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| ID | Type | Description | Link |
|---|---|---|---|
| EUPAS44615 | Registry Identifier | EU PAS Registry |
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The purpose of this study is to determine the rates of adverse events of interest (AEIs) in a real-world population of participants with relapsing remitting multiple sclerosis (RRMS) receiving Ozanimod, sphingosine-1 phosphate (S1P) receptor modulator, compared to the rates of these events in two population of participants:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants initiating treatment with ozanimod | |||
| Participants initiating an sphingosine-1 phosphate (S1P) modulator | |||
| Participants initiating other non-S1P-receptor modulators disease modifying treatments (DMTs) |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of major adverse cardiovascular events (MACE) | Up to 10 years | |
| Incidence of serious opportunistic infection (SOI) | Up to 10 years | |
| Incidence of serious acute liver injury (SALI) | Up to 10 years | |
| Incidence of macular edema | Up to 10 years | |
| Identified rate of malignancies identified based upon the presence of at least 1 international classification of diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnosis code | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of symptomatic bradycardia | Up to approximately 5 years | |
| Incidence of progressive multifocal leukoencephalopathy (PML) | Up to approximately 5 years | |
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Inclusion Criteria:
Exclusion Criteria:
• Participants with dispensing/prescription of more than one cohort defining drug on the index date
Other protocol-defined inclusion/exclusion criteria apply
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The study population will include men and women at least 18 years old who have a diagnosis of multiple sclerosis and are new users of ("initiate") treatment with one of three cohort-defining treatments. Participants will be grouped into the following cohorts:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evidera | Bethesda | Maryland | 20814 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D009369 | Neoplasms |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| Incidence of posterior reversible encephalopathy syndrome (PRES) |
| Up to approximately 5 years |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |