Trial Outcomes & Findings for Supplementation of VigantOL® Oil Versus Placebo as Add-on in Patients With Relapsing Remitting Multiple Sclerosis Receiving Rebif® Treatment (NCT NCT01285401)
NCT ID: NCT01285401
Last Updated: 2016-11-28
Results Overview
Disease activity free status was defined as absence of any of the clinical and imaging parameters related to the assessment of disease activity; no relapses, no expanded disability status scale (EDSS) progression and no new gadolinium (Gd)-enhancing or relaxation time 2 (T2) magnetic resonance imaging (MRI) lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
260 participants
Primary outcome timeframe
Up to Week 48
Results posted on
2016-11-28
Participant Flow
Total 260 subject were enrolled, out of which 232 subjects were randomized and started the study. 229 subjects were treated since 3 subjects of the 232 randomized subjects were excluded from analysis as they did not received any medication.
Participant milestones
| Measure |
VigantOL Oil Interferon Beta-1a (Rebif)
Subjects with 25-hydroxyvitamin D \[25(OH)D3\] serum levels below 150 nano mol per liter (nmol/L) received Vigantol oil 6,670 international unit per day (IU/d) \[167 microgram per day (mcg/d)\] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous three times a week (tiw).
|
Placebo Interferon Beta-1a (Rebif)
Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
|
|---|---|---|
|
Overall Study
STARTED
|
115
|
117
|
|
Overall Study
Treated
|
113
|
116
|
|
Overall Study
COMPLETED
|
98
|
88
|
|
Overall Study
NOT COMPLETED
|
17
|
29
|
Reasons for withdrawal
| Measure |
VigantOL Oil Interferon Beta-1a (Rebif)
Subjects with 25-hydroxyvitamin D \[25(OH)D3\] serum levels below 150 nano mol per liter (nmol/L) received Vigantol oil 6,670 international unit per day (IU/d) \[167 microgram per day (mcg/d)\] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous three times a week (tiw).
|
Placebo Interferon Beta-1a (Rebif)
Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
|
|---|---|---|
|
Overall Study
Prematurely withdrawn from the study
|
17
|
29
|
Baseline Characteristics
Supplementation of VigantOL® Oil Versus Placebo as Add-on in Patients With Relapsing Remitting Multiple Sclerosis Receiving Rebif® Treatment
Baseline characteristics by cohort
| Measure |
VigantOL Oil Interferon Beta-1a (Rebif)
n=115 Participants
Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d \[167 mcg/d\] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
|
Placebo Interferon Beta-1a (Rebif)
n=117 Participants
Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
|
Total
n=232 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.2 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
33.6 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
33.9 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Week 48Population: ITT set included all randomized subjects who received at least 1 dose of the IMP.
Disease activity free status was defined as absence of any of the clinical and imaging parameters related to the assessment of disease activity; no relapses, no expanded disability status scale (EDSS) progression and no new gadolinium (Gd)-enhancing or relaxation time 2 (T2) magnetic resonance imaging (MRI) lesions.
Outcome measures
| Measure |
VigantOL Oil Interferon Beta-1a (Rebif)
n=113 Participants
Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d \[167 mcg/d\] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
|
Placebo Interferon Beta-1a (Rebif)
n=116 Participants
Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
|
|---|---|---|
|
Percentage of Subjects With Disease Activity Free Status up to Week 48
|
37.2 percentage of subjects
|
35.3 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 48Population: ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.
A relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, lasting for 24 hours and with a previous period for more than 30 days with a stable or an improving condition.
Outcome measures
| Measure |
VigantOL Oil Interferon Beta-1a (Rebif)
n=113 Participants
Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d \[167 mcg/d\] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
|
Placebo Interferon Beta-1a (Rebif)
n=116 Participants
Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
|
|---|---|---|
|
Percentage of Relapse-free Subjects at Week 48
|
78.8 percentage of subjects
|
75.0 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 48Population: ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.
EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. A confirmed EDSS progression was defined EDSS greater than or equal to 1.0 point confirmed during a visit performed 6 months later. An EDSS progression was defined as an increase of the EDSS score of at least 1.0 point compared to baseline (SD1) for subjects with a baseline EDSS ≤ 4.0. For subjects with an EDSS score of 0 at baseline (SD1), EDSS progression was defined as an increase of at least 1.5 points. A confirmed EDSS progression was defined as an EDSS progression confirmed after 24 weeks.
Outcome measures
| Measure |
VigantOL Oil Interferon Beta-1a (Rebif)
n=113 Participants
Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d \[167 mcg/d\] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
|
Placebo Interferon Beta-1a (Rebif)
n=116 Participants
Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
|
|---|---|---|
|
Percentage of Subjects Free From Any Expanded Disability Status Scale (EDSS) Progression at Week 48
|
71.7 percentage of subjects
|
75.0 percentage of subjects
|
SECONDARY outcome
Timeframe: Baseline upto 48 WeeksPopulation: ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.
EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. A confirmed EDSS progression was defined EDSS greater than or equal to 1.0 point confirmed during a visit performed 6 months later. An EDSS progression was defined as an increase of the EDSS score of at least 1.0 point compared to baseline (SD1) for subjects with a baseline EDSS ≤ 4.0. For subjects with an EDSS score of 0 at baseline (SD1), EDSS progression was defined as an increase of at least 1.5 points. A confirmed EDSS progression was defined as an EDSS progression confirmed after 24 weeks.
Outcome measures
| Measure |
VigantOL Oil Interferon Beta-1a (Rebif)
n=113 Participants
Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d \[167 mcg/d\] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
|
Placebo Interferon Beta-1a (Rebif)
n=116 Participants
Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
|
|---|---|---|
|
Number od Subjects With Confirmed EDSS Progression
|
8 subjects
|
4 subjects
|
SECONDARY outcome
Timeframe: 48 WeeksPopulation: ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP. Here "N" signifies number of subject analyzed for respective outcome measure.
Outcome measures
| Measure |
VigantOL Oil Interferon Beta-1a (Rebif)
n=102 Participants
Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d \[167 mcg/d\] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
|
Placebo Interferon Beta-1a (Rebif)
n=92 Participants
Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
|
|---|---|---|
|
Cumulative Number of Relaxation Time 1 (T1) Gadolinium Enhancing Lesions at Week 48
|
0.36 lesions per subject per scan
Standard Deviation 1.73
|
0.25 lesions per subject per scan
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: 48 WeeksPopulation: ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.
CUA lesions was defined as new T1 (Gd enhancing) lesions, new Relaxation time 2 (T2) lesions, or enlarging T2 lesions.
Outcome measures
| Measure |
VigantOL Oil Interferon Beta-1a (Rebif)
n=113 Participants
Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d \[167 mcg/d\] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
|
Placebo Interferon Beta-1a (Rebif)
n=116 Participants
Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
|
|---|---|---|
|
Mean Number of Combined Unique Active (CUA) Lesions Per Subject Per Scan at Week 48
|
1.09 lesions per subject per scan
Standard Deviation 3.84
|
1.49 lesions per subject per scan
Standard Deviation 4.31
|
SECONDARY outcome
Timeframe: 48 WeeksPopulation: ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.
CUA lesions was defined as new T1 (Gd enhancing) lesions, new T2 lesions, or enlarging T2 lesions.
Outcome measures
| Measure |
VigantOL Oil Interferon Beta-1a (Rebif)
n=113 Participants
Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d \[167 mcg/d\] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
|
Placebo Interferon Beta-1a (Rebif)
n=116 Participants
Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
|
|---|---|---|
|
Cumulative Number of New Combined Unique Active (CUA) Lesions at Week 48
|
1.09 lesions per subject per scan
Standard Deviation 3.84
|
1.49 lesions per subject per scan
Standard Deviation 4.31
|
SECONDARY outcome
Timeframe: Baseline, 48 WeeksPopulation: ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP. Here "N" signifies number of subjects analyzed for respective outcome measure.
