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: 2025-11-26
Results Overview
Number of new or enlarged T2 lesions per scan was defined as the total number of new or enlarged T2 lesion that occurred during a specified period divided by the total number of scans performed during that specified period.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
16 participants
Primary outcome timeframe
Period 1: Month -4 up to Month 0, Period 2: Month 4 to Month 8
Results posted on
2025-11-26
Participant Flow
The study is being conducted at 21 sites in 10 countries. A total of 16 participants were screened and enrolled between 24-October-2017 and 07-September-2020.
Prior to alemtuzumab treatment phase (Month 0 to Month 8), participants underwent prior disease modifying therapy (DMT) phase during Month -4 to Month 0 (conducted to check participants eligibility for treatment). The DMT was discontinued 7 days prior to administration of first dose of alemtuzumab at Month 0. Data reported based on primary completion date of 04-May-2021.
Participant milestones
| Measure |
Alemtuzumab
Participants with relapsing remitting multiple sclerosis (RRMS) underwent prior disease modifying therapy (DMT), from Month -4 to Month 0 (conducted to check participants eligibility for treatment) in prior DMT phase. After DMT phase, participants who were eligible for treatment, and with body weight greater than or equal to (\>=) 50 kilograms (kg) received 12 milligrams per day (mg/day) of alemtuzumab, and participants with body weight less than (\<) 50 kg received 0.24 milligrams per kilogram per day (mg/kg/day) of alemtuzumab administered as daily intravenous (IV) infusions at Month 0 for 5 consecutive days as first course of study treatment in alemtuzumab treatment phase.
|
|---|---|
|
Phase1: Prior DMT:Month -4 to Month 0
STARTED
|
16
|
|
Phase1: Prior DMT:Month -4 to Month 0
COMPLETED
|
12
|
|
Phase1: Prior DMT:Month -4 to Month 0
NOT COMPLETED
|
4
|
|
Phase2:AlemtuzumabTreatment:Month 0 to 8
STARTED
|
11
|
|
Phase2:AlemtuzumabTreatment:Month 0 to 8
Treated
|
11
|
|
Phase2:AlemtuzumabTreatment:Month 0 to 8
COMPLETED
|
11
|
|
Phase2:AlemtuzumabTreatment:Month 0 to 8
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Alemtuzumab
Participants with relapsing remitting multiple sclerosis (RRMS) underwent prior disease modifying therapy (DMT), from Month -4 to Month 0 (conducted to check participants eligibility for treatment) in prior DMT phase. After DMT phase, participants who were eligible for treatment, and with body weight greater than or equal to (\>=) 50 kilograms (kg) received 12 milligrams per day (mg/day) of alemtuzumab, and participants with body weight less than (\<) 50 kg received 0.24 milligrams per kilogram per day (mg/kg/day) of alemtuzumab administered as daily intravenous (IV) infusions at Month 0 for 5 consecutive days as first course of study treatment in alemtuzumab treatment phase.
|
|---|---|
|
Phase1: Prior DMT:Month -4 to Month 0
Physician Decision
|
1
|
|
Phase1: Prior DMT:Month -4 to Month 0
Participant was withdrawn from study
|
1
|
|
Phase1: Prior DMT:Month -4 to Month 0
Principal Investigator and Parents Decision
|
1
|
|
Phase1: Prior DMT:Month -4 to Month 0
Still on Prior DMT Phase or missing Completion
|
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
Participants with RRMS underwent prior DMT, from Month -4 to Month 0 (conducted to check participants eligibility for treatment) in prior DMT phase. After DMT phase, participants who were eligible for treatment, 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 of alemtuzumab administered as daily IV infusions at Month 0 for 5 consecutive days as first course of study treatment in alemtuzumab treatment phase.
|
|---|---|
|
Age, Continuous
|
14.5 years
STANDARD_DEVIATION 2.2 • n=492 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=492 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=492 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=492 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=492 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=492 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=492 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=492 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=492 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=492 Participants
|
PRIMARY outcome
Timeframe: Period 1: Month -4 up to Month 0, Period 2: Month 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 scan was defined as the total number of new or enlarged T2 lesion that occurred during a specified period divided by the total number of scans performed during that specified 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 of study treatment. 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: Number of New or Enlarged T2 Lesions Per MRI Scan
|
3.53 lesions per scan
Interval 1.78 to 7.03
|
0.13 lesions per scan
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 per MRI scan was reported in this outcome measure. Number of new or enlarged T2 lesions per scan was defined as the total number of new or enlarged T2 lesion that occurred during treatment period divided by the total number of scans performed during treatment 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 of study treatment. 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: Number of Participants With New or Enlarged T2 Lesions Per MRI Scan
|
10 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline, Months 4 and 8Population: Analysis was performed on mITT population. Here, 'number analyzed' signifies participants with available data for each specified category.
EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It consists of 8 ordinal rating scales assessing seven functional systems (pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral, and other). EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicated worst outcomes.
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 of study treatment. 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: Up to 5 yearsData for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsData for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsData for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsData for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsData for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsData for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsData for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsData for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsData for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsData for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsData for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsData for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsData for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsData for this outcome measure will be reported at the time of anticipated last participant last visit results posting (December 2026).
