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To evaluate the efficacy, safety and pharmacokinetic profiles of KW-0761, the anti-CC chemokine receptor 4 (CCR4) antibody, when administered weekly for 8 weeks as an intravenous infusion at a dose of 1.0 mg/kg in relapsed subjects with CCR4-positive adult T-cell leukemia-lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KW-0761 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KW-0761 | Biological | KW-0761 is administered weekly for 8 weeks as an intravenous infusion of 2 hours at a dose of 1.0 mg/kg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | Response rate defined as the proportion of responders relative to the total population and its exact 95% confidence interval were calculated for best overall response. The antitumor response criteria (Complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD)) were created based on the criteria for non-Hodgkin's lymphoma and chronic lymphocytic leukemia provided in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology as well as the criteria for non-Hodgkin's lymphoma by the Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG).Overall Response (OR)= CR + PR. | From date of first subject's consent to participate in the study until the date of last protocol-specified examination for last subject completed, assessed up to 14 months. |
| Pharmacokinetics-Plasma KW-0761 Concentrations | Statistics of plasma KW-0761 concentrations were tabulated. Individual and mean (+standard deviation) plasma KW-0761 concentrations were plotted on a linear and a logarithmic scale against the time of blood sampling. The baseline and maximum time point at which Cmax and Ctrough were collected are 0 to 7 days post-dose. | 0 to 7 days post final dose |
| Pharmacokinetics-Plasma KW-0761 Concentrations (AUC0-7days) | Statistics of plasma KW-0761 concentrations were tabulated. Individual and mean (+standard deviation) plasma KW-0761 concentrations were plotted on a linear and a logarithmic scale against the time of blood sampling. | 0 to 7 days post final dose |
| Pharmacokinetics-Plasma KW-0761 Concentrations (t1/2) | 0 to 28 days post final dose and follow-up examinations (1 month and 3 months after the end of the post-dosing observation period). |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | The time from the date of first KW-0761 dosing to the date of progressive disease(PD) confirmation or death. The antitumor response criteria including PD were created based on the criteria for non-Hodgkin's lymphoma and chronic lymphocytic leukemia provided in the National Comprehensive Cancer Network(NCCN) Clinical Practice Guidelines in Oncology as well as the criteria for non-Hodgkin's lymphoma by the Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22312108 | Result | Ishida T, Joh T, Uike N, Yamamoto K, Utsunomiya A, Yoshida S, Saburi Y, Miyamoto T, Takemoto S, Suzushima H, Tsukasaki K, Nosaka K, Fujiwara H, Ishitsuka K, Inagaki H, Ogura M, Akinaga S, Tomonaga M, Tobinai K, Ueda R. Defucosylated anti-CCR4 monoclonal antibody (KW-0761) for relapsed adult T-cell leukemia-lymphoma: a multicenter phase II study. J Clin Oncol. 2012 Mar 10;30(8):837-42. doi: 10.1200/JCO.2011.37.3472. Epub 2012 Feb 6. |
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Participants were enrolled from 1 June 2009 through 9 November 2010
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| ID | Title | Description |
|---|---|---|
| FG000 | KW-0761 | IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | KW-0761 | IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Overall Response Rate (ORR) | Response rate defined as the proportion of responders relative to the total population and its exact 95% confidence interval were calculated for best overall response. The antitumor response criteria (Complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD)) were created based on the criteria for non-Hodgkin's lymphoma and chronic lymphocytic leukemia provided in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology as well as the criteria for non-Hodgkin's lymphoma by the Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG).Overall Response (OR)= CR + PR. | Of the 27 subjects enrolled, 26 were included in the efficacy analysis set, whereas 1 was excluded. | Posted | Number | 95% Confidence Interval | percentage of participants with response | From date of first subject's consent to participate in the study until the date of last protocol-specified examination for last subject completed, assessed up to 14 months. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | KW-0761 | IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Project Management Department, Development Division | Kyowa Hakko Kirin | clinical.info@kyowa-kirin.co.jp |
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| ID | Term |
|---|---|
| D015459 | Leukemia-Lymphoma, Adult T-Cell |
