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To understand the safety and efficacy of Revlimid® Capsules 2.5 mg and 5 mg (hereinafter referred to as Revlimid) under actual conditions of use in patients with relapsed or refractory adult T-cell leukemia lymphoma (hereinafter referred to as relapsed or refractory Adult T-cell Leukemia Lymphoma (ATLL)).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with T-cell leukemia lymphoma treated with Revlimid | Among patients with relapsed or refractory adult T-cell leukemia lymphoma, patients who received Revlimid will be targeted in this surveillance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Revlimid | Drug | Revlimid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs) | Number of participants with adverse events | Up to approximately 4 years |
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Inclusion Criteria:
- Relapsed or Refractory Adult T-cell Leukemia Lymphoma
Exclusion Criteria:
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Among patients with relapsed or refractory adult T-cell leukemia lymphoma (hereinafter referred to as "Adult T-cell Leukemia Lymphoma (ATLL)") who are treated with Revlimid Capsules (hereinafter referred to as "Revlimid", used by both 2.5 mg and 5 mg capsules).
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASO KK Iizuka Hospital | Iizuka | Fukuoka | 820-8505 | Japan |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| D064793 | Teratogenesis |
| D006470 | Hemorrhage |
| D007239 | Infections |
| D013923 | Thromboembolism |
| D006967 | Hypersensitivity |
| D015275 | Tumor Lysis Syndrome |
| D010523 | Peripheral Nervous System Diseases |
| D003324 | Coronary Artery Disease |
| D006333 | Heart Failure |
| D001145 | Arrhythmias, Cardiac |
| D051437 | Renal Insufficiency |
| D017563 | Lung Diseases, Interstitial |
| D004066 | Digestive System Diseases |
| D007037 | Hypothyroidism |
| D007024 | Hypotension, Orthostatic |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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| D000077260 | Sleepiness |
| D003221 | Confusion |
| D005221 | Fatigue |
| D004244 | Dizziness |
| D016609 | Neoplasms, Second Primary |
| D002386 | Cataract |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D007022 | Hypotension |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D019954 | Neurobehavioral Manifestations |
| D012678 | Sensation Disorders |
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |