Pediatric Hodgkin Lymphoma, Peripheral T Cell Lymphoma
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Brentuximab Vedotin Intravenous Infusion
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Participants with relapsed or refractory lymphoma. 2. CD30-positive participants. 3. Participants who receive study drug after obtaining approval of CD30-positive PTCL indication of study drug.
Exclusion criteria
1. Participants with a history of severe hypersensitivity to Brentuximab Vedotin. 2. Participants taking bleomycin hydrochloride treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Lung Disorder | Up to 12 Months | 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. |
| Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy | Up to 12 Months | 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. |
| Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Peripheral Neuropathy | Up to 12 Months | 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. |
| Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | Up to 12 Months | 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. |
| Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | Up to 12 Months | 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. |
| Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Lung Disorder | Up to 12 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieve or Maintain Any Best Response for Adult Participants With ATLL | Up to 12 Months | 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. |
| Percentage of Participants Who Achieve or Maintain Any Best Response for Pediatric Participants With PTCL and HL | Up to 12 Months | 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. |
| Percentage of Participants Who Had One or More Adverse Event | Up to 12 Months | 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. |
| Percentage of Participants Who Had One or More Adverse Drug Reaction | Up to 12 Months | 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 Achieve or Maintain Any Best Response for Adult Participants With PTCL-NOS, AITL, the Other PTCL, and Pediatric Participants With PTCL | Up to 12 Months | 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. |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the survey at 50 investigative sites in Japan, from 14 February 2020 to 13 December 2023.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 31 |
| 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. | 35 |
| 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. | 14 |
| 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. | 6 |
| 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. | 4 |
| 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. | 4 |
| Total | 94 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Adult Participants With PTCL-NOS | Adult Participants With AITL | Adult Participants With ATLL | Adult Participants With Other PTCL | Pediatric Participants With PTCL | Pediatric Participants With HL | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 69.9 Years STANDARD_DEVIATION 12.01 | 72.6 Years STANDARD_DEVIATION 9.23 | 68.0 Years STANDARD_DEVIATION 12.82 | 49.2 Years STANDARD_DEVIATION 23.52 | 12.3 Years STANDARD_DEVIATION 3.69 | 12.0 Years STANDARD_DEVIATION 4.24 | 64.4 Years STANDARD_DEVIATION 20.47 |
| BMI | 22.20 Kilogram (kg)/meter (m)^2 STANDARD_DEVIATION 3.536 | 21.85 Kilogram (kg)/meter (m)^2 STANDARD_DEVIATION 3.764 | 20.86 Kilogram (kg)/meter (m)^2 STANDARD_DEVIATION 4.059 | 22.43 Kilogram (kg)/meter (m)^2 STANDARD_DEVIATION 5.033 | 18.08 Kilogram (kg)/meter (m)^2 STANDARD_DEVIATION 2.981 | 20.73 Kilogram (kg)/meter (m)^2 STANDARD_DEVIATION 5.239 | 21.65 Kilogram (kg)/meter (m)^2 STANDARD_DEVIATION 3.858 |
| Duration of Diagnosis of PTCL or HL | 35.7 Months STANDARD_DEVIATION 42.96 | 31.0 Months STANDARD_DEVIATION 36.3 | 37.2 Months STANDARD_DEVIATION 64.9 | 5.7 Months STANDARD_DEVIATION 8.57 | 5.0 Months STANDARD_DEVIATION 2.94 | 18.3 Months STANDARD_DEVIATION 12.69 | 30.2 Months STANDARD_DEVIATION 42.01 |
| Eastern Cooperative Oncology Group Performance Status Scale = 0 | 11 Participants | 11 Participants | 5 Participants | 3 Participants | 1 Participants | 4 Participants | 35 Participants |
| Eastern Cooperative Oncology Group Performance Status Scale = 1 | 13 Participants | 17 Participants | 6 Participants | 3 Participants | 2 Participants | 0 Participants | 41 Participants |
| Eastern Cooperative Oncology Group Performance Status Scale = 2 | 5 Participants | 5 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 11 Participants |
| Eastern Cooperative Oncology Group Performance Status Scale = 3 | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 5 Participants |
| Eastern Cooperative Oncology Group Performance Status Scale = 4 | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Healthcare Category Inpatient | 24 Participants | 33 Participants | 11 Participants | 5 Participants | 4 Participants | 2 Participants | 79 Participants |
