Trial Outcomes & Findings for A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT (NCT NCT03368664)
NCT ID: NCT03368664
Last Updated: 2026-08-04
Results Overview
Number of new or enlarged T2 lesions per month was defined as the total number of new or enlarged T2 lesion that occurred during the study divided by the total number of follow-up months until the end of each period and was estimated based on negative binomial regression.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
16 participants
Primary outcome timeframe
Period 1: Month -4 up to Month 0, Period 2: Month up 4 to Month 8
Results posted on
2026-08-04
Participant Flow
The study was conducted at 9 sites in 6 countries. A total of 16 participants were screened and enrolled between 23-October-2017 and 07-September-2020. The study was terminated by the Sponsor due to low recruitment and an European Medicines Agency (EMA) Article-20 Pharmacovigilance review of Alemtuzumab in adult relapse remitting multiple sclerosis (RRMS).
Prior to alemtuzumab treatment phase (ATP) (Month 0 to 24), participants underwent screening phase followed by prior disease modifying therapy (DMT) phase (Month -4 to 0) during which participants received prior DMT and eligibility criteria for alemtuzumab treatment were confirmed. DMT was discontinued 7 days prior to first dose of alemtuzumab at Month 0. 2 assessment periods (4 months each) for endpoint evaluation: Period 1: Month -4 to 0 in prior DMT phase; Period 2: Month 4 to 8 in ATP.
Participant milestones
| Measure |
Alemtuzumab
Screened participants with RRMS entered the prior DMT phase (Month -4 to Month 0) during which the prior DMT was continued and eligibility criteria for alemtuzumab treatment was confirmed. At progression with prior DMT, they were enrolled in the alemtuzumab treatment phase to receive 2 courses at 12-month interval. The first course was given at Month 0 for 5 consecutive days and the second course at Month 12 for 3 consecutive days. The alemtuzumab daily dose was 12 milligrams per day (mg)/day if body weight greater than or equal to (\>=) 50 kilograms (kg) and 0.24 mg/kg/day if body weight less than (\<) 50 kg. The alemtuzumab treatment phase was followed by a safety monitoring phase of approximately 3 years.
|
|---|---|
|
Prior DMT Phase: Month -4 to Month 0
STARTED
|
16
|
|
Prior DMT Phase: Month -4 to Month 0
COMPLETED
|
12
|
|
Prior DMT Phase: Month -4 to Month 0
NOT COMPLETED
|
4
|
|
Alemtuzumab Treatment Phase:Month0 to 24
STARTED
|
11
|
|
Alemtuzumab Treatment Phase:Month0 to 24
Treated
|
11
|
|
Alemtuzumab Treatment Phase:Month0 to 24
COMPLETED
|
7
|
|
Alemtuzumab Treatment Phase:Month0 to 24
NOT COMPLETED
|
4
|
|
Safety Monitoring Phase(Month 24 to 60)
STARTED
|
7
|
|
Safety Monitoring Phase(Month 24 to 60)
COMPLETED
|
6
|
|
Safety Monitoring Phase(Month 24 to 60)
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Alemtuzumab
Screened participants with RRMS entered the prior DMT phase (Month -4 to Month 0) during which the prior DMT was continued and eligibility criteria for alemtuzumab treatment was confirmed. At progression with prior DMT, they were enrolled in the alemtuzumab treatment phase to receive 2 courses at 12-month interval. The first course was given at Month 0 for 5 consecutive days and the second course at Month 12 for 3 consecutive days. The alemtuzumab daily dose was 12 milligrams per day (mg)/day if body weight greater than or equal to (\>=) 50 kilograms (kg) and 0.24 mg/kg/day if body weight less than (\<) 50 kg. The alemtuzumab treatment phase was followed by a safety monitoring phase of approximately 3 years.
|
|---|---|
|
Prior DMT Phase: Month -4 to Month 0
Physician Decision
|
1
|
|
Prior DMT Phase: Month -4 to Month 0
Participant was withdrawn from study
|
1
|
|
Prior DMT Phase: Month -4 to Month 0
Principal Investigator and Parents Decision
|
1
|
|
Prior DMT Phase: Month -4 to Month 0
Still on Prior DMT Phase or missing Completion
|
1
|
|
Alemtuzumab Treatment Phase:Month0 to 24
Lack of Efficacy
|
1
|
|
Alemtuzumab Treatment Phase:Month0 to 24
Other
|
3
|
|
Safety Monitoring Phase(Month 24 to 60)
Poor compliance with protocol
|
1
|
Baseline Characteristics
A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT
Baseline characteristics by cohort
| Measure |
Alemtuzumab
n=16 Participants
Screened participants with RRMS entered the prior DMT phase (Month -4 to Month 0) during which the prior DMT was continued and eligibility criteria for alemtuzumab treatment was confirmed. At progression with prior DMT, they were enrolled in the alemtuzumab treatment phase to receive 2 courses at 12-month interval. The first course was given at Month 0 for 5 consecutive days and the second course at Month 12 for 3 consecutive days. The alemtuzumab daily dose was 12 mg/day if body weight \>=50 kg and 0.24 mg/kg/day if body weight \<50 kg. The alemtuzumab treatment phase was followed by a safety monitoring phase of approximately 3 years.
|
|---|---|
|
Age, Continuous
|
14.5 years
STANDARD_DEVIATION 2.2 • n=20 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Period 1: Month -4 up to Month 0, Period 2: Month up 4 to Month 8Population: Analysis was performed on modified intent-to-treat (mITT) population that included participants who had received at least 1 dose of alemtuzumab and also had evaluable data for both Period 1 and Period 2. Data for this outcome measure was planned to be collected and analyzed separately for both periods.
Number of new or enlarged T2 lesions per month was defined as the total number of new or enlarged T2 lesion that occurred during the study divided by the total number of follow-up months until the end of each period and was estimated based on negative binomial regression.
Outcome measures
| Measure |
Period 1
n=11 Participants
Participants with RRMS who were assessed from Month -4 up to Month 0 (prior DMT phase) to confirm their eligibility for the administration of alemtuzumab IV infusion at Month 0. A baseline MRI was performed close to Month -4 during the screening period and another at Visit 3 (in between Day -14 to Day -7). Both MRI were taken while participants were on their prior DMT. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
|
Period 2
n=11 Participants
Participants with RRMS and with body weight \>=50 kg received 12 mg/day of alemtuzumab, and participants with body weight \<50 kg received 0.24 mg/kg/day alemtuzumab administered as daily IV infusions at Month 0 for 5 consecutive days as first course and at Month 12 for 3 consecutive days as second course of study treatment in alemtuzumab treatment phase. Period 2 occurred from Month 4 to Month 8. The MRI performed at the Month 4 visit was the baseline MRI for Period 2. A second MRI was performed after alemtuzumab first course of treatment at Month 8. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
|
|---|---|---|
|
Brain Magnetic Resonance Imaging (MRI) Assessment: Adjusted Number of New or Enlarged T2 Lesions Per Month
|
3.53 lesions per month
Interval 1.78 to 7.03
|
0.13 lesions per month
Interval 0.03 to 0.48
|
SECONDARY outcome
Timeframe: Period 1: Month -4 up to Month 0, Period 2: Month 4 to Month 8Population: Analysis was performed on mITT population. Data for this outcome measure was planned to be collected and analyzed separately for both periods.
Number of participants with at least one new or enlarged T2 lesions was reported in this outcome measure. Number of new or enlarged T2 lesions was defined as the total number of new or enlarged T2 lesion that occurred during the study divided by the total number of follow-up months until the end of each period.
