| Secondary | Relapse-Free Rate in Each Year After Initiation of Cladribine Tablet Treatment | Relapse-free is defined as the time from the on-treatment period start date until first relapse or death as assessed by the investigator. Relapse-free rate, i.e., the survival rate using Kaplan Meier method, was summarized every year. | Full Analysis Set included all participants who were treated with at least one course of treatment with cladribine tablets. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at specified time points for this outcome measure. | Posted | | Number | 95% Confidence Interval | estimated probability | | Year 1, 2, 3, 4 and 5 after treatment initiation with Cladribine tablets until relapse or death | | | | ID | Title | Description |
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| OG000 | Cladribine | Participants diagnosed with Highly-active Disease Relapsing-remitting Multiple Sclerosis (HDA-RRMS), who completed at least Year 1 of treatment with cladribine tablets in routine clinical practice were enrolled into this study and assessed up to maximum 5 years after cladribine tablets initiation. |
| | | Title | Denominators | Categories |
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| Year 1 | | | | Year 2 | | | | Year 3 | | |
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| Primary | Annualized Relapse Rate in the Year Prior to Treatment Initiation With Cladribine Tablets | The annualized relapse rate for a participant is defined here as the number of clinician's confirmed relapses that occurred in the year prior to the date of Cladribine tablet initiation. | Full Analysis Set included all participants who were treated with at least one course of treatment with cladribine tablets. | Posted | | Mean | 95% Confidence Interval | Relapse per year | | 1 Year prior to date of Cladribine tablet initiation | | | | ID | Title | Description |
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| OG000 | Cladribine | Participants diagnosed with Highly-active Disease Relapsing-remitting Multiple Sclerosis (HDA-RRMS), who completed at least Year 1 of treatment with cladribine tablets in routine clinical practice were enrolled into this study and assessed up to maximum 5 years after cladribine tablets initiation. |
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| Primary | Annualized Relapse Rate in the Year One After Treatment Initiation With Cladribine Tablets | The annualized relapse rate for a participant is defined here as the number of clinician's confirmed relapses that occurred in Year 1 after treatment initiation with Cladribine tablets. | Full Analysis Set included all participants who were treated with at least one course of treatment with cladribine tablets. | Posted | | Mean | 95% Confidence Interval | Relapse per year | | Year 1 after treatment initiation with Cladribine tablets | | | | ID | Title | Description |
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| OG000 | Cladribine | Participants diagnosed with Highly-active Disease Relapsing-remitting Multiple Sclerosis (HDA-RRMS), who completed at least Year 1 of treatment with cladribine tablets in routine clinical practice were enrolled into this study and assessed up to maximum 5 years after cladribine tablets initiation. |
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| Primary | Annualized Relapse Rate in the Year 2 After Treatment Initiation With Cladribine Tablets | The annualized relapse rate for a participant is defined here as the number of clinician's confirmed relapses that occurred in Years 2 after treatment initiation with Cladribine tablets. | Full Analysis Set included all participants who were treated with at least one course of treatment with cladribine tablets. | Posted | | Mean | 95% Confidence Interval | Relapse per year | | Year 2 after treatment initiation with Cladribine tablets | | | | ID | Title | Description |
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| OG000 | Cladribine | Participants diagnosed with Highly-active Disease Relapsing-remitting Multiple Sclerosis (HDA-RRMS), who completed at least Year 1 of treatment with cladribine tablets in routine clinical practice were enrolled into this study and assessed up to maximum 5 years after cladribine tablets initiation. |
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| Primary | Annualized Relapse Rate in the Year 3 After Treatment Initiation With Cladribine Tablets | The annualized relapse rate for a participant is defined here as the number of clinician's confirmed relapses that occurred in Year 3 after treatment initiation with Cladribine tablets. | Full Analysis Set included all participants who were treated with at least one course of treatment with cladribine tablets. | Posted | | Mean | 95% Confidence Interval | Relapse per year | | Year 3 after treatment initiation with Cladribine tablets | | | | ID | Title | Description |
