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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT1080224999 | Registry Identifier | jRCT |
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The purpose of this survey is to examine the safety of adult patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL) (excluding anaplastic large cell lymphoma (ALCL)) and pediatric patients with relapsed or refractory CD30-positive PTCL or Hodgkin lymphoma (HL) in the actual use of on concomitant Brentuximab Vedotin in routine clinical practice.
The drug being tested in this survey is called Brentuximab Vedotin intravenous infusion 50 mg. This intravenous infusion is being tested to treat adult patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL) (excluding anaplastic large cell lymphoma (ALCL)) and pediatric patients with relapsed or refractory CD30-positive PTCL or Hodgkin lymphoma (HL).
This survey is an observational (non-interventional) study and will look at the safety of adult patients with relapsed or refractory CD30-positive PTCL (excluding ALCL) and pediatric patients with relapsed or refractory CD30-positive PTCL or HL in the routine clinical setting. The number of observed patients will be approximately 86 as total (80; Adult participants and 6; Pediatric participants).
This multi-center observational survey will be conducted in Japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brentuximab Vedotin 1.8 mg/kg (body weight) | The usual dosage for intravenous administration is 1.8 milligrams per kilograms (mg/kg) (body weight) as Brentuximab Vedotin (genetic recombination) once every three weeks (up to 12 months). The dose may be reduced appropriately according to the participant's condition. Participants receive interventions as part of routine medical care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brentuximab Vedotin (Genetical Recombination) | Drug | Brentuximab Vedotin Intravenous Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Percentage of participants who had one or more serious or non-serious adverse event of peripheral motor neuropathy or peripheral sensory neuropathy which were classified as peripheral neuropathy was reported. | Up to 12 Months |
| Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Peripheral Neuropathy | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug. Percentage of participants who had one or more serious or non-serious adverse drug reaction of peripheral motor neuropathy or peripheral sensory neuropathy which were classified as peripheral neuropathy was reported. | Up to 12 Months |
| Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Percentage of participants who had one or more serious or non-serious adverse event of febrile neutropenia, neutropenia, or neutrophil count decreased which were classified as myelosuppression was reported. | Up to 12 Months |
| Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug. Percentage of participants who had one or more serious or non-serious adverse drug reaction of febrile neutropenia, neutropenia, or neutrophil count decreased which were classified as myelosuppression was reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieve or Maintain Any Best Response for Adult Participants With PTCL-NOS, AITL, the Other PTCL, and Pediatric Participants With PTCL | Best response is defined as the cumulative numbers of participants who achieve each level of best response including complete response (CR), complete response uncertain (CRu) (when no positron emission tomography [PET] data are available), partial response (PR), Stable Disease (SD), and Progressive Disease (PD) after treatment. Best response was assessed by the antitumor response criteria for adult PTCL. Reported data are divided into 2 populations; with or without PET data for each group. PET was used in cancer diagnosis and treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with relapsed or refractory CD30-positive PTCL (excluding ALCL) and pediatric patients with relapsed or refractory CD30-positive PTCL or HL as part of routine medical care.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Takeda Selected Site | Tokyo | Japan |
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| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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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.
Adult participants with a historical diagnosis of relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL) (excluding anaplastic large cell lymphoma (ALCL)) and pediatric participants with a historical diagnosis of relapsed or refractory CD30-positive PTCL or Hodgkin lymphoma (HL) were enrolled. Participants received Brentuximab Vedotin Intravenous Infusion as part of a routine medical care.