Outcome measures
| Measure |
Period 1
n=11 Participants
Participants with RRMS who were assessed from Month -4 up to Month 0 (prior DMT phase) to confirm their eligibility for the administration of alemtuzumab IV infusion at Month 0. A baseline MRI was performed close to Month -4 during the screening period and another at Visit 3 (in between Day -14 to Day -7). Both MRI were taken while participants were on their prior DMT. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
|
Period 2
n=11 Participants
Participants with RRMS and with body weight \>=50 kg received 12 mg/day of alemtuzumab, and participants with body weight \<50 kg received 0.24 mg/kg/day alemtuzumab administered as daily IV infusions at Month 0 for 5 consecutive days as first course and at Month 12 for 3 consecutive days as second course of study treatment in alemtuzumab treatment phase. Period 2 occurred from Month 4 to Month 8. The MRI performed at the Month 4 visit was the baseline MRI for Period 2. A second MRI was performed after alemtuzumab first course of treatment at Month 8. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
|
|---|---|---|
|
Brain Magnetic Resonance Imaging Assessment: Number of Participants With New or Enlarged T2 Lesions
|
10 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline (Month 0), Months 4 and 8Population: Analysis was performed on mITT population.
EDSS was an ordinal scale in half-point increments that qualified disability in participants with MS. It consisted of 8 ordinal rating scales assessing seven functional systems (FS) (pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral, and other). Ambulation scoring was done to conclude evaluation. EDSS steps 1.0 to 4.5 referred to participants with MS who were fully ambulatory, while EDSS steps 5.0 to 9.5 were defined by the impairment to ambulation. Individual FS scores were then used in conjugation with ambulation score to obtain total EDSS score which ranged from 0 (normal neurological examination) to 10 (death due to MS) in half-point increments, where higher scores indicated worst outcomes. Baseline for EDSS was defined as the last non-missing value prior to the first course of alemtuzumab.
Outcome measures
| Measure |
Period 1
n=11 Participants
Participants with RRMS who were assessed from Month -4 up to Month 0 (prior DMT phase) to confirm their eligibility for the administration of alemtuzumab IV infusion at Month 0. A baseline MRI was performed close to Month -4 during the screening period and another at Visit 3 (in between Day -14 to Day -7). Both MRI were taken while participants were on their prior DMT. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
|
Period 2
Participants with RRMS and with body weight \>=50 kg received 12 mg/day of alemtuzumab, and participants with body weight \<50 kg received 0.24 mg/kg/day alemtuzumab administered as daily IV infusions at Month 0 for 5 consecutive days as first course and at Month 12 for 3 consecutive days as second course of study treatment in alemtuzumab treatment phase. Period 2 occurred from Month 4 to Month 8. The MRI performed at the Month 4 visit was the baseline MRI for Period 2. A second MRI was performed after alemtuzumab first course of treatment at Month 8. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
|
|---|---|---|
|
Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Months 4 and 8
Month 4
|
0.05 scores on scale
Standard Deviation 0.52
|
—
|
|
Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Months 4 and 8
Month 8
|
0.00 scores on scale
Standard Deviation 0.55
|
—
|
SECONDARY outcome
Timeframe: At Year 2Population: Analysis was performed on mITT population.
Adjusted ARR was defined as the total number of relapses that occurred during the alemtuzumab treatment phase divided by the total number of follow-up years and was estimated based on negative binomial regression. Relapses were defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the neurologist and documented by the functional system scores.
Outcome measures
| Measure |
Period 1
n=11 Participants
Participants with RRMS who were assessed from Month -4 up to Month 0 (prior DMT phase) to confirm their eligibility for the administration of alemtuzumab IV infusion at Month 0. A baseline MRI was performed close to Month -4 during the screening period and another at Visit 3 (in between Day -14 to Day -7). Both MRI were taken while participants were on their prior DMT. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
|
Period 2
Participants with RRMS and with body weight \>=50 kg received 12 mg/day of alemtuzumab, and participants with body weight \<50 kg received 0.24 mg/kg/day alemtuzumab administered as daily IV infusions at Month 0 for 5 consecutive days as first course and at Month 12 for 3 consecutive days as second course of study treatment in alemtuzumab treatment phase. Period 2 occurred from Month 4 to Month 8. The MRI performed at the Month 4 visit was the baseline MRI for Period 2. A second MRI was performed after alemtuzumab first course of treatment at Month 8. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
|
|---|---|---|
|
Adjusted Annualized Relapse Rate (ARR) at Year 2
|
0.53 relapses per participant year
Interval 0.12 to 2.37
|
—
|
SECONDARY outcome
Timeframe: Period 1: Baseline (Month -4) and Month 0, Period 2: Baseline (Month 4) and Month 8Population: Analysis was performed on mITT population. Data for this outcome measure was planned to be collected and analyzed separately for both periods.
BVMT-R: tool to measure visuospatial learning and memory abilities across research and clinical settings. Visual display of 6 simple figures arranged in 2x3 matrix on separate pages was shown to participants for 3 consecutive 10-second trials. After each trial, participants drew as many designs as accurately as they could in correct location. They were asked to reproduce designs in exact layout after 25-minute delay filled with other distractor tasks. Forced-choice recognition trial was administered immediately after delayed memory trial. Optional copy trial was included at end of test where participants were asked to copy figure display accurately. Scoring of immediate, delayed recall and copy trials were based on accuracy of drawings and location of figures. Score range 0 to 12 per trial; total score: 0 to 36 for all 3 trials. Higher scores: better visuospatial memory. Change from baseline in total score is presented. Baseline:Month -4 for Period 1;Month 4 for Period 2.
Outcome measures
| Measure |
Period 1
n=11 Participants
Participants with RRMS who were assessed from Month -4 up to Month 0 (prior DMT phase) to confirm their eligibility for the administration of alemtuzumab IV infusion at Month 0. A baseline MRI was performed close to Month -4 during the screening period and another at Visit 3 (in between Day -14 to Day -7). Both MRI were taken while participants were on their prior DMT. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
|
Period 2
n=11 Participants
Participants with RRMS and with body weight \>=50 kg received 12 mg/day of alemtuzumab, and participants with body weight \<50 kg received 0.24 mg/kg/day alemtuzumab administered as daily IV infusions at Month 0 for 5 consecutive days as first course and at Month 12 for 3 consecutive days as second course of study treatment in alemtuzumab treatment phase. Period 2 occurred from Month 4 to Month 8. The MRI performed at the Month 4 visit was the baseline MRI for Period 2. A second MRI was performed after alemtuzumab first course of treatment at Month 8. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
|
|---|---|---|
|
Change From Baseline in Cognition Test Score of Brief Visuospatial Memory Test - Revised (BVMT-R) Total Score
|
-2.0 scores on scale
Standard Deviation 8.5
|
-1.0 scores on scale
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: Period 1: Baseline (Month -4) and Month 0, Period 2: Baseline (Month 4) and Month 8Population: Analysis was performed on mITT population. Data for this outcome measure was planned to be collected and analyzed separately for both periods.
The SDMT was used to assess cognitive impairment and involved a simple substitution task that normal children and adults could easily perform. Using a reference key, the examinee/participant had 90 seconds to pair specific numbers with given geometric figures. Responses were only in oral form for this study and administration time was just 5 minutes. The number of corrected substitutions and number of completed responses were recorded. The score for each was the number of correctly coded items ranging 0-110 in 90 seconds; higher scores indicated a better outcome. Change from baseline in number of completed responses and number of corrected substitutions by SDMT is presented. Baseline: Month -4 for Period 1; Month 4 for Period 2.
Outcome measures
| Measure |
Period 1
n=11 Participants
Participants with RRMS who were assessed from Month -4 up to Month 0 (prior DMT phase) to confirm their eligibility for the administration of alemtuzumab IV infusion at Month 0. A baseline MRI was performed close to Month -4 during the screening period and another at Visit 3 (in between Day -14 to Day -7). Both MRI were taken while participants were on their prior DMT. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
|
Period 2
n=11 Participants
Participants with RRMS and with body weight \>=50 kg received 12 mg/day of alemtuzumab, and participants with body weight \<50 kg received 0.24 mg/kg/day alemtuzumab administered as daily IV infusions at Month 0 for 5 consecutive days as first course and at Month 12 for 3 consecutive days as second course of study treatment in alemtuzumab treatment phase. Period 2 occurred from Month 4 to Month 8. The MRI performed at the Month 4 visit was the baseline MRI for Period 2. A second MRI was performed after alemtuzumab first course of treatment at Month 8. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
|
|---|---|---|
|
Change From Baseline in Cognition Test Score of Symbol Digit Modality Test (SDMT): Number of Completed Responses and Corrected Substitutions
Corrected substitutions
|
5.2 scores on scale
Standard Deviation 7.9
|
2.8 scores on scale
Standard Deviation 7.7
|
|
Change From Baseline in Cognition Test Score of Symbol Digit Modality Test (SDMT): Number of Completed Responses and Corrected Substitutions
Completed responses
|
5.0 scores on scale
Standard Deviation 7.6
|
2.4 scores on scale
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: Child and teen report: Baseline (Month 0) and Months 4, 8, 12, 18, 24, 36, 48 and 60; Parent report for children and teens: Baseline (Month 0) and Months 4, 8, 12, 18, 24 and 36Population: Analysis was performed on mITT population. During the study, participants missed few scheduled site visits for data collection, and only participants with data collected at specified timepoints are reported. 'Overall Number of Participants Analyzed' indicates the total of maximum number of children and teens ('number analyzed') evaluated in this outcome measure.
