Trial Outcomes & Findings for A Study of Suboptimally Controlled Participants Previously Taking Oral or Infusion DMDs for RMS (MASTER-2) (NCT NCT03933202)

Last Updated: 2026-01-02

Results Overview

A relapse was defined as per routine clinical practice as determined by the investigator. As a guide, relapse may be defined as exacerbation of symptoms that occur over a minimum of 24 hours and separated from a previous attack by at least 30 days, in the absence of fever or infection. ARR was calculated as the total number of reported relapses in the 24 months after treatment divided by the days on study corresponding to relapse information and multiplied by 365.25.

Recruitment status

COMPLETED

Target enrollment

291 participants

Primary outcome timeframe

From first dose of cladribine tablets up to 24 months

Results posted on

2026-01-02

Participant Flow

Participant milestones

Participant milestones
Measure	Cladribine Tablets: Switch From Oral Participants who had decided prior to enrollment to transition from any oral Disease-Modifying Drug (DMD) to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.	Cladribine Tablets: Switch From Infusion Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.
Overall Study STARTED	163	120
Overall Study Participants Who Received at Least 1 Dose of Cladribine Tablets	103	85
Overall Study Switch From Ocrelizumab	0	53
Overall Study COMPLETED	116	92
Overall Study NOT COMPLETED	47	28

Reasons for withdrawal

Reasons for withdrawal
Measure	Cladribine Tablets: Switch From Oral Participants who had decided prior to enrollment to transition from any oral Disease-Modifying Drug (DMD) to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.	Cladribine Tablets: Switch From Infusion Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.
Overall Study Participant withdrawn by Principal Investigator	1	0
Overall Study Participant transferred care	1	0
Overall Study Site research department closing	1	0
Overall Study Site closed prematurely due to unexpected circumstances	0	1
Overall Study Participant discontinuation due to Sponsor decision to close study	0	2
Overall Study Participant changed primary neurology provider	1	0
Overall Study Participant could not be entered as a follow-up	0	1
Overall Study Participant non-compliant, therefore, has been discontinued	1	0
Overall Study Participant delayed year 2 due to subject fear of COVID-19	1	0
Overall Study Missed visit	0	1
Overall Study Investigator decision	4	0
Overall Study Discontinuation due to safety extension removal by Sponsor	0	1
Overall Study Withdrawal by Subject	10	8
Overall Study Death	2	0
Overall Study Progressive disease	0	3
Overall Study Protocol non-compliance	6	3
Overall Study Lost to Follow-up	16	8
Overall Study Adverse Event	3	0

Baseline Characteristics

A Study of Suboptimally Controlled Participants Previously Taking Oral or Infusion DMDs for RMS (MASTER-2)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cladribine Tablets: Switch From Oral n=103 Participants Participants who had decided prior to enrollment to transition from any oral DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.	Cladribine Tablets: Switch From Infusion n=85 Participants Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.	Total n=188 Participants Total of all reporting groups
Age, Continuous	50 years STANDARD_DEVIATION 10.8 • n=228 Participants	48 years STANDARD_DEVIATION 12.5 • n=115 Participants	49 years STANDARD_DEVIATION 11.6 • n=343 Participants
Sex: Female, Male Female	84 Participants n=228 Participants	58 Participants n=115 Participants	142 Participants n=343 Participants
Sex: Female, Male Male	19 Participants n=228 Participants	27 Participants n=115 Participants	46 Participants n=343 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=228 Participants	3 Participants n=115 Participants	8 Participants n=343 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	93 Participants n=228 Participants	74 Participants n=115 Participants	167 Participants n=343 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=228 Participants	8 Participants n=115 Participants	13 Participants n=343 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=228 Participants	0 Participants n=115 Participants	0 Participants n=343 Participants
Race (NIH/OMB) Asian	1 Participants n=228 Participants	2 Participants n=115 Participants	3 Participants n=343 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=228 Participants	0 Participants n=115 Participants	0 Participants n=343 Participants
Race (NIH/OMB) Black or African American	13 Participants n=228 Participants	6 Participants n=115 Participants	19 Participants n=343 Participants
Race (NIH/OMB) White	85 Participants n=228 Participants	68 Participants n=115 Participants	153 Participants n=343 Participants
Race (NIH/OMB) More than one race	0 Participants n=228 Participants	4 Participants n=115 Participants	4 Participants n=343 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=228 Participants	5 Participants n=115 Participants	9 Participants n=343 Participants

PRIMARY outcome

Timeframe: From first dose of cladribine tablets up to 24 months

Population: The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets.

Outcome measures

Outcome measures
Measure	Cladribine Tablets: Switch From Oral n=103 Participants Participants who had decided prior to enrollment to transition from any oral DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.	Cladribine Tablets: Switch From Infusion n=85 Participants Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.
Annualized Relapse Rate (ARR)	0.04 relapses per year Standard Deviation 0.145	0.03 relapses per year Standard Deviation 0.153

SECONDARY outcome

Timeframe: Baseline (Month 0), Month 6, 12 and 24

Population: The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets. "Overall number of participants analyzed" refers to those evaluable for the outcome measure, while "number analyzed" refers to those evaluable at specific timepoints.

The TSQM-14 was a participant-rated scale used to assess subjective satisfaction with medication. The TSQM has 14 questions that assesses participants' global satisfaction level with their treatment in 4 domains: side effects (There are 5 questions in the side effects domain, however one of them is a Yes/No question and there are 4 sub-components, hence a maximum score of 20), effectiveness (3 questions), global satisfaction (3 questions), and convenience (3 questions). All questions are scored from 1 (least satisfied) to 5 or 7 (most satisfied). The total score is summed for each domain to obtain: side effects (1-20), effectiveness (1-21), global satisfaction (1-17), and convenience (1-21), using transformed scores between 0 and 100. Lower total scores in each domain indicate dissatisfaction with the study medication and higher total scores indicate satisfaction.

