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This is an open-label, multicenter, phase 2 clinical trial to evaluate the efficacy and safety of brentuximab vedotin as a single agent in patients with CD30-positive non-Hodgkin lymphoma (NHL) (Part A). The study will also evaluate the safety and efficacy of brentuximab vedotin in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (Part B) as well as further evaluate correlation of CD30 expression and response in DLBCL (Part C).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brentuximab vedotin+rituximab | Experimental |
| |
| Brentuximab vedotin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brentuximab vedotin | Drug | 1.8 mg/kg every 3 weeks by IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Monotherapy | Percentage of participants treated with brentuximab vedotin monotherapy who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma. | Up to approximately 3 years |
| Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Plus Rituximab | Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-012). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category. | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Plus Rituximab | Percentage of participants treated with brentuximab vedotin plus rituximab who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Corinna Palanca-Wessels, MD, PhD | Seagen Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294-3300 | United States | ||
| City of Hope |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24652992 | Result | Horwitz SM, Advani RH, Bartlett NL, Jacobsen ED, Sharman JP, O'Connor OA, Siddiqi T, Kennedy DA, Oki Y. Objective responses in relapsed T-cell lymphomas with single-agent brentuximab vedotin. Blood. 2014 May 15;123(20):3095-100. doi: 10.1182/blood-2013-12-542142. Epub 2014 Mar 20. | |
| 25573987 | Result | Jacobsen ED, Sharman JP, Oki Y, Advani RH, Winter JN, Bello CM, Spitzer G, Palanca-Wessels MC, Kennedy DA, Levine P, Yang J, Bartlett NL. Brentuximab vedotin demonstrates objective responses in a phase 2 study of relapsed/refractory DLBCL with variable CD30 expression. Blood. 2015 Feb 26;125(9):1394-402. doi: 10.1182/blood-2014-09-598763. Epub 2015 Jan 8. |
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Four additional patients enrolled, but withdrew prior to receiving treatment.
Aug 2011 - Jun 2015
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| ID | Title | Description |
|---|---|---|
| FG000 | CD30+ T-Cell NHL, BV | Part A - Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients in with CD30-positive mature T-cell non-Hodgkin lymphomas (NHL) |
| FG001 | CD30+ B-Cell NHL, BV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| rituximab | Drug | 375 mg/m2 every 3 weeks by IV infusion |
|
| Up to approximately 3 years |
| Complete Remission (CR) Rate by Investigator | Percentage of participants treated with brentuximab vedotin monotherapy or brentuximab vedotin plus rituximab who achieved a best response of complete remission (CR, disappearance of all evidence of disease) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma. | Up to approximately 3 years |
| Duration of Objective Response With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis | Duration of complete remission (CR) or partial remission (PR), defined as time of initial response until disease progression or death. Response criteria per Cheson 2007 Revised Response Criteria for Malignant Lymphoma. | Up to approximately 3 years |
| Duration of Complete Remission With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis | Duration of complete remission (CR), defined as time of initial response until disease progression or death. Response criteria per Cheson 2007 Revised Response Criteria for Malignant Lymphoma. | Up to approximately 3 years |
| Progression-Free Survival With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis | Progression-free survival, defined as time from start of study treatment to disease progression per investigator or death due to any cause | Up to approximately 3 years |
| Correlation Between Antitumor Activity of Brentuximab Vedotin Monotherapy and CD30 Expression | Percentage of participants treated with brentuximab vedotin monotherapy who achieved a best response of complete remission (CR, disappearance of all evidence of disease), partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites), or stable disease (SD, no new sites and no change in size of previous lesions) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma. Patients are grouped by CD30-positivity or CD30u (undetectable CD30). | Up to 3 years |
| Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Monotherapy | Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-012). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category. | Up to 3 years |
| Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi) (Cycle 1) | End of infusion concentration of ADC following the first dose of brentuximab vedotin | 1 day |
| Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough) (Cycle 1) | Trough concentration of ADC from 0 to 21 days following the first dose of brentuximab vedotin | 3 weeks |
| Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE) (Cycle 1) | Maximum serum concentration of MMAE from 0 to 21 days following the first dose of brentuximab vedotin | 3 weeks |
| Time to Maximum Concentration (Tmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE) | Time of maximum serum concentration of MMAE from 0 to 21 days following the first dose of brentuximab vedotin | 3 weeks |
| Baseline Soluble CD30 Expression | Serum concentration of soluble CD30 before first dose of brentuximab vedotin | Baseline |
| Duarte |
| California |
| 91010-3000 |
| United States |
| PMK Medical Group Inc., DBA Ventura County Hematology Oncology Specialists | Oxnard | California | 93030 | United States |
| Stanford Cancer Center | Stanford | California | 94305-5821 | United States |
| Rocky Mountain Cancer Centers - Aurora | Aurora | Colorado | 80012 | United States |
| Colorado Blood Cancer Institute | Denver | Colorado | 80218 | United States |
| Cancer Specialists of North Florida - St. Augustine | Saint Augustine | Florida | 32086 | United States |
| Emory Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Chicago | Chicago | Illinois | 60637-1470 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Minnesota Oncology Hematology P.A. | Minneapolis | Minnesota | 55404 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| New York Oncology Hematology, P.C. | Albany | New York | 12206 | United States |
| NYU Clinical Cancer Center | New York | New York | 10016 | United States |
| Columbia University Medical Center | New York | New York | 10019 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10021 | United States |
| Cleveland Clinic, The | Cleveland | Ohio | 44195 | United States |
| Willamette Valley Cancer and Research / USOR | Eugene | Oregon | 97401 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| St. Francis Hospital | Greenville | South Carolina | 29605 | United States |
| Texas Oncology - Medical City Dallas | Dallas | Texas | 75230 | United States |
| Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| Texas Oncology-Southwest Fort Worth | Fort Worth | Texas | 76132 | United States |
| MD Anderson Cancer Center / University of Texas | Houston | Texas | 77030-4003 | United States |
| Texas Oncology - Seton Williamson | Round Rock | Texas | 78665 | United States |
| Texas Oncology - Tyler | Tyler | Texas | 75702 | United States |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | United States |
| Swedish Cancer Institute Medical Oncology | Edmonds | Washington | 98026 | United States |
| Seattle Cancer Care Alliance / University of Washington Medical Center | Seattle | Washington | 98109 | United States |
| Northwest Cancer Specialists, P.C. | Vancouver | Washington | 98684 | United States |
| British Columbia Cancer Agency - Vancouver Centre | Vancouver | British Columbia | V5Z 4E6 | Canada |
| 27868471 | Derived | Bartlett NL, Smith MR, Siddiqi T, Advani RH, O'Connor OA, Sharman JP, Feldman T, Savage KJ, Shustov AR, Diefenbach CS, Oki Y, Palanca-Wessels MC, Uttarwar M, Li M, Yang J, Jacobsen ED. Brentuximab vedotin activity in diffuse large B-cell lymphoma with CD30 undetectable by visual assessment of conventional immunohistochemistry. Leuk Lymphoma. 2017 Jul;58(7):1607-1616. doi: 10.1080/10428194.2016.1256481. Epub 2016 Nov 20. |
Part A - Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive B-cell non-Hodgkin lymphomas (NHL), including CD30-positive diffuse large B-cell lymphoma (DLBCL) and other CD30-positive B-cell NHLs
| FG002 | CD30u DLBCL, BV | Part C - Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with diffuse large B-cell lymphoma (DLBCL) with undetectable CD30 (CD30u) |
| FG003 | CD30+ DLBCL, BV+R | Part B - Brentuximab vedotin (BV) 1.8 mg/kg plus rituximab (R; first 8 cycles only) (375 mg/m2) every 3 weeks by intravenous (IV) infusion in patients with CD30-positive diffuse large B-cell lymphoma (DLBCL) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All participants who received treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CD30+ T-Cell NHL, BV | |
| BG001 | CD30+ B-Cell NHL, BV | |
| BG002 | CD30u DLBCL, BV | |
| BG003 | CD30+ DLBCL, BV+R | |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Pathological Diagnosis | Number | participants |
| ||||||||||||||||
| Transformed Disease from Prior Non-Hodgkin Lymphoma | Number | participants |
| ||||||||||||||||
| Disease Stage | Number | participants |
| ||||||||||||||||
| Bulky Disease (≥5 cm on at least one baseline index lesion) | Number | participants |
| ||||||||||||||||
| Eastern Cooperative Oncology Group Performance Status (ECOG) | 0 = Normal activity; 1 = Symptoms but ambulatory; 2 = In bed <50% of the time; 3 = In bed >50% of the time; 4 = 100% bedridden; 5 = Dead | Number | participants |
