Trial Outcomes & Findings for Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study Two (NCT NCT00548405)
NCT ID: NCT00548405
Last Updated: 2017-04-17
Results Overview
EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score: 0 (normal neurological examination) to 10 (death due to MS). As measured by EDSS score, SAD was defined as increase of at least 1.5 points for participants with Baseline score of 0 and increase of at least 1.0 point for participants with a Baseline score of 1.0 or more; and the increase persisted for at least the next 2 scheduled assessments, that is, 6 consecutive months. The onset date of SAD was date of first EDSS assessment that began 6 month consecutive period of SAD. Participants who did not reach SAD endpoint were censored at their last visit. Percentage of participants with SAD, estimated by Kaplan-Meier (KM) method, was reported.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
840 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2017-04-17
Participant Flow
Participants were screened at 192 investigational sites between October 10, 2007 and September 15, 2011.
Participant milestones
| Measure |
Interferon Beta-1a
Interferon Beta-1a (Rebif®) 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
|
Alemtuzumab 12 mg
Alemtuzumab (Lemtrada™) 12 milligram (mg) per day intravenous (IV) infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
|
Alemtuzumab 24mg
Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion on 3 consecutive days at Month 12.
|
|---|---|---|---|
|
Overall Study
STARTED
|
231
|
436
|
173
|
|
Overall Study
Treated
|
202
|
426
|
170
|
|
Overall Study
COMPLETED
|
175
|
416
|
164
|
|
Overall Study
NOT COMPLETED
|
56
|
20
|
9
|
Reasons for withdrawal
| Measure |
Interferon Beta-1a
Interferon Beta-1a (Rebif®) 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
|
Alemtuzumab 12 mg
Alemtuzumab (Lemtrada™) 12 milligram (mg) per day intravenous (IV) infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
|
Alemtuzumab 24mg
Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion on 3 consecutive days at Month 12.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
6
|
2
|
0
|
|
Overall Study
Lack of Efficacy
|
6
|
0
|
0
|
|
Overall Study
Physician Decision
|
3
|
4
|
1
|
|
Overall Study
Pregnancy
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
36
|
12
|
5
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
2
|
|
Overall Study
Death
|
0
|
1
|
1
|
|
Overall Study
Sponsor decision
|
1
|
0
|
0
|
|
Overall Study
Randomized but not treated
|
1
|
0
|
0
|
Baseline Characteristics
Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study Two
Baseline characteristics by cohort
| Measure |
Interferon Beta-1a
n=202 Participants
Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
|
Alemtuzumab 12 mg
n=426 Participants
Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion over 4 hours on 3 consecutive days at Month 12.
|
Alemtuzumab 24mg
n=170 Participants
Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion over 4 hours on 3 consecutive days at Month 12.
|
Total
n=798 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
35.8 years
STANDARD_DEVIATION 8.77 • n=5 Participants
|
34.8 years
STANDARD_DEVIATION 8.36 • n=7 Participants
|
35.1 years
STANDARD_DEVIATION 8.40 • n=5 Participants
|
35.1 years
STANDARD_DEVIATION 8.47 • n=4 Participants
|
|
Sex: Female, Male
Female
|
131 Participants
n=5 Participants
|
281 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
532 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
266 Participants
n=4 Participants
|
|
Time Since First Relapse
|
4.1 years
n=5 Participants
|
3.8 years
n=7 Participants
|
3.7 years
n=5 Participants
|
3.8 years
n=4 Participants
|
|
Number of Relapse Episodes in the Preceding 2 Years
1 Relapse
|
7 participants
n=5 Participants
|
15 participants
n=7 Participants
|
11 participants
n=5 Participants
|
33 participants
n=4 Participants
|
|
Number of Relapse Episodes in the Preceding 2 Years
2 Relapses
|
109 participants
n=5 Participants
|
215 participants
n=7 Participants
|
94 participants
n=5 Participants
|
418 participants
n=4 Participants
|
|
Number of Relapse Episodes in the Preceding 2 Years
Greater than or equal to 3 Relapses
|
86 participants
n=5 Participants
|
196 participants
n=7 Participants
|
65 participants
n=5 Participants
|
347 participants
n=4 Participants
|
|
Expanded Disability Status Scale (EDSS) Score
|
2.7 units on a scale
STANDARD_DEVIATION 1.21 • n=5 Participants
|
2.7 units on a scale
STANDARD_DEVIATION 1.26 • n=7 Participants
|
2.7 units on a scale
STANDARD_DEVIATION 1.17 • n=5 Participants
|
2.7 units on a scale
STANDARD_DEVIATION 1.22 • n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: FAS population included all randomized participants who received at least 1 dose of study drug as per initial randomization. Analysis was not performed for Alemtuzumab 24 mg as recruitment to this arm was closed early to reduce overall sample size, duration of enrollment period, overall duration of study.
EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score: 0 (normal neurological examination) to 10 (death due to MS). As measured by EDSS score, SAD was defined as increase of at least 1.5 points for participants with Baseline score of 0 and increase of at least 1.0 point for participants with a Baseline score of 1.0 or more; and the increase persisted for at least the next 2 scheduled assessments, that is, 6 consecutive months. The onset date of SAD was date of first EDSS assessment that began 6 month consecutive period of SAD. Participants who did not reach SAD endpoint were censored at their last visit. Percentage of participants with SAD, estimated by Kaplan-Meier (KM) method, was reported.
Outcome measures
| Measure |
Interferon Beta-1a
n=202 Participants
Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
|
Alemtuzumab 12 mg
n=426 Participants
Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
|
|---|---|---|
|
Percentage of Participants With Sustained Accumulation of Disability (SAD)
|
21.13 percentage of participants
Interval 15.95 to 27.68
|
12.71 percentage of participants
Interval 9.89 to 16.27
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: FAS population. Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1.
Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to multiple sclerosis that lasted for at least 48 hours, that were present at normal body temperature, and that were preceded by at least 30 days of clinical stability. Annualized relapse rate was estimated through negative binomial regression with robust variance estimation and covariate adjustment for geographic region using observed number of relapses as dependent variable, the log total amount of follow-up from date of first study treatment for each participant as an offset variable, and treatment group and geographic region as model covariates.
Outcome measures
| Measure |
Interferon Beta-1a
n=202 Participants
Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
|
Alemtuzumab 12 mg
n=426 Participants
Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
|
|---|---|---|
|
Annualized Relapse Rate
|
0.52 relapses per participant per year
Interval 0.41 to 0.66
|
0.26 relapses per participant per year
Interval 0.21 to 0.33
|
SECONDARY outcome
Timeframe: Year 2Population: FAS population. Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1.
Participants were considered relapse free at Year 2 if they did not experience a relapse from the date of first study treatment to study completion at 24 months. Percentage of participants who were relapse free at Year 2, estimated using the KM method, was reported.
Outcome measures
| Measure |
Interferon Beta-1a
n=202 Participants
Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
|
Alemtuzumab 12 mg
n=426 Participants
Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
|
|---|---|---|
|
Percentage of Participants Who Were Relapse Free at Year 2
|
46.70 percentage of participants
Interval 39.53 to 53.54
|
65.38 percentage of participants
Interval 60.65 to 69.7
|
SECONDARY outcome
Timeframe: Baseline, Year 2Population: FAS population. Here, number of participants analyzed was subset of FAS who had EDSS assessment at both Baseline and end-of-study (Year 2). Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1.
EDSS is an ordinal scale in half-point increments that qualifies disability in participants with multiple sclerosis (MS). It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS). Change was calculated by subtracting Baseline value from value at Year 2.
Outcome measures
| Measure |
Interferon Beta-1a
n=174 Participants
Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
|
Alemtuzumab 12 mg
n=413 Participants
Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
|
|---|---|---|
|
Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Year 2
|
0.21 units on a scale
Standard Deviation 1.167
|
-0.20 units on a scale
Standard Deviation 1.084
|
SECONDARY outcome
Timeframe: Baseline, Year 2Population: FAS population. Here, number of participants analyzed signifies subset of FAS who had MSFC score assessment at Baseline; 'n' signifies participants who had MSFC score assessment at Baseline (for Baseline) and at both Baseline and Year 2 (for change at Year 2). Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1.
MSFC is a multidimensional measure consisting of quantitative tests of ambulation (Timed 25-Foot Walk), manual dexterity (9-Hole Peg Test; 9HPT), and cognitive function (Paced Auditory Serial Addition Test; PASAT). The MSFC score was calculated as the mean of the Z-scores of the 3 components. A Z-score was calculated by subtracting the mean of the reference population from the test result, then dividing by the standard deviation of the reference population. Higher Z-scores reflected better neurological function and a positive change from Baseline indicates improvement. An increase in score indicated an improvement (Z-score range: -3 to +3). Acquisition of disability was measured by change from Baseline in MSFC score at Year 2.
Outcome measures
| Measure |
Interferon Beta-1a
n=198 Participants
Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
|
Alemtuzumab 12 mg
n=423 Participants
Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
|
|---|---|---|
|
Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score at Year 2
Baseline (n=198, 423)
|
-0.03 Z-score
Standard Deviation 0.791
|
0.02 Z-score
Standard Deviation 0.689
|
|
Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score at Year 2
Change at Year 2 (n=169, 399)
|
-0.04 Z-score
Standard Deviation 0.449
|
0.09 Z-score
Standard Deviation 0.358
|
SECONDARY outcome
Timeframe: Baseline, Year 2Population: FAS population. Here, number of participants analyzed was subset of FAS who had assessment for T2 volume at both Baseline and end-of-study (Year 2). Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1.
Percent change in MS lesion volume as measured by MRI-T2 scan was calculated from MRI-T2-weighted scans as the following: (lesion volume at 2 years - lesion volume at Baseline)\*100/ (lesion volume at Baseline).
Outcome measures
| Measure |
Interferon Beta-1a
n=190 Participants
Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
|
Alemtuzumab 12 mg
n=412 Participants
Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
|
|---|---|---|
|
Percent Change From Baseline in Magnetic Resonance Imaging Time Constant 2 (MRI-T2) Hyperintense Lesion Volume at Year 2
|
2.41 percent change
Standard Deviation 26.48
|
-1.12 percent change
Standard Deviation 24.40
|
Adverse Events
Interferon Beta-1a
Serious events: 44 serious events
Other events: 189 other events
Deaths: 0 deaths
Alemtuzumab 12 mg
Serious events: 85 serious events
Other events: 427 other events
Deaths: 0 deaths
Alemtuzumab 24 mg
Serious events: 30 serious events
Other events: 159 other events
Deaths: 0 deaths
Alemtuzumab (Pooled)
Serious events: 115 serious events
Other events: 586 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Interferon Beta-1a
n=202 participants at risk
Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
|
Alemtuzumab 12 mg
n=435 participants at risk
Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
|
Alemtuzumab 24 mg
n=161 participants at risk
Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion on 3 consecutive days at Month 12.
|
Alemtuzumab (Pooled)
n=596 participants at risk
Included all participants who received alemtuzumab 12 mg or 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg or 24 mg per day IV infusion on 3 consecutive days at Month 12.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Blood and lymphatic system disorders
Autoimmune thrombocytopenia
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
1.2%
2/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.50%
3/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.46%
2/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.34%
2/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.50%
1/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Endocrine disorders
Goitre
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.46%
2/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.50%
3/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Eye disorders
Eye pain
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Eye disorders
Retinal pigment epitheliopathy
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.50%
1/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.46%
2/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.34%
2/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.50%
1/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.34%
2/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Gastrointestinal disorders
Nausea
|
0.50%
1/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.34%
2/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Gastrointestinal disorders
Peptic ulcer perforation
|
0.50%
1/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Gastrointestinal disorders
Sigmoiditis
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Gastrointestinal disorders
Vomiting
|
0.50%
1/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
General disorders
Abasia
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
General disorders
Chest discomfort
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
General disorders
Chest pain
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.46%
2/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.34%
2/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
General disorders
Death
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
General disorders
Infusion related reaction
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
General disorders
Oedema peripheral
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
General disorders
Pain
|
0.50%
1/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
General disorders
Pyrexia
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.46%
2/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.34%
2/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Hepatobiliary disorders
Biliary colic
|
0.50%
1/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.5%
3/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.46%
2/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.34%
2/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.46%
2/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.34%
2/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.50%
1/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Hepatobiliary disorders
Liver disorder
|
0.50%
1/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.46%
2/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.34%
2/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Infections and infestations
Catheter site infection
|
0.50%
1/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Infections and infestations
Febrile infection
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.69%
3/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.67%
4/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
1.2%
2/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.50%
3/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Infections and infestations
Influenza
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Infections and infestations
Injection site abscess
|
0.50%
1/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Infections and infestations
Pasteurella infection
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.92%
4/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.84%
5/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Infections and infestations
Pyelonephritis chronic
|
0.50%
1/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.50%
1/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.50%
1/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Injury, poisoning and procedural complications
Injury
|
0.50%
1/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.50%
1/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.50%
1/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.50%
1/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.50%
1/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.34%
2/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.50%
1/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval cancer stage 0
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Nervous system disorders
Headache
|
0.50%
1/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Nervous system disorders
Intracranial hypotension
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.34%
2/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Nervous system disorders
Migraine
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.34%
2/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Nervous system disorders
Monoparesis
|
0.50%
1/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Nervous system disorders
Multiple sclerosis
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Nervous system disorders
Multiple sclerosis relapse
|
12.4%
25/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
7.6%
33/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
1.9%
3/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
6.0%
36/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Nervous system disorders
Status migrainosus
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Psychiatric disorders
Drug dependence
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Psychiatric disorders
Mania
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.34%
2/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Renal and urinary disorders
Automatic bladder
|
0.50%
1/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.34%
2/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.50%
1/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.50%
1/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Reproductive system and breast disorders
Vulvar dysplasia
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.50%
1/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal blistering
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.46%
2/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.34%
2/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.50%
1/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
1.2%
2/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.34%
2/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.46%
2/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.50%
3/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Surgical and medical procedures
Female sterilisation
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Vascular disorders
Hypertension
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.23%
1/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.17%
1/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
Other adverse events
| Measure |
Interferon Beta-1a
n=202 participants at risk
Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
|
Alemtuzumab 12 mg
n=435 participants at risk
Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
|
Alemtuzumab 24 mg
n=161 participants at risk
Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion on 3 consecutive days at Month 12.