Outcome measures

Outcome measures
Measure	Cladribine Tablets: Switch From Oral n=46 Participants Participants who had decided prior to enrollment to transition from any oral DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.	Cladribine Tablets: Switch From Infusion n=29 Participants Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.
Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 Global Satisfaction: Month 6	18.5 units on a scale Standard Deviation 30.42	22.2 units on a scale Standard Deviation 15.14
Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 Global Satisfaction: Month 12	11.1 units on a scale Standard Deviation 25.95	19.0 units on a scale Standard Deviation 21.82
Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 Convenience: Month 24	1.4 units on a scale Standard Deviation 53.74	44.4 units on a scale Standard Deviation NA Standard deviation could not be calculated due to high missingness and low response rate.
Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 Global Satisfaction: Month 24	16.1 units on a scale Standard Deviation 24.31	-28.6 units on a scale Standard Deviation NA Standard deviation could not be calculated due to high missingness and low response rate.
Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 Effectiveness: Month 6	10.5 units on a scale Standard Deviation 29.13	22.2 units on a scale Standard Deviation 21.08
Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 Effectiveness: Month 12	3.9 units on a scale Standard Deviation 24.09	24.1 units on a scale Standard Deviation 30.60
Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 Effectiveness: Month 24	2.8 units on a scale Standard Deviation 21.52	16.7 units on a scale Standard Deviation NA Standard deviation could not be calculated due to high missingness and low response rate.
Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 Side Effects: Month 6	11.4 units on a scale Standard Deviation 40.28	7.1 units on a scale Standard Deviation 16.31
Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 Side Effects: Month 12	6.3 units on a scale Standard Deviation 24.63	2.1 units on a scale Standard Deviation 40.67
Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 Side Effects: Month 24	10.9 units on a scale Standard Deviation 12.88	—
Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 Convenience: Month 6	15.4 units on a scale Standard Deviation 27.25	24.6 units on a scale Standard Deviation 14.29
Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 Convenience: Month 12	7.7 units on a scale Standard Deviation 29.90	18.5 units on a scale Standard Deviation 28.51

SECONDARY outcome

Timeframe: Baseline (Month 0), Month 6, 12 and 24

The SF-36 Health Survey is a validated, self-administered questionnaire designed to assess general health status across eight domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It includes one item evaluating perceived change in health over the past year and generates two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-derived using factor analytic methods. Each domain and summary score is scaled from 0 to 100, with higher scores indicating better health status.

Outcome measures

Outcome measures
Measure	Cladribine Tablets: Switch From Oral n=61 Participants Participants who had decided prior to enrollment to transition from any oral DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.	Cladribine Tablets: Switch From Infusion n=46 Participants Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Domain Score at Month 6, 12 and 24 MCS: Month 6	2.3 units on a scale Standard Deviation 8.63	-1.6 units on a scale Standard Deviation 6.45
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Domain Score at Month 6, 12 and 24 MCS: Month 12	0.8 units on a scale Standard Deviation 7.98	-2.9 units on a scale Standard Deviation 4.70
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Domain Score at Month 6, 12 and 24 MCS: Month 24	-0.6 units on a scale Standard Deviation 8.77	2.8 units on a scale Standard Deviation 10.42
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Domain Score at Month 6, 12 and 24 PCS: Baseline	44.2 units on a scale Standard Deviation 11.17	38.1 units on a scale Standard Deviation 10.76
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Domain Score at Month 6, 12 and 24 PCS: Month 6	0.4 units on a scale Standard Deviation 5.43	2.2 units on a scale Standard Deviation 6.75
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Domain Score at Month 6, 12 and 24 PCS: Month 12	0.2 units on a scale Standard Deviation 6.44	-1.9 units on a scale Standard Deviation 5.54
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Domain Score at Month 6, 12 and 24 PCS: Month 24	1.0 units on a scale Standard Deviation 6.06	-2.0 units on a scale Standard Deviation 6.94
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Domain Score at Month 6, 12 and 24 MCS: Baseline	48.2 units on a scale Standard Deviation 9.35	46.4 units on a scale Standard Deviation 12.01

SECONDARY outcome

Timeframe: Baseline (Month 0), Month 6, 12 and 24

The MFIS-5 is a shortened version of the Fatigue Impact Scale consisting of 5 items that assess the impact of fatigue on physical, cognitive, and psychosocial functioning. Each item is rated on a 5-point Likert scale: 0 (Never), 1 (Rarely), 2 (Sometimes), 3 (Often), and 4 (Almost always). The total score ranges from 0 to 20, with higher scores indicating a greater impact of fatigue. Items include: reduced alertness, limitations in activities away from home, difficulty sustaining physical effort, reduced ability to complete tasks requiring physical effort, and trouble concentrating.

Outcome measures

Outcome measures
Measure	Cladribine Tablets: Switch From Oral n=54 Participants Participants who had decided prior to enrollment to transition from any oral DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.	Cladribine Tablets: Switch From Infusion n=37 Participants Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.
Change From Baseline in Modified Fatigue Impact Scale - 5-item Version (MFIS-5) Total Score at Month 6, 12 and 24 Baseline	9.0 units on a scale Standard Deviation 5.14	10.5 units on a scale Standard Deviation 5.22
Change From Baseline in Modified Fatigue Impact Scale - 5-item Version (MFIS-5) Total Score at Month 6, 12 and 24 Month 6	0.0 units on a scale Standard Deviation 2.43	-0.8 units on a scale Standard Deviation 3.52
Change From Baseline in Modified Fatigue Impact Scale - 5-item Version (MFIS-5) Total Score at Month 6, 12 and 24 Month 12	-0.3 units on a scale Standard Deviation 2.87	1.5 units on a scale Standard Deviation 1.00
Change From Baseline in Modified Fatigue Impact Scale - 5-item Version (MFIS-5) Total Score at Month 6, 12 and 24 Month 24	0.9 units on a scale Standard Deviation 3.29	2.0 units on a scale Standard Deviation 1.41

SECONDARY outcome

Timeframe: Baseline (Month 0), Month 6, 12 and 24

The 7-item Beck Depression Inventory-Fast Screen (BDI-FS) is a self-report tool used to assess the severity of depressive symptoms. It includes seven items: Sadness, Pessimism, Past Failure, Loss of Pleasure, Self-Dislike, Self-Criticalness, and Suicidal Thoughts. Each item is rated on a 4-point scale from 0 to 3, with higher scores indicating greater symptom severity. The total score ranges from 0 to 21 and is calculated by summing the highest-rated response for each item.