| |||||||||||||||
| % CD30 Expression by Visual Immunohistochemistry (vIHC) | Percent CD30 expression by standard immunohistochemistry assessed visually by central laboratory (vIHC) | Median | Full Range | percentage |
| ||||||||||||||
| Refractory to Frontline Therapy | Number | participants |
| ||||||||||||||||
| Disease Status Relative to Most Recent Prior Therapy | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Monotherapy | Percentage of participants treated with brentuximab vedotin monotherapy who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma. | All participants who received treatment with brentuximab vedotin monotherapy and had both a baseline and at least one post-baseline disease assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 3 years |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Plus Rituximab | Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-012). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category. | All participants who received treatment with brentuximab vedotin plus rituximab. | Posted | Number | participants | Up to 3 years |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Plus Rituximab | Percentage of participants treated with brentuximab vedotin plus rituximab who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma. | All participants who received treatment with brentuximab vedotin plus rituximab and had both a baseline and at least one post-baseline disease assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 3 years |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Complete Remission (CR) Rate by Investigator | Percentage of participants treated with brentuximab vedotin monotherapy or brentuximab vedotin plus rituximab who achieved a best response of complete remission (CR, disappearance of all evidence of disease) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma. | All participants who received brentuximab vedotin monotherapy or brentuximab vedotin plus rituximab and had both a baseline and at least one post-baseline disease assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 3 years |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Objective Response With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis | Duration of complete remission (CR) or partial remission (PR), defined as time of initial response until disease progression or death. Response criteria per Cheson 2007 Revised Response Criteria for Malignant Lymphoma. | All participants who received treatment with brentuximab vedotin monotherapy and achieved a CR or PR. | Posted | Median | Full Range | months | Up to approximately 3 years |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Duration of Complete Remission With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis | Duration of complete remission (CR), defined as time of initial response until disease progression or death. Response criteria per Cheson 2007 Revised Response Criteria for Malignant Lymphoma. | All participants who received treatment with brentuximab vedotin monotherapy and achieved CR | Posted | Median | Full Range | months | Up to approximately 3 years |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis | Progression-free survival, defined as time from start of study treatment to disease progression per investigator or death due to any cause | All participants who received treatment with brentuximab vedotin monotherapy and had both a baseline and at least one post-baseline disease assessment. | Posted | Median | Full Range | months | Up to approximately 3 years |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Correlation Between Antitumor Activity of Brentuximab Vedotin Monotherapy and CD30 Expression | Percentage of participants treated with brentuximab vedotin monotherapy who achieved a best response of complete remission (CR, disappearance of all evidence of disease), partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites), or stable disease (SD, no new sites and no change in size of previous lesions) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma. Patients are grouped by CD30-positivity or CD30u (undetectable CD30). | All participants who received treatment with brentuximab vedotin monotherapy and had both a baseline and at least one post-baseline disease assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 3 years |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Monotherapy | Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-012). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category. | All participants who received treatment with brentuximab vedotin monotherapy. | Posted | Number | participants | Up to 3 years |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi) (Cycle 1) | End of infusion concentration of ADC following the first dose of brentuximab vedotin | All patients who were treated with brentuximab vedotin monotherapy and had Ceoi of ADC results. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | 1 day |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough) (Cycle 1) | Trough concentration of ADC from 0 to 21 days following the first dose of brentuximab vedotin | All patients who were treated with brentuximab vedotin monotherapy and had Ctrough of ADC results. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | 3 weeks |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE) (Cycle 1) | Maximum serum concentration of MMAE from 0 to 21 days following the first dose of brentuximab vedotin | All patients who were treated with brentuximab vedotin monotherapy and had Cmax of MMAE results. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 3 weeks |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Time to Maximum Concentration (Tmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE) | Time of maximum serum concentration of MMAE from 0 to 21 days following the first dose of brentuximab vedotin | All patients who were treated with brentuximab vedotin monotherapy and had Tmax of MMAE results. | Posted | Median | Full Range | days | 3 weeks |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Baseline Soluble CD30 Expression | Serum concentration of soluble CD30 before first dose of brentuximab vedotin | All patients who were treated with brentuximab vedotin monotherapy and had baseline sCD30 expression results. | Posted | Median | Full Range | ng/mL | Baseline |
|
|
Up to 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of treatment
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 | CD30+ NHL (T-Cell and B-Cell), BV | Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients in with CD30-positive non-Hodgkin lymphomas (NHL), including T-cell lymphomas and B-cell lymphomas, as well as diffuse large B-cell lymphoma (DLBCL) | 49 | 103 | 96 | 103 | ||
| EG001 | CD30u DLBCL, BV | Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients in Part C with diffuse large B-cell lymphoma (DLBCL) with undetectable CD30 (CD30u) | 22 | 53 | 48 | 53 | ||
| EG002 | CD30+ DLBCL, BV+R | Brentuximab vedotin (BV) 1.8 mg/kg plus rituximab (R; first 8 cycles only) (375 mg/m2) every 3 weeks by intravenous (IV) infusion in patients in Part B with diffuse large B-cell lymphoma (DLBCL) | 3 | 16 | 15 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Breast cellulitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Central nervous system abscess | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Herpes zoster disseminated | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Mastoiditis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Meningoencephalitis herpetic | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Staphylococcal bacteremia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Angioimmunoblastic T-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Peripheral T-cell lymphoma unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Gastric ulcer hemorrhage | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Jejunal perforation | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypomagnasemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Tumor lysis syndrome | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Bronchostenosis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dyspnea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Mediastinal mass | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pulmonary alveolar hemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Brain mass | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hallucination, visual | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Toxic epidermal necrolysis | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Graft versus host disease | Immune system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Vomting | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Edema peripheral | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypoesthesia | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Seattle Genetics, Inc. | 855-473-2436 | medinfo@seagen.com |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008228 | Lymphoma, Non-Hodgkin |
| D016399 | Lymphoma, T-Cell |
| D006402 | Hematologic Diseases |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000079963 | Brentuximab Vedotin |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Epstein-Barr Virus-Associated DLBCL of Elderly |
|
| Follicular Lymphoma |
|
| Gray Zone Lymphoma |
|
| Primary Mediastinal B-Cell Lymphoma |
|
| Post-Transplant Lymphoproliferative Disorder |
|
| Plasmablastic Lymphoma |
|
| T-Cell Rich B-Cell Lymphoma |
|
| Angioimmunoblastic T-cell Lymphoma |
|
| Peripheral T-Cell Lymphoma Not Otherwise Specified |
|
| No |
|
| Stage II |
|
| Stage III |
|
| Stage IV |
|
| Unknown |
|
| No |
|
| 1 |
|
| 2 |
|
| 3-5 |
|
| Missing |
|
| No |
|
| Missing/Unknown |
|
| Relapsed |
|
| Missing |
|
|
|
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|---|
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