Participants took part in the survey at 50 investigative sites in Japan, from 14 February 2020 to 13 December 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adult Participants With PTCL-NOS | Adult participants with peripheral T-cell lymphoma not otherwise specified (PTCL-NOS) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. 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 | Sep 12, 2023 | Jun 10, 2024 |
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| Up to 12 Months |
| Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Lung Disorder | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Percentage of participants who had one or more serious or non-serious adverse event of only interstitial lung disease which were classified as lung disorder was reported. | Up to 12 Months |
| Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Lung Disorder | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug. Percentage of participants who had one or more serious or non-serious adverse drug reaction of only interstitial lung disease which were classified as lung disorder was reported. | Up to 12 Months |
| Up to 12 Months |
| Percentage of Participants Who Achieve or Maintain Any Best Response for Adult Participants With ATLL | Best response is defined as the cumulative numbers of participants who achieve each level of best response including complete response (CR), partial response (PR), Stable Disease (SD), and Progressive Disease (PD) after treatment. Best response was assessed by the antitumor response criteria. | Up to 12 Months |
| Percentage of Participants Who Achieve or Maintain Any Best Response for Pediatric Participants With PTCL and HL | Best response is defined as the cumulative numbers of participants who achieve each level of best response including complete response (CR), complete response uncertain (CRu) (for PTCL), partial response (PR), Stable Disease (SD), and Progressive Disease (PD) after treatment. Best response was assessed by the Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) version of antitumor response criteria. | Up to 12 Months |
| Percentage of Participants Who Had One or More Adverse Event | AE is defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. | Up to 12 Months |
| Percentage of Participants Who Had One or More Adverse Drug Reaction | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug. | Up to 12 Months |
| FG001 | Adult Participants With AITL | Adult participants with angioimmunoblastic T-cell lymphoma (AITL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
| FG002 | Adult Participants With ATLL | Adult participants with adult T-cell leukemia/lymphoma (ATLL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
| FG003 | Adult Participants With Other PTCL | Adult participants with the other PTCL (peripheral T-cell lymphoma [PTCL] subtypes other than anaplastic large-cell lymphoma [ALCL] [not surveyed], PTCL-NOS, AITL, and ATLL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
| FG004 | Pediatric Participants With PTCL | Pediatric participants with peripheral T-cell lymphoma (PTCL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
| FG005 | Pediatric Participants With HL | Pediatric participants with Hodgkin lymphoma (HL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
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| ID | Title | Description |
|---|---|---|
| BG000 | Adult Participants With PTCL-NOS | Adult participants with peripheral T-cell lymphoma not otherwise specified (PTCL-NOS) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
| BG001 | Adult Participants With AITL | Adult participants with angioimmunoblastic T-cell lymphoma (AITL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
| BG002 | Adult Participants With ATLL | Adult participants with adult T-cell leukemia/lymphoma (ATLL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
| BG003 | Adult Participants With Other PTCL | Adult participants with the other PTCL (peripheral T-cell lymphoma [PTCL] subtypes other than anaplastic large-cell lymphoma [ALCL] [not surveyed], PTCL-NOS, AITL, and ATLL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
| BG004 | Pediatric Participants With PTCL | Pediatric participants with peripheral T-cell lymphoma (PTCL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
| BG005 | Pediatric Participants With HL | Pediatric participants with Hodgkin lymphoma (HL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Duration of Diagnosis of PTCL or HL | Mean duration between the first diagnosis of relapsed or refractory CD30 positive peripheral T-cell lymphoma (PTCL) or Hodgkin lymphoma (HL: pediatric participants only) and the first dose was reported. | Mean | Standard Deviation | Months |
| |||||||||
| Eastern Cooperative Oncology Group Performance Status | Eastern Cooperative Oncology Group performance status assess participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than [>] 50 percent [%] of waking hours), capable of all self-care, unable to carry out any work activities; 3=capable of only limited selfcare, confined to bed/chair >50% of waking hours; 4=completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5=dead. | Count of Participants | Participants |
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| Healthcare Category | Count of Participants | Participants |
| |||||||||||
| Medical Complications | 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 | 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. Unknown: Data could not be collected. | Count of Participants | Participants |
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| Smoking Classification | Unknown: Data could not be collected. | Count of Participants | Participants |