Outcome measures

Outcome measures
Measure	Cladribine Tablets: Switch From Oral n=54 Participants Participants who had decided prior to enrollment to transition from any oral DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.	Cladribine Tablets: Switch From Infusion n=38 Participants Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.
Change From Baseline in 7-Item Beck-Depression Inventory-Fast Screen (BDI-FS) Total Score at Month 6, 12 and 24 Baseline	1.8 units on a scale Standard Deviation 2.08	3.5 units on a scale Standard Deviation 3.55
Change From Baseline in 7-Item Beck-Depression Inventory-Fast Screen (BDI-FS) Total Score at Month 6, 12 and 24 Month 6	0.5 units on a scale Standard Deviation 1.54	1.0 units on a scale Standard Deviation 1.70
Change From Baseline in 7-Item Beck-Depression Inventory-Fast Screen (BDI-FS) Total Score at Month 6, 12 and 24 Month 12	0.2 units on a scale Standard Deviation 1.77	1.0 units on a scale Standard Deviation 2.16
Change From Baseline in 7-Item Beck-Depression Inventory-Fast Screen (BDI-FS) Total Score at Month 6, 12 and 24 Month 24	0.8 units on a scale Standard Deviation 1.48	0.3 units on a scale Standard Deviation 2.52

SECONDARY outcome

Timeframe: Baseline (Month 0), Month 6, 12 and 24

The WPAI-MS questionnaire is a 6-item validated instrument to measure impairments in work and activities. The WPAI-MS included 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI-MS generated four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity. Change from baseline in percentage of work time missed (absenteeism) was reported.

Outcome measures

Outcome measures
Measure	Cladribine Tablets: Switch From Oral n=16 Participants Participants who had decided prior to enrollment to transition from any oral DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.	Cladribine Tablets: Switch From Infusion n=6 Participants Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.
Change From Baseline in Percentage of Work Time Missed Assessed by 6-Item Work Productivity Activity Impairment - Multiple Sclerosis (WPAI-MS) Score at Month 6, 12 and 24 Change at Month 6	0.0 percentage of work time missed Standard Deviation 39.22	-8.7 percentage of work time missed Standard Deviation 17.76
Change From Baseline in Percentage of Work Time Missed Assessed by 6-Item Work Productivity Activity Impairment - Multiple Sclerosis (WPAI-MS) Score at Month 6, 12 and 24 Change at Month 12	-7.7 percentage of work time missed Standard Deviation 25.46	30.8 percentage of work time missed Standard Deviation 60.08
Change From Baseline in Percentage of Work Time Missed Assessed by 6-Item Work Productivity Activity Impairment - Multiple Sclerosis (WPAI-MS) Score at Month 6, 12 and 24 Change at Month 24	0.00 percentage of work time missed Standard Deviation 0.00	-100.0 percentage of work time missed Standard Deviation NA Standard deviation could not be calculated due to high missingness and low response rate.

SECONDARY outcome

Timeframe: Baseline (Month 0), Month 6, 12 and 24

Outcome measures

Outcome measures
Measure	Cladribine Tablets: Switch From Oral n=10 Participants Participants who had decided prior to enrollment to transition from any oral DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.	Cladribine Tablets: Switch From Infusion n=1 Participants Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.
Change From Baseline in Percentage of Impairment While Working Assessed by 6-Item Work Productivity Activity Impairment - Multiple Sclerosis (WPAI-MS) Score at Month 6, 12 and 24 Change at Month 6	-10.0 percentage of impairment while working Standard Deviation 16.58	-10.0 percentage of impairment while working Standard Deviation NA Standard deviation could not be calculated due to high missingness and low response rate.
Change From Baseline in Percentage of Impairment While Working Assessed by 6-Item Work Productivity Activity Impairment - Multiple Sclerosis (WPAI-MS) Score at Month 6, 12 and 24 Change at Month 12	-10.0 percentage of impairment while working Standard Deviation 34.32	0.0 percentage of impairment while working Standard Deviation NA Standard deviation could not be calculated due to high missingness and low response rate.
Change From Baseline in Percentage of Impairment While Working Assessed by 6-Item Work Productivity Activity Impairment - Multiple Sclerosis (WPAI-MS) Score at Month 6, 12 and 24 Change at Month 24	-1.7 percentage of impairment while working Standard Deviation 18.35	—

SECONDARY outcome

Timeframe: Baseline (Month 0), Month 6, 12 and 24

The WPAI-MS questionnaire is a 6-item validated instrument to measure impairments in work and activities. The WPAI-MS included 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI-MS generated four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity. Change from baseline in total percentage of work impairment (absenteeism and presentisms) were reported.

Outcome measures

Outcome measures
Measure	Cladribine Tablets: Switch From Oral n=10 Participants Participants who had decided prior to enrollment to transition from any oral DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.	Cladribine Tablets: Switch From Infusion n=1 Participants Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.
Change From Baseline in Percentage of Overall Work Impairment Assessed by 6-Item Work Productivity Activity Impairment - Multiple Sclerosis (WPAI-MS) Score at Month 6, 12 and 24 Change at Month 6	-10.0 percentage of overall work impairment Standard Deviation 16.58	-10.0 percentage of overall work impairment Standard Deviation NA Standard deviation could not be calculated due to high missingness and low response rate.
Change From Baseline in Percentage of Overall Work Impairment Assessed by 6-Item Work Productivity Activity Impairment - Multiple Sclerosis (WPAI-MS) Score at Month 6, 12 and 24 Change at Month 12	-9.8 percentage of overall work impairment Standard Deviation 34.40	0.0 percentage of overall work impairment Standard Deviation NA Standard deviation could not be calculated due to high missingness and low response rate.
Change From Baseline in Percentage of Overall Work Impairment Assessed by 6-Item Work Productivity Activity Impairment - Multiple Sclerosis (WPAI-MS) Score at Month 6, 12 and 24 Change at Month 24	-1.7 percentage of overall work impairment Standard Deviation 18.35	—

