30 days after the last dose of study medication (Up to 24 months) |
|
| |||||||||||||||||||||||||||
| Secondary | Antibody-drug Conjugate (ADC) Serum Concentrations | Blood samples were collected and tested for serum concentrations of brentuximab vedotin antibody-drug conjugate. | Pharmacokinetic (PK)-evaluable Population was defined as participants with sufficient dosing and PK data to reliably estimate PK parameters. Number analyzed is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | ng/mL | Cycle 1 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 2 pre-dose and 10 minutes post-dose; Cycle 3 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 4 to 16 pre-dose and 10 minutes post-dose; EOT (Up to 24 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Serum Concentration of Total Antibodies (Conjugated and Unconjugated) | Blood samples were collected and tested for conjugated and unconjugated antibodies. | PK-evaluable Population was defined as participants with sufficient dosing and PK data to reliably estimate PK parameters. Number analyzed is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | ng/mL | Cycle 1 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 2 pre-dose and 10 minutes post-dose; Cycle 3 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 4 to 16 pre-dose and 10 minutes post-dose; EOT (Up to 24 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Monomethyl Auristatin E (MMAE) Serum Concentrations | Blood samples were collected and tested for MMAE serum concentrations. | PK-evaluable Population was defined as participants with sufficient dosing and PK data to reliably estimate PK parameters. Number analyzed is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | pg/mL | Cycle 1 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 2 pre-dose and 10 minutes post-dose; Cycle 3 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 4 to 16 pre-dose and 10 minutes post-dose; EOT (Up to 24 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Antitherapeutic Antibodies (ATA) | Blood samples were collected to assess the immunogenicity of brentuximab vedotin (ATA development) using a laboratory test. Confirmed ATA-positive response was categorized as transient (defined as 1 or 2 post-Baseline confirmed ATA-positive responses) and persistent (defined as more than 2 post-Baseline confirmed ATA positive responses) and neutralizing ATA (nATA) status. The confirmed ATA-positive samples were assessed for ATA titer and delineated into having high or low titers. | Participants from the Safety Population, all enrolled participants who received at least one dose of brentuximab vedotin, with data available for analysis. | Posted | Count of Participants | Participants | Day 1 of every 3-week cycle up to 16 cycles and EOT (Up to 24 months) |
|
|
First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
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.
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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 1.8 mg/kg | Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose could be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin. | 22 | 60 | 11 | 60 | 51 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Serum sickness-like reaction | Immune system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Autoimmune thyroiditis | Endocrine disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Catheter site inflammation | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Extravasation | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Soft tissue inflammation | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Temperature regulation disorder | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vaccination site pain | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Breast cellulitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Coxsackie viral infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Klebsiella infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Autonomic neuropathy | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Facial nerve disorder | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Renal tubular disorder | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Genital haemorrhage | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | 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 | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 22, 2016 | Mar 10, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| D008223 | Lymphoma |
| D012008 | Recurrence |
| D006402 | Hematologic Diseases |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016393 | Lymphoma, B-Cell |
| D016399 | Lymphoma, T-Cell |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008228 | Lymphoma, Non-Hodgkin |
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 |
|
| Malaysia |
|
| Poland |
|
| Spain |
|
| Thailand |
|
| Turkey |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
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| Participants |
|
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