|
Alemtuzumab (Pooled)
n=596 participants at risk
Included all participants who received alemtuzumab 12 mg or 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg or 24 mg per day IV infusion on 3 consecutive days at Month 12.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
2.0%
4/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
5.3%
23/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
5.6%
9/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
5.4%
32/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Cardiac disorders
Tachycardia
|
0.50%
1/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
6.2%
27/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
6.2%
10/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
6.2%
37/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Eye disorders
Vision blurred
|
5.0%
10/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
4.8%
21/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
5.6%
9/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
5.0%
30/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.0%
6/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
5.3%
23/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
11.2%
18/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
6.9%
41/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.0%
6/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
3.7%
16/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
6.8%
11/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
4.5%
27/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Gastrointestinal disorders
Constipation
|
7.4%
15/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
4.4%
19/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
8.7%
14/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
5.5%
33/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.4%
17/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
13.3%
58/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
21.1%
34/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
15.4%
92/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.5%
9/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
7.4%
32/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
11.8%
19/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
8.6%
51/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Gastrointestinal disorders
Nausea
|
10.4%
21/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
24.1%
105/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
31.7%
51/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
26.2%
156/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
8/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
9.0%
39/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
16.1%
26/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
10.9%
65/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
General disorders
Asthenia
|
5.0%
10/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
5.1%
22/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
5.6%
9/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
5.2%
31/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
General disorders
Chest discomfort
|
0.50%
1/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
7.4%
32/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
16.8%
27/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
9.9%
59/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
General disorders
Chills
|
4.5%
9/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
8.0%
35/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
13.7%
22/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
9.6%
57/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
General disorders
Fatigue
|
12.9%
26/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
18.6%
81/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
21.7%
35/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
19.5%
116/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
General disorders
Influenza like illness
|
23.3%
47/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
7.1%
31/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
8.1%
13/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
7.4%
44/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
General disorders
Injection site erythema
|
13.9%
28/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
General disorders
Injection site reaction
|
6.4%
13/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.00%
0/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
General disorders
Oedema peripheral
|
2.0%
4/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
6.0%
26/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
7.5%
12/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
6.4%
38/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
General disorders
Pain
|
3.5%
7/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
8.0%
35/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
9.9%
16/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
8.6%
51/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
General disorders
Pyrexia
|
8.9%
18/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
21.6%
94/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
29.2%
47/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
23.7%
141/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Infections and infestations
Bronchitis
|
5.0%
10/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
7.8%
34/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
9.3%
15/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
8.2%
49/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Infections and infestations
Gastroenteritis
|
2.5%
5/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
4.6%
20/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
5.6%
9/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
4.9%
29/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Infections and infestations
Gastroenteritis viral
|
5.9%
12/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
3.9%
17/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
5.0%
8/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
4.2%
25/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Infections and infestations
Herpes zoster
|
1.5%
3/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
5.5%
24/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
7.5%
12/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
6.0%
36/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Infections and infestations
Influenza
|
5.4%
11/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
9.2%
40/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
11.2%
18/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
9.7%
58/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Infections and infestations
Nasopharyngitis
|
23.8%
48/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
29.4%
128/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
32.3%
52/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
30.2%
180/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Infections and infestations
Oral herpes
|
2.0%
4/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
8.0%
35/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
5.6%
9/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
7.4%
44/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Infections and infestations
Pharyngitis
|
0.50%
1/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
4.4%
19/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
5.6%
9/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
4.7%
28/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Infections and infestations
Sinusitis
|
9.9%
20/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
13.3%
58/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
12.4%
20/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
13.1%
78/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.4%
25/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
16.1%
70/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
21.1%
34/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
17.4%
104/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Infections and infestations
Urinary tract infection
|
11.4%
23/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
21.1%
92/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
23.0%
37/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
21.6%
129/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Injury, poisoning and procedural complications
Contusion
|
7.4%
15/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
11.5%
50/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
18.6%
30/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
13.4%
80/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Injury, poisoning and procedural complications
Fall
|
5.4%
11/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
6.4%
28/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
6.2%
10/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
6.4%
38/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Investigations
Bacterial test positive
|
2.0%
4/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
3.0%
13/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
5.6%
9/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
3.7%
22/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Investigations
CD4 lymphocytes decreased
|
0.99%
2/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
5.3%
23/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