SECONDARY outcome

Timeframe: Baseline (Month 0), Month 6, 12 and 24

Outcome measures

Outcome measures
Measure	Cladribine Tablets: Switch From Oral n=20 Participants Participants who had decided prior to enrollment to transition from any oral DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.	Cladribine Tablets: Switch From Infusion n=9 Participants Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.
Change From Baseline in Percentage of Activity Impairment Assessed by 6-Item Work Productivity Activity Impairment- Multiple Sclerosis (WPAI-MS) Score at Month 6, 12 and 24 Change at Month 6	3.5 percentage of activity impairment Standard Deviation 27.58	-8.9 percentage of activity impairment Standard Deviation 18.33
Change From Baseline in Percentage of Activity Impairment Assessed by 6-Item Work Productivity Activity Impairment- Multiple Sclerosis (WPAI-MS) Score at Month 6, 12 and 24 Change at Month 12	-12.2 percentage of activity impairment Standard Deviation 23.40	10.0 percentage of activity impairment Standard Deviation 14.14
Change From Baseline in Percentage of Activity Impairment Assessed by 6-Item Work Productivity Activity Impairment- Multiple Sclerosis (WPAI-MS) Score at Month 6, 12 and 24 Change at Month 24	0.0 percentage of activity impairment Standard Deviation 18.52	-10.0 percentage of activity impairment Standard Deviation 14.14

SECONDARY outcome

Timeframe: Baseline (Month 0), Month 6, 12 and 24

The PDDS is a patient-reported scale to assess the disability status in participants with MS, and it focuses mainly on how participants walk. Scores on the PDDS range from 0 (normal) to 8 (bedridden): 0 (Normal), 1 (Mild Disability), 2 (Moderate Disability), 3 (Gait Disability), 4 (Early Cane), 5 (Late Cane), 6 (Bilateral Support), 7 (Wheelchair/Scooter), and 8 (Bedridden). A higher score represents higher level of disability.

Outcome measures

Outcome measures
Measure	Cladribine Tablets: Switch From Oral n=61 Participants Participants who had decided prior to enrollment to transition from any oral DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.	Cladribine Tablets: Switch From Infusion n=45 Participants Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.
Change From Baseline in Patient Determined Disease Steps (PDDS) Scale Total Score at Month 6, 12 and 24 Month 24	-0.2 units on a scale Standard Deviation 1.04	0.0 units on a scale Standard Deviation 1.10
Change From Baseline in Patient Determined Disease Steps (PDDS) Scale Total Score at Month 6, 12 and 24 Month 12	0.0 units on a scale Standard Deviation 0.87	-0.1 units on a scale Standard Deviation 0.81
Change From Baseline in Patient Determined Disease Steps (PDDS) Scale Total Score at Month 6, 12 and 24 Baseline	2.1 units on a scale Standard Deviation 2.7	3.4 units on a scale Standard Deviation 2.47
Change From Baseline in Patient Determined Disease Steps (PDDS) Scale Total Score at Month 6, 12 and 24 Month 6	-0.1 units on a scale Standard Deviation 1.01	-0.4 units on a scale Standard Deviation 0.67

SECONDARY outcome

Timeframe: Month 1, 2, 13 and 14

7 Treatment adherence questions, based on MS-TAQ, were developed to determine level of adherence as well as identify barriers to adherence for MS participants taking DMDs. 1.What treatment week of cladribine (Clad.) tablets (tab.) did you most recently complete? 2.How many Clad. tab. were you supposed to take during this treatment week? 3.Did you miss/forget to take any Clad. tab. during this treatment week? 4. How many Clad. tab. did you miss/ forget to take? 5.How important were following factors in missing/forgetting to take a dose? (scale from 0-3, where, 0=Not important at all and 3=Extremely important). 6.Overall, how hard/easy do you feel it is to take Clad. tab. as recommended by your physician during your treatment week? (scale from 1- 5, where 1=Extremely easy and 5=Extremely hard). 7.How satisfied are you with how things have been with your Clad. tab. treatment during your treatment week? (scale from 1-5, where 1=Not satisfied at all and 5=Completely satisfied).

Outcome measures

Outcome measures
Measure	Cladribine Tablets: Switch From Oral n=74 Participants Participants who had decided prior to enrollment to transition from any oral DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.	Cladribine Tablets: Switch From Infusion n=53 Participants Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.
Number of Participants With Adherence to Treatment as Assessed by Modified Versions of the Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ) Month 1	71 Participants	50 Participants
Number of Participants With Adherence to Treatment as Assessed by Modified Versions of the Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ) Month 2	72 Participants	53 Participants
Number of Participants With Adherence to Treatment as Assessed by Modified Versions of the Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ) Month 13	32 Participants	22 Participants
Number of Participants With Adherence to Treatment as Assessed by Modified Versions of the Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ) Month 14	20 Participants	11 Participants

SECONDARY outcome

Timeframe: Over the 12-month and 24-month period

Population: The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets.

Outcome measures

Outcome measures
Measure	Cladribine Tablets: Switch From Oral n=103 Participants Participants who had decided prior to enrollment to transition from any oral DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.	Cladribine Tablets: Switch From Infusion n=85 Participants Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.
Number of Participants Who Experienced Relapse Over the 12-month period	4 Participants	4 Participants
Number of Participants Who Experienced Relapse Over the 24-month period	6 Participants	4 Participants

SECONDARY outcome

Timeframe: Over the 12-month period, 13th to 24th month and over the 24 month period.

Population: The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets.

A relapse was defined according to routine clinical practice as determined by the investigator. A relapse will be associated with hospitalization if the participants will be hospitalized for the relapse. As a guide, relapse was considered an exacerbation of symptoms that occurred over a minimum of 24 hours and was separated from a previous attack by at least 30 days, in the absence of fever or infection. The percentage of participants who experienced a relapse associated with hospitalization was reported.

Outcome measures

Outcome measures
Measure	Cladribine Tablets: Switch From Oral n=103 Participants Participants who had decided prior to enrollment to transition from any oral DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.	Cladribine Tablets: Switch From Infusion n=85 Participants Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.
Percentage of Participants With Relapse Associated With Hospitalization Over the 24-month period	1.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With Relapse Associated With Hospitalization Over the 12-month period	1.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With Relapse Associated With Hospitalization 13th to 24th month period	0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Month 12 and Month 24

Population: The FAS included all participants enrolled in the study who received at least 1 dose of 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 each specified timepoints.