| Healthcare Category Outpatient | 7 Participants | 2 Participants | 3 Participants | 1 Participants | 0 Participants | 2 Participants | 15 Participants |
| Medical Complications Had Medical Complications | 20 Participants | 27 Participants | 8 Participants | 5 Participants | 2 Participants | 2 Participants | 64 Participants |
| Medical Complications Had No Medical Complications | 11 Participants | 8 Participants | 6 Participants | 1 Participants | 2 Participants | 2 Participants | 30 Participants |
| Medical History Had Medical History | 13 Participants | 13 Participants | 3 Participants | 2 Participants | 0 Participants | 1 Participants | 32 Participants |
| Medical History Had No Medical History | 18 Participants | 21 Participants | 11 Participants | 4 Participants | 4 Participants | 3 Participants | 61 Participants |
| Medical History Unknown | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race and Ethnicity Not Collected | — | — | — | — | — | — | 0 Participants |
| Region of Enrollment Japan | 31 Participants | 35 Participants | 14 Participants | 6 Participants | 4 Participants | 4 Participants | 94 Participants |
| Sex: Female, Male Female | 13 Participants | 19 Participants | 9 Participants | 4 Participants | 1 Participants | 2 Participants | 48 Participants |
| Sex: Female, Male Male | 18 Participants | 16 Participants | 5 Participants | 2 Participants | 3 Participants | 2 Participants | 46 Participants |
| Smoking Classification Current Smoker | 1 Participants | 3 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 5 Participants |
| Smoking Classification Ex-Smoker | 12 Participants | 9 Participants | 7 Participants | 1 Participants | 0 Participants | 0 Participants | 29 Participants |
| Smoking Classification Never Smoked | 12 Participants | 14 Participants | 6 Participants | 4 Participants | 4 Participants | 4 Participants | 44 Participants |
| Smoking Classification Unknown | 6 Participants | 9 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 16 Participants |
| Weight | 57.65 Kilograms (kg) STANDARD_DEVIATION 11.031 | 54.01 Kilograms (kg) STANDARD_DEVIATION 12.328 | 52.14 Kilograms (kg) STANDARD_DEVIATION 10.082 | 56.77 Kilograms (kg) STANDARD_DEVIATION 12.517 | 41.75 Kilograms (kg) STANDARD_DEVIATION 7.677 | 47.00 Kilograms (kg) STANDARD_DEVIATION 21.386 | 54.29 Kilograms (kg) STANDARD_DEVIATION 12.167 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 31 | 5 / 35 | 2 / 14 | 0 / 6 | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 18 / 31 | 14 / 35 | 6 / 14 | 4 / 6 | 2 / 4 | 2 / 4 |
| serious Total, serious adverse events | 8 / 31 | 12 / 35 | 2 / 14 | 1 / 6 | 3 / 4 | 2 / 4 |
Outcome results
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.
Time frame: Up to 12 Months
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adult Participants With PTCL-NOS | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Lung Disorder | Serious: Interstitial Lung Disease | 1 Participants |
| Adult Participants With PTCL-NOS | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Lung Disorder | Non-Serious: Interstitial Lung Disease | 0 Participants |
| Adult Participants With AITL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Lung Disorder | Serious: Interstitial Lung Disease | 1 Participants |
| Adult Participants With AITL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Lung Disorder | Non-Serious: Interstitial Lung Disease | 0 Participants |
| Adult Participants With ATLL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Lung Disorder | Serious: Interstitial Lung Disease | 0 Participants |
| Adult Participants With ATLL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Lung Disorder | Non-Serious: Interstitial Lung Disease | 0 Participants |
| Adult Participants With Other PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Lung Disorder | Serious: Interstitial Lung Disease | 0 Participants |
| Adult Participants With Other PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Lung Disorder | Non-Serious: Interstitial Lung Disease | 0 Participants |
| Pediatric Participants With PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Lung Disorder | Serious: Interstitial Lung Disease | 0 Participants |
| Pediatric Participants With PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Lung Disorder | Non-Serious: Interstitial Lung Disease | 0 Participants |
| Pediatric Participants With HL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Lung Disorder | Serious: Interstitial Lung Disease | 0 Participants |
| Pediatric Participants With HL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Lung Disorder | Non-Serious: Interstitial Lung Disease | 0 Participants |
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.