The PedsQL™ measurement model was a modular approach to measure health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions. It included a child and teen self-report, and parents' report of children and teen. Each report consisted of 23 items and 4 scales (physical, emotional, social and school functioning). Each item used a 5-point rating scale (from 0='it is never a problem' to 4='it is almost always a problem'). Items are reverse scored and linearly transformed to a 0 (almost always) to 100 (never) scale. Total scores (0 to 100) for each report were mean of specific items where higher score indicated better HRQoL. Baseline: last non-missing value prior to first course of alemtuzumab.
Outcome measures
| Measure |
Period 1
n=11 Participants
Participants with RRMS who were assessed from Month -4 up to Month 0 (prior DMT phase) to confirm their eligibility for the administration of alemtuzumab IV infusion at Month 0. A baseline MRI was performed close to Month -4 during the screening period and another at Visit 3 (in between Day -14 to Day -7). Both MRI were taken while participants were on their prior DMT. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
|
Period 2
Participants with RRMS and with body weight \>=50 kg received 12 mg/day of alemtuzumab, and participants with body weight \<50 kg received 0.24 mg/kg/day alemtuzumab administered as daily IV infusions at Month 0 for 5 consecutive days as first course and at Month 12 for 3 consecutive days as second course of study treatment in alemtuzumab treatment phase. Period 2 occurred from Month 4 to Month 8. The MRI performed at the Month 4 visit was the baseline MRI for Period 2. A second MRI was performed after alemtuzumab first course of treatment at Month 8. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
|
|---|---|---|
|
Change From Baseline in Pediatric Quality of Life (PedsQL) Questionnaire Score
Child report: Month 4
|
-5.0 scores on scale
|
—
|
|
Change From Baseline in Pediatric Quality of Life (PedsQL) Questionnaire Score
Child report: Month 8
|
-5.5 scores on scale
Standard Deviation 12.0
|
—
|
|
Change From Baseline in Pediatric Quality of Life (PedsQL) Questionnaire Score
Child report: Month 12
|
3.0 scores on scale
|
—
|
|
Change From Baseline in Pediatric Quality of Life (PedsQL) Questionnaire Score
Child report: Month 18
|
-4.0 scores on scale
|
—
|
|
Change From Baseline in Pediatric Quality of Life (PedsQL) Questionnaire Score
Child report: Month 24
|
2.0 scores on scale
|
—
|
|
Change From Baseline in Pediatric Quality of Life (PedsQL) Questionnaire Score
Child report: Month 36
|
0.0 scores on scale
|
—
|
|
Change From Baseline in Pediatric Quality of Life (PedsQL) Questionnaire Score
Child report: Month 48
|
-11.0 scores on scale
|
—
|
|
Change From Baseline in Pediatric Quality of Life (PedsQL) Questionnaire Score
Child report: Month 60
|
-25.0 scores on scale
|
—
|
|
Change From Baseline in Pediatric Quality of Life (PedsQL) Questionnaire Score
Parent report for children: Month 4
|
1.0 scores on scale
|
—
|
|
Change From Baseline in Pediatric Quality of Life (PedsQL) Questionnaire Score
Parent report for children: Month 8
|
-4.5 scores on scale
Standard Deviation 0.7
|
—
|
|
Change From Baseline in Pediatric Quality of Life (PedsQL) Questionnaire Score
Parent report for children: Month 12
|
-11.0 scores on scale
|
—
|
|
Change From Baseline in Pediatric Quality of Life (PedsQL) Questionnaire Score
Parent report for children: Month 18
|
-10.0 scores on scale
|
—
|
|
Change From Baseline in Pediatric Quality of Life (PedsQL) Questionnaire Score
Parent report for children: Month 24
|
-11.0 scores on scale
|
—
|
|
Change From Baseline in Pediatric Quality of Life (PedsQL) Questionnaire Score
Parent report for children: Month 36
|
6.0 scores on scale
|
—
|
|
Change From Baseline in Pediatric Quality of Life (PedsQL) Questionnaire Score
Teen report: Month 4
|
7.6 scores on scale
Standard Deviation 15.8
|
—
|
|
Change From Baseline in Pediatric Quality of Life (PedsQL) Questionnaire Score
Teen report: Month 8
|
1.7 scores on scale
Standard Deviation 11.6
|
—
|
|
Change From Baseline in Pediatric Quality of Life (PedsQL) Questionnaire Score
Teen report: Month 12
|
1.6 scores on scale
Standard Deviation 7.9
|
—
|
|
Change From Baseline in Pediatric Quality of Life (PedsQL) Questionnaire Score
Teen report: Month 18
|
6.3 scores on scale
Standard Deviation 16.6
|
—
|
|
Change From Baseline in Pediatric Quality of Life (PedsQL) Questionnaire Score
Teen report: Month 24
|
-2.8 scores on scale
Standard Deviation 5.2
|
—
|
|
Change From Baseline in Pediatric Quality of Life (PedsQL) Questionnaire Score
Teen report: Month 36
|
-8.8 scores on scale
Standard Deviation 3.1
|
—
|
|
Change From Baseline in Pediatric Quality of Life (PedsQL) Questionnaire Score
Teen report: Month 48
|
-1.3 scores on scale
Standard Deviation 9.3
|
—
|
|
Change From Baseline in Pediatric Quality of Life (PedsQL) Questionnaire Score
Teen report: Month 60
|
11.0 scores on scale
Standard Deviation 4.2
|
—
|
|
Change From Baseline in Pediatric Quality of Life (PedsQL) Questionnaire Score
Parent report for teens: Month 4
|
4.7 scores on scale
Standard Deviation 17.2
|
—
|
|
Change From Baseline in Pediatric Quality of Life (PedsQL) Questionnaire Score
Parent report for teens: Month 8
|
-1.4 scores on scale
Standard Deviation 8.0
|
—
|
|
Change From Baseline in Pediatric Quality of Life (PedsQL) Questionnaire Score
Parent report for teens: Month 12
|
-0.4 scores on scale
Standard Deviation 6.3
|
—
|
|
Change From Baseline in Pediatric Quality of Life (PedsQL) Questionnaire Score
Parent report for teens: Month 18
|
4.0 scores on scale
Standard Deviation 18.6
|
—
|
|
Change From Baseline in Pediatric Quality of Life (PedsQL) Questionnaire Score
Parent report for teens: Month 24
|
0.0 scores on scale
Standard Deviation 0.0
|
—
|
|
Change From Baseline in Pediatric Quality of Life (PedsQL) Questionnaire Score
Parent report for teens: Month 36
|
-11.0 scores on scale
|
—
|
SECONDARY outcome
Timeframe: Baseline (Month 0) and Months 4, 8, 12, 18, 24, 36, 48 and 60Population: Analysis was performed on mITT population. During the study, participants missed few scheduled site visits for data collection, and only participants with data collected at specified timepoints are reported.
Pediatric NeuroQoL was measurement system that evaluated and monitored physical, mental and social effects experienced by children living with neurological conditions. Physical effects (fatigue, pain) and mental effects (cognitive function, anxiety, depression) was assessed. Each domain had 8 to 10 items and participants indicated how often they experienced feelings and circumstances related to each domain on scale 1 to 5 (1='never' to 5='almost always'). This scale was reversed for cognitive function (1='very much' to 5='not at all'). Higher values: worse outcome for fatigue, pain, anxiety, depression, and better cognitive function. Raw scores were re-scaled to standardized scores with mean=50 and standard deviation=10. T-score range: 20 to 80. T-score \<30 indicated clinically significant impairment. Change from baseline in physical and mental effects scores by pediatric NeuroQoL is presented. Baseline: last non-missing value prior to first course of alemtuzumab.
Outcome measures
| Measure |
Period 1
n=11 Participants
Participants with RRMS who were assessed from Month -4 up to Month 0 (prior DMT phase) to confirm their eligibility for the administration of alemtuzumab IV infusion at Month 0. A baseline MRI was performed close to Month -4 during the screening period and another at Visit 3 (in between Day -14 to Day -7). Both MRI were taken while participants were on their prior DMT. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
|
Period 2
Participants with RRMS and with body weight \>=50 kg received 12 mg/day of alemtuzumab, and participants with body weight \<50 kg received 0.24 mg/kg/day alemtuzumab administered as daily IV infusions at Month 0 for 5 consecutive days as first course and at Month 12 for 3 consecutive days as second course of study treatment in alemtuzumab treatment phase. Period 2 occurred from Month 4 to Month 8. The MRI performed at the Month 4 visit was the baseline MRI for Period 2. A second MRI was performed after alemtuzumab first course of treatment at Month 8. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
|
|---|---|---|
|
Change From Baseline in Pediatric Quality of Life in Neurological Disorders (NeuroQoL) Questionnaire Score
Physical effects score: Month 4
|
0.6 T-score
Standard Deviation 7.3
|
—
|
|
Change From Baseline in Pediatric Quality of Life in Neurological Disorders (NeuroQoL) Questionnaire Score
Physical effects score: Month 8
|
1.2 T-score
Standard Deviation 8.7
|
—
|
|
Change From Baseline in Pediatric Quality of Life in Neurological Disorders (NeuroQoL) Questionnaire Score
Physical effects score: Month 12
|
0.1 T-score
Standard Deviation 7.8
|
—
|
|
Change From Baseline in Pediatric Quality of Life in Neurological Disorders (NeuroQoL) Questionnaire Score
Physical effects score: Month 18
|
0.0 T-score
Standard Deviation 8.1
|
—
|
|
Change From Baseline in Pediatric Quality of Life in Neurological Disorders (NeuroQoL) Questionnaire Score
Physical effects score: Month 24
|
-2.6 T-score
Standard Deviation 7.9
|
—
|
|
Change From Baseline in Pediatric Quality of Life in Neurological Disorders (NeuroQoL) Questionnaire Score
Physical effects score: Month 36
|
-6.1 T-score
Standard Deviation 7.1
|
—
|
|
Change From Baseline in Pediatric Quality of Life in Neurological Disorders (NeuroQoL) Questionnaire Score
Physical effects score: Month 48
|
-5.5 T-score
Standard Deviation 9.9
|
—
|
|
Change From Baseline in Pediatric Quality of Life in Neurological Disorders (NeuroQoL) Questionnaire Score
Physical effects score: Month 60
|
-11.7 T-score
Standard Deviation 17.2
|
—
|
|
Change From Baseline in Pediatric Quality of Life in Neurological Disorders (NeuroQoL) Questionnaire Score
Mental effects score: Month 4
|
-0.4 T-score
Standard Deviation 7.4
|
—
|
|
Change From Baseline in Pediatric Quality of Life in Neurological Disorders (NeuroQoL) Questionnaire Score
Mental effects score: Month 8
|
-0.1 T-score
Standard Deviation 11.0
|
—
|
|
Change From Baseline in Pediatric Quality of Life in Neurological Disorders (NeuroQoL) Questionnaire Score
Mental effects score: Month 12
|
4.7 T-score
Standard Deviation 8.3
|
—
|
|
Change From Baseline in Pediatric Quality of Life in Neurological Disorders (NeuroQoL) Questionnaire Score
Mental effects score: Month 18
|
2.9 T-score
Standard Deviation 8.9
|
—
|
|
Change From Baseline in Pediatric Quality of Life in Neurological Disorders (NeuroQoL) Questionnaire Score
Mental effects score: Month 24
|
6.0 T-score
Standard Deviation 5.6
|
—
|
|
Change From Baseline in Pediatric Quality of Life in Neurological Disorders (NeuroQoL) Questionnaire Score
Mental effects score: Month 36
|
1.7 T-score
Standard Deviation 6.0
|
—
|
|
Change From Baseline in Pediatric Quality of Life in Neurological Disorders (NeuroQoL) Questionnaire Score
Mental effects score: Month 48
|
3.2 T-score
Standard Deviation 11.3
|
—
|
|
Change From Baseline in Pediatric Quality of Life in Neurological Disorders (NeuroQoL) Questionnaire Score
Mental effects score: Month 60
|
5.5 T-score
Standard Deviation 6.4
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1, end of infusion on Day 5, Day 14 of Month 0; Months 1 and 2; pre-dose on Day 1, end of infusion on Day 3, Day 12 of Month 12; Months 13 and 14Population: Analysis was performed on pharmacokinetic (PK) population that included participants who had received at least 1 dose of alemtuzumab and also had evaluable PK data (at least 1 measurement of PK endpoints). During the study, participants missed few scheduled site visits for sample collection, and only participants with data collected at specified timepoints are reported.
Blood samples were collected at the specified timepoints for measurement of serum concentrations of alemtuzumab.
Outcome measures
| Measure |
Period 1
n=11 Participants
Participants with RRMS who were assessed from Month -4 up to Month 0 (prior DMT phase) to confirm their eligibility for the administration of alemtuzumab IV infusion at Month 0. A baseline MRI was performed close to Month -4 during the screening period and another at Visit 3 (in between Day -14 to Day -7). Both MRI were taken while participants were on their prior DMT. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
|
Period 2
Participants with RRMS and with body weight \>=50 kg received 12 mg/day of alemtuzumab, and participants with body weight \<50 kg received 0.24 mg/kg/day alemtuzumab administered as daily IV infusions at Month 0 for 5 consecutive days as first course and at Month 12 for 3 consecutive days as second course of study treatment in alemtuzumab treatment phase. Period 2 occurred from Month 4 to Month 8. The MRI performed at the Month 4 visit was the baseline MRI for Period 2. A second MRI was performed after alemtuzumab first course of treatment at Month 8. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
|
|---|---|---|
|
Serum Concentrations of Alemtuzumab Over Time
Month 14
|
0.00 microgram per milliliter (mcg/mL)
Standard Deviation 0.00
|
—
|
|
Serum Concentrations of Alemtuzumab Over Time
Month 0 Day 1: Pre-dose
|
0.00 microgram per milliliter (mcg/mL)
Standard Deviation 0.00
|
—
|
|
Serum Concentrations of Alemtuzumab Over Time
Month 0 Day 5: End of infusion
|
9.15 microgram per milliliter (mcg/mL)
Standard Deviation 2.46
|
—
|
|
Serum Concentrations of Alemtuzumab Over Time
Month 0 Day 14
|
1.54 microgram per milliliter (mcg/mL)
Standard Deviation 1.30
|
—
|
|
Serum Concentrations of Alemtuzumab Over Time
Month 1
|
0.04 microgram per milliliter (mcg/mL)
Standard Deviation 0.08
|
—
|
|
Serum Concentrations of Alemtuzumab Over Time
Month 2
|
0.02 microgram per milliliter (mcg/mL)
Standard Deviation 0.07
|
—
|
|
Serum Concentrations of Alemtuzumab Over Time
Month 12 Day 1: Pre-dose
|
0.00 microgram per milliliter (mcg/mL)
Standard Deviation 0.00
|
—
|
|
Serum Concentrations of Alemtuzumab Over Time
Month 12 Day 3: End of infusion
|
5.04 microgram per milliliter (mcg/mL)
Standard Deviation 1.62
|
—
|
|
Serum Concentrations of Alemtuzumab Over Time
Month 12 Day 12
|
0.00 microgram per milliliter (mcg/mL)
Standard Deviation 0.00
|
—
|
|
Serum Concentrations of Alemtuzumab Over Time
Month 13
|
0.00 microgram per milliliter (mcg/mL)
Standard Deviation 0.00
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1, end of infusion on Day 5, Day 14 of Month 0; Months 1 and 2; pre-dose on Day 1, end of infusion on Day 3, Day 12 of Month 12; Months 13 and 14Population: Analysis was performed on PK population that included participants who had received at least 1 dose of alemtuzumab and also had evaluable PK data (at least 1 measurement of PK endpoints).
Blood samples were collected at the specified timepoints for determination of Cmax of alemtuzumab.
Outcome measures
| Measure |
Period 1
n=11 Participants
Participants with RRMS who were assessed from Month -4 up to Month 0 (prior DMT phase) to confirm their eligibility for the administration of alemtuzumab IV infusion at Month 0. A baseline MRI was performed close to Month -4 during the screening period and another at Visit 3 (in between Day -14 to Day -7). Both MRI were taken while participants were on their prior DMT. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
|
Period 2
Participants with RRMS and with body weight \>=50 kg received 12 mg/day of alemtuzumab, and participants with body weight \<50 kg received 0.24 mg/kg/day alemtuzumab administered as daily IV infusions at Month 0 for 5 consecutive days as first course and at Month 12 for 3 consecutive days as second course of study treatment in alemtuzumab treatment phase. Period 2 occurred from Month 4 to Month 8. The MRI performed at the Month 4 visit was the baseline MRI for Period 2. A second MRI was performed after alemtuzumab first course of treatment at Month 8. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
|
|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) of Alemtuzumab
|
8.729 mcg/mL
Standard Deviation 2.708
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1, end of infusion on Day 5, Day 14 of Month 0; Months 1 and 2; pre-dose on Day 1, end of infusion on Day 3, Day 12 of Month 12; Months 13 and 14Population: Analysis was performed on PK population that included participants who had received at least 1 dose of alemtuzumab and also had evaluable PK data (at least 1 measurement of PK endpoints).
Blood samples were collected at the specified timepoints for determination of Tmax of alemtuzumab.
Outcome measures
| Measure |
Period 1
n=11 Participants
Participants with RRMS who were assessed from Month -4 up to Month 0 (prior DMT phase) to confirm their eligibility for the administration of alemtuzumab IV infusion at Month 0. A baseline MRI was performed close to Month -4 during the screening period and another at Visit 3 (in between Day -14 to Day -7). Both MRI were taken while participants were on their prior DMT. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
|
Period 2
Participants with RRMS and with body weight \>=50 kg received 12 mg/day of alemtuzumab, and participants with body weight \<50 kg received 0.24 mg/kg/day alemtuzumab administered as daily IV infusions at Month 0 for 5 consecutive days as first course and at Month 12 for 3 consecutive days as second course of study treatment in alemtuzumab treatment phase. Period 2 occurred from Month 4 to Month 8. The MRI performed at the Month 4 visit was the baseline MRI for Period 2. A second MRI was performed after alemtuzumab first course of treatment at Month 8. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
|
|---|---|---|
|
Time to Reach Maximum Observed Serum Concentration (Tmax) of Alemtuzumab
|
4.433 hour
Interval 3.75 to 6.08
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1, end of infusion on Day 5, Day 14 of Month 0; Months 1 and 2; pre-dose on Day 1, end of infusion on Day 3, Day 12 of Month 12; Months 13 and 14Population: Analysis was performed on PK population that included participants who had received at least 1 dose of alemtuzumab and also had evaluable PK data (at least 1 measurement of PK endpoints).
Blood samples were collected at the specified timepoints for determination of AUC of alemtuzumab.
Outcome measures
| Measure |
Period 1
n=11 Participants
Participants with RRMS who were assessed from Month -4 up to Month 0 (prior DMT phase) to confirm their eligibility for the administration of alemtuzumab IV infusion at Month 0. A baseline MRI was performed close to Month -4 during the screening period and another at Visit 3 (in between Day -14 to Day -7). Both MRI were taken while participants were on their prior DMT. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
|
Period 2
Participants with RRMS and with body weight \>=50 kg received 12 mg/day of alemtuzumab, and participants with body weight \<50 kg received 0.24 mg/kg/day alemtuzumab administered as daily IV infusions at Month 0 for 5 consecutive days as first course and at Month 12 for 3 consecutive days as second course of study treatment in alemtuzumab treatment phase. Period 2 occurred from Month 4 to Month 8. The MRI performed at the Month 4 visit was the baseline MRI for Period 2. A second MRI was performed after alemtuzumab first course of treatment at Month 8. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
|
|---|---|---|
|
Area Under the Cumulative Serum Concentration-Time Curve (AUC) of Alemtuzumab
|
NA mcg*hour/mL
Standard Deviation NA
NA indicates that mean and standard deviation (SD) were not estimable. This is because there are not sufficient evaluable PK concentrations per participant to derive PK parameters reliably because most values were below the lower limit of quantification (LLOQ) of 166 nanograms (ng)/mL.
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1, end of infusion on Day 5, Day 14 of Month 0; Months 1 and 2; pre-dose on Day 1, end of infusion on Day 3, Day 12 of Month 12; Months 13 and 14Population: Analysis was performed on PK population that included participants who had received at least 1 dose of alemtuzumab and also had evaluable PK data (at least 1 measurement of PK endpoints).
Blood samples for full PK analysis were collected at the specified timepoints for determination of AUC0-last of alemtuzumab.
Outcome measures
| Measure |
Period 1
n=11 Participants
Participants with RRMS who were assessed from Month -4 up to Month 0 (prior DMT phase) to confirm their eligibility for the administration of alemtuzumab IV infusion at Month 0. A baseline MRI was performed close to Month -4 during the screening period and another at Visit 3 (in between Day -14 to Day -7). Both MRI were taken while participants were on their prior DMT. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
|
Period 2
Participants with RRMS and with body weight \>=50 kg received 12 mg/day of alemtuzumab, and participants with body weight \<50 kg received 0.24 mg/kg/day alemtuzumab administered as daily IV infusions at Month 0 for 5 consecutive days as first course and at Month 12 for 3 consecutive days as second course of study treatment in alemtuzumab treatment phase. Period 2 occurred from Month 4 to Month 8. The MRI performed at the Month 4 visit was the baseline MRI for Period 2. A second MRI was performed after alemtuzumab first course of treatment at Month 8. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
|
|---|---|---|
|
Area Under the Cumulative Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Alemtuzumab
|
NA mcg*hour/mL
Standard Deviation NA
NA indicates that mean and SD were not estimable. This is because there are not sufficient evaluable PK concentrations per participant to derive PK parameters reliably because most values were below the LLOQ of 166 ng/mL.
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1, end of infusion on Day 5, Day 14 of Month 0; Months 1 and 2; pre-dose on Day 1, end of infusion on Day 3, Day 12 of Month 12; Months 13 and 14Population: Analysis was performed on PK population that included participants who had received at least 1 dose of alemtuzumab and also had evaluable PK data (at least 1 measurement of PK endpoints).
Blood samples were collected at the specified timepoints for determination of T1/2z of alemtuzumab.
Outcome measures
| Measure |
Period 1
n=11 Participants
Participants with RRMS who were assessed from Month -4 up to Month 0 (prior DMT phase) to confirm their eligibility for the administration of alemtuzumab IV infusion at Month 0. A baseline MRI was performed close to Month -4 during the screening period and another at Visit 3 (in between Day -14 to Day -7). Both MRI were taken while participants were on their prior DMT. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
|
Period 2
Participants with RRMS and with body weight \>=50 kg received 12 mg/day of alemtuzumab, and participants with body weight \<50 kg received 0.24 mg/kg/day alemtuzumab administered as daily IV infusions at Month 0 for 5 consecutive days as first course and at Month 12 for 3 consecutive days as second course of study treatment in alemtuzumab treatment phase. Period 2 occurred from Month 4 to Month 8. The MRI performed at the Month 4 visit was the baseline MRI for Period 2. A second MRI was performed after alemtuzumab first course of treatment at Month 8. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
|
|---|---|---|
|
Terminal Half-Life (T1/2z) of Alemtuzumab
|
NA hour
NA indicates that median and full range were not estimable. This is because there are not sufficient evaluable PK concentrations per participant to derive PK parameters reliably because most values were below the LLOQ of 166 ng/mL.
|
—
|
SECONDARY outcome
Timeframe: Baseline (Month 0); Months 1, 4, 8, 12, 13, 15, 18, 21, 24, 36, 48 and 60Population: Analysis was performed on pharmacodynamic (PD) population that included participants who had received at least 1 dose of alemtuzumab and also had evaluable PD data (at least 1 measurement of PD endpoints). During the study, participants missed few scheduled site visits for sample collection, and only participants with data collected for the specified categories are reported.