The qualifying relapse is the occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis (MS) (for more than \[\>\] 24 hours, no fever, infection, injury, adverse events (AEs), and preceded by a stable or improving neurological state for more than or equal to \[\>=\] 30 days).ARR was calculated as the total number of reported relapses in the 24 months after treatment divided by the days on study corresponding to relapse information and multiplied by 365.25. ARR associated with hospitalization at Months 12 and 24 were reported. A relapse was associated with hospitalization if the participant will be hospitalized for the relapse.

Outcome measures

Outcome measures
Measure	Cladribine Tablets: Switch From Oral n=76 Participants Participants who had decided prior to enrollment to transition from any oral DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.	Cladribine Tablets: Switch From Infusion n=72 Participants Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.
Annualized Relapse Rate (ARR) Associated With Hospitalization at Months 12 and 24 Month 12	0.01 relapses per year Standard Deviation 0.114	0.00 relapses per year Standard Deviation 0.00
Annualized Relapse Rate (ARR) Associated With Hospitalization at Months 12 and 24 Month 24	0.01 relapses per year Standard Deviation 0.057	0.00 relapses per year Standard Deviation 0.00

SECONDARY outcome

Timeframe: Over the 12-month period, 13th to 24th month and over the 24 month period.

A relapse was defined according to routine clinical practice as determined by the investigator. As a guide, relapse was considered an exacerbation of symptoms that occurred over a minimum of 24 hours and was separated from a previous attack by at least 30 days, in the absence of fever or infection. The percentage of participants with relapse associated with glucocorticoid use over the 12-month period, 13th to 24th month and over the 24-month period of treatment with cladribine tablets was reported.

Outcome measures

Outcome measures
Measure	Cladribine Tablets: Switch From Oral n=103 Participants Participants who had decided prior to enrollment to transition from any oral DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.	Cladribine Tablets: Switch From Infusion n=85 Participants Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.
Percentage of Participants With Relapse Associated With Glucocorticoid Use Over the 12-month period	1.0 percentage of participants	3.5 percentage of participants
Percentage of Participants With Relapse Associated With Glucocorticoid Use 13th to 24th month period	1.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With Relapse Associated With Glucocorticoid Use Over the 24-month period	1.9 percentage of participants	2.4 percentage of participants

SECONDARY outcome

Timeframe: Months 12 and 24

Population: The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets.

The qualifying relapse is the occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis (MS) (for more than \[\>\] 24 hours, no fever, infection, injury, adverse events (AEs), and preceded by a stable or improving neurological state for more than or equal to \[\>=\] 30 days). ARR was calculated as the total number of reported relapses in the 24 months after treatment divided by the days on study corresponding to relapse information and multiplied by 365.25. ARR associated with glucocorticoid use at Months 12 and 24 were reported. A relapse will be associated with glucocorticoid use if steroid treatment will be required for the relapse.

Outcome measures

Outcome measures
Measure	Cladribine Tablets: Switch From Oral n=76 Participants Participants who had decided prior to enrollment to transition from any oral DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.	Cladribine Tablets: Switch From Infusion n=72 Participants Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.
Annualized Relapse Rate (ARR) Associated With Glucocorticoid Use at Months 12 and 24 Month 12	0.01 relapses per year Standard Deviation 0.114	0.04 relapses per year Standard Deviation 0.201
Annualized Relapse Rate (ARR) Associated With Glucocorticoid Use at Months 12 and 24 Month 24	0.02 relapses per year Standard Deviation 0.093	0.03 relapses per year Standard Deviation 0.142

SECONDARY outcome

Timeframe: At Baseline (Month 0)

Population: The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets.

Number of previous DMD received by participants with MS were reported.

Outcome measures

Outcome measures
Measure	Cladribine Tablets: Switch From Oral n=103 Participants Participants who had decided prior to enrollment to transition from any oral DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.	Cladribine Tablets: Switch From Infusion n=85 Participants Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.
Number of Previous Disease-Modifying Drugs (DMD) Received for Multiple Sclerosis (MS) at Baseline	3.0 number of DMDs received Standard Deviation 1.66	3.4 number of DMDs received Standard Deviation 1.82

SECONDARY outcome

Timeframe: Baseline (Month 0) up to 24 Months

Population: The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets.

Percentage of participants who discontinued cladribine tablets were reported.

Outcome measures

Outcome measures
Measure	Cladribine Tablets: Switch From Oral n=103 Participants Participants who had decided prior to enrollment to transition from any oral DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.	Cladribine Tablets: Switch From Infusion n=85 Participants Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.
Percentage of Participants Who Discontinued Cladribine Tablets	41.7 percentage of participants	22.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Month 0) up to 24 Months

Population: The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets.

Number of participants who discontinued cladribine tablets in each category of reason for discontinuation were reported.

Outcome measures

Outcome measures
Measure	Cladribine Tablets: Switch From Oral n=103 Participants Participants who had decided prior to enrollment to transition from any oral DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.	Cladribine Tablets: Switch From Infusion n=85 Participants Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.
Number of Participants With Reason for Discontinuation of Cladribine Tablets Withdrew consent from study	9 Participants	5 Participants
Number of Participants With Reason for Discontinuation of Cladribine Tablets Other/ Not Mentioned	8 Participants	2 Participants
Number of Participants With Reason for Discontinuation of Cladribine Tablets Adverse Event	9 Participants	1 Participants
Number of Participants With Reason for Discontinuation of Cladribine Tablets Lost to follow-up	12 Participants	6 Participants
Number of Participants With Reason for Discontinuation of Cladribine Tablets Protocol deviation	4 Participants	2 Participants
Number of Participants With Reason for Discontinuation of Cladribine Tablets Progressive disease	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline (Month 0) up to 24 Months

Elapsed time to discontinuation after first dose of cladribine tablets was reported. Elapsed time to discontinuation of cladribine tablets is calculated by subtracting the date of the first study dose from the date on which the participant discontinued cladribine tablets.