Outcome measures
| Measure |
VigantOL Oil Interferon Beta-1a (Rebif)
n=103 Participants
Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d \[167 mcg/d\] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
|
Placebo Interferon Beta-1a (Rebif)
n=92 Participants
Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
|
|---|---|---|
|
Mean Change From Baseline in the Total Volume of T2 Lesions at Week 48 (T2 Burden of Disease)
|
130.38 millimeter^3 (mm^3)
Standard Deviation 830.82
|
95.75 millimeter^3 (mm^3)
Standard Deviation 401.87
|
SECONDARY outcome
Timeframe: 48 WeeksPopulation: ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.
Outcome measures
| Measure |
VigantOL Oil Interferon Beta-1a (Rebif)
n=113 Participants
Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d \[167 mcg/d\] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
|
Placebo Interferon Beta-1a (Rebif)
n=116 Participants
Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
|
|---|---|---|
|
Percentage of Subjects Free From T1 Gadolinium Enhancing Lesions at Week 48
|
83.2 percentage of subjects
|
70.7 percentage of subjects
|
SECONDARY outcome
Timeframe: 48 WeeksPopulation: ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.
Outcome measures
| Measure |
VigantOL Oil Interferon Beta-1a (Rebif)
n=113 Participants
Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d \[167 mcg/d\] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
|
Placebo Interferon Beta-1a (Rebif)
n=116 Participants
Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
|
|---|---|---|
|
Percentage of Subjects Free From New T1 Hypointense Lesions (Black Holes) at Week 48
|
78.8 percentage of subjects
|
63.8 percentage of subjects
|
SECONDARY outcome
Timeframe: 48 WeeksPopulation: ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP. Here "N" signifies number of subjects analyzed for respective outcome measure (here in the subgroup of subjects having new or enlarging T2 lesions).
Outcome measures
| Measure |
VigantOL Oil Interferon Beta-1a (Rebif)
n=25 Participants
Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d \[167 mcg/d\] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
|
Placebo Interferon Beta-1a (Rebif)
n=36 Participants
Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
|
|---|---|---|
|
Percentage of New T1 Hypointense Lesions (Black Holes) at Week 48 Within the Subgroup of New or Enlarging Non-enhancing T2 Lesions
|
20.11 percentage of new T1 hypointense lesions
Standard Deviation 34.72
|
27.70 percentage of new T1 hypointense lesions
Standard Deviation 39.33
|
SECONDARY outcome
Timeframe: Baseline upto 48 weeksPopulation: ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.
Relapse was defined as neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both as neurological abnormality separated by at least 30 days from onset of a preceding MS attack and Neurological abnormality lasting for at least 24 hours, absence of fever or known infection greater than 37.5 degree centigrade /99.5 degree fahrenheit , objective neurological impairment, correlating with the subject's reported symptoms, defined as either increase in at least one of the functional systems of the EDSS or increase of the total EDSS score and occurrence of paraesthesia, fatigue, mental symptoms, and/or vegetative symptoms without any additional symptom will not be classified as an MS attack.
Outcome measures
| Measure |
VigantOL Oil Interferon Beta-1a (Rebif)
n=113 Participants
Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d \[167 mcg/d\] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
|
Placebo Interferon Beta-1a (Rebif)
n=116 Participants
Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
|
|---|---|---|
|
Number of Subjects With Relapse
|
24 subjects
|
29 subjects
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.