Blood samples were collected for assessment of lymphocytes (CD19, CD3, CD3-/16+56, CD4 and CD8). Baseline was defined as the last non-missing value prior to first course of alemtuzumab.
Outcome measures
| Measure |
Period 1
n=10 Participants
Participants with RRMS who were assessed from Month -4 up to Month 0 (prior DMT phase) to confirm their eligibility for the administration of alemtuzumab IV infusion at Month 0. A baseline MRI was performed close to Month -4 during the screening period and another at Visit 3 (in between Day -14 to Day -7). Both MRI were taken while participants were on their prior DMT. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
|
Period 2
Participants with RRMS and with body weight \>=50 kg received 12 mg/day of alemtuzumab, and participants with body weight \<50 kg received 0.24 mg/kg/day alemtuzumab administered as daily IV infusions at Month 0 for 5 consecutive days as first course and at Month 12 for 3 consecutive days as second course of study treatment in alemtuzumab treatment phase. Period 2 occurred from Month 4 to Month 8. The MRI performed at the Month 4 visit was the baseline MRI for Period 2. A second MRI was performed after alemtuzumab first course of treatment at Month 8. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
|
|---|---|---|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD19: Month 1
|
-0.40 10^9 cells per liter
Standard Deviation 0.11
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD19: Month 4
|
-0.13 10^9 cells per liter
Standard Deviation 0.10
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD19: Month 8
|
0.01 10^9 cells per liter
Standard Deviation 0.07
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD19: Month 12
|
0.09 10^9 cells per liter
Standard Deviation 0.15
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD19: Month 13
|
-0.25 10^9 cells per liter
Standard Deviation 0.23
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD19: Month 15
|
-0.15 10^9 cells per liter
Standard Deviation 0.13
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD19: Month 18
|
-0.14 10^9 cells per liter
Standard Deviation 0.08
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD19: Month 21
|
-0.06 10^9 cells per liter
Standard Deviation 0.07
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD19: Month 24
|
-0.08 10^9 cells per liter
Standard Deviation 0.16
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD19: Month 36
|
-0.05 10^9 cells per liter
Standard Deviation 0.21
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD19: Month 48
|
-0.06 10^9 cells per liter
Standard Deviation 0.09
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD19: Month 60
|
-0.08 10^9 cells per liter
Standard Deviation 0.12
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD3: Month 1
|
-1.43 10^9 cells per liter
Standard Deviation 0.49
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD3: Month 4
|
-1.36 10^9 cells per liter
Standard Deviation 0.40
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD3: Month 8
|
-0.85 10^9 cells per liter
Standard Deviation 0.36
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD3: Month 12
|
-0.78 10^9 cells per liter
Standard Deviation 0.43
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD3: Month 13
|
-1.25 10^9 cells per liter
Standard Deviation 0.64
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD3: Month 15
|
-1.19 10^9 cells per liter
Standard Deviation 0.48
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD3: Month 18
|
-1.15 10^9 cells per liter
Standard Deviation 0.30
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD3: Month 21
|
-0.95 10^9 cells per liter
Standard Deviation 0.45
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD3: Month 24
|
-0.97 10^9 cells per liter
Standard Deviation 0.42
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD3: Month 36
|
-0.79 10^9 cells per liter
Standard Deviation 0.70
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD3: Month 48
|
-0.61 10^9 cells per liter
Standard Deviation 0.33
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD3: Month 60
|
-0.59 10^9 cells per liter
Standard Deviation 0.58
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD3-/16+56: Month 1
|
-0.14 10^9 cells per liter
Standard Deviation 0.19
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD3-/16+56: Month 4
|
-0.04 10^9 cells per liter
Standard Deviation 0.11
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD3-/16+56: Month 8
|
0.04 10^9 cells per liter
Standard Deviation 0.09
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD3-/16+56: Month 12
|
-0.10 10^9 cells per liter
Standard Deviation 0.09
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD3-/16+56: Month 13
|
-0.03 10^9 cells per liter
Standard Deviation 0.13
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD3-/16+56: Month 15
|
-0.10 10^9 cells per liter
Standard Deviation 0.15
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD3-/16+56: Month 18
|
-0.08 10^9 cells per liter
Standard Deviation 0.20
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD3-/16+56: Month 21
|
-0.03 10^9 cells per liter
Standard Deviation 0.14
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD3-/16+56: Month 24
|
-0.11 10^9 cells per liter
Standard Deviation 0.15
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD3-/16+56: Month 36
|
-0.15 10^9 cells per liter
Standard Deviation 0.15
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD3-/16+56: Month 48
|
-0.02 10^9 cells per liter
Standard Deviation 0.09
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD3-/16+56: Month 60
|
-0.01 10^9 cells per liter
Standard Deviation 0.07
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD4: Month 1
|
-0.89 10^9 cells per liter
Standard Deviation 0.26
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD4: Month 4
|
-0.83 10^9 cells per liter
Standard Deviation 0.25
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD4: Month 8
|
-0.55 10^9 cells per liter
Standard Deviation 0.24
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD4: Month 12
|
-0.49 10^9 cells per liter
Standard Deviation 0.23
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD4: Month 13
|
-0.75 10^9 cells per liter
Standard Deviation 0.37
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD4: Month 15
|
-0.71 10^9 cells per liter
Standard Deviation 0.29
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD4: Month 18
|
-0.69 10^9 cells per liter
Standard Deviation 0.18
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD4: Month 21
|
-0.59 10^9 cells per liter
Standard Deviation 0.25
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD4: Month 24
|
-0.59 10^9 cells per liter
Standard Deviation 0.21
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD4: Month 36
|
-0.50 10^9 cells per liter
Standard Deviation 0.39
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD4: Month 48
|
-0.34 10^9 cells per liter
Standard Deviation 0.00
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD4: Month 60
|
-0.35 10^9 cells per liter
Standard Deviation 0.22
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD8: Month 1
|
-0.45 10^9 cells per liter
Standard Deviation 0.23
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD8: Month 4
|
-0.45 10^9 cells per liter
Standard Deviation 0.14
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD8: Month 8
|
-0.27 10^9 cells per liter
Standard Deviation 0.12
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD8: Month 12
|
-0.26 10^9 cells per liter
Standard Deviation 0.20
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD8: Month 13
|
-0.43 10^9 cells per liter
Standard Deviation 0.25
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD8: Month 15
|
-0.41 10^9 cells per liter
Standard Deviation 0.20
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD8: Month 18
|
-0.38 10^9 cells per liter
Standard Deviation 0.16
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD8: Month 21
|
-0.30 10^9 cells per liter
Standard Deviation 0.20
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD8: Month 24
|
-0.31 10^9 cells per liter
Standard Deviation 0.20
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD8: Month 36
|
-0.24 10^9 cells per liter
Standard Deviation 0.32
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD8: Month 48
|
-0.23 10^9 cells per liter
Standard Deviation 0.25
|
—
|
|
Change From Baseline in Lymphocytes: Cluster of Differentiation 19 (CD19), CD3, CD3-/16+56, CD4 and CD8
CD8: Month 60
|
-0.21 10^9 cells per liter
Standard Deviation 0.30
|
—
|
SECONDARY outcome
Timeframe: Baseline (Month 0); Months 1, 4, 8, 12, 13, 15, 18, 21, 24, 36, 48 and 60Population: Analysis was performed on PD population. During the study, participants missed few scheduled site visits for sample collection, and only participants with data collected at specified timepoints are reported.
