Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016947-20 | 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
Not provided
This is a randomized, double-blind, placebo-controlled, multicenter phase 3 trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) and best supportive care (BSC) compared to placebo and BSC in treatment of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brentuximab vedotin | Experimental | brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion |
|
| Placebo | Placebo Comparator | placebo every 3 weeks by IV infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brentuximab vedotin | Drug | Every 21 days by IV infusion (1.8 mg/kg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival by Independent Review | Time from date of randomization to the first documentation of disease progression by independent review or to death due to any cause, whichever comes first | Up to approximately 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Time from date of randomization to date of death due to any cause | Up to approximately 10 years |
| Incidence of Adverse Events or Laboratory Abnormalities | Up to 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Julie Lisano, PharmD | Seagen Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | 91010-3000 | United States | ||
| University of California at San Francisco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25796459 | Result | Moskowitz CH, Nademanee A, Masszi T, Agura E, Holowiecki J, Abidi MH, Chen AI, Stiff P, Gianni AM, Carella A, Osmanov D, Bachanova V, Sweetenham J, Sureda A, Huebner D, Sievers EL, Chi A, Larsen EK, Hunder NN, Walewski J; AETHERA Study Group. Brentuximab vedotin as consolidation therapy after autologous stem-cell transplantation in patients with Hodgkin's lymphoma at risk of relapse or progression (AETHERA): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015 May 9;385(9980):1853-62. doi: 10.1016/S0140-6736(15)60165-9. Epub 2015 Mar 19. | |
| 30266774 |
Not provided
Not provided
Not provided
Apr 2010-Aug 2014
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Brentuximab Vedotin | brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion |
| FG001 | Placebo | placebo every 3 weeks by IV infusion |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo | Drug | Every 21 days by IV infusion |
|
| Incidence of Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin | Up to 12 months |
| San Francisco |
| California |
| 94134 |
| United States |
| Stanford Cancer Center | Stanford | California | 94305 | United States |
| Colorado Blood Cancer Institute | Denver | Colorado | 80218 | United States |
| H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida | 33612 | United States |
| Northside Hospital | Atlanta | Georgia | 30342 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Chicago Section of Hematology/Oncology Lymphoma Program | Chicago | Illinois | 60637-1470 | United States |
| Cardinal Bernardin Cancer Center / Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Indiana University School of Medicine Simon Cancer Center 535 Barnhill Drive, RT 380 | Indianapolis | Indiana | 46202 | United States |
| Johns Hopkins Medical Center | Baltimore | Maryland | 21231 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | United States |
| Karmanos Cancer Institute / Wayne State University | Detroit | Michigan | 48201 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| New York University Cancer Institute | New York | New York | 10016 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10021 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| UNC Lineberger Comprehensive Cancer Center / University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Cleveland Clinic, The | Cleveland | Ohio | 44195 | United States |
| James Cancer Hospital / Ohio State University | Columbus | Ohio | 43210 | United States |
| Oregon Health and Science University / Center for Hematologic Malignancies | Portland | Oregon | 97239-3098 | United States |
| Temple Bone Marrow Transplant Program | Philadelphia | Pennsylvania | 19111 | United States |
| Western Pennsylvania Cancer Institute | Pittsburgh | Pennsylvania | 15224 | United States |
| Saint Francis Hospital | Greenville | South Carolina | 29601 | United States |
| Cancer Center of the Carolinas | Greenville | South Carolina | 29615 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| MD Anderson Cancer Center / University of Texas | Houston | Texas | 77030-4095 | United States |
| Virginia Commonwealth University Medical Center | Richmond | Virginia | 23298 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109-1024 | United States |