Relapse was defined as neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both as neurological abnormality separated by at least 30 days from onset of a preceding MS attack and Neurological abnormality lasting for at least 24 hours, absence of fever or known infection greater than 37.5 degree centigrade /99.5 degree fahrenheit , objective neurological impairment, correlating with the subject's reported symptoms, defined as either increase in at least one of the functional systems of the EDSS or increase of the total EDSS score and occurrence of paraesthesia, fatigue, mental symptoms, and/or vegetative symptoms without any additional symptom will not be classified as an MS attack.
Outcome measures
| Measure |
VigantOL Oil Interferon Beta-1a (Rebif)
n=113 Participants
Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d \[167 mcg/d\] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
|
Placebo Interferon Beta-1a (Rebif)
n=116 Participants
Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
|
|---|---|---|
|
Annualized Relapse Rate at Week 48
|
0.28 relapse per year
Standard Deviation 0.59
|
0.41 relapse per year
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.
Relapse was defined as neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both as neurological abnormality separated by at least 30 days from onset of a preceding MS attack and Neurological abnormality lasting for at least 24 hours, absence of fever or known infection greater than 37.5 degree centigrade /99.5 degree fahrenheit , objective neurological impairment, correlating with the subject's reported symptoms, defined as either increase in at least one of the functional systems of the EDSS or increase of the total EDSS score and occurrence of paraesthesia, fatigue, mental symptoms, and/or vegetative symptoms without any additional symptom will not be classified as an MS attack.
Outcome measures
| Measure |
VigantOL Oil Interferon Beta-1a (Rebif)
n=113 Participants
Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d \[167 mcg/d\] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
|
Placebo Interferon Beta-1a (Rebif)
n=116 Participants
Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
|
|---|---|---|
|
Total Number of Reported Relapses at All Time Points up to 48 Weeks
|
0.25 number of relapse per subject
Standard Deviation 0.53
|
0.34 number of relapse per subject
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: Baseline upto 48 weeksPopulation: ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.
Relapse was defined as neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both as neurological abnormality separated by at least 30 days from onset of a preceding MS attack and Neurological abnormality lasting for at least 24 hours, absence of fever or known infection greater than 37.5 degree centigrade /99.5 degree fahrenheit , objective neurological impairment, correlating with the subject's reported symptoms, defined as either increase in at least one of the functional systems of the EDSS or increase of the total EDSS score and occurrence of paraesthesia, fatigue, mental symptoms, and/or vegetative symptoms without any additional symptom will not be classified as an MS attack.
Outcome measures
| Measure |
VigantOL Oil Interferon Beta-1a (Rebif)
n=113 Participants
Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d \[167 mcg/d\] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
|
Placebo Interferon Beta-1a (Rebif)
n=116 Participants
Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
|
|---|---|---|
|
Percentage of Subjects Treated With Glucocorticoids Due to Relapses
|
15.9 percentage of subjects
|
20.7 percentage of subjects
|
SECONDARY outcome
Timeframe: Baseline, 48 WeeksPopulation: ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.
Outcome measures
| Measure |
VigantOL Oil Interferon Beta-1a (Rebif)
n=113 Participants
Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d \[167 mcg/d\] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
|
Placebo Interferon Beta-1a (Rebif)
n=116 Participants
Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
|
|---|---|---|
|
Mean Change From Baseline in the Total Volume of T1 Hypo Intense Lesions at Week 48
|
20.88 millimeter^3 (mm^3)
Standard Deviation 140.56
|
18.47 millimeter^3 (mm^3)
Standard Deviation 68.08
|
POST_HOC outcome
Timeframe: Week 48Population: ITT set included all randomized subjects who received at least 1 dose of the IMP.
Disease activity free (DAF) status was defined as absence of any of the clinical and imaging parameters related to the assessment of disease activity; no relapses, no confirmed expanded disability status scale (EDSS) progression and no new gadolinium (Gd)-enhancing or relaxation time 2 (T2) magnetic resonance imaging (MRI) lesions. Confirmed EDSS progression was defined as an EDSS progression confirmed after 24 weeks.
