Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an open-label, multicenter, phase 2 clinical trial to evaluate the antitumor activity of brentuximab vedotin as a single agent in patients with CD30-positive nonlymphomatous malignancies.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brentuximab vedotin 1.8 mg/kg | Experimental | Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion |
|
| Brentuximab vedotin 2.4 mg/kg | Experimental | Brentuximab vedotin 2.4 mg/kg every 3 weeks by IV infusion |
|
| Brentuximab vedotin 1.2 mg/kg | Experimental | Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by IV infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brentuximab vedotin | Drug | 1.8 mg/kg every 3 weeks by intravenous (IV) infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) by Investigator | Percentage of participants who achieved a best response of complete response/remission (CR), CR without hematologic recovery (CRi; leukemia only), or partial remission (PR) per the applicable response criteria. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003). | Up to approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Remission (CR) Rate by Investigator | Percentage of participants who achieved a best response of CR per the applicable response criteria. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Neil Josephson, MD | 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 |
|---|---|---|---|
| 29222199 | Derived | Albany C, Einhorn L, Garbo L, Boyd T, Josephson N, Feldman DR. Treatment of CD30-Expressing Germ Cell Tumors and Sex Cord Stromal Tumors with Brentuximab Vedotin: Identification and Report of Seven Cases. Oncologist. 2018 Mar;23(3):316-323. doi: 10.1634/theoncologist.2017-0544. Epub 2017 Dec 8. | |
| 26994848 | Derived |
Not provided
Not provided
One additional patient enrolled, but withdrew prior to treatment group assignment.
Oct 2011 - Dec 2014
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BV 1.8 mg/kg Q3Week | Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia |
| FG001 | BV 2.4 mg/kg Q3Week |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| brentuximab vedotin | Drug | 2.4 mg/kg every 3 weeks by intravenous (IV) infusion |
|
|
| brentuximab vedotin | Drug | 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion |
|
|
| Up to approximately 3 years |
| Duration of Objective Response by Kaplan-Meier Analysis | Duration of objective response (CR [+CRi; leukemia] + PR), defined as time of initial response until disease progression or death. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003). | Up to approximately 2 years |
| Duration of Complete Response by Kaplan-Meier Analysis | Duration of CR, defined as time of initial response until disease progression or death. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003). | Up to approximately 2 years |
| Progression-Free Survival 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 2 years |
| Adverse Events by Severity, Seriousness, and Relationship to Treatment | Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-013). 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 approximately 3 years |
| Laboratory Abnormalities >/= Grade 3 | Counts of study participants with post-baseline laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 4.03. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category | Up to approximately 3 years |
| Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi) | Up to approximately 3 years |
| Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough) | Up to approximately 3 years |
| Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE) | Up to approximately 3 years |
| Brentuximab Vedotin Monomethyl Auristatin E (MMAE) Trough Concentration (Ctrough) | Up to approximately 3 years |
| Incidence of Anti-therapeutic Antibodies (ATA) | Counts of participants with post-baseline anti-brentuximab vedotin antibodies. Persistently positive is defined as confirmed ATA in more than 2 post-baseline samples and transiently positive is defined as confirmed ATA in 1 or 2 post-baseline samples. | Up to approximately 3 years |
| Duarte |
| California |
| 91010-3000 |
| United States |
| PMK Medical Group Inc., DBA Ventura County Hematology Oncology Specialists | Oxnard | California | 93030 | United States |
| Rocky Mountain Cancer Centers - Aurora | Aurora | Colorado | 80012 | United States |
| Mayo Clinic Cancer Center | Jacksonville | Florida | 32224 | United States |
| Ocala Oncology Center | Ocala | Florida | 34471 | United States |
| Indiana University Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Minnesota Oncology Hematology P.A. | Minneapolis | Minnesota | 55404 | United States |
| New York Oncology Hematology, P.C. | Albany | New York | 12206 | United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106-5055 | United States |
| Willamette Valley Cancer and Research / USOR | Eugene | Oregon | 97401 | United States |
| Northwest Cancer Specialists, P.C. | Tulatin | Oregon | 97062 | United States |
| St. Francis Hospital | Greenville | South Carolina | 29605 | United States |
| Texas Oncology - Bedford | Bedford | Texas | 76022 | United States |
| Texas Oncology - Medical City Dallas | Dallas | Texas | 75230 | United States |
| Texas Oncology - Dallas Presbyterian | Dallas | Texas | 75231 | United States |
| Texas Oncology Denton South | Denton | Texas | 76210 | United States |
| Texas Oncology - Fort Worth 12th Avenue | Fort Worth | Texas | 76104 | United States |
| MD Anderson Cancer Center / University of Texas | Houston | Texas | 77030-4003 | United States |
| MD Anderson Cancer Center Leukemia Group | Houston | Texas | 77030 | United States |
| Texas Oncology - Central Austin Cancer Center | Round Rock | Texas | 78731 | United States |
| Cancer Centers of South Texas - HOAST | San Antonio | Texas | 78229 | United States |
| Texas Oncology - Waco | Waco | Texas | 76712 | United States |
| Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care | Blacksburg | Virginia | 24060 | United States |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | United States |
| Puget Sound Cancer Centers | Edmonds | Washington | 98026 | United States |
| Cancer Care Northwest | Spokane Valley | Washington | 99216 | United States |
| Yakima Valley Memorial Hospital / North Star Lodge | Yakima | Washington | 98902 | United States |
| Borate U, Mehta A, Reddy V, Tsai M, Josephson N, Schnadig I. Treatment of CD30-positive systemic mastocytosis with brentuximab vedotin. Leuk Res. 2016 May;44:25-31. doi: 10.1016/j.leukres.2016.02.010. Epub 2016 Feb 27. |
| 23624209 | Derived | Giannatempo P, Paolini B, Miceli R, Raggi D, Nicolai N, Fare E, Catanzaro M, Biasoni D, Torelli T, Stagni S, Piva L, Mariani L, Salvioni R, Colecchia M, Gianni AM, Necchi A. Persistent CD30 expression by embryonal carcinoma in the treatment time course: prognostic significance of a worthwhile target for personalized treatment. J Urol. 2013 Nov;190(5):1919-24. doi: 10.1016/j.juro.2013.04.057. Epub 2013 Apr 25. |
Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
| FG002 | BV 1.2 mg/kg Q1Week | Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All participants who received treatment. One additional patient enrolled, but withdrew prior to treatment group assignment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BV 1.8 mg/kg Q3Week | Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia |
| BG001 | BV 2.4 mg/kg Q3Week | Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia |
| BG002 | BV 1.2 mg/kg Q1Week | Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS) |
| BG003 | 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 |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Eastern Cooperative Oncology Group Performance Status | 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 |
| |||||||||||||||
| Height | Median | Full Range | centimeters (cm) |
| |||||||||||||||
| Weight | Median | Full Range | kilograms (kg) |
| |||||||||||||||
| Body Mass Index | Median | Full Range | kg per meter squared (kg/m^2) |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) by Investigator | Percentage of participants who achieved a best response of complete response/remission (CR), CR without hematologic recovery (CRi; leukemia only), or partial remission (PR) per the applicable response criteria. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003). | Efficacy-evaluable population | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 3 years |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Complete Remission (CR) Rate by Investigator | Percentage of participants who achieved a best response of CR per the applicable response criteria. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003). | Efficacy-evaluable population | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 3 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Duration of Objective Response by Kaplan-Meier Analysis | Duration of objective response (CR [+CRi; leukemia] + PR), defined as time of initial response until disease progression or death. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003). | Participants with objective response (CR [+CRi; leukemia] + PR) | Posted | Median | Full Range | months | Up to approximately 2 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Duration of Complete Response by Kaplan-Meier Analysis | Duration of CR, defined as time of initial response until disease progression or death. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003). | Participants with CR | Posted | Median | Full Range | months | Up to approximately 2 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival 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 treated patients, excluding 3 patients without available response results | Posted | Median | 95% Confidence Interval | months | Up to approximately 2 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Adverse Events by Severity, Seriousness, and Relationship to Treatment | Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-013). 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 treated patients | Posted | Number | participants | Up to approximately 3 years |
| |||||||||||||||||||||||||||||||
| Secondary | Laboratory Abnormalities >/= Grade 3 | Counts of study participants with post-baseline laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 4.03. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category | All treated patients | Posted | Number | participants | Up to approximately 3 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi) | All treated patients with available ADC Ceoi results | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | Up to approximately 3 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough) | All treated patients with available ADC Ctrough results | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | Up to approximately 3 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE) | All treated patients with available Cmax of MMAE results | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Up to approximately 3 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Brentuximab Vedotin Monomethyl Auristatin E (MMAE) Trough Concentration (Ctrough) | All treated patients with available MMAE Ctrough results | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Up to approximately 3 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Incidence of Anti-therapeutic Antibodies (ATA) | Counts of participants with post-baseline anti-brentuximab vedotin antibodies. Persistently positive is defined as confirmed ATA in more than 2 post-baseline samples and transiently positive is defined as confirmed ATA in 1 or 2 post-baseline samples. | Immunogenicity-evaluable set | Posted | Number | participants | Up to approximately 3 years |
|
|
Up to approximately 3 years
TEAEs, defined as newly occurring (not present at baseline) or worsening after first dose of brentuximab vedotin
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 | BV 1.8 mg/kg Q3Week | Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia | 24 | 46 | 42 | 46 | ||
| EG001 | BV 2.4 mg/kg Q3Week | Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia | 13 | 28 | 28 | 28 | ||
| EG002 | BV 1.2 mg/kg Q1Week | Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS) | 5 | 9 | 8 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Systemic mastocytosis | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dysphagia | 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 |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hepatosplenomegaly | Hepatobiliary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| 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 |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Acute myeloid leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Erythroleukemia | 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 |
| |
| Mesothelioma malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Rhabdomyosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Azotemia | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Lymphoedema | 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 |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Splenomegaly | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac 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 |
| |
| Ascites | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Edema peripheral | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 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 |
| |
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyperphosphatemia | 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 |
| |
| Hypophosphatemia | 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 |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Headache | 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 |
| |
| Delirium | 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 |
| |
| Dysphonia | 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 |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue 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 mass | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Office | Seattle Genetics, Inc. | 855-473-2436 | medinfo@seagen.com |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015470 | Leukemia, Myeloid, Acute |
| D000754 | Anemia, Refractory, with Excess of Blasts |
| D009190 | Myelodysplastic Syndromes |
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007951 | Leukemia, Myeloid |
| D000753 | Anemia, Refractory |
| D000740 | Anemia |
| D001855 | Bone Marrow Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000079963 | Brentuximab Vedotin |
| ID | Term |
|---|---|
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| 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 |
|
| 1 |
|
| 2 |
|
| 3-5 |
|
| Missing |
|
|
|
|
|
|
|
| Participants |
|
|
|
|
|
|
| Participants |
|
|