Time frame: Up to 12 Months
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adult Participants With PTCL-NOS | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | Serious: Febrile Neutropenia | 1 Participants |
| Adult Participants With PTCL-NOS | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | Non-Serious: Febrile Neutropenia | 0 Participants |
| Adult Participants With PTCL-NOS | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | Serious: Neutropenia | 1 Participants |
| Adult Participants With PTCL-NOS | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | Non-Serious: Neutropenia | 0 Participants |
| Adult Participants With PTCL-NOS | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | Serious: Neutrophil Count Decreased | 3 Participants |
| Adult Participants With PTCL-NOS | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | Non-Serious: Neutrophil Count Decreased | 9 Participants |
| Adult Participants With AITL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | Non-Serious: Febrile Neutropenia | 0 Participants |
| Adult Participants With AITL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | Non-Serious: Neutropenia | 0 Participants |
| Adult Participants With AITL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | Non-Serious: Neutrophil Count Decreased | 3 Participants |
| Adult Participants With AITL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | Serious: Febrile Neutropenia | 0 Participants |
| Adult Participants With AITL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | Serious: Neutropenia | 0 Participants |
| Adult Participants With AITL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | Serious: Neutrophil Count Decreased | 0 Participants |
| Adult Participants With ATLL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | Non-Serious: Neutrophil Count Decreased | 2 Participants |
| Adult Participants With ATLL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | Serious: Neutrophil Count Decreased | 0 Participants |
| Adult Participants With ATLL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | Non-Serious: Neutropenia | 0 Participants |
| Adult Participants With ATLL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | Serious: Neutropenia | 0 Participants |
| Adult Participants With ATLL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | Serious: Febrile Neutropenia | 0 Participants |
| Adult Participants With ATLL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | Non-Serious: Febrile Neutropenia | 0 Participants |
| Adult Participants With Other PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | Non-Serious: Neutropenia | 0 Participants |
| Adult Participants With Other PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | Non-Serious: Febrile Neutropenia | 0 Participants |
| Adult Participants With Other PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | Serious: Neutropenia | 0 Participants |
| Adult Participants With Other PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | Non-Serious: Neutrophil Count Decreased | 0 Participants |
| Adult Participants With Other PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | Serious: Neutrophil Count Decreased | 0 Participants |
| Adult Participants With Other PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | Serious: Febrile Neutropenia | 0 Participants |
| Pediatric Participants With PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | Serious: Febrile Neutropenia | 0 Participants |
| Pediatric Participants With PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | Serious: Neutrophil Count Decreased | 0 Participants |
| Pediatric Participants With PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | Non-Serious: Febrile Neutropenia | 0 Participants |
| Pediatric Participants With PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | Serious: Neutropenia | 0 Participants |
| Pediatric Participants With PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | Non-Serious: Neutropenia | 0 Participants |
| Pediatric Participants With PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | Non-Serious: Neutrophil Count Decreased | 0 Participants |
| Pediatric Participants With HL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | Non-Serious: Neutropenia | 0 Participants |
| Pediatric Participants With HL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | Serious: Neutropenia | 0 Participants |
| Pediatric Participants With HL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | Serious: Neutrophil Count Decreased | 0 Participants |
| Pediatric Participants With HL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | Non-Serious: Neutrophil Count Decreased | 0 Participants |
| Pediatric Participants With HL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | Non-Serious: Febrile Neutropenia | 0 Participants |
| Pediatric Participants With HL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression | Serious: Febrile Neutropenia | 0 Participants |
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.
