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The main aim is to check the long-term side effects of treatment with Brentuximab Vedotin and to see if that treatment improves symptoms of cluster of differentiation antigen 30 (CD30-Positive) Cutaneous T-Cell Lymphoma in Chinese adults.
Participants will receive brentuximab vedotin through the vein on day 1 of each 21 day cycle up to maximum 16 cycles.
The drug being tested in this study is called brentuximab vedotin (SGN-35). Brentuximab vedotin is being tested to treat people who have CD30-positive cutaneous T-Cell lymphoma.
The study will enroll approximately 10 patients. Participants will receive a single treatment i.e., brentuximab vedotin monotherapy:
• Brentuximab vedotin 1.8 mg/kg
Participants will be administered with brentuximab vedotin by intravenous (IV) infusion given for approximately 30 minutes on Day 1 of each 21-day cycle up to 16 cycles followed by the end of treatment (EOT) visit 30 days after receiving the final dose of study drug. Participants with progressive disease (PD) at any time during the study will be discontinued from study drug.
This multi-center trial will be conducted in China. Participants will remain in this study for approximately 56 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brentuximab Vedotin | Experimental | Participants received brentuximab vedotin 1.8 milligrams per kilogram (mg/kg), IV on Day 1 of each 21-day cycle for up to a total of 16 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brentuximab vedotin | Drug | Brentuximab vedotin IV infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) Lasting at Least 4 Months in Participants With CD30+ MF or pcALCL | ORR is defined as the percentage of participants who achieve complete response (CR) or partial response (PR) that lasts at least 4 months. CR is defined as complete disappearance of all clinical evidence of disease and PR is defined as regression of measurable disease. ORR was determined based on Global Response Score (GRS) which consisted of a skin assessment by the investigator using the modified severity-weighted assessment tool (mSWAT), nodal and visceral involvement using computed tomography (CT) scan, and for the participants with mycosis fungoides (MF) only, detection of circulating Sezary cells. Response Criteria were based on International Society for Cutaneous Lymphomas (ISCL), United States Cutaneous Lymphoma Consortium (USCLC) and European Organisation for Research and Treatment of Cancer (EORTC) Consensus guidelines. | Up to 58 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response (CR) Rate | CR rate is defined as the percentage of participants with CR. CR is defined as complete disappearance of all clinical evidence of disease. CR was determined based on GRS which consisted of a skin assessment by the investigator using the mSWAT, nodal and visceral involvement using computed tomography (CT) scan, and for the participants with MF only, detection of circulating Sezary cells. Response Criteria were based on ISCL, USCLC and EORTC Consensus guidelines. |
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Inclusion Criteria:
1. Histologically- confirmed cluster of differentiation antigen 30 positive (CD30+) disease by local laboratory assessment and pathology review.
2. Participants with primary cutaneous anaplastic large cell lymphoma (pcALCL) who have received prior radiation therapy or at least 1 prior systemic therapy, or participants with mycosis fungoides (MF) who have received at least 1 prior systemic therapy for their disease. 3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2. 4. Suitable venous access for the study-required blood sampling. 5. Participants must have radiographically or clinically measurable or evaluable disease.
6. Recovered (i.e., Grade 1 toxicity) from the reversible effects of prior antineoplastic therapy.
-Exclusion Criteria:
A concurrent diagnosis of systemic anaplastic large cell lymphoma (ALCL), or other non-Hodgkin lymphoma (excluding lymphomatoid papulosis [LyP]).
A concurrent diagnosis of sézary syndrome (SS) or high blood tumor burden (B2) disease.
Corticosteroid therapy for the treatment of cutaneous T-cell lymphoma (CTCL) within 3 weeks of first dose of study drug.
Known hypersensitivity to recombinant proteins, murine proteins, or any excipient contained in the drug formulation.
Life-threatening illness unrelated to cancer.
Severe central nervous system (CNS), pulmonary, renal, or hepatic disease not related to the participant's cancer.
Known active cerebral/meningeal disease, including signs or symptoms of progressive multifocal leukoencephalopathy (PML).
Known human immunodeficiency virus (HIV) positive.
Known hepatitis B surface antigen positive or known or suspected active hepatitis C infection.
Any severe active systemic viral, bacterial, or fungal infection within 1 week before first study drug dose requiring systemic antimicrobial therapy. (Oral antibiotics for prophylaxis are allowed.)
Receiving antibody-directed or immunoglobulin-based immune therapy (eg, immunoglobulin replacement, other monoclonal antibody therapies) within 12 weeks of first study drug dose.
Any of the following cardiovascular conditions or values within 6 months before the first dose of study drug:
History of another primary malignancy not in remission for at least 3 years. The following are exempt from the 3-year limit: completely resected in situ carcinoma, such as nonmelanoma skin cancer and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear.
Oral retinoid therapy for any indication within 3 weeks of the first dose of study drug.
History of pancreatitis or significant risk factors for developing pancreatitis (eg, prior pancreatitis, uncontrolled hyperlipidemia, excessive alcohol consumption, uncontrolled diabetes mellitus, biliary tract disease, and medications known to increase triglyceride levels or to be associated with pancreatic toxicity).
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China | ||
| Peking University Third Hospital |
Not provided
| Label | URL |
|---|---|
| To obtain more information about this study, click this link. | View source |
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Takeda does not provide access to Individual Participant Data when a study is in a very limited (small) study population due to participant privacy concerns such as potential reidentification of study participants.
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Participants with cluster of differentiation 30-positive mycosis fungoides (CD30+ MF) or primary cutaneous anaplastic large cell lymphoma (pcALCL) histologically confirmed by local pathology assessment participated in the study to receive brentuximab vedotin.
Participants took part in the study at 3 investigative sites in China from 28 November 2022 to 09 August 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brentuximab Vedotin | Participants received brentuximab vedotin 1.8 milligrams per kilogram (mg/kg), intravenously (IV) on Day 1 of each 21-day cycle for up to a total of 16 cycles. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Brentuximab Vedotin | Participants received brentuximab vedotin 1.8 mg/kg, IV on Day 1 of each 21-day cycle for up to a total of 16 cycles. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Overall Response Rate (ORR) Lasting at Least 4 Months in Participants With CD30+ MF or pcALCL | ORR is defined as the percentage of participants who achieve complete response (CR) or partial response (PR) that lasts at least 4 months. CR is defined as complete disappearance of all clinical evidence of disease and PR is defined as regression of measurable disease. ORR was determined based on Global Response Score (GRS) which consisted of a skin assessment by the investigator using the modified severity-weighted assessment tool (mSWAT), nodal and visceral involvement using computed tomography (CT) scan, and for the participants with mycosis fungoides (MF) only, detection of circulating Sezary cells. Response Criteria were based on International Society for Cutaneous Lymphomas (ISCL), United States Cutaneous Lymphoma Consortium (USCLC) and European Organisation for Research and Treatment of Cancer (EORTC) Consensus guidelines. | The response-evaluable population included a subset of the full analysis set (FAS) participants with measurable disease at baseline and with at least 1 post-baseline response assessment. FAS consisted of all enrolled participants identified as CD30+ and received at least 1 dose of the study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 58 weeks |
Up to 58 weeks
The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brentuximab Vedotin | Participants received brentuximab vedotin 1.8 mg/kg, IV on Day 1 of each 21-day cycle for up to a total of 16 cycles. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 31, 2022 | Aug 10, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 13, 2022 | Aug 10, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000079963 | Brentuximab Vedotin |
| ID | Term |
|---|---|
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
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| Up to 58 weeks |
| Overall Response Rate (ORR) | ORR is defined as the percentage of participants who achieve complete response (CR) or partial response (PR). CR is defined as complete disappearance of all clinical evidence of disease and PR is defined as regression of measurable disease. ORR was determined based on GRS which consisted of a skin assessment by the investigator using the mSWAT, nodal and visceral involvement using CT scan, and for the participants with MF only, detection of circulating Sezary cells. Response Criteria were based on ISCL, USCLC and EORTC Consensus guidelines. | Up to 58 weeks |