Blood samples were collected for assessment of lymphocytes (CD4 and CD8). Baseline was defined as the last non-missing value prior to first course of alemtuzumab. Change from baseline in CD4/CD8 ratio is presented.
Outcome measures
| Measure |
Period 1
n=11 Participants
Participants with RRMS who were assessed from Month -4 up to Month 0 (prior DMT phase) to confirm their eligibility for the administration of alemtuzumab IV infusion at Month 0. A baseline MRI was performed close to Month -4 during the screening period and another at Visit 3 (in between Day -14 to Day -7). Both MRI were taken while participants were on their prior DMT. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
|
Period 2
Participants with RRMS and with body weight \>=50 kg received 12 mg/day of alemtuzumab, and participants with body weight \<50 kg received 0.24 mg/kg/day alemtuzumab administered as daily IV infusions at Month 0 for 5 consecutive days as first course and at Month 12 for 3 consecutive days as second course of study treatment in alemtuzumab treatment phase. Period 2 occurred from Month 4 to Month 8. The MRI performed at the Month 4 visit was the baseline MRI for Period 2. A second MRI was performed after alemtuzumab first course of treatment at Month 8. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
|
|---|---|---|
|
Change From Baseline in Lymphocytes: CD4/CD8
Month 18
|
-0.50 ratio
Standard Deviation 0.52
|
—
|
|
Change From Baseline in Lymphocytes: CD4/CD8
Month 21
|
-0.34 ratio
Standard Deviation 0.39
|
—
|
|
Change From Baseline in Lymphocytes: CD4/CD8
Month 1
|
-0.80 ratio
Standard Deviation 0.55
|
—
|
|
Change From Baseline in Lymphocytes: CD4/CD8
Month 4
|
-0.56 ratio
Standard Deviation 0.35
|
—
|
|
Change From Baseline in Lymphocytes: CD4/CD8
Month 8
|
-0.24 ratio
Standard Deviation 0.35
|
—
|
|
Change From Baseline in Lymphocytes: CD4/CD8
Month 12
|
-0.14 ratio
Standard Deviation 0.44
|
—
|
|
Change From Baseline in Lymphocytes: CD4/CD8
Month 13
|
-0.23 ratio
Standard Deviation 0.66
|
—
|
|
Change From Baseline in Lymphocytes: CD4/CD8
Month 15
|
-0.44 ratio
Standard Deviation 0.57
|
—
|
|
Change From Baseline in Lymphocytes: CD4/CD8
Month 24
|
-0.24 ratio
Standard Deviation 0.49
|
—
|
|
Change From Baseline in Lymphocytes: CD4/CD8
Month 36
|
-0.24 ratio
Standard Deviation 0.52
|
—
|
|
Change From Baseline in Lymphocytes: CD4/CD8
Month 48
|
0.03 ratio
Standard Deviation 0.51
|
—
|
|
Change From Baseline in Lymphocytes: CD4/CD8
Month 60
|
-0.13 ratio
Standard Deviation 0.43
|
—
|
SECONDARY outcome
Timeframe: Prior DMT Phase: From signing of informed consent form (0-28 days before Month -4) to Month 0, approximately 5 months; Alemtuzumab Treatment Phase+Safety Monitoring Phase: From first alemtuzumab dose at Month 0 to end of study, approximately 60 monthsPopulation: Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. Safety population included participants who had received at least 1 dose of alemtuzumab. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily have a causal relationship with study treatment. A serious AE (SAE) was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was a medically important event. An AESI was an AE (serious or non-serious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required.
Outcome measures
| Measure |
Period 1
n=16 Participants
Participants with RRMS who were assessed from Month -4 up to Month 0 (prior DMT phase) to confirm their eligibility for the administration of alemtuzumab IV infusion at Month 0. A baseline MRI was performed close to Month -4 during the screening period and another at Visit 3 (in between Day -14 to Day -7). Both MRI were taken while participants were on their prior DMT. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
|
Period 2
n=11 Participants
Participants with RRMS and with body weight \>=50 kg received 12 mg/day of alemtuzumab, and participants with body weight \<50 kg received 0.24 mg/kg/day alemtuzumab administered as daily IV infusions at Month 0 for 5 consecutive days as first course and at Month 12 for 3 consecutive days as second course of study treatment in alemtuzumab treatment phase. Period 2 occurred from Month 4 to Month 8. The MRI performed at the Month 4 visit was the baseline MRI for Period 2. A second MRI was performed after alemtuzumab first course of treatment at Month 8. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
Any AE
|
10 Participants
|
11 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
Any SAE
|
3 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
Any AESI
|
0 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to 24 hours post-infusion, at Months 0 and 12Population: Analysis was performed on safety population.
An IAR was defined as any AE that occurred during alemtuzumab infusion or within the 24 hour post-infusion period. Number of participants with IARs in the alemtuzumab treatment phase is presented.
Outcome measures
| Measure |
Period 1
n=11 Participants
Participants with RRMS who were assessed from Month -4 up to Month 0 (prior DMT phase) to confirm their eligibility for the administration of alemtuzumab IV infusion at Month 0. A baseline MRI was performed close to Month -4 during the screening period and another at Visit 3 (in between Day -14 to Day -7). Both MRI were taken while participants were on their prior DMT. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
|
Period 2
Participants with RRMS and with body weight \>=50 kg received 12 mg/day of alemtuzumab, and participants with body weight \<50 kg received 0.24 mg/kg/day alemtuzumab administered as daily IV infusions at Month 0 for 5 consecutive days as first course and at Month 12 for 3 consecutive days as second course of study treatment in alemtuzumab treatment phase. Period 2 occurred from Month 4 to Month 8. The MRI performed at the Month 4 visit was the baseline MRI for Period 2. A second MRI was performed after alemtuzumab first course of treatment at Month 8. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
|
|---|---|---|
|
Number of Participants With Infusion-Associated Reactions (IARs) in the Alemtuzumab Treatment Phase
|
10 Participants
|
—
|
SECONDARY outcome
Timeframe: Months 1, 3, 12, 13, 15, 24, 36, 48 and 60Population: Analysis was performed on safety population. During the study, participants missed few scheduled site visits for sample collection, and only participants with data collected at specified timepoints are reported.
Blood samples were collected to evaluate antibodies to alemtuzumab. Percentage of participants with positive ADA sample status are reported. Percentages are rounded off to tenth decimal place.
Outcome measures
| Measure |
Period 1
n=11 Participants
Participants with RRMS who were assessed from Month -4 up to Month 0 (prior DMT phase) to confirm their eligibility for the administration of alemtuzumab IV infusion at Month 0. A baseline MRI was performed close to Month -4 during the screening period and another at Visit 3 (in between Day -14 to Day -7). Both MRI were taken while participants were on their prior DMT. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
|
Period 2
Participants with RRMS and with body weight \>=50 kg received 12 mg/day of alemtuzumab, and participants with body weight \<50 kg received 0.24 mg/kg/day alemtuzumab administered as daily IV infusions at Month 0 for 5 consecutive days as first course and at Month 12 for 3 consecutive days as second course of study treatment in alemtuzumab treatment phase. Period 2 occurred from Month 4 to Month 8. The MRI performed at the Month 4 visit was the baseline MRI for Period 2. A second MRI was performed after alemtuzumab first course of treatment at Month 8. It was important to ensure that these 2 MRI assessments were performed 4 months (±7 days) apart.
