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To understand the safety and efficacy of Revlimid® 5 mg Capsules (hereinafter referred to as Revlimid) in patients with "relapsed or refractory multiple myeloma" (hereinafter referred to as "relapsed or refractory MM") who have received long-term treatment with it under the actual condition of use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relapsed or refractory multiple myeloma (MM) patients | Relapsed or refractory MM patients in the special use-results surveillance (all-case surveillance) (hereinafter referred to as the all-case surveillance) who have received Revlimid treatment for at least 7 cycles at institutions cooperating in performing the all-case surveillance and this surveillance. |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs) | Number of participants with adverse events | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
N/A
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Relapsed or refractory multiple myeloma (MM) patients in the special use-results surveillance (all-case surveillance) (hereinafter referred to as the all-case surveillance) who have received Revlimid treatment for at least 7 cycles at institutions cooperating in performing the all-case surveillance and this surveillance.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shinko Hospital | Kobe | Hyōgo | 651-0072 | Japan |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D064793 | Teratogenesis |
| D013921 | Thrombocytopenia |
| D006470 | Hemorrhage |
| D009503 | Neutropenia |
| D007239 | Infections |
| D054556 | Venous Thromboembolism |
| D006967 | Hypersensitivity |
| D003967 | Diarrhea |
| D003248 | Constipation |
| D010523 | Peripheral Nervous System Diseases |
| D006333 | Heart Failure |
| D001145 | Arrhythmias, Cardiac |
| D051437 | Renal Insufficiency |
| D009203 | Myocardial Infarction |
| D017563 | Lung Diseases, Interstitial |
| D015275 | Tumor Lysis Syndrome |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D007960 | Leukocyte Disorders |
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D006331 | Heart 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 |
| D017202 | Myocardial Ischemia |
| D007238 | Infarction |
| D007511 | Ischemia |
| D009336 | Necrosis |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008206 | Lymphatic Diseases |
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