Outcome measures

Outcome measures
Measure	Cladribine Tablets: Switch From Oral n=103 Participants Participants who had decided prior to enrollment to transition from any oral DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.	Cladribine Tablets: Switch From Infusion n=80 Participants Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.
Elapsed Time to Discontinuation After First Dose of Cladribine Tablets	12.8 months Interval 0.0 to 17.4	13.1 months Interval 0.1 to 22.9

SECONDARY outcome

Timeframe: Baseline (Month 0) up to 24 Months

Population: The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets.

Number of doses received by participants as per United States prescribing information were reported.

Outcome measures

Outcome measures
Measure	Cladribine Tablets: Switch From Oral n=103 Participants Participants who had decided prior to enrollment to transition from any oral DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.	Cladribine Tablets: Switch From Infusion n=85 Participants Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.
Number of Doses Received by Participants as Per United States Prescribing Information	24.0 number of doses received Interval 2.0 to 40.0	25.0 number of doses received Interval 5.0 to 40.0

SECONDARY outcome

Timeframe: Baseline (Month 0) up to 24 Months

Population: The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets.

Total planned doses received by participants as per United States Prescribing Information was reported.

Outcome measures

Outcome measures
Measure	Cladribine Tablets: Switch From Oral n=103 Participants Participants who had decided prior to enrollment to transition from any oral DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.	Cladribine Tablets: Switch From Infusion n=85 Participants Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.
Total Planned Doses Received by Participants as Per United States Prescribing Information	3.4 mg/kg Interval 0.9 to 4.0	3.5 mg/kg Interval 0.9 to 3.9

SECONDARY outcome

Timeframe: Baseline (Month 0) up to 24 Months

Population: The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets.

Percentage of participants with subsequent treatment chosen following discontinuation of cladribine tablets was reported. The percentages were calculated using the number of participants who discontinued Cladribine tablets as denominator.

Outcome measures

Outcome measures
Measure	Cladribine Tablets: Switch From Oral n=43 Participants Participants who had decided prior to enrollment to transition from any oral DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.	Cladribine Tablets: Switch From Infusion n=19 Participants Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.
Percentage of Participants With Subsequent Treatment Chosen Following Discontinuation of Cladribine Tablets	4.7 percentage of participants	5.2 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Month 0) up to 24 Months

Population: The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets.

Number of participants with at least one concomitant medication were reported.

Outcome measures

Outcome measures
Measure	Cladribine Tablets: Switch From Oral n=103 Participants Participants who had decided prior to enrollment to transition from any oral DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.	Cladribine Tablets: Switch From Infusion n=85 Participants Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.
Number of Participants With At Least One Concomitant Medication	98 Participants	73 Participants

SECONDARY outcome

Timeframe: Up to 24 Months prior Baseline (Month 0)

Population: The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets.

A relapse was defined as an exacerbation of symptoms that occurred over a minimum of 24 hours and was separated from a previous attack by at least 30 days, in the absence of fever or infection. Annualized relapse rate (ARR) during the 24 months prior to baseline, based on retrospectively collected data, was reported. ARR was calculated as the total number of reported relapses in the 24 months after treatment divided by the days on study corresponding to relapse information and multiplied by 365.25.

Outcome measures

Outcome measures
Measure	Cladribine Tablets: Switch From Oral n=103 Participants Participants who had decided prior to enrollment to transition from any oral DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.	Cladribine Tablets: Switch From Infusion n=85 Participants Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.
Annualized Relapse Rate (ARR)	0.17 relapses per year Standard Deviation 0.313	0.14 relapses per year Standard Deviation 0.268

SECONDARY outcome

Timeframe: Baseline (Month 0) up to 24 months

Population: The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets.

A serious adverse event (SAE) is an adverse event (AE) that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or is otherwise considered medically important. An ADR is a response to a medicinal product which is noxious and unintended. An AESI is an AE of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor can be appropriate. Special Situations included AEs related to pregnancy, overdose, off-label use, misuse, medication error, occupational exposure, or lack of therapeutic effectiveness.

Outcome measures

Outcome measures
Measure	Cladribine Tablets: Switch From Oral n=103 Participants Participants who had decided prior to enrollment to transition from any oral DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.	Cladribine Tablets: Switch From Infusion n=85 Participants Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.
Number of Participants With Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and Adverse Events of Special Interest (AESIs) SAEs	10 Participants	14 Participants
Number of Participants With Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and Adverse Events of Special Interest (AESIs) ADR	35 Participants	19 Participants
Number of Participants With Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and Adverse Events of Special Interest (AESIs) AESIs	15 Participants	7 Participants
Number of Participants With Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and Adverse Events of Special Interest (AESIs) Special Situation	0 Participants	4 Participants
Number of Participants With Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and Adverse Events of Special Interest (AESIs) TEAEs	65 Participants	51 Participants

Adverse Events

Cladribine Tablets: Switch From Oral

Serious events: 10 serious events

Other events: 65 other events

Deaths: 2 deaths

Cladribine Tablets: Switch From Infusion

Serious events: 14 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cladribine Tablets: Switch From Oral n=103 participants at risk Participants who had decided prior to enrollment to transition from any oral DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.	Cladribine Tablets: Switch From Infusion n=85 participants at risk Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage I	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sarcoma	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Nervous system disorders Cerebrovascular accident	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Nervous system disorders Embolic stroke	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Nervous system disorders Optic neuritis	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Nervous system disorders Psychogenic seizure	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Nervous system disorders Seizure	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Nervous system disorders Trigeminal neuralgia	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Pregnancy, puerperium and perinatal conditions Abortion threatened	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Pregnancy, puerperium and perinatal conditions Pregnancy	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Psychiatric disorders Drug abuse	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Psychiatric disorders Suicide attempt	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Renal and urinary disorders Acute kidney injury	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Renal and urinary disorders Ureterolithiasis	0.00% 0/103 • Baseline (Month 0) up to 24 months	2.4% 2/85 • Baseline (Month 0) up to 24 months
Renal and urinary disorders Urinary tract obstruction	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Vascular disorders Deep vein thrombosis	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Blood and lymphatic system disorders Lymphopenia	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Cardiac disorders Acute myocardial infarction	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
General disorders Pyrexia	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Hepatobiliary disorders Cholecystitis	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Infections and infestations Breast cellulitis	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Infections and infestations Clostridium difficile infection	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Infections and infestations COVID-19	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Infections and infestations Pyelonephritis	0.00% 0/103 • Baseline (Month 0) up to 24 months	2.4% 2/85 • Baseline (Month 0) up to 24 months
Infections and infestations Sepsis	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Infections and infestations Tubo-ovarian abscess	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Infections and infestations Ureteritis	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Infections and infestations Urinary tract infection	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Infections and infestations Urosepsis	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Injury, poisoning and procedural complications Fall	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Injury, poisoning and procedural complications Head injury	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Investigations Lymphocyte count decreased	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months

