Trial Outcomes & Findings for Exploring the Immune Response to SARS-CoV-2 COVID-19 Vaccines in Patients With Relapsing Multiple Sclerosis (RMS) Treated With Ofatumumab (NCT NCT04869358)
NCT ID: NCT04869358
Last Updated: 2025-05-16
Results Overview
Participants who established SARS-CoV-2-specific T cells as defined by detection of SARS-CoV-2 reactive T-cells, measured by e.g. ELIspot assay from T-cells that were stimulated with SARS-CoV-2 peptide mix, either 1 month after second dose of vaccine or 1 month after booster vaccine in participants who received the respective vaccine before or after starting ofatumumab treatment.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
34 participants
Primary outcome timeframe
1 month after second dose of vaccine or booster vaccine
Results posted on
2025-05-16
Participant Flow
Thirty-seven participants were screened and 34 participants met the criteria for entry into the trial.
Participant milestones
| Measure |
Cohort 1a
Patients received first SARS-CoV-2 vaccination within the study prior to starting ofatumumab treatment.
|
Cohort 1b
Patients had already completed initial vaccination cycle and received a booster vaccine within the study prior to starting ofatumumab treatment.
|
Cohort 2a
Patients who received their first SARS-CoV-2 vaccination within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose).
|
Cohort 2b
Patients who had already completed their initial vaccination cycle and received a booster vaccine within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
8
|
5
|
15
|
|
Overall Study
COMPLETED
|
5
|
8
|
5
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1a
Patients received first SARS-CoV-2 vaccination within the study prior to starting ofatumumab treatment.
|
Cohort 1b
Patients had already completed initial vaccination cycle and received a booster vaccine within the study prior to starting ofatumumab treatment.
|
Cohort 2a
Patients who received their first SARS-CoV-2 vaccination within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose).
|
Cohort 2b
Patients who had already completed their initial vaccination cycle and received a booster vaccine within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose).
|
|---|---|---|---|---|
|
Overall Study
Wish to have children.
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Exploring the Immune Response to SARS-CoV-2 COVID-19 Vaccines in Patients With Relapsing Multiple Sclerosis (RMS) Treated With Ofatumumab
Baseline characteristics by cohort
| Measure |
Cohort 1a
n=6 Participants
Patients received first SARS-CoV-2 vaccination within the study prior to starting ofatumumab treatment.
|
Cohort 1b
n=8 Participants
Patients had already completed initial vaccination cycle and received a booster vaccine within the study prior to starting ofatumumab treatment.
|
Cohort 2a
n=5 Participants
Patients who received their first SARS-CoV-2 vaccination within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose).
|
Cohort 2b
n=15 Participants
Patients who had already completed their initial vaccination cycle and received a booster vaccine within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose).
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
32.5 years
STANDARD_DEVIATION 8.1 • n=99 Participants
|
47.1 years
STANDARD_DEVIATION 14.1 • n=107 Participants
|
32.4 years
STANDARD_DEVIATION 7.7 • n=206 Participants
|
45.5 years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
41.6 years
STANDARD_DEVIATION 12.9 • n=31 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
32 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 1 month after second dose of vaccine or booster vaccinePopulation: Efficacy and safety analysis sets
Participants who established SARS-CoV-2-specific T cells as defined by detection of SARS-CoV-2 reactive T-cells, measured by e.g. ELIspot assay from T-cells that were stimulated with SARS-CoV-2 peptide mix, either 1 month after second dose of vaccine or 1 month after booster vaccine in participants who received the respective vaccine before or after starting ofatumumab treatment.