| ID | Term |
|---|---|
| D015458 | Leukemia, T-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C549035 | mogamulizumab |
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| Baseline to response |
| Overall Survival (OS) | The time from the date of first KW-0761 dosing to the date of death. | Baseline to response |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| KW-0761 |
IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg |
|
|
| Secondary | Progression Free Survival (PFS) | The time from the date of first KW-0761 dosing to the date of progressive disease(PD) confirmation or death. The antitumor response criteria including PD were created based on the criteria for non-Hodgkin's lymphoma and chronic lymphocytic leukemia provided in the National Comprehensive Cancer Network(NCCN) Clinical Practice Guidelines in Oncology as well as the criteria for non-Hodgkin's lymphoma by the Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG). | Of the 27 subjects enrolled, 26 were included in the efficacy analysis set, whereas 1 was excluded. | Posted | Median | Full Range | days | Baseline to response |
|
|
|
| Secondary | Overall Survival (OS) | The time from the date of first KW-0761 dosing to the date of death. | Of the 27 subjects enrolled, 26 were included in the overall survival analysis set, whereas 1 was excluded. | Posted | Median | Full Range | days | Baseline to response |
|
|
|
| Primary | Pharmacokinetics-Plasma KW-0761 Concentrations | Statistics of plasma KW-0761 concentrations were tabulated. Individual and mean (+standard deviation) plasma KW-0761 concentrations were plotted on a linear and a logarithmic scale against the time of blood sampling. The baseline and maximum time point at which Cmax and Ctrough were collected are 0 to 7 days post-dose. | Of the 27 subjects enrolled, 27 were included in the pharmacokinetics analysis set. | Posted | Mean | Standard Deviation | ng/mL | 0 to 7 days post final dose |
|
|
|
| Primary | Pharmacokinetics-Plasma KW-0761 Concentrations (AUC0-7days) | Statistics of plasma KW-0761 concentrations were tabulated. Individual and mean (+standard deviation) plasma KW-0761 concentrations were plotted on a linear and a logarithmic scale against the time of blood sampling. | Of the 27 subjects enrolled, 27 were included in the pharmacokinetics analysis set. | Posted | Mean | Standard Deviation | ng·h/mL | 0 to 7 days post final dose |
|
|
|
| Primary | Pharmacokinetics-Plasma KW-0761 Concentrations (t1/2) | Of the 27 subjects enrolled, 27 were included in the pharmacokinetics analysis set. | Posted | Mean | Standard Deviation | hours | 0 to 28 days post final dose and follow-up examinations (1 month and 3 months after the end of the post-dosing observation period). |
|
|
|
| 6 |
| 27 |
| 27 |
| 27 |
| Rash | Skin and subcutaneous tissue disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Left ventricular dysfunction | Cardiac disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Left atrial dilatation | Cardiac disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment | Conjunctivitis |
|
| Eye pruritus | Eye disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Application site erythema | General disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Hypothermia | General disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Sarcoidosis | Immune system disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Blood sodium decreased | Investigations | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Protein total decreased | Investigations | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Blood phosphorus decreased | Investigations | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Blood chloride increased | Investigations | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Blood urine present | Investigations | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Eosinophil percentage increased | Investigations | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Blood calcium decreased | Investigations | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Hyperammonaemia | Metabolism and nutrition disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Mononeuritis | Nervous system disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Movement disorder | Nervous system disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Tracheal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Eczema nummular | Skin and subcutaneous tissue disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Erythema nodosum | Skin and subcutaneous tissue disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Peripheral circulatory failure | Vascular disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
| Infusion related reaction | General disorders | MedDRA/J ver. 13.0 | Non-systematic Assessment |
|
Not provided
| D009369 |
| Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |