Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2008-006035-12 | 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
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Not provided
This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory ALCL.
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 intravenous (IV) infusion |
|
| 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 by Independent Review Group | Percentage of participants 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 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Remission Rate by Independent Review Group | Percentage of participants who achieved a best response of CR (disappearance of all evidence of disease) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma. | up to 12 months |
| Duration of Objective Response by Kaplan-Meier Analysis |
| Measure | Description | Time Frame |
|---|---|---|
| B Symptom Resolution | Percentage of participants with lymphoma-related symptoms (B symptoms: fever, night sweats, or weight loss >10%) at baseline who achieved resolution of all B symptoms at any time during the treatment period. | up to 12 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dana Kennedy, PharmD | Seagen Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294-3300 | United States | ||
| Stanford University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22614995 | Result | Pro B, Advani R, Brice P, Bartlett NL, Rosenblatt JD, Illidge T, Matous J, Ramchandren R, Fanale M, Connors JM, Yang Y, Sievers EL, Kennedy DA, Shustov A. Brentuximab vedotin (SGN-35) in patients with relapsed or refractory systemic anaplastic large-cell lymphoma: results of a phase II study. J Clin Oncol. 2012 Jun 20;30(18):2190-6. doi: 10.1200/JCO.2011.38.0402. Epub 2012 May 21. | |
| 28974506 |
Not provided
Not provided
Not provided
Enrollment period: Jun 2009 - May 2010
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Brentuximab Vedotin | Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Duration of objective response (CR + PR) by independent review group, defined as time of initial response until disease progression or death. |
| up to approximately 3 years |
| Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis | Duration of response from start of first objective tumor response (CR or PR) by independent review group to disease progression or death due to any cause in participants with CR. | up to approximately 3 years |
| Progression-free Survival by Kaplan-Meier Analysis | Time from start of study treatment to disease progression per independent review group or death due to any cause. | up to approximately 3 years |
| Overall Survival | Time from start of study treatment to date of death due to any cause. | up to approximately 7 years |
| 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). 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 12 months |
| Hematology Laboratory Abnormalities >/= Grade 3 | Counts of study participants with post-baseline hematology 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 12 months |
| Chemistry Laboratory Abnormalities >/= Grade 3 | Counts of study participants with post-baseline chemistry 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 12 months |
| Area Under the Curve | Area under the serum concentration-time curve from time 0 to 21 days following the first dose of brentuximab vedotin | 3 weeks |
| Maximum Serum Concentration | Maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin | 3 weeks |
| Time of Maximum Serum Concentration | Time of maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin | 3 weeks |
| Palo Alto |
| California |
| 94304 |
| United States |
| Rocky Mountain Cancer Centers | Denver | Colorado | 80218 | United States |
| University of Miami Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Karmanos Cancer Institute / Wayne State University | Detroit | Michigan | 48201 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10021 | United States |
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Baylor Sammons Cancer Center / Texas Oncology | Dallas | Texas | 75246 | United States |
| MD Anderson Cancer Center / University of Texas | Houston | Texas | 77030-4003 | United States |
| University of Washington | Seattle | Washington | 98109 | United States |
| UZ Gasthuisberg | Leuven | 3000 | Belgium |
| B.C Cancer Agency | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| Institut Paoli Calmettes | Marseille | 13273 | France |
| Hospital Saint Louis | Paris | 75475 | France |
| Centre Henri Becquerel | Rouen | 76038 | France |
| Christie Hospital NHS | Manchester | M20 4BX | United Kingdom |
| Derived |
| Pro B, Advani R, Brice P, Bartlett NL, Rosenblatt JD, Illidge T, Matous J, Ramchandren R, Fanale M, Connors JM, Fenton K, Huebner D, Pinelli JM, Kennedy DA, Shustov A. Five-year results of brentuximab vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma. Blood. 2017 Dec 21;130(25):2709-2717. doi: 10.1182/blood-2017-05-780049. Epub 2017 Oct 3. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Follow-up Period |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Brentuximab Vedotin | Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion |
| 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 |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Eastern Cooperative Oncology Group Performance Status | 0 = Normal activity
| Number | participants |
| ||||||||||||||||||||||
| ALK Status | Immunophenotype status with respect to anaplastic lymphoma kinase (ALK) protein | 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 Independent Review Group | Percentage of participants 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. | Intention to treat | Posted | Number | 95% Confidence Interval | percent of participants | up to 12 months |
|
|
| |||||||||||||||||||||||||
| Secondary | Complete Remission Rate by Independent Review Group | Percentage of participants who achieved a best response of CR (disappearance of all evidence of disease) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma. | Intention to treat | Posted | Number | 95% Confidence Interval | percent of participants | up to 12 months |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Objective Response by Kaplan-Meier Analysis | Duration of objective response (CR + PR) by independent review group, defined as time of initial response until disease progression or death. | Participants with objective response among the intention to treat population | Posted | Median | 95% Confidence Interval | months | up to approximately 3 years |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis | Duration of response from start of first objective tumor response (CR or PR) by independent review group to disease progression or death due to any cause in participants with CR. | Participants with complete remission among the intention to treat population | Posted | Median | 95% Confidence Interval | months | up to approximately 3 years |
|
| ||||||||||||||||||||||||||
| Secondary | Progression-free Survival by Kaplan-Meier Analysis | Time from start of study treatment to disease progression per independent review group or death due to any cause. | Intention to treat | Posted | Median | 95% Confidence Interval | months | up to approximately 3 years |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival | Time from start of study treatment to date of death due to any cause. | Intention to treat | Posted | Median | 95% Confidence Interval | months | up to approximately 7 years |
|
|
| |||||||||||||||||||||||||
| Secondary | 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). 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 12 months |
|
| |||||||||||||||||||||||||||
| Secondary | Hematology Laboratory Abnormalities >/= Grade 3 | Counts of study participants with post-baseline hematology 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 12 months |
|
| |||||||||||||||||||||||||||
| Secondary | Chemistry Laboratory Abnormalities >/= Grade 3 | Counts of study participants with post-baseline chemistry 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 12 months |
|
| |||||||||||||||||||||||||||
| Secondary | Area Under the Curve | Area under the serum concentration-time curve from time 0 to 21 days following the first dose of brentuximab vedotin | All participants who received treatment | Posted | Geometric Mean | Geometric Coefficient of Variation | day * microgram/mL | 3 weeks |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | B Symptom Resolution | Percentage of participants with lymphoma-related symptoms (B symptoms: fever, night sweats, or weight loss >10%) at baseline who achieved resolution of all B symptoms at any time during the treatment period. | Participants with B symptoms at baseline | Posted | Number | 95% Confidence Interval | percent of participants | up to 12 months |
|
| ||||||||||||||||||||||||||
| Secondary | Maximum Serum Concentration | Maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin | All participants who received treatment | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram/mL | 3 weeks |
|
| ||||||||||||||||||||||||||
| Secondary | Time of Maximum Serum Concentration | Time of maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin | All participants who received treatment | Posted | Median | Full Range | days | 3 weeks |
|
|
Adverse events through 30 days after last dose (up to 12 months)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brentuximab Vedotin | Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion | 25 | 58 | 58 | 58 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Arrhythmia supraventricular | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Retinal vein occlusion | Eye disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Endocarditis staphylococcal | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Klebsiella bacteraemia | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Superinfection bacterial | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Anaplastic large cell lymphoma t- and null-cell types recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
| |
| Mycosis fungoides | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
| |
| Tumour flare | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Tracheal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Demyelinating polyneuropathy | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Tumour flare | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Anaplastic large cell lymphoma t- and null-cell types recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Seattle Genetics, Inc. | 855-473-2436 | medinfo@seagen.com |
| ID | Term |
|---|---|
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| D008228 | Lymphoma, Non-Hodgkin |
| D006402 | Hematologic Diseases |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| 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
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 2 |
|
| 3-5 |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories | ||||
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Any >/= Grade 3 hematology laboratory abnormality |
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| Leukocytes (low) |
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| Lymphocytes (low) |
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| Neutrophils (low) |
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| Platelets (low) |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Any >/= Grade 3 chemistry laboratory abnormality |
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| Aspartate aminotransferase (high) |
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| Calcium (low) |
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| Glucose (high) |
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| Potassium (low) |
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| Sodium (low) |
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| Urate (high) |
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| Denominators |
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