Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019932-11 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Millennium Pharmaceuticals, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
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This is a multicenter, open-label study to evaluate the safety and efficacy of treatment with brentuximab vedotin (SGN-35) in patients who have previously participated in an brentuximab vedotin study.
This is a multicenter, open-label study to evaluate single-agent brentuximab vedotin (SGN-35) treatment in patients who previously participated in a brentuximab vedotin study, including Studies SGN35-005 (NCT01100502), SGN35-007 (NCT01026233), and SGN35-008 (NCT01026415). Patients treated on this study (SGN35-006) could re-enroll on study if eligible. The study consisted of 2 arms, as follows:
Not provided
Not provided
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Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BV Retreatment | Experimental | Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse) |
|
| BV Extension | Experimental | Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brentuximab vedotin | Drug | Every 3 weeks by IV infusion (1.2 or 1.8 mg/kg) until disease progression, unacceptable toxicity, or study closure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate by Investigator | Percentage of participants in the retreatment arm 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 38 months |
| Adverse Events by Severity, Seriousness, and Relationship to Treatment | Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on SGN35-006). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death). 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 39 months |
| Laboratory Abnormalities >/= Grade 3 | Counts of study participants with post-baseline laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category. | Up to 39 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Objective Response by Kaplan-Meier Analysis | Duration of objective response (CR + PR) on retreatment, defined as time of initial response until disease progression or death | Up to 38 months |
| Progression-free Survival by Kaplan-Meier Analysis |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Withdrew consent to participate in any prior brentuximab vedotin study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Laurie Grove, PA-C | 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 National Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24642247 | Result | Bartlett NL, Chen R, Fanale MA, Brice P, Gopal A, Smith SE, Advani R, Matous JV, Ramchandren R, Rosenblatt JD, Huebner D, Levine P, Grove L, Forero-Torres A. Retreatment with brentuximab vedotin in patients with CD30-positive hematologic malignancies. J Hematol Oncol. 2014 Mar 19;7:24. doi: 10.1186/1756-8722-7-24. | |
| 22510871 | Derived |
Not provided
Not provided
Not provided
Jul 2009 - Mar 2013
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BV Extension | Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment) |
| FG001 | BV Retreatment | Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Progression-free survival, defined as time from start of study treatment in the retreatment arm to disease progression per investigator or death due to any cause |
| Up to approximately 29 months |
| Overall Survival | Overall survival for both extension and retreatment arms, defined as time from start of study treatment to date of death due to any cause | Up to approximately 41 months |
| Incidence of Antitherapeutic Antibodies | Counts of participants with anti-brentuximab vedotin antibodies at any time during extension treatment on Study SGN35-006 or number of retreatment experiences with anti-brentuximab vedotin antibodies at any time during retreatment | Up to 39 months |
| Duarte |
| California |
| 91010 |
| United States |
| Stanford Cancer Center | Stanford | California | 94305 | United States |
| Colorado Blood Cancer Institute | Denver | Colorado | 80218 | United States |
| University of Miami Miller School of Medicine / Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States |
| Loyola University Medical Center - Cardinal Bernadin Cancer Center | Maywood | Illinois | 60153 | United States |
| St. Francis Medical Group Oncology & Hematology Specialists | Indianapolis | Indiana | 46237 | United States |
| Karmanos Cancer Institute / Wayne State University | Detroit | Michigan | 48201 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| The John Theurer Cancer Center, Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| NYU Clinical Cancer Center | New York | New York | 10016 | United States |
| Columbia University Medical Center | New York | New York | 10019 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| MD Anderson Cancer Center /The University of Texas | Houston | Texas | 77030 | United States |
| Seattle Cancer Care Alliance / University of Washington Medical Center | Seattle | Washington | 98109-1023 | United States |
| Hopital Saint-Louis/Service d'Hematologie | Paris | Cedex 10 | 75475 | France |
| Gopal AK, Ramchandren R, O'Connor OA, Berryman RB, Advani RH, Chen R, Smith SE, Cooper M, Rothe A, Matous JV, Grove LE, Zain J. Safety and efficacy of brentuximab vedotin for Hodgkin lymphoma recurring after allogeneic stem cell transplantation. Blood. 2012 Jul 19;120(3):560-8. doi: 10.1182/blood-2011-12-397893. Epub 2012 Apr 17. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Follow-up Period |
|
|
All participants who received treatment
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BV Extension | Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment) |
| BG001 | BV Retreatment | Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse) |
| BG002 | 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, Customized | Median | Full Range | years |
| |||||||||||||||
| Gender | 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
| Number | participants |
| |||||||||||||||
| Disease diagnosis | 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 by Investigator | Percentage of participants in the retreatment arm 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. | Any patient who received retreatment and had postbaseline response results; 1 HL patient did not have postbaseline response results and 3 ALCL patients were retreated more than once. | Posted | Number | 95% Confidence Interval | percentage of retreatment experiences | Up to approximately 38 months | Retreatment Experiences | Retreatment Experiences |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Adverse Events by Severity, Seriousness, and Relationship to Treatment | Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on SGN35-006). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death). 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 | Posted | Number | participants | up to 39 months |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Laboratory Abnormalities >/= Grade 3 | Counts of study participants with post-baseline laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category. | All participants who received treatment | Posted | Number | participants | Up to 39 months |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Objective Response by Kaplan-Meier Analysis | Duration of objective response (CR + PR) on retreatment, defined as time of initial response until disease progression or death | Participants with objective response among those who received retreatment | Posted | Median | 95% Confidence Interval | months | Up to 38 months | Retreatment Experiences | Retreatment Experiences |
| ||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival by Kaplan-Meier Analysis | Progression-free survival, defined as time from start of study treatment in the retreatment arm to disease progression per investigator or death due to any cause | Any patient who received retreatment and had postbaseline response results; 1 HL patient did not have postbaseline response results and 3 ALCL patients were retreated more than once. | Posted | Median | 95% Confidence Interval | months | Up to approximately 29 months | Retreatment Experiences | Retreatment Experiences |
| ||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival for both extension and retreatment arms, defined as time from start of study treatment to date of death due to any cause | Patients who received treatment on the extension arm, and patients who received retreatment and had postbaseline response results; 1 HL patient on the retreatment arm did not have postbaseline response results and 3 ALCL patients on the retreatment arm were retreated more than once. | Posted | Median | 95% Confidence Interval | months | Up to approximately 41 months | Retreatment or Extension Trt Experiences | Retreatment or Extension Trt Experiences |
| ||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Antitherapeutic Antibodies | Counts of participants with anti-brentuximab vedotin antibodies at any time during extension treatment on Study SGN35-006 or number of retreatment experiences with anti-brentuximab vedotin antibodies at any time during retreatment | Any patient who received extension treatment or retreatment and had baseline and postbaseline sample results; 1 HL patient on the retreatment arm did not have postbaseline sample results and 3 ALCL patients on the retreatment arm were retreated more than once and had samples. | Posted | Number | participants or experiences | Up to 39 months | Retreatment or Extension Txt Experiences | Retreatment or Extension Txt Experiences |
|
|
Not provided
Treatment-emergent adverse events (TEAEs) defined as newly occurring (not present at baseline) or worsening after first dose of investigational product on Study SGN35-006
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 Extension | Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion | 16 | 78 | 75 | 78 | ||
| EG001 | BV Retreatment | Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion | 9 | 32 | 31 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Methaemoglobinaemia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Necrotising retinitis | Eye disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Peptic ulcer | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Graft versus host disease | Immune system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Bronchitis viral | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Herpes zoster disseminated | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Small intestine obstruction | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Gastrointestinal candidiasis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Pneumocystis jiroveci pneumonia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Pneumonia influenzal | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Pneumonia pseudomonas aeruginosa | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Acute myeloid leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Extrapyramidal disorder | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Infusion site extravasation | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Skin injury | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Seattle Genetics, Inc. | 855-473-2436 | medinfo@seagen.com |
| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| D008228 | Lymphoma, Non-Hodgkin |
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016399 | Lymphoma, T-Cell |
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
| Lost to Follow-up |
|
| Patient unavailable for site visits |
|
| Withdrawal by Subject |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
| 1 |
|
| 2 |
|
| 3-5 |
|
| Missing |
|
| Systemic anaplastic large cell lymphoma (ALCL) |
|
| Other |
|
| Retreatment Experiences |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
| Retreatment Experiences |
|
|
|
|
Patients with other disease diagnoses enrolled and treated on the retreatment arm
| OG004 | BV Retreatment Total | All patients enrolled and treated on the retreatment arm, including 3 patients retreated more than once |
|
|
| Retreatment or Extension Txt Experiences |
|
|