| Specializirana bolnica aktivno lechenie detsa ohcohematologichni zabolyavania Hematologichno | Sofia | 1527 | Bulgaria |
| Specializirana bolnica za aktivno lechenie na hematologichni zabolyavania | Sofia | 1756 | Bulgaria |
| Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie | Hradec Králové | 500 05 | Czechia |
| Fakultni nemocnice Kralovske Vinohrady-oddeleni klinicke hematologie | Prague | 10034 | Czechia |
| Vseobecni fakultni nemocnice v Prahe-I. interni klinika | Prague | 128 08 | Czechia |
| CHU Nantes - Hopital Hotel Dieu Service Hematologie | Nantes | 44000 | France |
| Service des Maladies du Sang / Hospital Saint Louis | Paris | 75475 Cedex 10 | France |
| CHU Bordeaux Hopital Haut-Levaque | Pessac | 33600 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69310 | France |
| Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer | Rouen | 76038 | France |
| University Hospital of Cologne | Cologne | 50924 | Germany |
| Szent Istvan es Szent Laszlo Korhaz Rendelointezet Haematologiai es Ossejt-transzplantacios osztaly | Budapest | 1097 | Hungary |
| Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika | Debrecen | 4004 | Hungary |
| Medical Center of the University of Pecs, 1st Clinic for Internal Medicine | Pécs | Hungary |
| Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont | Szeged | 6720 | Hungary |
| Instituto di Ematologia ed Oncologia Medica | Bologna | 40138 | Italy |
| Azienda Ospedaliera Universitaria San Martino | Genova | 16132 | Italy |
| Istituto Nazionale dei Tumori | Milan | 20133 | Italy |
| Klinika Hematologii i Transplantologii, Uniwersyteckie Centrum Kliniczne | Gdansk | 80-952 | Poland |
| Oddzial Transplantacji Szpiku Centrum Onkologii- Instytut M. Sklodowskiej-Curie, Oddzial Gliwicach | Gliwice | 44-101 | Poland |
| Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego | Katowice | 40-032 | Poland |
| Szpital Uniwersytecki w Krakowie | Krakow | 31-501 | Poland |
| Klinika Hematologii, Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi | Lodz | 93-510 | Poland |
| Oddzial Hematoonkologii, Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie | Lublin | 20-950 | Poland |
| MTZ Clinical Research Sp. z o.o. | Warsaw | 02-106 | Poland |
| Klinika Hematologii, Instytut Hematologii i Transfuzjologii | Warsaw | 02-766 | Poland |
| Centrum Onkologii Institut im. Marii Sklodowskiej-Curie | Warsaw | 02-781 | Poland |
| Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular | Târgu Mureş | Mureș County | 540136 | Romania |
| Spitalul Clinic de Urgenta pentru Copii Louis Turcanu, Clinica III Pediatrie | Timișoara | Timiș County | 300011 | Romania |
| Fundeni Clinical Institute | Bucharest | 022328 | Romania |
| Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu | Bucharest | 022328 | Romania |
| Burdenko Central Military Clinical Hospital | Moscow | 105229 | Russia |
| Rossijskij onkologicheskij nauchnyj centr im. N.N. Blokhina RAMN | Moscow | 115478 | Russia |
| Federal Medical Biophysical Center n.a. A.I. Burnazyan | Moscow | 123098 | Russia |
| Gematologicheskj nauchnyj centr RAMN | Moscow | 125167 | Russia |
| Uchrezhdenie Rossijskoj nauk Nauchno-issledovatel'skij institut klinicheskoj immunologii | Novosibirsk | 630099 | Russia |
| Respublikanskaja bol'nica im. V.A. Baranova | Petrozavodsk | 185019 | Russia |
| Leningradskaja oblastnaja klinicheskaja bol'nica | Saint Petersburg | 194291 | Russia |
| Sankt-Peterburgskij gosudarstvennyj medicinskij universitet im. akademika I. P. Pavlova | Saint Petersburg | 197022 | Russia |
| St. Petersburg Pavlov State Medical University | Saint Petersburg | 197101 | Russia |
| Gorodskaya bol'nica #31 | Saint Petersburg | 197110 | Russia |
| Federal Center of Heart, Blood and Endocrinology n.a. V.A. Almazov under the Federal Agency for High | Saint Petersburg | 197341 | Russia |
| Sverdlovskaja oblastnaja klinicheskaja bol'nica #1 | Yekaterinburg | 620102 | Russia |
| Klinicki centar Srbije, Klinika za hematologiju | Belgrade | 11000 | Serbia |
| Vojnomedicinska akademija, Klinika za hematologiju | Belgrade | 11000 | Serbia |
| Klinicko bolnicki centar "Vojvodina", Klinika za hematologiju | Novi Sad | 21000 | Serbia |
| Complejo Hospitalano de Navarra Servicio Hematologia | Pamplona | Navarre | 31130 | Spain |
| Hospital de la Santa Creu i Sant Paul | Barcelona | 08025 | Spain |
| Hospital Clinic i Provincial Servicio Hematologia | Barcelona | 08036 | Spain |
| Centro Oncologico MD Anderson | Madrid | 28033 | Spain |
| Hospital Universitaro de Salamanca | Salamanca | 37007 | Spain |
| Addenbrooke's Hospital | Cambridge | CB2 0QQ | United Kingdom |
| St James University Hospital | Leeds | LS9 7TF | United Kingdom |
| Guy's Hospital Haematology Department, 4th Floor Southwark Wing | London | SE1 9RT | United Kingdom |
| Christie Hospital NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| Derived |
| Moskowitz CH, Walewski J, Nademanee A, Masszi T, Agura E, Holowiecki J, Abidi MH, Chen AI, Stiff P, Viviani S, Bachanova V, Sureda A, McClendon T, Lee C, Lisano J, Sweetenham J. Five-year PFS from the AETHERA trial of brentuximab vedotin for Hodgkin lymphoma at high risk of progression or relapse. Blood. 2018 Dec 20;132(25):2639-2642. doi: 10.1182/blood-2018-07-861641. Epub 2018 Sep 28. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intention-to-Treat analysis set
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Brentuximab Vedotin | brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion |
| BG001 | Placebo | placebo every 3 weeks by IV infusion |
| 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, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | 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 | Count of Participants | Participants |
| |||||||||||||||
| Hodgkin Lymphoma Status after end of Frontline Therapy | Count of Participants | Participants |
| ||||||||||||||||
| Best Response to Salvage Therapy pre-ASCT | Count of Participants | 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 | Progression-free Survival by Independent Review | Time from date of randomization to the first documentation of disease progression by independent review or to death due to any cause, whichever comes first | Intention-to-Treat analysis set | Posted | Median | 95% Confidence Interval | months | Up to approximately 4 years |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Time from date of randomization to date of death due to any cause | Intention-to-Treat analysis set | Posted | Median | Full Range | months | Up to approximately 10 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Adverse Events or Laboratory Abnormalities | Safety Analysis Set includes all patients who received at least 1 dose of brentuximab vedotin or only received placebo: 2 patients randomized to placebo received a single dose of brentuximab vedotin and are included in the brentuximab vedotin arm; 2 patients randomized to placebo received no study treatment and are not included in the analysis | Posted | Number | participants | Up to 12 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin | ATA-evaluable patients (patients with a baseline and at least 1 postbaseline sample) | Posted | Number | participants | Up to 12 months |
|
|
Non-serious adverse events were followed for up to 15 months. Serious adverse event data were collected for up to approximately 10 years (116 months).
Safety Analysis Set includes all patients who received at least 1 dose of brentuximab vedotin or only received placebo: 2 patients randomized to placebo received a single dose of brentuximab vedotin and are included in the brentuximab vedotin arm; 2 patients randomized to placebo received no study treatment and are not included in the analysis
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 | Placebo | placebo every 3 weeks by IV infusion | 40 | 160 | 21 | 160 | 127 | 160 |
| EG001 | Brentuximab Vedotin | brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion | 45 | 167 | 43 | 167 | 151 | 167 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Erosive duodenitis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute hepatitis b | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Hepatic candidiasis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Anogenital warts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Mantle cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Basilar migraine | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Depression suicidal | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Idiopathic pneumonia syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pulmonary toxicity | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pelvic venous thrombosis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Radiation myelopathy | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Metastases to spine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Seagen Inc. | (855)473-2436 | medinfo@seagen.com |
| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| 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 |
| 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 |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Romania |
|
| Hungary |
|
| United States |
|
| United Kingdom |
|
| Spain |
|
| Czech Republic |
|
| Poland |
|
| Italy |
|
| France |
|
| Serbia |
|
| Bulgaria |
|
| Germany |
|
| 1 |
|
| 2 |
|
| Relapse in less than 12 months |
|
| Relapse 12 months or later with extranodal disease |
|
| Partial remission |
|
| Stable disease |
|
|
|
|