| Duration of Response (DOR) | Duration of response was assessed in participants with CR or PR and is defined as the time between first documentation of response and progressive disease (PD). Response criteria were based on ISCL, USCLC and EORTC Consensus guidelines. Participants who were lost to follow-up, withdrew consent, or discontinued treatment due to undocumented PD after the last adequate disease assessment were censored at the last disease assessment. | Up to 58 weeks |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g. a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. TEAE is defined as an adverse event with an onset that occurs after receiving study drug. SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. TEAE and SAE were determined as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. | From first dose of study drug through 30 days after the last dose of study drug (up to approximately 58 weeks) |
| Changes From Baseline in Participant's Vital Sign: Systolic and Diastolic Blood Pressure | Vital signs included seated blood pressure (systolic and diastolic) measurements. | Baseline, at end of treatment (approximately Week 54) |
| Changes From Baseline in Participant's Vital Sign: Heart Rate | Vital signs included heart rate (beats per minute) measurements. | Baseline, at end of treatment (approximately Week 54) |
| Changes From Baseline in Participant's Vital Sign: Body Temperature | Vital signs included body temperature (degree Celsius) measurements. | Baseline, at end of treatment (approximately Week 54) |
| Number of Participants From Baseline to Worst Post-Baseline Assessment Categories Based on Eastern Cooperative Oncology Group (ECOG) Performance Status Scale | ECOG scale was used to assess performance status of participants. Grades range from 0 (fully active) to 5 (dead) where Grade 0: Normal activity. Grade 1: Symptoms but ambulatory. Grade 2: In bed <50% of the time. Grade 3: In bed >50% of the time. Grade 4: 100% bedridden. Grade 5: Dead. Lower grades indicate improvement. Reported here is the number of participants in each reported baseline grade to their worst post-baseline grade assessment on the ECOG scale. | Baseline up to 30 days after the last dose of study drug (up to approximately 58 weeks) |
| Change From Baseline in Hematology Parameter: Hemoglobin | Baseline, at end of treatment (approximately Week 54) |
| Change From Baseline in Hematology Parameter: Neutrophil Count | Baseline, at end of treatment (approximately Week 54) |
| Change From Baseline in Hematology Parameter: Platelet Count | Baseline, at end of treatment (approximately Week 54) |
| Change From Baseline in Hematology Parameter: Lymphocyte Count | Baseline, at end of treatment (approximately Week 54) |
| Change From Baseline in Hematology Parameter: Leukocyte Count | Baseline, at end of treatment (approximately Week 54) |
| Change From Baseline in Serum Chemistry Parameter: Alkaline Phosphatase (ALP) | Baseline, at end of treatment (approximately Week 54) |
| Change From Baseline in Serum Chemistry Parameter: Alanine Aminotransferase (ALT) | Baseline, at end of treatment (approximately Week 54) |
| Change From Baseline in Serum Chemistry Parameter: Aspartate Aminotransferase (AST) | Baseline, at end of treatment (approximately Week 54) |
| Change From Baseline in Serum Chemistry Parameter: Total Bilirubin | Baseline, at end of treatment (approximately Week 54) |
| Change From Baseline in Serum Chemistry Parameter: Lipase | Baseline, at end of treatment (approximately Week 54) |
| Change From Baseline in Serum Chemistry Parameter: Amylase | Baseline, at end of treatment (approximately Week 54) |
| Beijing |
| Beijing Municipality |
| 100191 |
| China |
| Huashan Hospital, Fudan University | Shanghai | Shanghai Municipality | 200040 | China |
| West China Hospital, Sichuan University | Chengdu | Sichuan | 610041 | China |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Brentuximab Vedotin | Participants received brentuximab vedotin 1.8 mg/kg, IV on Day 1 of each 21-day cycle for up to a total of 16 cycles. |
|
|
| Secondary | Complete Response (CR) Rate | CR rate is defined as the percentage of participants with CR. CR is defined as complete disappearance of all clinical evidence of disease. CR was determined based on GRS which consisted of a skin assessment by the investigator using the mSWAT, nodal and visceral involvement using computed tomography (CT) scan, and for the participants with MF only, detection of circulating Sezary cells. Response Criteria were based on ISCL, USCLC and EORTC Consensus guidelines. | The response-evaluable population included a subset of the FAS participants with measurable disease at baseline and with at least 1 post-baseline response assessment. FAS consisted of all enrolled participants identified as CD30+ and received at least 1 dose of the study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 58 weeks |