|
|---|---|---|
|
Percentage of Participants With Incidence of Antidrug Antibodies (ADA)
Month 36
|
62.5 percentage of participants
|
—
|
|
Percentage of Participants With Incidence of Antidrug Antibodies (ADA)
Month 1
|
100 percentage of participants
|
—
|
|
Percentage of Participants With Incidence of Antidrug Antibodies (ADA)
Month 3
|
90.0 percentage of participants
|
—
|
|
Percentage of Participants With Incidence of Antidrug Antibodies (ADA)
Month 12
|
60.0 percentage of participants
|
—
|
|
Percentage of Participants With Incidence of Antidrug Antibodies (ADA)
Month 13
|
71.4 percentage of participants
|
—
|
|
Percentage of Participants With Incidence of Antidrug Antibodies (ADA)
Month 15
|
87.5 percentage of participants
|
—
|
|
Percentage of Participants With Incidence of Antidrug Antibodies (ADA)
Month 24
|
66.7 percentage of participants
|
—
|
|
Percentage of Participants With Incidence of Antidrug Antibodies (ADA)
Month 48
|
80.0 percentage of participants
|
—
|
|
Percentage of Participants With Incidence of Antidrug Antibodies (ADA)
Month 60
|
83.3 percentage of participants
|
—
|
Adverse Events
Prior DMT Phase
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Alemtuzumab Treatment Phase + Safety Monitoring Phase
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prior DMT Phase
n=16 participants at risk
Screened participants with RRMS who entered the prior DMT phase (Month -4 to Month 0) during which the prior DMT was continued and eligibility criteria for alemtuzumab treatment was confirmed, were included in this arm.
|
Alemtuzumab Treatment Phase + Safety Monitoring Phase
n=11 participants at risk
At progression with prior DMT, participants who were enrolled in the alemtuzumab treatment phase to receive 2 courses at 12-month interval were included in this arm. The first course was given at Month 0 for 5 consecutive days and the second course at Month 12 for 3 consecutive days. The alemtuzumab daily dose was 12 mg/day if body weight \>=50 kg and 0.24 mg/kg/day if body weight \<50 kg. The alemtuzumab treatment phase was followed by a safety monitoring phase of approximately 3 years.
|
|---|---|---|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Nervous system disorders
Multiple Sclerosis Pseudo Relapse
|
6.2%
1/16 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
0.00%
0/11 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Nervous system disorders
Multiple Sclerosis Relapse
|
18.8%
3/16 • Number of events 4 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Renal and urinary disorders
Calculus Urinary
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
18.2%
2/11 • Number of events 2 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
Other adverse events
| Measure |
Prior DMT Phase
n=16 participants at risk
Screened participants with RRMS who entered the prior DMT phase (Month -4 to Month 0) during which the prior DMT was continued and eligibility criteria for alemtuzumab treatment was confirmed, were included in this arm.
|
Alemtuzumab Treatment Phase + Safety Monitoring Phase
n=11 participants at risk
At progression with prior DMT, participants who were enrolled in the alemtuzumab treatment phase to receive 2 courses at 12-month interval were included in this arm. The first course was given at Month 0 for 5 consecutive days and the second course at Month 12 for 3 consecutive days. The alemtuzumab daily dose was 12 mg/day if body weight \>=50 kg and 0.24 mg/kg/day if body weight \<50 kg. The alemtuzumab treatment phase was followed by a safety monitoring phase of approximately 3 years.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
18.2%
2/11 • Number of events 2 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Cardiac disorders
Sinus Bradycardia
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
18.2%
2/11 • Number of events 2 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Ear and labyrinth disorders
Vertigo Positional
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Eye disorders
Eye Pain
|
6.2%
1/16 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Eye disorders
Ocular Discomfort
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Eye disorders
Photophobia
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
27.3%
3/11 • Number of events 5 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
6.2%
1/16 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 2 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
18.2%
2/11 • Number of events 2 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
1/16 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
36.4%
4/11 • Number of events 7 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Gastrointestinal disorders
Faeces Discoloured
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
36.4%
4/11 • Number of events 8 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Gastrointestinal disorders
Paraesthesia Oral
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 3 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
18.2%
2/11 • Number of events 3 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
36.4%
4/11 • Number of events 4 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
General disorders
Asthenia
|
6.2%
1/16 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 2 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
General disorders
Chest Discomfort
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 3 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
General disorders
Discomfort
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
General disorders
Fatigue
|
6.2%
1/16 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
45.5%
5/11 • Number of events 7 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
General disorders
Influenza Like Illness
|
6.2%
1/16 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
27.3%
3/11 • Number of events 5 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
18.2%
2/11 • Number of events 3 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
General disorders
Oedema Peripheral
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
18.2%
2/11 • Number of events 2 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
General disorders
Peripheral Swelling
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
General disorders
Pyrexia
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
36.4%
4/11 • Number of events 9 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Immune system disorders
Mite Allergy
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Infections and infestations
Covid-19
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Infections and infestations
Ear Infection
|
12.5%
2/16 • Number of events 2 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
0.00%
0/11 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Infections and infestations
Enteritis Infectious
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Infections and infestations
Genitourinary Tract Infection
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Infections and infestations
Influenza
|
6.2%
1/16 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
0.00%
0/11 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Infections and infestations
Nasopharyngitis
|
18.8%
3/16 • Number of events 4 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
54.5%
6/11 • Number of events 7 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Infections and infestations
Periodontitis
|
6.2%
1/16 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
0.00%
0/11 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
18.2%
2/11 • Number of events 2 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
6.2%
1/16 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
0.00%
0/11 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Infections and infestations
Rhinitis
|
18.8%
3/16 • Number of events 3 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
27.3%
3/11 • Number of events 5 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Infections and infestations
Tinea Versicolour
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
27.3%
3/11 • Number of events 13 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
18.2%
2/11 • Number of events 3 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Infections and infestations
Viral Pharyngitis
|
6.2%
1/16 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
0.00%
0/11 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
18.2%
2/11 • Number of events 3 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 2 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 2 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Investigations
Blood Urine
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Investigations
Body Temperature Increased
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Investigations
Eosinophil Count Increased
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 2 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Investigations
Epstein-Barr Virus Antigen Positive
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Investigations
Heart Rate Increased
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Investigations
Tri-Iodothyronine Increased
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Investigations
Weight Increased
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
18.2%
2/11 • Number of events 2 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Investigations
White Blood Cell Count Decreased
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Metabolism and nutrition disorders
Glucose Tolerance Impaired
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 2 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
18.2%
2/11 • Number of events 2 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
6.2%
1/16 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Musculoskeletal and connective tissue disorders
Tendon Pain
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 4 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 2 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Nervous system disorders
Electric Shock Sensation
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
54.5%
6/11 • Number of events 18 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Nervous system disorders
Multiple Sclerosis Pseudo Relapse
|
6.2%
1/16 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
0.00%
0/11 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Nervous system disorders
Multiple Sclerosis Relapse
|
18.8%
3/16 • Number of events 4 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
0.00%
0/11 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Nervous system disorders
Paraesthesia
|
6.2%
1/16 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 3 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Psychiatric disorders
Fear
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
6.2%
1/16 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
0.00%
0/11 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
18.2%
2/11 • Number of events 2 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Psychiatric disorders
Depression
|
6.2%
1/16 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
0.00%
0/11 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
18.2%
2/11 • Number of events 2 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Psychiatric disorders
Mental Disorder
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Psychiatric disorders
Sleep Disorder
|
6.2%
1/16 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
18.2%
2/11 • Number of events 2 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
27.3%
3/11 • Number of events 4 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Disorder
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.2%
1/16 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 2 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
18.2%
2/11 • Number of events 2 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic Eczema
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
18.2%
2/11 • Number of events 5 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
18.2%
2/11 • Number of events 2 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 2 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Skin and subcutaneous tissue disorders
Skin Disorder
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
36.4%
4/11 • Number of events 4 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
|
Surgical and medical procedures
Abortion Induced
|
0.00%
0/16 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
9.1%
1/11 • Number of events 1 • Prior DMT Phase: From signing of the informed consent form (0 to 28 days before Month -4) up to Month 0, approximately 5 months; Alemtuzumab Treatment Phase + Safety Monitoring Phase: From the first alemtuzumab dose at Month 0 up to end of study, approximately 60 months
Analysis was performed on enrolled population for prior DMT phase and on safety population for alemtuzumab treatment phase + safety monitoring phase. As pre-specified in the statistical analysis plan, the safety data was collected separately for pre-treatment period (prior DMT phase) and on-treatment period (alemtuzumab treatment phase + safety monitoring phase).
|
Additional Information
Trial Transparency Team
Sanofi aventis recherche & développement
Phone: 800-633-1610
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
- Publication restrictions are in place
Restriction type: OTHER