Other adverse events

Other adverse events
Measure	Cladribine Tablets: Switch From Oral n=103 participants at risk Participants who had decided prior to enrollment to transition from any oral DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.	Cladribine Tablets: Switch From Infusion n=85 participants at risk Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.
Blood and lymphatic system disorders Lymphadenopathy	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Blood and lymphatic system disorders Lymphopenia	19.4% 20/103 • Baseline (Month 0) up to 24 months	4.7% 4/85 • Baseline (Month 0) up to 24 months
Blood and lymphatic system disorders Neutropenia	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Cardiac disorders Left ventricular dysfunction	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Cardiac disorders Palpitations	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Cardiac disorders Tachycardia	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Congenital, familial and genetic disorders Type V hyperlipidaemia	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Ear and labyrinth disorders Deafness	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Ear and labyrinth disorders Vertigo	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Endocrine disorders Autoimmune thyroiditis	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Endocrine disorders Goitre	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Endocrine disorders Hypothyroidism	1.9% 2/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Eye disorders Blindness unilateral	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Eye disorders Cataract	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Eye disorders Eye pain	0.97% 1/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Eye disorders Visual impairment	0.00% 0/103 • Baseline (Month 0) up to 24 months	2.4% 2/85 • Baseline (Month 0) up to 24 months
Eye disorders Vitreous opacities	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Gastrointestinal disorders Abdominal distension	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Gastrointestinal disorders Abdominal pain	0.00% 0/103 • Baseline (Month 0) up to 24 months	2.4% 2/85 • Baseline (Month 0) up to 24 months
Gastrointestinal disorders Abdominal pain upper	0.97% 1/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Gastrointestinal disorders Anal incontinence	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Gastrointestinal disorders Constipation	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Gastrointestinal disorders Dental caries	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Gastrointestinal disorders Diarrhoea	4.9% 5/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Gastrointestinal disorders Dysphagia	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Gastrointestinal disorders Food poisoning	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/103 • Baseline (Month 0) up to 24 months	2.4% 2/85 • Baseline (Month 0) up to 24 months
Gastrointestinal disorders Haemorrhoids	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Gastrointestinal disorders Hypoaesthesia oral	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Gastrointestinal disorders Nausea	5.8% 6/103 • Baseline (Month 0) up to 24 months	2.4% 2/85 • Baseline (Month 0) up to 24 months
Gastrointestinal disorders Rectal haemorrhage	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Gastrointestinal disorders Vomiting	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
General disorders Adverse drug reaction	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
General disorders Asthenia	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
General disorders Fatigue	8.7% 9/103 • Baseline (Month 0) up to 24 months	12.9% 11/85 • Baseline (Month 0) up to 24 months
General disorders Gait disturbance	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
General disorders Pain	2.9% 3/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
General disorders Peripheral swelling	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Hepatobiliary disorders Hepatic steatosis	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Infections and infestations Bronchitis	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Infections and infestations Cellulitis	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Infections and infestations Conjunctivitis	0.00% 0/103 • Baseline (Month 0) up to 24 months	2.4% 2/85 • Baseline (Month 0) up to 24 months
Infections and infestations Coronavirus infection	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Infections and infestations Cystitis	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Infections and infestations External ear cellulitis	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Infections and infestations Fungal skin infection	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Infections and infestations Helicobacter infection	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Infections and infestations Herpes zoster	0.97% 1/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Infections and infestations Nasopharyngitis	0.97% 1/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Infections and infestations Oral fungal infection	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Infections and infestations Oral herpes	0.97% 1/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Infections and infestations Pneumonia	0.97% 1/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Infections and infestations Respiratory syncytial virus infection	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Infections and infestations Sinusitis	0.97% 1/103 • Baseline (Month 0) up to 24 months	3.5% 3/85 • Baseline (Month 0) up to 24 months
Infections and infestations Skin candida	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Infections and infestations Subcutaneous abscess	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Infections and infestations Upper respiratory tract infection	3.9% 4/103 • Baseline (Month 0) up to 24 months	4.7% 4/85 • Baseline (Month 0) up to 24 months
Infections and infestations Urinary tract infection	2.9% 3/103 • Baseline (Month 0) up to 24 months	8.2% 7/85 • Baseline (Month 0) up to 24 months
Infections and infestations Urinary tract infection fungal	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Infections and infestations Vulvovaginal mycotic infection	0.97% 1/103 • Baseline (Month 0) up to 24 months	3.5% 3/85 • Baseline (Month 0) up to 24 months
Injury, poisoning and procedural complications Arthropod bite	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Injury, poisoning and procedural complications Arthropod sting	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Injury, poisoning and procedural complications Concussion	0.00% 0/103 • Baseline (Month 0) up to 24 months	2.4% 2/85 • Baseline (Month 0) up to 24 months
Injury, poisoning and procedural complications Contusion	0.97% 1/103 • Baseline (Month 0) up to 24 months	2.4% 2/85 • Baseline (Month 0) up to 24 months
Injury, poisoning and procedural complications Fall	1.9% 2/103 • Baseline (Month 0) up to 24 months	4.7% 4/85 • Baseline (Month 0) up to 24 months
Injury, poisoning and procedural complications Foot fracture	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Injury, poisoning and procedural complications Hand fracture	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Injury, poisoning and procedural complications Joint injury	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Injury, poisoning and procedural complications Meniscus injury	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Injury, poisoning and procedural complications Muscle strain	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Injury, poisoning and procedural complications Rib fracture	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Injury, poisoning and procedural complications Skin laceration	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Injury, poisoning and procedural complications Wrist fracture	0.97% 1/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Investigations Blood cholesterol increased	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Investigations Blood pressure increased	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Investigations Liver function test abnormal	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Investigations Lymphocyte count decreased	1.9% 2/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Investigations SARS-CoV-2 test positive	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Investigations Weight increased	0.97% 1/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Metabolism and nutrition disorders Dehydration	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Metabolism and nutrition disorders Dyslipidaemia	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Metabolism and nutrition disorders Glucose tolerance impaired	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Metabolism and nutrition disorders Gout	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Metabolism and nutrition disorders Vitamin B12 deficiency	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Metabolism and nutrition disorders Vitamin D deficiency	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Musculoskeletal and connective tissue disorders Arthralgia	1.9% 2/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Musculoskeletal and connective tissue disorders Arthritis	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Musculoskeletal and connective tissue disorders Back pain	5.8% 6/103 • Baseline (Month 0) up to 24 months	4.7% 4/85 • Baseline (Month 0) up to 24 months