|
|
|
| Secondary | Overall Response Rate (ORR) | ORR is defined as the percentage of participants who achieve complete response (CR) or partial response (PR). CR is defined as complete disappearance of all clinical evidence of disease and PR is defined as regression of measurable disease. ORR was determined based on GRS which consisted of a skin assessment by the investigator using the mSWAT, nodal and visceral involvement using CT scan, and for the participants with MF only, detection of circulating Sezary cells. Response Criteria were based on ISCL, USCLC and EORTC Consensus guidelines. | The response-evaluable population included a subset of the FAS participants with measurable disease at baseline and with at least 1 post-baseline response assessment. FAS consisted of all enrolled participants identified as CD30+ and received at least 1 dose of the study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 58 weeks |
|
|
|
| Secondary | Duration of Response (DOR) | Duration of response was assessed in participants with CR or PR and is defined as the time between first documentation of response and progressive disease (PD). Response criteria were based on ISCL, USCLC and EORTC Consensus guidelines. Participants who were lost to follow-up, withdrew consent, or discontinued treatment due to undocumented PD after the last adequate disease assessment were censored at the last disease assessment. | The response-evaluable population included a subset of the FAS participants with measurable disease at baseline and with at least 1 post-baseline response assessment. FAS consisted of all enrolled participants identified as CD30+ and received at least 1 dose of the study drug. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | Median | 95% Confidence Interval | months | Up to 58 weeks |
|
|
|
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g. a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. TEAE is defined as an adverse event with an onset that occurs after receiving study drug. SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. TEAE and SAE were determined as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. | The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | From first dose of study drug through 30 days after the last dose of study drug (up to approximately 58 weeks) |
|
|
|
| Secondary | Changes From Baseline in Participant's Vital Sign: Systolic and Diastolic Blood Pressure | Vital signs included seated blood pressure (systolic and diastolic) measurements. | The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug. Number of participants analyzed is the number of participants with data available for analysis at the specified time points. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | Baseline, at end of treatment (approximately Week 54) |
|
|
|
| Secondary | Changes From Baseline in Participant's Vital Sign: Heart Rate | Vital signs included heart rate (beats per minute) measurements. | The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug. Number of participants analyzed is the number of participants with data available for analysis at the specified time points. | Posted | Mean | Standard Deviation | beats per minute | Baseline, at end of treatment (approximately Week 54) |
|
|
|
| Secondary | Changes From Baseline in Participant's Vital Sign: Body Temperature | Vital signs included body temperature (degree Celsius) measurements. | The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug. Number of participants analyzed is the number of participants with data available for analysis at the specified time points. | Posted | Mean | Standard Deviation | degree Celsius (°C) | Baseline, at end of treatment (approximately Week 54) |
|
|
|
| Secondary | Number of Participants From Baseline to Worst Post-Baseline Assessment Categories Based on Eastern Cooperative Oncology Group (ECOG) Performance Status Scale | ECOG scale was used to assess performance status of participants. Grades range from 0 (fully active) to 5 (dead) where Grade 0: Normal activity. Grade 1: Symptoms but ambulatory. Grade 2: In bed <50% of the time. Grade 3: In bed >50% of the time. Grade 4: 100% bedridden. Grade 5: Dead. Lower grades indicate improvement. Reported here is the number of participants in each reported baseline grade to their worst post-baseline grade assessment on the ECOG scale. | The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Baseline up to 30 days after the last dose of study drug (up to approximately 58 weeks) |
|
|
|
| Secondary | Change From Baseline in Hematology Parameter: Hemoglobin | The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug. Number of participants analyzed is the number of participants with data available for analysis at the specified time points. | Posted | Mean | Standard Deviation | grams per liter (g/L) | Baseline, at end of treatment (approximately Week 54) |