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| Weight | Mean | Standard Deviation | Kilograms (kg) |
| ||||||||||
| BMI | Body Mass Index = weight (kg)/[height (m)^2] | Mean | Standard Deviation | Kilogram (kg)/meter (m)^2 |
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| 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 | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Percentage of participants who had one or more serious or non-serious adverse event of peripheral motor neuropathy or peripheral sensory neuropathy which were classified as peripheral neuropathy was reported. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Count of Participants | Participants | Up to 12 Months |
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| Primary | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Peripheral Neuropathy | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug. Percentage of participants who had one or more serious or non-serious adverse drug reaction of peripheral motor neuropathy or peripheral sensory neuropathy which were classified as peripheral neuropathy was reported. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Count of Participants | Participants | Up to 12 Months |
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| Primary | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Percentage of participants who had one or more serious or non-serious adverse event of febrile neutropenia, neutropenia, or neutrophil count decreased which were classified as myelosuppression was reported. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Count of Participants | Participants | Up to 12 Months |
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| Primary | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug. Percentage of participants who had one or more serious or non-serious adverse drug reaction of febrile neutropenia, neutropenia, or neutrophil count decreased which were classified as myelosuppression was reported. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Count of Participants | Participants | Up to 12 Months |
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| Primary | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Lung Disorder | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Percentage of participants who had one or more serious or non-serious adverse event of only interstitial lung disease which were classified as lung disorder was reported. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Count of Participants | Participants | Up to 12 Months |
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| Primary | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Lung Disorder | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug. Percentage of participants who had one or more serious or non-serious adverse drug reaction of only interstitial lung disease which were classified as lung disorder was reported. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Count of Participants | Participants | Up to 12 Months |
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| Secondary | Percentage of Participants Who Achieve or Maintain Any Best Response for Adult Participants With PTCL-NOS, AITL, the Other PTCL, and Pediatric Participants With PTCL | Best response is defined as the cumulative numbers of participants who achieve each level of best response including complete response (CR), complete response uncertain (CRu) (when no positron emission tomography [PET] data are available), partial response (PR), Stable Disease (SD), and Progressive Disease (PD) after treatment. Best response was assessed by the antitumor response criteria for adult PTCL. Reported data are divided into 2 populations; with or without PET data for each group. PET was used in cancer diagnosis and treatment. | Efficacy analysis set: all participants who received at least one dose of protocol treatment without major protocol deviation. The number analyzed was the number of participants with data available for analysis. | Posted | Count of Participants | Participants | Up to 12 Months |
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| Secondary | Percentage of Participants Who Achieve or Maintain Any Best Response for Adult Participants With ATLL | Best response is defined as the cumulative numbers of participants who achieve each level of best response including complete response (CR), partial response (PR), Stable Disease (SD), and Progressive Disease (PD) after treatment. Best response was assessed by the antitumor response criteria. | Efficacy analysis set: all participants who received at least one dose of protocol treatment without major protocol deviation. The number analyzed was the number of participants with data available for analysis. | Posted | Count of Participants | Participants | Up to 12 Months |
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| Secondary | Percentage of Participants Who Achieve or Maintain Any Best Response for Pediatric Participants With PTCL and HL | Best response is defined as the cumulative numbers of participants who achieve each level of best response including complete response (CR), complete response uncertain (CRu) (for PTCL), partial response (PR), Stable Disease (SD), and Progressive Disease (PD) after treatment. Best response was assessed by the Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) version of antitumor response criteria. | Efficacy analysis set: all participants who received at least one dose of protocol treatment without major protocol deviation. The number analyzed was the number of participants with data available for analysis. | Posted | Count of Participants | Participants | Up to 12 Months |