5.6%
9/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
5.4%
32/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Investigations
CD8 lymphocytes decreased
|
2.0%
4/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
5.3%
23/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
4.3%
7/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
5.0%
30/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Investigations
Lymphocyte count decreased
|
2.5%
5/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
4.1%
18/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
6.8%
11/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
4.9%
29/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Investigations
Platelet count decreased
|
5.9%
12/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
3.7%
16/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.62%
1/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
2.9%
17/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Investigations
T-lymphocyte count decreased
|
2.5%
5/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
3.7%
16/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
6.2%
10/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
4.4%
26/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.4%
25/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
13.1%
57/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
16.1%
26/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
13.9%
83/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.9%
18/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
12.0%
52/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
18.6%
30/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
13.8%
82/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.4%
15/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
6.4%
28/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
7.5%
12/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
6.7%
40/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.9%
14/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
6.7%
29/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
9.3%
15/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
7.4%
44/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.4%
13/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
7.8%
34/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
14.9%
24/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
9.7%
58/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.9%
20/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
14.9%
65/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
16.1%
26/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
15.3%
91/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Nervous system disorders
Dizziness
|
5.4%
11/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
11.0%
48/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
16.1%
26/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
12.4%
74/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Nervous system disorders
Dysgeusia
|
4.0%
8/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
6.7%
29/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
8.7%
14/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
7.2%
43/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Nervous system disorders
Headache
|
17.3%
35/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
52.9%
230/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
62.7%
101/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
55.5%
331/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Nervous system disorders
Hypoaesthesia
|
7.9%
16/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
8.0%
35/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
11.8%
19/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
9.1%
54/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Nervous system disorders
Migraine
|
5.4%
11/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
2.5%
11/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
3.7%
6/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
2.9%
17/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Nervous system disorders
Multiple sclerosis relapse
|
41.6%
84/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
27.4%
119/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
31.7%
51/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
28.5%
170/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Nervous system disorders
Paraesthesia
|
9.9%
20/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
11.5%
50/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
11.2%
18/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
11.4%
68/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Nervous system disorders
Tremor
|
1.5%
3/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
3.2%
14/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
6.2%
10/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
4.0%
24/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Psychiatric disorders
Anxiety
|
6.9%
14/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
7.1%
31/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
9.9%
16/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
7.9%
47/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Psychiatric disorders
Depression
|
12.4%
25/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
6.7%
29/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
9.9%
16/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
7.6%
45/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Psychiatric disorders
Insomnia
|
13.9%
28/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
15.9%
69/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
19.9%
32/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
16.9%
101/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.0%
6/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
8.0%
35/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
13.7%
22/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
9.6%
57/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.50%
1/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
8.5%
37/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
16.8%
27/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
10.7%
64/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.5%
3/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
5.3%
23/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
4.3%
7/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
5.0%
30/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
10/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
10.8%
47/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
14.9%
24/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
11.9%
71/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.99%
2/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
0.92%
4/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
5.6%
9/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
2.2%
13/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.5%
5/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
2.8%
12/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
6.2%
10/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
3.7%
22/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.5%
3/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
5.3%
23/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
7.5%
12/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
5.9%
35/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.5%
5/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
15.2%
66/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
21.7%
35/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
16.9%
101/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.4%
11/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
44.4%
193/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
59.0%
95/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
48.3%
288/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.99%
2/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
7.6%
33/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
9.9%
16/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
8.2%
49/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
2.1%
9/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
6.8%
11/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
3.4%
20/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.99%
2/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
17.0%
74/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
26.1%
42/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
19.5%
116/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
|
Vascular disorders
Flushing
|
3.5%
7/202 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
7.8%
34/435 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
9.9%
16/161 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
8.4%
50/596 • First dose of study drug up to 2 years
If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI can publish after sponsor published, after a defined period of time after study completion, and/or with written Sponsor approval. Generally PI gives sponsor a draft 60 days before publication. Sponsor can ask that confidential information can be removed, and can further defer publication upon notifying PI that it will file a patent application on inventions contained in the draft.
- Publication restrictions are in place
Restriction type: OTHER