|
|
|
| Secondary | Change From Baseline in Hematology Parameter: Neutrophil Count | The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug. Number of participants analyzed is the number of participants with data available for analysis at the specified time points. | Posted | Mean | Standard Deviation | 10^9 cells/liter (L) | Baseline, at end of treatment (approximately Week 54) |
|
|
|
| Secondary | Change From Baseline in Hematology Parameter: Platelet Count | The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug. Number of participants analyzed is the number of participants with data available for analysis at the specified time points. | Posted | Mean | Standard Deviation | 10^9 cells/L | Baseline, at end of treatment (approximately Week 54) |
|
|
|
| Secondary | Change From Baseline in Hematology Parameter: Lymphocyte Count | The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug. Number of participants analyzed is the number of participants with data available for analysis at the specified time points. | Posted | Mean | Standard Deviation | 10^9 cells/L | Baseline, at end of treatment (approximately Week 54) |
|
|
|
| Secondary | Change From Baseline in Hematology Parameter: Leukocyte Count | The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug. Number of participants analyzed is the number of participants with data available for analysis at the specified time points. | Posted | Mean | Standard Deviation | 10^9 cells/L | Baseline, at end of treatment (approximately Week 54) |
|
|
|
| Secondary | Change From Baseline in Serum Chemistry Parameter: Alkaline Phosphatase (ALP) | The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug. Number of participants analyzed is the number of participants with data available for analysis at the specified time points. | Posted | Mean | Standard Deviation | Units per liter (U/L) | Baseline, at end of treatment (approximately Week 54) |
|
|
|
| Secondary | Change From Baseline in Serum Chemistry Parameter: Alanine Aminotransferase (ALT) | The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug. Number of participants analyzed is the number of participants with data available for analysis at the specified time points. | Posted | Mean | Standard Deviation | U/L | Baseline, at end of treatment (approximately Week 54) |
|
|
|
| Secondary | Change From Baseline in Serum Chemistry Parameter: Aspartate Aminotransferase (AST) | The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug. Number of participants analyzed is the number of participants with data available for analysis at the specified time points. | Posted | Mean | Standard Deviation | U/L | Baseline, at end of treatment (approximately Week 54) |
|
|
|
| Secondary | Change From Baseline in Serum Chemistry Parameter: Total Bilirubin | The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug. Number of participants analyzed is the number of participants with data available for analysis at the specified time points. | Posted | Mean | Standard Deviation | micromoles per liter (µmol/L) | Baseline, at end of treatment (approximately Week 54) |
|
|
|
| Secondary | Change From Baseline in Serum Chemistry Parameter: Lipase | The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug. Number of participants analyzed is the number of participants with data available for analysis at the specified time points. | Posted | Mean | Standard Deviation | U/L | Baseline, at end of treatment (approximately Week 54) |
|
|
|
| Secondary | Change From Baseline in Serum Chemistry Parameter: Amylase | The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug. Number of participants analyzed is the number of participants with data available for analysis at the specified time points. | Posted | Mean | Standard Deviation | U/L | Baseline, at end of treatment (approximately Week 54) |
|
|
|
| 0 |
| 10 |
| 4 |
| 10 |
| 10 |
| 10 |
| Neuropathy peripheral | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Renal tubular necrosis | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Bile acids increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Blood creatinine decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Cystatin C increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Left ventricular dysfunction | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Red blood cell sedimentation rate increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Tricuspid valve incompetence | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 27.0 | Systematic Assessment |
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Not provided
Not provided
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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| Diastolic Blood Pressure: Baseline |
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| Diastolic Blood Pressure: Change from Baseline at the End of Treatment |
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