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| Secondary | Percentage of Participants Who Had One or More Adverse Event | AE is defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Count of Participants | Participants | Up to 12 Months |
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| Secondary | Percentage of Participants Who Had One or More Adverse Drug Reaction | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Count of Participants | Participants | Up to 12 Months |
|
Up to 12 Months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey 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 | Adult Participants With PTCL-NOS | Adult participants with peripheral T-cell lymphoma not otherwise specified (PTCL-NOS) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. | 1 | 31 | 8 | 31 | 18 | 31 |
| EG001 | Adult Participants With AITL | Adult participants with angioimmunoblastic T-cell lymphoma (AITL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. | 5 | 35 | 12 | 35 | 14 | 35 |
| EG002 | Adult Participants With ATLL | Adult participants with adult T-cell leukemia/lymphoma (ATLL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. | 2 | 14 | 2 | 14 | 6 | 14 |
| EG003 | Adult Participants With Other PTCL | Adult participants with the other PTCL (peripheral T-cell lymphoma [PTCL] subtypes other than anaplastic large-cell lymphoma [ALCL] [not surveyed], PTCL-NOS, AITL, and ATLL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. | 0 | 6 | 1 | 6 | 4 | 6 |
| EG004 | Pediatric Participants With PTCL | Pediatric participants with peripheral T-cell lymphoma (PTCL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. | 0 | 4 | 3 | 4 | 2 | 4 |
| EG005 | Pediatric Participants With HL | Pediatric participants with Hodgkin lymphoma (HL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. | 0 | 4 | 2 | 4 | 2 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA/J v26.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA/J v26.0 | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | MedDRA/J v26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA/J v26.0 | Systematic Assessment |
| |
| Angioimmunoblastic T-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J v26.0 | Systematic Assessment |
| |
| Peripheral T-cell lymphoma unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J v26.0 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J v26.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA/J v26.0 | Systematic Assessment |
| |
| Myelosuppression | Blood and lymphatic system disorders | MedDRA/J v26.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA/J v26.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA/J v26.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA/J v26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA/J v26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA/J v26.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA/J v26.0 | Systematic Assessment |
| |
| Posterior reversible encephalopathy syndrome | Nervous system disorders | MedDRA/J v26.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA/J v26.0 | Systematic Assessment |
| |
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA/J v26.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA/J v26.0 | Systematic Assessment |
| |
| Dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA/J v26.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA/J v26.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA/J v26.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA/J v26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Otitis media acute | Infections and infestations | MedDRA/J v26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA/J v26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA/J v26.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA/J v26.0 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA/J v26.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA/J v26.0 | Systematic Assessment |
| |
| VIth nerve disorder | Nervous system disorders | MedDRA/J v26.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA/J v26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA/J v26.0 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA/J v26.0 | Systematic Assessment |
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| Pruritus allergic | Skin and subcutaneous tissue disorders | MedDRA/J v26.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA/J v26.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA/J v26.0 | Systematic Assessment |
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| Blood lactate dehydrogenase increased | Investigations | MedDRA/J v26.0 | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA/J v26.0 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA/J v26.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA/J v26.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA/J v26.0 | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA/J v26.0 | Systematic Assessment |
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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 | Nov 21, 2023 | Jun 10, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| 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
|
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| Non-Serious: Peripheral Motor Neuropathy |
|
| Serious: Peripheral Sensory Neuropathy |
|
| Non-Serious: Peripheral Sensory Neuropathy |
|