Outcome measures
Outcome data not reported
Adverse Events
Prior DMT Phase
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Alemtuzumab
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
Participants with RRMS were assessed from Month -4 up to Month 0 in prior DMT phase to confirm their eligibility for the administration of alemtuzumab IV infusions in alemtuzumab treatment phase.
|
Alemtuzumab
n=11 participants at risk
After DMT phase, participants who were eligible for treatment, 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 of alemtuzumab administered as daily IV infusions at Month 0 for 5 consecutive days as first course of study treatment in alemtuzumab treatment phase.
|
|---|---|---|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Nervous system disorders
Multiple Sclerosis Relapse
|
18.8%
3/16 • Number of events 4 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Nervous system disorders
Uhthoff's Phenomenon
|
6.2%
1/16 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
0.00%
0/11 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Renal and urinary disorders
Calculus Urinary
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
18.2%
2/11 • Number of events 2 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
Other adverse events
| Measure |
Prior DMT Phase
n=16 participants at risk
Participants with RRMS were assessed from Month -4 up to Month 0 in prior DMT phase to confirm their eligibility for the administration of alemtuzumab IV infusions in alemtuzumab treatment phase.
|
Alemtuzumab
n=11 participants at risk
After DMT phase, participants who were eligible for treatment, 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 of alemtuzumab administered as daily IV infusions at Month 0 for 5 consecutive days as first course of study treatment in alemtuzumab treatment phase.
|
|---|---|---|
|
Investigations
Weight Decreased
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Investigations
Weight Increased
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
18.2%
2/11 • Number of events 2 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 2 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
18.2%
2/11 • Number of events 2 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
6.2%
1/16 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Musculoskeletal and connective tissue disorders
Tendon Pain
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 3 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 2 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
54.5%
6/11 • Number of events 17 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Nervous system disorders
Multiple Sclerosis Relapse
|
18.8%
3/16 • Number of events 4 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
0.00%
0/11 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Nervous system disorders
Paraesthesia
|
6.2%
1/16 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 3 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
6.2%
1/16 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
0.00%
0/11 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Nervous system disorders
Presyncope
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Nervous system disorders
Sensory Disturbance
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Nervous system disorders
Uhthoff's Phenomenon
|
6.2%
1/16 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
0.00%
0/11 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Psychiatric disorders
Depression
|
6.2%
1/16 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
0.00%
0/11 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Psychiatric disorders
Fear
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
18.2%
2/11 • Number of events 2 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Psychiatric disorders
Sleep Disorder
|
6.2%
1/16 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
18.2%
2/11 • Number of events 2 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
27.3%
3/11 • Number of events 4 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.2%
1/16 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
0.00%
0/11 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 2 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
18.2%
2/11 • Number of events 2 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
18.2%
2/11 • Number of events 4 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
18.2%
2/11 • Number of events 2 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
36.4%
4/11 • Number of events 4 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Vascular disorders
Hypertension
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
18.2%
2/11 • Number of events 2 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Cardiac disorders
Palpitations
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Cardiac disorders
Sinus Bradycardia
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Ear and labyrinth disorders
Vertigo Positional
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Eye disorders
Eye Pain
|
6.2%
1/16 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Eye disorders
Photophobia
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
27.3%
3/11 • Number of events 4 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
6.2%
1/16 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 2 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
18.2%
2/11 • Number of events 2 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
1/16 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
36.4%
4/11 • Number of events 6 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Gastrointestinal disorders
Faeces Discoloured
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
27.3%
3/11 • Number of events 4 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Gastrointestinal disorders
Paraesthesia Oral
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 3 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 2 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
36.4%
4/11 • Number of events 4 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
General disorders
Asthenia
|
6.2%
1/16 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
General disorders
Chest Discomfort
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 3 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
General disorders
Discomfort
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
General disorders
Fatigue
|
6.2%
1/16 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
45.5%
5/11 • Number of events 7 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
General disorders
Influenza Like Illness
|
6.2%
1/16 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
18.2%
2/11 • Number of events 2 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
18.2%
2/11 • Number of events 3 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
General disorders
Oedema Peripheral
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
18.2%
2/11 • Number of events 2 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
General disorders
Pain
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
General disorders
Peripheral Swelling
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
General disorders
Pyrexia
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
45.5%
5/11 • Number of events 10 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Immune system disorders
Mite Allergy
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Infections and infestations
Ear Infection
|
12.5%
2/16 • Number of events 2 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
0.00%
0/11 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Infections and infestations
Genitourinary Tract Infection
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Infections and infestations
Influenza
|
6.2%
1/16 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
0.00%
0/11 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Infections and infestations
Nasopharyngitis
|
18.8%
3/16 • Number of events 4 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
54.5%
6/11 • Number of events 7 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Infections and infestations
Periodontitis
|
6.2%
1/16 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
0.00%
0/11 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
6.2%
1/16 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
0.00%
0/11 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Infections and infestations
Rhinitis
|
18.8%
3/16 • Number of events 3 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
27.3%
3/11 • Number of events 5 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Infections and infestations
Tinea Versicolour
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
27.3%
3/11 • Number of events 6 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
18.2%
2/11 • Number of events 2 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Infections and infestations
Viral Pharyngitis
|
6.2%
1/16 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
0.00%
0/11 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 2 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Investigations
Blood Urine
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Investigations
Heart Rate Increased
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
|
Investigations
Lymphocyte Count Decreased
|
0.00%
0/16 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
9.1%
1/11 • Number of events 1 • All reported AEs were collected from Month -4 up to Month 0 for prior DMT Phase; and from first dose of alemtuzumab (Month 0) up to 8 months for alemtuzumab treatment phase
|
Additional Information
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