Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Number of Participants With Adverse Events (AEs) |
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not related to the study drug. |
Up to 24 months |
|
| Primary |
Number of Participants With Adverse Drug Reactions (ADRs) |
An ADR is defined as all the adverse and unintended responses which are generated from the normal administration/use of study drugs which are cases of not excluding the casual relationship with the study drug, and which shall be regarded as ADRs in the case the relationship with study drug is not known among AEs reported voluntarily. |
Up to 24 months |
|
| Primary |
Number of Participants With Serious Adverse Events (SAEs) |
A SAE is defined as any untoward medical occurrence at any dose that meets any of the following criteria: is fatal or life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; constitutes a congenital anomaly/birth defect; or includes other important medical events. |
Up to 24 months |
|
| Primary |
Number of Participants With Serious Adverse Drug Reactions (SADRs) |
SADRs are defined as SAEs considered related to Tecfidera by the treating physician. |
Up to 24 months |
|
| Primary |
Number of Participants With Unexpected AEs |
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not related to the study drug. Expectedness of events are determined according to the approved local label. Unexpected AE is except for any expectedness of events. An unexpected AE is defined as an AE with a difference in nature, severity, specificity, or outcome, compared to the product licensure/safety notification of the drug. |
Up to 24 months |
|
| Primary |
Number of Participants With Unexpected ADRs |
An ADR is defined as all the adverse and unintended responses which are generated from the normal administration/use of study drugs which are cases of not excluding the casual relationship with the study drug, and which shall be regarded as ADRs in the case the relationship with study drug is not known among AEs reported voluntarily. Expectedness of events will be determined according to the approved local label. Unexpected ADR means except for any expected ADR in local label. An unexpected ADR is defined as an ADR with difference in the nature or severity, specificity, or the outcome, compared to the product licensure/notification of the drug. |
Up to 24 months |
|
| Secondary |
Annualized Relapse Rate |
Annualized relapse rate will be calculated as the total number of relapses experienced divided by the total number of participant-years on study treatment. A relapse is defined as the appearance of a new neurological abnormality, or worsening of previously stable, or improving pre-existing neurological abnormality, separated by at least 30 days from the onset of a preceding clinical demyelinating event. |
Up to 24 months |
|
| Secondary |
Percentage of Relapsing Participants |
Percentage of relapsing participants will be assessed at the time of 24 months from the first administration of Tecfidera. A relapse is defined as the appearance of a new neurological abnormality, or worsening of previously stable, or improving pre-existing neurological abnormality, separated by at least 30 days from the onset of a preceding clinical demyelinating event. |
Up to 24 months |
|
| Secondary |
Number of Gadolinium (Gd) Enhancing Lesions |
Number of Gd enhancing lesions will be observed using magnetic resonance imaging (MRI) scans. |
Up to 24 months |
|
| Secondary |
Change from Baseline in Participant's Global Efficacy Assessment by the Treating Physician |
Global efficacy assessment will be evaluated according to the treating physician's clinical discretion with 3-point rating scale at the time of 24 months from the first administration considering participant's overall condition compared to baseline. The score ranges from 1-3. The 3-point rating scale is classified as: 1=Improvement (symptoms are improved, or it is considered as maintaining effect after administration of Tecfidera). Maintaining effect is defined as it is highly expected that Tecfidera discontinuation worsens symptoms, or the same effect is persistent when the previous drug is replaced by Tecfidera; 2=No change (no changes were seen compared to before administration of Tecfidera without any change in concomitant medication or treatment related to MS; not considered as maintaining effect); 3=Worsening (symptoms are worsened compared to before administration of Tecfidera). |
Up to 24 months |
|