| OG002 | Adult Participants With ATLL | Adult participants with adult T-cell leukemia/lymphoma (ATLL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
| OG003 | Adult Participants With Other PTCL | Adult participants with the other PTCL (peripheral T-cell lymphoma [PTCL] subtypes other than anaplastic large-cell lymphoma [ALCL] [not surveyed], PTCL-NOS, AITL, and ATLL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
| OG004 | Pediatric Participants With PTCL | Pediatric participants with peripheral T-cell lymphoma (PTCL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
| OG005 | Pediatric Participants With HL | Pediatric participants with Hodgkin lymphoma (HL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
|
|
| OG002 | Adult Participants With ATLL | Adult participants with adult T-cell leukemia/lymphoma (ATLL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
| OG003 | Adult Participants With Other PTCL | Adult participants with the other PTCL (peripheral T-cell lymphoma [PTCL] subtypes other than anaplastic large-cell lymphoma [ALCL] [not surveyed], PTCL-NOS, AITL, and ATLL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
| OG004 | Pediatric Participants With PTCL | Pediatric participants with peripheral T-cell lymphoma (PTCL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
| OG005 | Pediatric Participants With HL | Pediatric participants with Hodgkin lymphoma (HL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
|
|
| OG002 | Adult Participants With ATLL | Adult participants with adult T-cell leukemia/lymphoma (ATLL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
| OG003 | Adult Participants With Other PTCL | Adult participants with the other PTCL (peripheral T-cell lymphoma [PTCL] subtypes other than anaplastic large-cell lymphoma [ALCL] [not surveyed], PTCL-NOS, AITL, and ATLL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
| OG004 | Pediatric Participants With PTCL | Pediatric participants with peripheral T-cell lymphoma (PTCL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
| OG005 | Pediatric Participants With HL | Pediatric participants with Hodgkin lymphoma (HL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
|
|
| OG002 | Adult Participants With ATLL | Adult participants with adult T-cell leukemia/lymphoma (ATLL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
| OG003 | Adult Participants With Other PTCL | Adult participants with the other PTCL (peripheral T-cell lymphoma [PTCL] subtypes other than anaplastic large-cell lymphoma [ALCL] [not surveyed], PTCL-NOS, AITL, and ATLL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
| OG004 | Pediatric Participants With PTCL | Pediatric participants with peripheral T-cell lymphoma (PTCL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
| OG005 | Pediatric Participants With HL | Pediatric participants with Hodgkin lymphoma (HL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
|
|
| OG002 | Adult Participants With ATLL | Adult participants with adult T-cell leukemia/lymphoma (ATLL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
| OG003 | Adult Participants With Other PTCL | Adult participants with the other PTCL (peripheral T-cell lymphoma [PTCL] subtypes other than anaplastic large-cell lymphoma [ALCL] [not surveyed], PTCL-NOS, AITL, and ATLL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
| OG004 | Pediatric Participants With PTCL | Pediatric participants with peripheral T-cell lymphoma (PTCL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
| OG005 | Pediatric Participants With HL | Pediatric participants with Hodgkin lymphoma (HL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
|
|
Adult participants with angioimmunoblastic T-cell lymphoma (AITL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.
| OG002 | Adult Participants With Other PTCL | Adult participants with the other PTCL (peripheral T-cell lymphoma [PTCL] subtypes other than anaplastic large-cell lymphoma [ALCL] [not surveyed], PTCL-NOS, AITL, and ATLL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
| OG003 | Pediatric Participants With PTCL | Pediatric participants with peripheral T-cell lymphoma (PTCL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
|
|
|
|
|
| Adult Participants With ATLL |
Adult participants with adult T-cell leukemia/lymphoma (ATLL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
| OG003 | Adult Participants With Other PTCL | Adult participants with the other PTCL (peripheral T-cell lymphoma [PTCL] subtypes other than anaplastic large-cell lymphoma [ALCL] [not surveyed], PTCL-NOS, AITL, and ATLL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
| OG004 | Pediatric Participants With PTCL | Pediatric participants with peripheral T-cell lymphoma (PTCL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
| OG005 | Pediatric Participants With HL | Pediatric participants with Hodgkin lymphoma (HL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
|
|
| OG002 | Adult Participants With ATLL | Adult participants with adult T-cell leukemia/lymphoma (ATLL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
| OG003 | Adult Participants With Other PTCL | Adult participants with the other PTCL (peripheral T-cell lymphoma [PTCL] subtypes other than anaplastic large-cell lymphoma [ALCL] [not surveyed], PTCL-NOS, AITL, and ATLL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
| OG004 | Pediatric Participants With PTCL | Pediatric participants with peripheral T-cell lymphoma (PTCL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
| OG005 | Pediatric Participants With HL | Pediatric participants with Hodgkin lymphoma (HL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care. |
|
|
| Title | Measurements |
|---|---|
|