Multiple Myeloma, Myelodysplastic Syndromes
Conditions
Keywords
Teratogenicity, Thrombocytopenia and haemorrhage, Neutropenia and infection, Venous thromboembolism, Allergic reactions, Diarrhoea or constipation, Peripheral neuropathy, Cardiac failure, Arrhythmia, Renal failure, Myocardial infarction, Interstitial lung disease, Tumour lysis syndrome, Transformation from myelodysplastic syndrome to acute myeloid leukemia
Brief summary
To understand the safety and efficacy of Revlimid® 5 mg Capsules (hereinafter referred to as Revlimid) in all patients who are treated with it under the actual condition of use pursuant to the conditions of approval. 1. Planned registration period This period started on the date of initial marketing of Revlimid and will end at the time when the planned number of patients to be enrolled is reached. 2. Planned surveillance period This period started on the date of initial marketing of Revlimid and will end on the day when the approval condition related to all-case surveillance is terminated.
Interventions
None listed
Sponsors
Celgene
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Among relapsed or refractory multiple myeloma and Myelodysplastic syndrome (MDS) with a deletion 5q cytogenetic abnormality patients, all patients who received Revlimid will be targeted in this surveillance.
Exclusion criteria
N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (AEs) | Up to 6 months | Number of participants with adverse events for 6 month treatment |
Countries
Japan
Outcome results
None listed