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| OG000 | Cladribine | Participants diagnosed with Highly-active Disease Relapsing-remitting Multiple Sclerosis (HDA-RRMS), who completed at least Year 1 of treatment with cladribine tablets in routine clinical practice were enrolled into this study and assessed up to maximum 5 years after cladribine tablets initiation. |
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| Primary | Annualized Relapse Rate in the Year 4 After Treatment Initiation With Cladribine Tablets | The annualized relapse rate for a participant is defined here as the number of clinician's confirmed relapses that occurred in Years 4 after treatment initiation with Cladribine tablets. | Full Analysis Set included all participants who were treated with at least one course of treatment with cladribine tablets. | Posted | | Mean | 95% Confidence Interval | Relapse per year | | Year 4 after treatment initiation with Cladribine tablets | | | | ID | Title | Description |
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| OG000 | Cladribine | Participants diagnosed with Highly-active Disease Relapsing-remitting Multiple Sclerosis (HDA-RRMS), who completed at least Year 1 of treatment with cladribine tablets in routine clinical practice were enrolled into this study and assessed up to maximum 5 years after cladribine tablets initiation. |
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| Primary | Annualized Relapse Rate in the Year 5 After Treatment Initiation With Cladribine Tablets | The annualized relapse rate for a participant is defined here as the number of clinician's confirmed relapses that occurred in Year 5 after treatment initiation with Cladribine tablets. | Full Analysis Set included all participants who were treated with at least one course of treatment with cladribine tablets. | Posted | | Mean | 95% Confidence Interval | Relapse per year | | Year 5 after treatment initiation with Cladribine tablets | | | | ID | Title | Description |
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| OG000 | Cladribine | Participants diagnosed with Highly-active Disease Relapsing-remitting Multiple Sclerosis (HDA-RRMS), who completed at least Year 1 of treatment with cladribine tablets in routine clinical practice were enrolled into this study and assessed up to maximum 5 years after cladribine tablets initiation. |
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| Secondary | Time From Cladribine Tablet Initiation to First Relapse | A qualifying relapse is defined as new, worsening or recurrent neurological symptoms attributed to Multiple Sclerosis (MS) that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. Percentage of participants with qualified relapse-free status at week 24 were reported. | Full Analysis Set included all participants who were treated with at least one course of treatment with cladribine tablets. | Posted | | Median | 95% Confidence Interval | years | | up to maximum 5 years after treatment initiation with Cladribine tablets | | | | ID | Title | Description |
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| OG000 | Cladribine | Participants diagnosed with Highly-active Disease Relapsing-remitting Multiple Sclerosis (HDA-RRMS), who completed at least Year 1 of treatment with cladribine tablets in routine clinical practice were enrolled into this study and assessed up to maximum 5 years after cladribine tablets initiation. |
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| Secondary | Number of Participants Who Discontinued Cladribine Tablets | The number of participants who discontinued treatment with cladribine are reported here. | Full Analysis Set included all participants who were treated with at least one course of treatment with cladribine tablets. | Posted | | Count of Participants | | Participants | | From Cladribine treatment initiation up to end of Cladribine treatment (assessed up end of Treatment Year 2) | | | | ID | Title | Description |
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| OG000 | Cladribine | Participants diagnosed with Highly-active Disease Relapsing-remitting Multiple Sclerosis (HDA-RRMS), who completed at least Year 1 of treatment with cladribine tablets in routine clinical practice were enrolled into this study and assessed up to maximum 5 years after cladribine tablets initiation. |
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| Secondary | Number of Participants Who Received Subsequent Disease-modifying Therapies (DMTs) After Cladribine Tablets Discontinuation/Treatment Completion | The number of participants who received Subsequent Disease-modifying Therapies (DMTs) after Cladribine Tablets Discontinuation/Treatment Completion were reported here. | Full Analysis Set included all participants who were treated with at least one course of treatment with cladribine tablets. | Posted | | Count of Participants | | Participants | | From Cladribine treatment initiation up to end of Cladribine treatment (assessed up end of Treatment Year 2) | | | | ID | Title | Description |
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| OG000 | Cladribine | Participants diagnosed with Highly-active Disease Relapsing-remitting Multiple Sclerosis (HDA-RRMS), who completed at least Year 1 of treatment with cladribine tablets in routine clinical practice were enrolled into this study and assessed up to maximum 5 years after cladribine tablets initiation. |
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| Secondary | Number of Participants With Disability Progression Assessed by Expanded Disease Severity Scale (EDSS) at Treatment Initiation and Start of Treatment Year 2 | he EDSS is an ordinal clinical rating scale in half-point increments. It assesses the following eight functional systems, areas of the central nervous system that control bodily functions: Pyramidal (ability to walk), Cerebellar (coordination), Brain stem (speech and swallowing), Sensory (touch and pain), Bowel and bladder functions, Visual, Mental, Other (includes any other neurological findings due to Multiple Sclerosis [MS]). EDSS overall score ranging from 0 (normal) to 10 (death due to MS). | Full Analysis Set included all participants who were treated with at least one course of treatment with cladribine tablets. | Posted | | Count of Participants | | Participants | | At Treatment Initiation and Start of Treatment Year 2 | | | | ID | Title | Description |
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| OG000 | Cladribine | Participants diagnosed with Highly-active Disease Relapsing-remitting Multiple Sclerosis (HDA-RRMS), who completed at least Year 1 of treatment with cladribine tablets in routine clinical practice were enrolled into this study and assessed up to maximum 5 years after cladribine tablets initiation. |
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| Secondary | Number of Participants With Disability Progression Confirmed Over 6 Months, Assessed by Expanded Disease Severity Scale (EDSS) at 2 Years After Cladribine Tablet Treatment Initiation | he EDSS is an ordinal clinical rating scale in half-point increments. It assesses the following eight functional systems, areas of the central nervous system that control bodily functions: Pyramidal (ability to walk), Cerebellar (coordination), Brain stem (speech and swallowing), Sensory (touch and pain), Bowel and bladder functions, Visual, Mental, Other (includes any other neurological findings due to Multiple Sclerosis [MS]). EDSS overall score ranging from 0 (normal) to 10 (death due to MS). | Full Analysis Set included all participants who were treated with at least one course of treatment with cladribine tablets. | Posted | | Count of Participants | | Participants | | At 2 years after treatment initiation with Cladribine tablets | | | | ID | Title | Description |
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| OG000 | Cladribine | Participants diagnosed with Highly-active Disease Relapsing-remitting Multiple Sclerosis (HDA-RRMS), who completed at least Year 1 of treatment with cladribine tablets in routine clinical practice were enrolled into this study and assessed up to maximum 5 years after cladribine tablets initiation. |
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| Secondary | Number of Participants With Grade 3 Lymphopenia, Grade 4 Lymphopenia, Herpes Infections, Serious Infections, Opportunistic Infections and Malignancies | Number of Participants with Grade 3 Lymphopenia, Grade 4 Lymphopenia, Herpes Infections, Serious Infections, Opportunistic Infections and Malignancies were reported. | Full Analysis Set included all participants who were treated with at least one course of treatment with cladribine tablets. | Posted | | Count of Participants | | Participants | | At 2 years after treatment initiation with Cladribine tablets | | | | ID | Title | Description |
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| OG000 | Cladribine | Participants diagnosed with Highly-active Disease Relapsing-remitting Multiple Sclerosis (HDA-RRMS), who completed at least Year 1 of treatment with cladribine tablets in routine clinical practice were enrolled into this study and assessed up to maximum 5 years after cladribine tablets initiation. |
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