Time frame: Up to 12 Months
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adult Participants With PTCL-NOS | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Peripheral Neuropathy | Serious: Peripheral Motor Neuropathy | 0 Participants |
| Adult Participants With PTCL-NOS | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Peripheral Neuropathy | Non-Serious: Peripheral Motor Neuropathy | 1 Participants |
| Adult Participants With PTCL-NOS | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Peripheral Neuropathy | Serious: Peripheral Sensory Neuropathy | 0 Participants |
| Adult Participants With PTCL-NOS | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Peripheral Neuropathy | Non-Serious: Peripheral Sensory Neuropathy | 8 Participants |
| Adult Participants With AITL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Peripheral Neuropathy | Serious: Peripheral Sensory Neuropathy | 1 Participants |
| Adult Participants With AITL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Peripheral Neuropathy | Non-Serious: Peripheral Motor Neuropathy | 0 Participants |
| Adult Participants With AITL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Peripheral Neuropathy | Serious: Peripheral Motor Neuropathy | 0 Participants |
| Adult Participants With AITL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Peripheral Neuropathy | Non-Serious: Peripheral Sensory Neuropathy | 9 Participants |
| Adult Participants With ATLL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Peripheral Neuropathy | Non-Serious: Peripheral Sensory Neuropathy | 2 Participants |
| Adult Participants With ATLL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Peripheral Neuropathy | Serious: Peripheral Sensory Neuropathy | 0 Participants |
| Adult Participants With ATLL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Peripheral Neuropathy | Non-Serious: Peripheral Motor Neuropathy | 0 Participants |
| Adult Participants With ATLL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Peripheral Neuropathy | Serious: Peripheral Motor Neuropathy | 0 Participants |
| Adult Participants With Other PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Peripheral Neuropathy | Serious: Peripheral Motor Neuropathy | 0 Participants |
| Adult Participants With Other PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Peripheral Neuropathy | Non-Serious: Peripheral Sensory Neuropathy | 1 Participants |
| Adult Participants With Other PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Peripheral Neuropathy | Non-Serious: Peripheral Motor Neuropathy | 1 Participants |
| Adult Participants With Other PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Peripheral Neuropathy | Serious: Peripheral Sensory Neuropathy | 0 Participants |
| Pediatric Participants With PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Peripheral Neuropathy | Serious: Peripheral Sensory Neuropathy | 0 Participants |
| Pediatric Participants With PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Peripheral Neuropathy | Non-Serious: Peripheral Sensory Neuropathy | 2 Participants |
| Pediatric Participants With PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Peripheral Neuropathy | Non-Serious: Peripheral Motor Neuropathy | 0 Participants |
| Pediatric Participants With PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Peripheral Neuropathy | Serious: Peripheral Motor Neuropathy | 0 Participants |
| Pediatric Participants With HL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Peripheral Neuropathy | Non-Serious: Peripheral Motor Neuropathy | 0 Participants |
| Pediatric Participants With HL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Peripheral Neuropathy | Serious: Peripheral Sensory Neuropathy | 0 Participants |
| Pediatric Participants With HL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Peripheral Neuropathy | Non-Serious: Peripheral Sensory Neuropathy | 0 Participants |
| Pediatric Participants With HL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Peripheral Neuropathy | Serious: Peripheral Motor Neuropathy | 0 Participants |
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.
Time frame: Up to 12 Months
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adult Participants With PTCL-NOS | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Lung Disorder | Serious: Interstitial Lung Disease | 1 Participants |
| Adult Participants With PTCL-NOS | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Lung Disorder | Non-Serious: Interstitial Lung Disease | 0 Participants |
| Adult Participants With AITL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Lung Disorder | Serious: Interstitial Lung Disease | 1 Participants |
| Adult Participants With AITL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Lung Disorder | Non-Serious: Interstitial Lung Disease | 0 Participants |
| Adult Participants With ATLL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Lung Disorder | Serious: Interstitial Lung Disease | 0 Participants |
| Adult Participants With ATLL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Lung Disorder | Non-Serious: Interstitial Lung Disease | 0 Participants |
| Adult Participants With Other PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Lung Disorder | Serious: Interstitial Lung Disease | 0 Participants |
| Adult Participants With Other PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Lung Disorder | Non-Serious: Interstitial Lung Disease | 0 Participants |
| Pediatric Participants With PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Lung Disorder | Serious: Interstitial Lung Disease | 0 Participants |
| Pediatric Participants With PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Lung Disorder | Non-Serious: Interstitial Lung Disease | 0 Participants |
| Pediatric Participants With HL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Lung Disorder | Serious: Interstitial Lung Disease | 0 Participants |
| Pediatric Participants With HL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Lung Disorder | Non-Serious: Interstitial Lung Disease | 0 Participants |
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.
Time frame: Up to 12 Months
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adult Participants With PTCL-NOS | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | Serious: Febrile Neutropenia | 1 Participants |
| Adult Participants With PTCL-NOS | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | Non-Serious: Febrile Neutropenia | 0 Participants |
| Adult Participants With PTCL-NOS | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | Serious: Neutropenia | 1 Participants |
| Adult Participants With PTCL-NOS | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | Non-Serious: Neutropenia | 0 Participants |
| Adult Participants With PTCL-NOS | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | Serious: Neutrophil Count Decreased | 3 Participants |
| Adult Participants With PTCL-NOS | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | Non-Serious: Neutrophil Count Decreased | 9 Participants |
| Adult Participants With AITL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | Non-Serious: Neutrophil Count Decreased | 3 Participants |
| Adult Participants With AITL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | Serious: Neutropenia | 0 Participants |
| Adult Participants With AITL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | Non-Serious: Febrile Neutropenia | 0 Participants |
| Adult Participants With AITL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | Non-Serious: Neutropenia | 0 Participants |
| Adult Participants With AITL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | Serious: Neutrophil Count Decreased | 0 Participants |
| Adult Participants With AITL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | Serious: Febrile Neutropenia | 1 Participants |
| Adult Participants With ATLL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | Non-Serious: Neutrophil Count Decreased | 2 Participants |
| Adult Participants With ATLL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | Non-Serious: Neutropenia | 0 Participants |
| Adult Participants With ATLL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | Non-Serious: Febrile Neutropenia | 0 Participants |
| Adult Participants With ATLL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | Serious: Neutropenia | 0 Participants |
| Adult Participants With ATLL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | Serious: Neutrophil Count Decreased | 0 Participants |
| Adult Participants With ATLL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | Serious: Febrile Neutropenia | 0 Participants |
| Adult Participants With Other PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | Non-Serious: Neutrophil Count Decreased | 0 Participants |
| Adult Participants With Other PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | Serious: Neutrophil Count Decreased | 0 Participants |
| Adult Participants With Other PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | Non-Serious: Febrile Neutropenia | 0 Participants |
| Adult Participants With Other PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | Serious: Neutropenia | 0 Participants |
| Adult Participants With Other PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | Non-Serious: Neutropenia | 0 Participants |
| Adult Participants With Other PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | Serious: Febrile Neutropenia | 0 Participants |
| Pediatric Participants With PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | Serious: Neutrophil Count Decreased | 0 Participants |
| Pediatric Participants With PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | Non-Serious: Neutrophil Count Decreased | 0 Participants |
| Pediatric Participants With PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | Non-Serious: Febrile Neutropenia | 0 Participants |
| Pediatric Participants With PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | Serious: Neutropenia | 1 Participants |
| Pediatric Participants With PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | Non-Serious: Neutropenia | 0 Participants |
| Pediatric Participants With PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | Serious: Febrile Neutropenia | 1 Participants |
| Pediatric Participants With HL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | Serious: Neutropenia | 0 Participants |
| Pediatric Participants With HL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | Serious: Febrile Neutropenia | 0 Participants |
| Pediatric Participants With HL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | Non-Serious: Febrile Neutropenia | 0 Participants |
| Pediatric Participants With HL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | Non-Serious: Neutrophil Count Decreased | 1 Participants |
| Pediatric Participants With HL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | Non-Serious: Neutropenia | 0 Participants |
| Pediatric Participants With HL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression | Serious: Neutrophil Count Decreased | 0 Participants |
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.
Time frame: Up to 12 Months
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adult Participants With PTCL-NOS | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy | Serious: Peripheral Motor Neuropathy | 0 Participants |
| Adult Participants With PTCL-NOS | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy | Non-Serious: Peripheral Motor Neuropathy | 1 Participants |
| Adult Participants With PTCL-NOS | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy | Serious: Peripheral Sensory Neuropathy | 0 Participants |
| Adult Participants With PTCL-NOS | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy | Non-Serious: Peripheral Sensory Neuropathy | 8 Participants |
| Adult Participants With AITL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy | Serious: Peripheral Sensory Neuropathy | 1 Participants |
| Adult Participants With AITL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy | Non-Serious: Peripheral Motor Neuropathy | 0 Participants |
| Adult Participants With AITL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy | Serious: Peripheral Motor Neuropathy | 0 Participants |
| Adult Participants With AITL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy | Non-Serious: Peripheral Sensory Neuropathy | 9 Participants |
| Adult Participants With ATLL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy | Non-Serious: Peripheral Sensory Neuropathy | 2 Participants |
| Adult Participants With ATLL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy | Serious: Peripheral Sensory Neuropathy | 0 Participants |
| Adult Participants With ATLL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy | Non-Serious: Peripheral Motor Neuropathy | 0 Participants |
| Adult Participants With ATLL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy | Serious: Peripheral Motor Neuropathy | 0 Participants |
| Adult Participants With Other PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy | Serious: Peripheral Motor Neuropathy | 0 Participants |
| Adult Participants With Other PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy | Non-Serious: Peripheral Sensory Neuropathy | 1 Participants |
| Adult Participants With Other PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy | Non-Serious: Peripheral Motor Neuropathy | 1 Participants |
| Adult Participants With Other PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy | Serious: Peripheral Sensory Neuropathy | 0 Participants |
| Pediatric Participants With PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy | Serious: Peripheral Sensory Neuropathy | 0 Participants |
| Pediatric Participants With PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy | Non-Serious: Peripheral Sensory Neuropathy | 2 Participants |
| Pediatric Participants With PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy | Non-Serious: Peripheral Motor Neuropathy | 0 Participants |
| Pediatric Participants With PTCL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy | Serious: Peripheral Motor Neuropathy | 0 Participants |
| Pediatric Participants With HL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy | Non-Serious: Peripheral Motor Neuropathy | 0 Participants |
| Pediatric Participants With HL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy | Serious: Peripheral Sensory Neuropathy | 0 Participants |
| Pediatric Participants With HL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy | Non-Serious: Peripheral Sensory Neuropathy | 0 Participants |
| Pediatric Participants With HL | Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy | Serious: Peripheral Motor Neuropathy | 0 Participants |
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.
Time frame: Up to 12 Months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adult Participants With PTCL-NOS | Percentage of Participants Who Achieve or Maintain Any Best Response for Adult Participants With ATLL | 3 Participants |
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.
Time frame: Up to 12 Months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adult Participants With PTCL-NOS | 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 | With PET Assessment | 7 Participants |
| Adult Participants With PTCL-NOS | 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 | Without PET Assessment | 4 Participants |
| Adult Participants With AITL | 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 | Without PET Assessment | 5 Participants |
| Adult Participants With AITL | 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 | With PET Assessment | 12 Participants |
| Adult Participants With ATLL | 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 | With PET Assessment | 0 Participants |
| Adult Participants With ATLL | 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 | Without PET Assessment | 0 Participants |
| Adult Participants With Other PTCL | 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 | With PET Assessment | 1 Participants |
| Adult Participants With Other PTCL | 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 | Without PET Assessment | 0 Participants |
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.
Time frame: Up to 12 Months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adult Participants With PTCL-NOS | Percentage of Participants Who Achieve or Maintain Any Best Response for Pediatric Participants With PTCL and HL | 3 Participants |
| Adult Participants With AITL | Percentage of Participants Who Achieve or Maintain Any Best Response for Pediatric Participants With PTCL and HL | 2 Participants |
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.
Time frame: Up to 12 Months
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adult Participants With PTCL-NOS | Percentage of Participants Who Had One or More Adverse Drug Reaction | 20 Participants |
| Adult Participants With AITL | Percentage of Participants Who Had One or More Adverse Drug Reaction | 18 Participants |
| Adult Participants With ATLL | Percentage of Participants Who Had One or More Adverse Drug Reaction | 6 Participants |
| Adult Participants With Other PTCL | Percentage of Participants Who Had One or More Adverse Drug Reaction | 3 Participants |
| Pediatric Participants With PTCL | Percentage of Participants Who Had One or More Adverse Drug Reaction | 2 Participants |
| Pediatric Participants With HL | Percentage of Participants Who Had One or More Adverse Drug Reaction | 1 Participants |
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.
Time frame: Up to 12 Months
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adult Participants With PTCL-NOS | Percentage of Participants Who Had One or More Adverse Event | 21 Participants |
| Adult Participants With AITL | Percentage of Participants Who Had One or More Adverse Event | 22 Participants |
| Adult Participants With ATLL | Percentage of Participants Who Had One or More Adverse Event | 8 Participants |
| Adult Participants With Other PTCL | Percentage of Participants Who Had One or More Adverse Event | 5 Participants |
| Pediatric Participants With PTCL | Percentage of Participants Who Had One or More Adverse Event | 3 Participants |
| Pediatric Participants With HL | Percentage of Participants Who Had One or More Adverse Event | 3 Participants |