Outcome measures
| Measure |
VigantOL Oil Interferon Beta-1a (Rebif)
n=113 Participants
Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d \[167 mcg/d\] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
|
Placebo Interferon Beta-1a (Rebif)
n=116 Participants
Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
|
|---|---|---|
|
Percentage of Subjects With Disease Activity Free Status (Alternate Definition) at Week 48
|
47.8 percentage of subjects
|
37.9 percentage of subjects
|
Adverse Events
VigantOL Oil Interferon Beta-1a (Rebif)
Serious events: 18 serious events
Other events: 99 other events
Deaths: 0 deaths
Placebo Interferon Beta-1a (Rebif)
Serious events: 8 serious events
Other events: 93 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VigantOL Oil Interferon Beta-1a (Rebif)
n=113 participants at risk
Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d \[167 mcg/d\] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
|
Placebo Interferon Beta-1a (Rebif)
n=116 participants at risk
Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
|
|---|---|---|
|
Infections and infestations
Abscess limb
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Appendicitis
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Cellulitis
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Eye infection
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Pneumonia
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Pyelonephritis
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Psychiatric disorders
Depression
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Nervous system disorders
Headache
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Nervous system disorders
Syncope
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Cardiac disorders
Cardiac failure
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Vascular disorders
Hypertension
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Gastrointestinal disorders
Abdominal pain
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Injury, poisoning and procedural complications
Overdose
|
7.1%
8/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
5.2%
6/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
Other adverse events
| Measure |
VigantOL Oil Interferon Beta-1a (Rebif)
n=113 participants at risk
Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d \[167 mcg/d\] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
|
Placebo Interferon Beta-1a (Rebif)
n=116 participants at risk
Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.7%
3/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Blood and lymphatic system disorders
Haematotoxicity
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Cardiac disorders
Angina pectoris
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Cardiac disorders
Palpitations
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Cardiac disorders
Tachycardia
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Ear and labyrinth disorders
Tinnitus
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Ear and labyrinth disorders
Vertigo
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
1.7%
2/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Endocrine disorders
Hyperparathyroidism secondary
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Endocrine disorders
Hyperthyroidism
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Endocrine disorders
Hypothyroidism
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
2.6%
3/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Endocrine disorders
Thyroid disorder
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Eye disorders
Conjunctivitis
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
1.7%
2/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Eye disorders
Diplopia
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Eye disorders
Dry eye
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Eye disorders
Eye irritation
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Eye disorders
Eye pain
|
2.7%
3/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
2.6%
3/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Eye disorders
Glaucoma
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Eye disorders
Oscillopsia
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Eye disorders
Ulcerative keratitis
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Eye disorders
Vision blurred
|
2.7%
3/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
2.6%
3/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Eye disorders
Visual impairment
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
2.6%
3/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Gastrointestinal disorders
Abdominal pain
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
3.4%
4/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.0%
9/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
2.6%
3/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Gastrointestinal disorders
Constipation
|
5.3%
6/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
1.7%
2/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Gastrointestinal disorders
Diarrhoea
|
8.8%
10/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
6.0%
7/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Gastrointestinal disorders
Dyspepsia
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Gastrointestinal disorders
Flatulence
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Gastrointestinal disorders
Food poisoning
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Gastrointestinal disorders
Gingivitis
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Gastrointestinal disorders
Nausea
|
2.7%
3/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
3.4%
4/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Gastrointestinal disorders
Oral discomfort
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Gastrointestinal disorders
Toothache
|
2.7%
3/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
1.7%
2/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Gastrointestinal disorders
Vomiting
|
2.7%
3/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
3.4%
4/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Gastrointestinal disorders
Vomiting in pregnancy
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
General disorders
Asthenia
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
General disorders
Chest discomfort
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
General disorders
Chest pain
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
3.4%
4/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
General disorders
Chills
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
General disorders
Fatigue
|
7.1%
8/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
11.2%
13/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
General disorders
Feeling cold
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
General disorders
Gait disturbance
|
2.7%
3/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
1.7%
2/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
General disorders
Inflammation
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
General disorders
Influenza like illness
|
10.6%
12/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
11.2%
13/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
General disorders
Injection site erythema
|
3.5%
4/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
General disorders
Injection site induration
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
General disorders
Injection site inflammation
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
General disorders
Injection site irritation
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
General disorders
Injection site pain
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
1.7%
2/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
General disorders
Injection site pruritus
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
General disorders
Injection site reaction
|
4.4%
5/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
2.6%
3/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
General disorders
Injection site swelling
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
General disorders
Injection site urticaria
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
2.6%
3/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
General disorders
Irritability
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
General disorders
Malaise
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
General disorders
Oedema peripheral
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
General disorders
Pain
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
General disorders
Pyrexia
|
6.2%
7/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
10.3%
12/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
General disorders
Sensation of foreign body
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Immune system disorders
Multiple allergies
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Acute tonsillitis
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Bacterial infection
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Bronchitis
|
3.5%
4/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
1.7%
2/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Cystitis
|
2.7%
3/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
6.0%
7/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Ear infection
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Eye infection
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Eyelid infection
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Folliculitis
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Fungal infection
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Furuncle
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Gastric infection
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Gastroenteritis
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
4.3%
5/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Gastroenteritis viral
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Groin abscess
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Herpes simplex
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Herpes virus infection
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Impetigo
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Infected cyst
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Infection
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Influenza
|
11.5%
13/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
16.4%
19/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Injection site abscess
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Laryngitis
|
2.7%
3/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
1.7%
2/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Localised infection
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Nasopharyngitis
|
15.9%
18/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
14.7%
17/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Oral herpes
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Otitis media
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Pharyngitis
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
1.7%
2/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Pneumonia
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Pseudofolliculitis barbae
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Respiratory tract infection
|
3.5%
4/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
1.7%
2/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Rhinitis
|
4.4%
5/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Sinusitis
|
4.4%
5/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
3.4%
4/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Skin infection
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Tinea pedis
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Tonsillitis
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Tooth infection
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Upper respiratory tract infection
|
2.7%
3/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
3.4%
4/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Urinary tract infection
|
10.6%
12/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
5.2%
6/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Vaginal infection
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Vulvovaginal candidiasis
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Injury, poisoning and procedural complications
Concussion
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Injury, poisoning and procedural complications
Contusion
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Injury, poisoning and procedural complications
Fall
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Injury, poisoning and procedural complications
Joint injury
|
2.7%
3/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Injury, poisoning and procedural complications
Procedural headache
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Injury, poisoning and procedural complications
Tooth injury
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Injury, poisoning and procedural complications
Whiplash injury
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
1.7%
2/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Investigations
Alanine aminotransferase increased
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Investigations
Anti-thyroid antibody positive
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Investigations
Antibody test positive
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
1.7%
2/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Investigations
Blood creatine phosphokinase increased
|
2.7%
3/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Investigations
Blood creatinine decreased
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Investigations
Blood folate decreased
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Investigations
Blood glucose increased
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Infections and infestations
Blood iron decreased
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Investigations
Blood parathyroid hormone increased
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Investigations
Blood thyroid stimulating hormone abnormal
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Investigations
Creatine urine abnormal
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Investigations
Creatinine urine increased
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Investigations
Drug specific antibody present
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Investigations
Hepatic enzyme increased
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Investigations
Liver function test abnormal
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
1.7%
2/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Investigations
Platelet count decreased
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Investigations
Thyroid function test abnormal
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Investigations
Urine calcium
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Investigations
Urine calcium/creatinine ratio increased
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Investigations
Vitamin B12 decreased
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Investigations
Weight decreased
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Investigations
Weight increased
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Investigations
White blood cell count increased
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.5%
4/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
4.3%
5/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.8%
10/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
6.0%
7/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Musculoskeletal and connective tissue disorders
Growing pains
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.2%
7/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.7%
3/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
1.7%
2/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Musculoskeletal and connective tissue disorders
Myokymia
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.4%
5/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
2.6%
3/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
4.3%
5/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.5%
13/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
5.2%
6/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Musculoskeletal and connective tissue disorders
Rheumatic fever
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
1.7%
2/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipofibroma
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Morton's neuroma
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mycosis fungoides
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Nervous system disorders
Balance disorder
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Nervous system disorders
Burning sensation
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Nervous system disorders
Carotid artery stenosis
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
1.7%
2/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Nervous system disorders
Dizziness
|
4.4%
5/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
3.4%
4/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Nervous system disorders
Dystonia
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Nervous system disorders
Facial neuralgia
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Nervous system disorders
Headache
|
17.7%
20/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
18.1%
21/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Nervous system disorders
Hypoaesthesia
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
1.7%
2/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Nervous system disorders
Memory impairment
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Nervous system disorders
Meralgia paraesthetica
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Nervous system disorders
Migraine
|
5.3%
6/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
4.3%
5/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Nervous system disorders
Migraine with aura
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Nervous system disorders
Motor dysfunction
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Nervous system disorders
Multiple sclerosis relapse
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
1.7%
2/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Nervous system disorders
Neuralgia
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Nervous system disorders
Paraesthesia
|
4.4%
5/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
3.4%
4/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Nervous system disorders
Presyncope
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
2.6%
3/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Nervous system disorders
Sciatica
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Nervous system disorders
Sensory disturbance
|
3.5%
4/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
2.6%
3/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Nervous system disorders
Syncope
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Nervous system disorders
Tremor
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
1.7%
2/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
1.7%
2/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Psychiatric disorders
Anxiety
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
4.3%
5/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Psychiatric disorders
Anxiety disorder
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Psychiatric disorders
Delusional perception
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Psychiatric disorders
Depression
|
3.5%
4/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
1.7%
2/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Psychiatric disorders
Fear of needles
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Psychiatric disorders
Insomnia
|
3.5%
4/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
3.4%
4/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Psychiatric disorders
Loss of libido
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Psychiatric disorders
Mood swings
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
2.6%
3/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Psychiatric disorders
Sleep disorder
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
3.4%
4/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Psychiatric disorders
Stress
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Renal and urinary disorders
Bladder dysfunction
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Renal and urinary disorders
Dysuria
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
3.4%
4/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Renal and urinary disorders
Pollakiuria
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Renal and urinary disorders
Urinary incontinence
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Renal and urinary disorders
Urinary retention
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Renal and urinary disorders
Urinary tract pain
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Reproductive system and breast disorders
Premenstrual syndrome
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Reproductive system and breast disorders
Sexual dysfunction
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Reproductive system and breast disorders
Uterine enlargement
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
7/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
5.2%
6/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.2%
7/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
4.3%
5/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus mucosal hypertrophy
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hilum mass
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Skin and subcutaneous tissue disorders
Dermatitis psoriasiform
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Skin and subcutaneous tissue disorders
Pityriasis rosea
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.8%
2/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
3.4%
4/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Surgical and medical procedures
Endodontic procedure
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Surgical and medical procedures
Hospitalisation
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Surgical and medical procedures
Mammoplasty
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Surgical and medical procedures
Parotidectomy
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Surgical and medical procedures
Shoulder operation
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Surgical and medical procedures
Tooth extraction
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Surgical and medical procedures
Wisdom teeth removal
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Vascular disorders
Haematoma
|
0.88%
1/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.00%
0/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Vascular disorders
Hypertension
|
5.3%
6/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
3.4%
4/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/113 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
0.86%
1/116 • Baseline up to end of trial (EOT: 50 months)
Safety Analysis Set: All randomized subjects who received at least 1 dose of the IMP
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER