Trial Outcomes & Findings for Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study One (NCT NCT00530348)
NCT ID: NCT00530348
Last Updated: 2014-11-24
Results Overview
EDSS is an ordinal scale in half-point increments that quantifies 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 next 2 scheduled assessments, that is, 6 consecutive months. 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
581 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2014-11-24
Participant Flow
Participants were screened at 101 investigational sites in Argentina, Australia, Brazil, Canada, Croatia, the Czech Republic, France, Germany, Mexico, Poland, Russia, Serbia, Sweden, Ukraine, the United Kingdom (UK), and the United States (US) between August 28, 2007 and April 27, 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
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.
|
|---|---|---|
|
Overall Study
STARTED
|
195
|
386
|
|
Overall Study
Treated
|
187
|
376
|
|
Overall Study
COMPLETED
|
173
|
367
|
|
Overall Study
NOT COMPLETED
|
22
|
19
|
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
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
1
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Physician Decision
|
1
|
2
|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
12
|
12
|
|
Overall Study
Randomised in error
|
1
|
0
|
|
Overall Study
Noncompliance with inclusion criterion 3
|
0
|
1
|
Baseline Characteristics
Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study One
Baseline characteristics by cohort
| Measure |
Interferon Beta-1a
n=187 Participants
Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
|
Alemtuzumab
n=376 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.
|
Total
n=563 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.2 years
STANDARD_DEVIATION 8.48 • n=5 Participants
|
33.0 years
STANDARD_DEVIATION 8.03 • n=7 Participants
|
33.1 years
STANDARD_DEVIATION 8.18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
122 Participants
n=5 Participants
|
243 Participants
n=7 Participants
|
365 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
198 Participants
n=5 Participants
|
|
Time Since First Relapse
|
2.0 years
STANDARD_DEVIATION 1.32 • n=5 Participants
|
2.1 years
STANDARD_DEVIATION 1.36 • n=7 Participants
|
2.1 years
STANDARD_DEVIATION 1.35 • n=5 Participants
|
|
Number of Relapse Episodes in the Preceding 2 Years
1 Relapse
|
3 participants
n=5 Participants
|
12 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Number of Relapse Episodes in the Preceding 2 Years
2 Relapses
|
118 participants
n=5 Participants
|
215 participants
n=7 Participants
|
333 participants
n=5 Participants
|
|
Number of Relapse Episodes in the Preceding 2 Years
Greater than or equal to 3 Relapses
|
66 participants
n=5 Participants
|
149 participants
n=7 Participants
|
215 participants
n=5 Participants
|
|
Expanded Disability Status Scale (EDSS) Score
|
2.0 units on a scale
STANDARD_DEVIATION 0.79 • n=5 Participants
|
2.0 units on a scale
STANDARD_DEVIATION 0.81 • n=7 Participants
|
2.0 units on a scale
STANDARD_DEVIATION 0.81 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: FAS population included all randomized participants who received at least 1 dose of study drug.
EDSS is an ordinal scale in half-point increments that quantifies 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 next 2 scheduled assessments, that is, 6 consecutive months. 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=187 Participants
Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
|
Alemtuzumab
n=376 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)
|
11.12 percentage of participants with SAD
Interval 7.32 to 16.71
|
8.00 percentage of participants with SAD
Interval 5.66 to 11.24
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: FAS population included all randomized participants who received at least 1 dose of study drug.
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=187 Participants
Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
|
Alemtuzumab
n=376 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
|
0.39 relapses per participant per year
Interval 0.29 to 0.53
|
0.18 relapses per participant per year
Interval 0.13 to 0.23
|
SECONDARY outcome
Timeframe: Year 2Population: FAS population included all randomized participants who received at least 1 dose of study drug.
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=187 Participants
Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
|
Alemtuzumab
n=376 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
|
58.69 percentage of participants
Interval 51.12 to 65.5
|
77.59 percentage of participants
Interval 72.87 to 81.6
|
SECONDARY outcome
Timeframe: Baseline, Year 2Population: FAS population included all randomized participants who received at least 1 dose of study drug. Here, number of participants analyzed was subset of FAS who had EDSS assessment at both Baseline and end-of-study (Year 2).
EDSS is an ordinal scale in half-point increments that quantifies disability in participants with 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=173 Participants
Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
|
Alemtuzumab
n=366 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
|
-0.2 units on a scale
Standard Deviation 1.05 • Interval -0.29 to 0.01
|
-0.2 units on a scale
Standard Deviation 0.87 • Interval -0.25 to -0.02
|
SECONDARY outcome
Timeframe: Baseline, Year 2Population: FAS population included all randomized participants who received at least 1 dose of study drug. 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).
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=186 Participants
Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
|
Alemtuzumab
n=375 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=186, 375)
|
0.05 Z-score
Standard Deviation 0.629
|
-0.02 Z-score
Standard Deviation 0.695
|
|
Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score at Year 2
Change at Year 2 (n=172, 362)
|
0.07 Z-score
Standard Deviation 0.450
|
0.15 Z-score
Standard Deviation 0.516
|
SECONDARY outcome
Timeframe: Baseline, Year 2Population: FAS population included all randomized participants who received at least 1 dose of study drug. Here, number of participants analyzed was subset of FAS who had assessment for T2 volume at both Baseline and end-of-study (Year 2).
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=177 Participants
Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
|
Alemtuzumab
n=364 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
|
-6.68 percent change
Standard Deviation 32.44 • Interval -20.7 to 2.5
|
-10.28 percent change
Standard Deviation 22.58 • Interval -19.6 to -0.2
|
Adverse Events
Interferon Beta-1a
Serious events: 27 serious events
Other events: 168 other events
Deaths: 0 deaths
Alemtuzumab
Serious events: 69 serious events
Other events: 360 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Interferon Beta-1a
n=187 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
n=376 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.
|
|---|---|---|
|
Metabolism and nutrition disorders
Feeding disorder neonatal
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.53%
2/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Blood and lymphatic system disorders
Autoimmune thrombocytopenia
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.80%
3/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.53%
2/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.53%
2/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Endocrine disorders
Basedow's disease
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.53%
2/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Endocrine disorders
Goitre
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Endocrine disorders
Thyrotoxic crisis
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.53%
1/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.00%
0/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Malocclusion
|
0.53%
1/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.00%
0/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.53%
1/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.00%
0/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
General disorders
Chest discomfort
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.53%
1/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.00%
0/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.53%
1/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.00%
0/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Infections and infestations
Appendicitis
|
0.53%
1/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.53%
2/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Infections and infestations
Disseminated tuberculosis
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Infections and infestations
Hepatitis A
|
0.53%
1/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.00%
0/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Infections and infestations
Meningitis herpes
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Infections and infestations
Uterine infection
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.53%
1/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.00%
0/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.53%
2/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.53%
1/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.00%
0/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.53%
1/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.00%
0/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.53%
1/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.00%
0/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
Incorrect dose administered
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.53%
2/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.53%
1/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.00%
0/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Investigations
Thyroxine free increased
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Investigations
Tri-iodothyronine free increased
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.53%
1/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.00%
0/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder papilloma
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.53%
2/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Nervous system disorders
Brain stem syndrome
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.53%
2/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Nervous system disorders
Migraine
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Nervous system disorders
Multiple sclerosis
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Nervous system disorders
Multiple sclerosis relapse
|
7.0%
13/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
5.1%
19/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.53%
2/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Psychiatric disorders
Mood altered
|
0.53%
1/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.00%
0/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.53%
2/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Reproductive system and breast disorders
Ovarian haemorrhage
|
0.53%
1/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.00%
0/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.53%
1/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.00%
0/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Increased tendency to bruise
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.53%
2/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Social circumstances
Physical assault
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.53%
2/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
Other adverse events
| Measure |
Interferon Beta-1a
n=187 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
n=376 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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.9%
11/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
2.1%
8/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.3%
10/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
2.9%
11/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
4.3%
8/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
6.9%
26/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.4%
12/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
1.9%
7/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Cardiac disorders
Tachycardia
|
1.6%
3/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
9.0%
34/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.7%
5/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
5.6%
21/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
5.9%
22/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.2%
6/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
9.6%
36/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.3%
8/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
8.8%
33/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Nausea
|
7.5%
14/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
17.3%
65/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
4/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
11.2%
42/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
General disorders
Chest discomfort
|
3.2%
6/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
6.6%
25/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
General disorders
Chills
|
1.6%
3/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
10.1%
38/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
General disorders
Fatigue
|
12.3%
23/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
18.1%
68/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
General disorders
Influenza like illness
|
31.6%
59/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
5.1%
19/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
General disorders
Injection site erythema
|
29.9%
56/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.00%
0/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
General disorders
Injection site haematoma
|
6.4%
12/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.27%
1/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
General disorders
Injection site pain
|
5.3%
10/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.00%
0/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
General disorders
Injection site reaction
|
7.5%
14/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.00%
0/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
General disorders
Pain
|
2.7%
5/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
6.1%
23/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
General disorders
Pyrexia
|
9.6%
18/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
36.7%
138/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Infections and infestations
Bronchitis
|
2.1%
4/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
6.1%
23/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Infections and infestations
Influenza
|
5.9%
11/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
7.4%
28/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
13.4%
25/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
19.7%
74/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Infections and infestations
Oral herpes
|
1.1%
2/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
10.6%
40/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Infections and infestations
Rhinitis
|
3.2%
6/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
5.3%
20/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Infections and infestations
Sinusitis
|
4.8%
9/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
8.0%
30/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
13.4%
25/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
15.2%
57/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Infections and infestations
Urinary tract infection
|
4.3%
8/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
17.0%
64/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.9%
11/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
10.1%
38/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
10.2%
19/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.53%
2/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
9.1%
17/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
0.80%
3/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Investigations
B-lymphocyte count decreased
|
0.00%
0/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
5.1%
19/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Investigations
Blood urine present
|
3.2%
6/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
5.3%
20/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Investigations
CD4 lymphocytes decreased
|
2.1%
4/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
6.9%
26/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Investigations
CD8 lymphocytes decreased
|
2.7%
5/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
6.9%
26/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Investigations
T-lymphocyte count decreased
|
2.7%
5/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
5.9%
22/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
10/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
10.9%
41/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.0%
13/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
12.8%
48/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.2%
6/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
5.3%
20/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.9%
11/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
7.7%
29/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.1%
2/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
5.6%
21/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.0%
15/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
9.3%
35/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Nervous system disorders
Dizziness
|
4.3%
8/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
8.8%
33/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Nervous system disorders
Dysgeusia
|
10.2%
19/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
10.4%
39/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Nervous system disorders
Headache
|
27.8%
52/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
50.3%
189/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
10.2%
19/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
7.4%
28/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Nervous system disorders
Migraine
|
5.9%
11/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
4.0%
15/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Nervous system disorders
Multiple sclerosis relapse
|
34.2%
64/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
17.3%
65/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Nervous system disorders
Paraesthesia
|
7.0%
13/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
8.5%
32/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Psychiatric disorders
Anxiety
|
5.3%
10/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
6.4%
24/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Psychiatric disorders
Depression
|
7.5%
14/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
7.4%
28/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Psychiatric disorders
Insomnia
|
16.6%
31/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
14.9%
56/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Reproductive system and breast disorders
Menorrhagia
|
1.1%
2/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
6.4%
24/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
10/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
10.4%
39/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.1%
4/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
8.5%
32/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.9%
11/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
11.2%
42/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.2%
6/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
5.3%
20/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.6%
3/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
13.8%
52/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.8%
9/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
46.3%
174/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
1.1%
2/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
7.4%
28/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.7%
5/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
13.3%
50/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
|
Vascular disorders
Flushing
|
5.3%
10/187 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
11.7%
44/376 • First dose of study drug up to 2 years
If a participant experienced both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
|
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 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