Musculoskeletal and connective tissue disorders Bursitis	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Musculoskeletal and connective tissue disorders Fibromyalgia	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Musculoskeletal and connective tissue disorders Joint effusion	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Musculoskeletal and connective tissue disorders Joint lock	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Musculoskeletal and connective tissue disorders Muscle spasms	2.9% 3/103 • Baseline (Month 0) up to 24 months	3.5% 3/85 • Baseline (Month 0) up to 24 months
Musculoskeletal and connective tissue disorders Muscle tightness	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Musculoskeletal and connective tissue disorders Muscular weakness	1.9% 2/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Musculoskeletal and connective tissue disorders Myalgia	0.97% 1/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Musculoskeletal and connective tissue disorders Neck pain	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Musculoskeletal and connective tissue disorders Pain in extremity	1.9% 2/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Nervous system disorders Altered state of consciousness	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Nervous system disorders Amnesia	0.97% 1/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Nervous system disorders Balance disorder	0.97% 1/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Nervous system disorders Burning sensation	0.00% 0/103 • Baseline (Month 0) up to 24 months	2.4% 2/85 • Baseline (Month 0) up to 24 months
Nervous system disorders Carpal tunnel syndrome	1.9% 2/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Nervous system disorders Cognitive disorder	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Nervous system disorders Dizziness	0.97% 1/103 • Baseline (Month 0) up to 24 months	2.4% 2/85 • Baseline (Month 0) up to 24 months
Nervous system disorders Facial spasm	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Nervous system disorders Headache	4.9% 5/103 • Baseline (Month 0) up to 24 months	3.5% 3/85 • Baseline (Month 0) up to 24 months
Nervous system disorders Hemiparesis	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Nervous system disorders Hypoaesthesia	3.9% 4/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Nervous system disorders Multiple sclerosis relapse	1.9% 2/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Nervous system disorders Neuralgia	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Nervous system disorders Optic neuritis	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Nervous system disorders Paraesthesia	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Nervous system disorders Post herpetic neuralgia	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Nervous system disorders Radial nerve palsy	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Nervous system disorders Restless legs syndrome	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Nervous system disorders Sciatica	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Nervous system disorders Seizure	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Nervous system disorders Sensory disturbance	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Nervous system disorders Tremor	0.00% 0/103 • Baseline (Month 0) up to 24 months	2.4% 2/85 • Baseline (Month 0) up to 24 months
Pregnancy, puerperium and perinatal conditions Pregnancy	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Psychiatric disorders Abnormal dreams	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Psychiatric disorders Anxiety	1.9% 2/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Psychiatric disorders Insomnia	2.9% 3/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Renal and urinary disorders Bladder hypertrophy	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Renal and urinary disorders Incontinence	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Renal and urinary disorders Micturition urgency	3.9% 4/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Renal and urinary disorders Pollakiuria	1.9% 2/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Renal and urinary disorders Ureterolithiasis	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Renal and urinary disorders Urethral polyp	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Renal and urinary disorders Urinary hesitation	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Reproductive system and breast disorders Breast cyst	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Reproductive system and breast disorders Breast pain	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Reproductive system and breast disorders Nipple pain	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Reproductive system and breast disorders Penile discharge	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Reproductive system and breast disorders Perineal pain	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Reproductive system and breast disorders Prostatitis	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Respiratory, thoracic and mediastinal disorders Cough	0.97% 1/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Respiratory, thoracic and mediastinal disorders Dysphonia	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Respiratory, thoracic and mediastinal disorders Emphysema	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Skin and subcutaneous tissue disorders Alopecia	0.97% 1/103 • Baseline (Month 0) up to 24 months	2.4% 2/85 • Baseline (Month 0) up to 24 months
Skin and subcutaneous tissue disorders Erythema	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Skin and subcutaneous tissue disorders Hyperhidrosis	0.97% 1/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Skin and subcutaneous tissue disorders Livedo reticularis	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Skin and subcutaneous tissue disorders Rash	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Skin and subcutaneous tissue disorders Rash pruritic	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Skin and subcutaneous tissue disorders Skin lesion	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Skin and subcutaneous tissue disorders Urticaria	0.97% 1/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Vascular disorders Aortic dilatation	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Vascular disorders Deep vein thrombosis	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Vascular disorders Essential hypertension	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Vascular disorders Hot flush	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Vascular disorders Hypertension	1.9% 2/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Vascular disorders Lymphoedema	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Vascular disorders Orthostatic hypotension	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Vascular disorders Peripheral coldness	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Vascular disorders Peripheral venous disease	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months
Infections and infestations COVID-19	7.8% 8/103 • Baseline (Month 0) up to 24 months	10.6% 9/85 • Baseline (Month 0) up to 24 months
Infections and infestations Pyelonephritis	0.00% 0/103 • Baseline (Month 0) up to 24 months	1.2% 1/85 • Baseline (Month 0) up to 24 months
Vascular disorders Subclavian artery stenosis	0.97% 1/103 • Baseline (Month 0) up to 24 months	0.00% 0/85 • Baseline (Month 0) up to 24 months

Additional Information

Communication Center

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA,Darmstadt, Germany

Phone: 6151725200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place