Outcome measures
| Measure |
Cohort 1a
n=5 Participants
Patients received first SARS-CoV-2 vaccination within the study prior to starting ofatumumab treatment.
|
Cohort 1b
n=8 Participants
Patients had already completed initial vaccination cycle and received a booster vaccine within the study prior to starting ofatumumab treatment.
|
Cohort 2a
n=4 Participants
Patients who received their first SARS-CoV-2 vaccination within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose).
|
Cohort 2b
n=15 Participants
Patients who had already completed their initial vaccination cycle and received a booster vaccine within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose).
|
Total
n=32 Participants
All cohorts
|
|---|---|---|---|---|---|
|
Percentage of Participants Having Established SARS-CoV-2-specific T Cells After Receiving a modRNA Vaccine
|
80.0 percentage of participants
Interval 28.4 to 99.5
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
100.0 percentage of participants
Interval 39.8 to 100.0
|
46.7 percentage of participants
Interval 21.3 to 73.4
|
68.8 percentage of participants
Interval 50.0 to 83.9
|
SECONDARY outcome
Timeframe: At Week 1, Months 6, 12 and 18 after second dose of vaccine or 1 Month after 1st booster, 1 Month after 2nd boosterPopulation: Efficacy and safety analysis sets
Participants who maintained detectable SARS-CoV-2 reactive T-cells (measured by e.g. ELIspot assay from T-cells that were stimulated with SARS-CoV-2 peptide mix) after second dose of vaccine or 6 and 12 months after booster vaccine in participants who received the vaccine before or after starting ofatumumab treatment. First booster vaccination was optional for cohorts 1a and 2a. In cohorts 1b and 2b the time points "Month 1 after Vacc" and "1 Month after booster" are identical.
Outcome measures
| Measure |
Cohort 1a
n=6 Participants
Patients received first SARS-CoV-2 vaccination within the study prior to starting ofatumumab treatment.
|
Cohort 1b
n=8 Participants
Patients had already completed initial vaccination cycle and received a booster vaccine within the study prior to starting ofatumumab treatment.
|
Cohort 2a
n=5 Participants
Patients who received their first SARS-CoV-2 vaccination within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose).
|
Cohort 2b
n=15 Participants
Patients who had already completed their initial vaccination cycle and received a booster vaccine within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose).
|
Total
n=34 Participants
All cohorts
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine
Week 1 after vacc n=4,0,5,0,9
|
100.0 percentage of participants
Interval 39.8 to 100.0
|
—
|
100.0 percentage of participants
Interval 47.8 to 100.0
|
—
|
100.0 percentage of participants
Interval 66.4 to 100.0
|
|
Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine
Month 6 after vacc n=4,8,5,14,31
|
100 percentage of participants
Interval 39.8 to 100.0
|
62.5 percentage of participants
Interval 24.5 to 91.5
|
60.0 percentage of participants
Interval 14.7 to 94.7
|
57.1 percentage of participants
Interval 28.9 to 82.3
|
64.5 percentage of participants
Interval 45.4 to 80.8
|
|
Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine
Month 12 after vacc n=5,5,5,15,30
|
100.0 percentage of participants
Interval 47.8 to 100.0
|
100.0 percentage of participants
Interval 47.8 to 100.0
|
80.0 percentage of participants
Interval 28.4 to 99.5
|
93.3 percentage of participants
Interval 68.1 to 99.8
|
93.3 percentage of participants
Interval 77.9 to 99.2
|
|
Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine
Month 18 after vacc n=4,0,4,0,8
|
50.0 percentage of participants
Interval 6.76 to 93.2
|
—
|
100.0 percentage of participants
Interval 39.8 to 100.0
|
—
|
93.3 percentage of participants
Interval 77.9 to 99.2
|
|
Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine
Month 1 after 1st booster n=4,8,3,15,30
|
75.0 percentage of participants
Interval 19.4 to 99.4
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
66.7 percentage of participants
Interval 9.43 to 99.2
|
46.7 percentage of participants
Interval 21.3 to 73.4
|
63.3 percentage of participants
Interval 43.9 to 80.1
|
|
Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine
Month 1 after 2nd booster n=2,4,0,10,16
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
75.0 percentage of participants
Interval 19.4 to 99.4
|
—
|
80.0 percentage of participants
Interval 44.4 to 97.5
|
81.3 percentage of participants
Interval 54.4 to 96.0
|
SECONDARY outcome
Timeframe: Last value before booster to 1 month after boosterPopulation: All patients in the efficacy analysis set, for whom ELISpot data for the time points "last visit before booster" and "month 1 after booster" were available, were included in the analysis.
Patients having established SARS-CoV-2-specific T cells as defined by detection of SARS-CoV-2 reactive T-cells, measured by e.g. ELIspot assay from T-cells that were stimulated with SARS-CoV-2 peptide mix 1 month after booster vaccine in participants who received the respective vaccine before or after starting ofatumumab treatment. The fold change of SI from last value before booster to Month 1 is the ratio of SI at Month 1 divided by SI at last value before booster.
Outcome measures
| Measure |
Cohort 1a
n=4 Participants
Patients received first SARS-CoV-2 vaccination within the study prior to starting ofatumumab treatment.
|
Cohort 1b
n=7 Participants
Patients had already completed initial vaccination cycle and received a booster vaccine within the study prior to starting ofatumumab treatment.
|
Cohort 2a
n=3 Participants
Patients who received their first SARS-CoV-2 vaccination within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose).
|
Cohort 2b
n=14 Participants
Patients who had already completed their initial vaccination cycle and received a booster vaccine within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose).
|
Total
n=28 Participants
All cohorts
|
|---|---|---|---|---|---|
|
Increase in Specific T-cells After Receiving an modRNA Booster Vaccine
|
0.8 fold change
Standard Deviation 0.9
|
12.6 fold change
Standard Deviation 25.5
|
2.0 fold change
Standard Deviation 2.1
|
3.6 fold change
Standard Deviation 4.4
|
5.3 fold change
Standard Deviation 13.2
|
SECONDARY outcome
Timeframe: Baseline, Week 1 after Vacc, Month 1, 6, 12 after Vacc, 1 month after 1st booster, 1 month after 2nd boosterPopulation: Efficacy analysis set
Level of SARS-CoV-2 serum functional antibodies were measured by a central laboratory using a neutralizing antibody detection kit.
Outcome measures
| Measure |
Cohort 1a
n=6 Participants
Patients received first SARS-CoV-2 vaccination within the study prior to starting ofatumumab treatment.
|
Cohort 1b
n=8 Participants
Patients had already completed initial vaccination cycle and received a booster vaccine within the study prior to starting ofatumumab treatment.
|
Cohort 2a
n=5 Participants
Patients who received their first SARS-CoV-2 vaccination within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose).
|
Cohort 2b
n=15 Participants
Patients who had already completed their initial vaccination cycle and received a booster vaccine within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose).
|
Total
All cohorts
|
|---|---|---|---|---|---|
|
Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS)
Baseline0 positive n=6,8, 5,14
|
0 percentage of participants
Interval 0.0 to 45.9
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
0 percentage of participants
Interval 0.0 to 52.2
|
71.4 percentage of participants
Interval 41.9 to 91.6
|
—
|
|
Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS)
Week 1 after Vacc positive n=5,0,5,0
|
100.0 percentage of participants
Interval 47.8 to 100.0
|
—
|
40.0 percentage of participants
Interval 5.27 to 85.3
|
—
|
—
|
|
Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS)
Month 1 after Vacc positive n=5,8,4,15
|
100.0 percentage of participants
Interval 47.8 to 100.0
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
25.0 percentage of participants
Interval 0.63 to 80.6
|
93.3 percentage of participants
Interval 68.1 to 99.8
|
—
|
|
Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS)
Month 6 after Vacc positive n=5,8,5,15
|
100.0 percentage of participants
Interval 47.8 to 100.0
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
40.0 percentage of participants
Interval 5.3 to 85.3
|
73.3 percentage of participants
Interval 44.9 to 92.2
|
—
|
|
Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS)
Month 12 after Vacc positive n=5,7,5,14
|
100.0 percentage of participants
Interval 47.8 to 100.0
|
100.0 percentage of participants
Interval 59.0 to 100.0
|
40.0 percentage of participants
Interval 5.3 to 85.3
|
92.9 percentage of participants
Interval 66.1 to 99.8
|
—
|
|
Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS)
Month 1 after 1st booster postive n=5,8,5,15
|
100.0 percentage of participants
Interval 47.8 to 100.0
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
66.7 percentage of participants
Interval 9.4 to 99.2
|
93.3 percentage of participants
Interval 68.1 to 99.8
|
—
|
|
Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS)
Month 1 after 2nd booster positive n=2,4,0,10
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 39.8 to 100.0
|
—
|
90.0 percentage of participants
Interval 55.5 to 99.7
|
—
|
SECONDARY outcome
Timeframe: Baseline, Months 1 ,6, 12 and 18 after vaccinationse of vaccine or 1,6 and 12 months after booster vaccinePopulation: Full analysis set -available participant data varied across time points. In alignment with the secondary study objectives of the protocol and the corresponding statistical analysis plan, the phenotypical parameters were assessed by cohort. Therefore, participants in the subcohorts 1a/1b and 2a/2b were combined.
Phenotypic description of the cellular immune response was performed at the central laboratory. T-cells were stimulated with SARS-CoV-2 peptide mix and analyzed for IFNg- and IL4 secretion using FACS analysis.
Outcome measures
| Measure |
Cohort 1a
n=14 Participants
Patients received first SARS-CoV-2 vaccination within the study prior to starting ofatumumab treatment.
|
Cohort 1b
n=20 Participants
Patients had already completed initial vaccination cycle and received a booster vaccine within the study prior to starting ofatumumab treatment.
|
Cohort 2a
Patients who received their first SARS-CoV-2 vaccination within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose).
|
Cohort 2b
Patients who had already completed their initial vaccination cycle and received a booster vaccine within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose).
|
Total
All cohorts
|
|---|---|---|---|---|---|
|
SARS-CoV-2 Specific CD4+ Effector Memory T-cells
BL before initial Vacc IL4 basal n=4,5
|
2.458 % of CD4+/CD8+ cells
Standard Deviation 4.915
|
0.262 % of CD4+/CD8+ cells
Standard Deviation 05.86
|
—
|
—
|
—
|
|
SARS-CoV-2 Specific CD4+ Effector Memory T-cells
BL before initial Vacc IL4 stim.n=4,5
|
2.583 % of CD4+/CD8+ cells
Standard Deviation 5.165
|
0.264 % of CD4+/CD8+ cells
Standard Deviation 0.59
|
—
|
—
|
—
|
|
SARS-CoV-2 Specific CD4+ Effector Memory T-cells
BL before initial Vacc INFg basal n=4,5
|
0.555 % of CD4+/CD8+ cells
Standard Deviation 0.549
|
0.03 % of CD4+/CD8+ cells
Standard Deviation 0.067
|
—
|
—
|
—
|
|
SARS-CoV-2 Specific CD4+ Effector Memory T-cells
BL before initial Vacc INGg stim n=4,5
|
0.235 % of CD4+/CD8+ cells
Standard Deviation 0.191
|
0.146 % of CD4+/CD8+ cells
Standard Deviation 0.326
|
—
|
—
|
—
|
|
SARS-CoV-2 Specific CD4+ Effector Memory T-cells
Month 1 after Vacc Il4 basal n=12,19
|
0.396 % of CD4+/CD8+ cells
Standard Deviation 2.318
|
1.209 % of CD4+/CD8+ cells
Standard Deviation 6.919
|
—
|
—
|
—
|
|
SARS-CoV-2 Specific CD4+ Effector Memory T-cells
Month 1 after Vacc IL4 stim. n=12,19
|
0.719 % of CD4+/CD8+ cells
Standard Deviation 0.62
|
2.449 % of CD4+/CD8+ cells
Standard Deviation 0.283
|
—
|
—
|
—
|
|
SARS-CoV-2 Specific CD4+ Effector Memory T-cells
Month 1 after Vacc INFg basal n=12,19
|
0.258 % of CD4+/CD8+ cells
Standard Deviation 2.165
|
0.171 % of CD4+/CD8+ cells
Standard Deviation 0.917
|
—
|
—
|
—
|
|
SARS-CoV-2 Specific CD4+ Effector Memory T-cells
Month 1 after Vacc INFg stim. n=12,19
|
0.947 % of CD4+/CD8+ cells
Standard Deviation 2.165
|
0.381 % of CD4+/CD8+ cells
Standard Deviation 0.917
|
—
|
—
|
—
|
|
SARS-CoV-2 Specific CD4+ Effector Memory T-cells
Month 6 after Vacc Il4 basal n=12,20
|
0.662 % of CD4+/CD8+ cells
Standard Deviation 1.44
|
0.061 % of CD4+/CD8+ cells
Standard Deviation 0.273
|
—
|
—
|
—
|
|
SARS-CoV-2 Specific CD4+ Effector Memory T-cells
0Month 6 after Vacc IL4 stim.n=12,20
|
0.93 % of CD4+/CD8+ cells
Standard Deviation 2.043
|
0.44 % of CD4+/CD8+ cells
Standard Deviation 0.197
|
—
|
—
|
—
|
|
SARS-CoV-2 Specific CD4+ Effector Memory T-cells
Month 6 after Vacc INFg basal n=12,20
|
0.236 % of CD4+/CD8+ cells
Standard Deviation 0.344
|
0.123 % of CD4+/CD8+ cells
Standard Deviation 0.205
|
—
|
—
|
—
|
|
SARS-CoV-2 Specific CD4+ Effector Memory T-cells
Month 6 after Vacc INFg stim.n=12,20
|
0.305 % of CD4+/CD8+ cells
Standard Deviation 0.352
|
0.342 % of CD4+/CD8+ cells
Standard Deviation 0.644
|
—
|
—
|
—
|
|
SARS-CoV-2 Specific CD4+ Effector Memory T-cells
Month 12 after Vacc Il4 basal n=10,17
|
0.361 % of CD4+/CD8+ cells
Standard Deviation 1.142
|
1.078 % of CD4+/CD8+ cells
Standard Deviation 2.468
|
—
|
—
|
—
|
|
SARS-CoV-2 Specific CD4+ Effector Memory T-cells
Month 12 after Vacc IL4 stim.n=10,17
|
0.174 % of CD4+/CD8+ cells
Standard Deviation 0.55
|
1.031 % of CD4+/CD8+ cells
Standard Deviation 2.491
|
—
|
—
|
—
|
|
SARS-CoV-2 Specific CD4+ Effector Memory T-cells
Month 12 after Vacc INFg basal n=10,17
|
0.132 % of CD4+/CD8+ cells
Standard Deviation 0.192
|
0.226 % of CD4+/CD8+ cells
Standard Deviation 0.478
|
—
|
—
|
—
|
|
SARS-CoV-2 Specific CD4+ Effector Memory T-cells
Month12 after Vacc INFg stim. n=10,17
|
0.122 % of CD4+/CD8+ cells
Standard Deviation 0.26
|
0.757 % of CD4+/CD8+ cells
Standard Deviation 2.332
|
—
|
—
|
—
|
|
SARS-CoV-2 Specific CD4+ Effector Memory T-cells
Month 18 after Vacc IL4 basal n=4,5
|
2.368 % of CD4+/CD8+ cells
Standard Deviation 4.735
|
0.118 % of CD4+/CD8+ cells
Standard Deviation 0.264
|
—
|
—
|
—
|
|
SARS-CoV-2 Specific CD4+ Effector Memory T-cells
Month 18 after Vacc IL4 stim.l n=4,5
|
1.833 % of CD4+/CD8+ cells
Standard Deviation 3.665
|
0.176 % of CD4+/CD8+ cells
Standard Deviation 0.394
|
—
|
—
|
—
|
|
SARS-CoV-2 Specific CD4+ Effector Memory T-cells
Month 18 after Vacc INFg basal l n=4,5
|
0.148 % of CD4+/CD8+ cells
Standard Deviation 0.295
|
0.11 % of CD4+/CD8+ cells
Standard Deviation 0.246
|
—
|
—
|
—
|
|
SARS-CoV-2 Specific CD4+ Effector Memory T-cells
Month 18 after Vacc INFg stim.l n=4,5
|
0.138 % of CD4+/CD8+ cells
Standard Deviation 0.159
|
0.12 % of CD4+/CD8+ cells
Standard Deviation 0.268
|
—
|
—
|
—
|
Adverse Events
Cohort 1a
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 1b
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 2a
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 2b
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1a
n=6 participants at risk
Patients received first SARS-CoV-2 vaccination within the study prior to starting ofatumumab treatment.
|
Cohort 1b
n=8 participants at risk
Patients had already completed initial vaccination cycle and received a booster vaccine within the study prior to starting ofatumumab treatmen
|
Cohort 2a
n=5 participants at risk
Patients who received their first SARS-CoV-2 vaccination within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose).
|
Cohort 2b
n=15 participants at risk
Patients who had already completed their initial vaccination cycle and received a booster vaccine within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose)
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neurilemmoma benign
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Nervous system disorders
Multiple sclerosis relapse
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
Other adverse events
| Measure |
Cohort 1a
n=6 participants at risk
Patients received first SARS-CoV-2 vaccination within the study prior to starting ofatumumab treatment.
|
Cohort 1b
n=8 participants at risk
Patients had already completed initial vaccination cycle and received a booster vaccine within the study prior to starting ofatumumab treatmen
|
Cohort 2a
n=5 participants at risk
Patients who received their first SARS-CoV-2 vaccination within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose).
|
Cohort 2b
n=15 participants at risk
Patients who had already completed their initial vaccination cycle and received a booster vaccine within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose)
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
12.5%
1/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
12.5%
1/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
General disorders
Asthenia
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
General disorders
Chills
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
12.5%
1/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
General disorders
Fatigue
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
12.5%
1/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
General disorders
Gait disturbance
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
General disorders
Injection site pain
|
50.0%
3/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
General disorders
Injection site swelling
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
General disorders
Peripheral swelling
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
General disorders
Swelling face
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
General disorders
Vaccination site reaction
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Immune system disorders
Immune-mediated adverse reaction
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Infections and infestations
COVID-19
|
33.3%
2/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
25.0%
2/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
100.0%
5/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
60.0%
9/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
40.0%
2/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
20.0%
3/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Infections and infestations
Oral herpes
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
12.5%
1/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
12.5%
1/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
25.0%
2/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
13.3%
2/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
12.5%
1/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
12.5%
1/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
12.5%
1/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
12.5%
1/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
40.0%
2/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Nervous system disorders
Headache
|
50.0%
3/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
25.0%
2/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
80.0%
4/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
20.0%
3/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Nervous system disorders
Meralgia paraesthetica
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Nervous system disorders
Multiple sclerosis
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Nervous system disorders
Multiple sclerosis relapse
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
12.5%
1/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Nervous system disorders
Peripheral nerve lesion
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
12.5%
1/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Nervous system disorders
Sciatica
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
12.5%
1/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Psychiatric disorders
Adjustment disorder
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
12.5%
1/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
12.5%
1/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
12.5%
1/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
12.5%
1/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
16.7%
1/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
12.5%
1/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
12.5%
1/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
12.5%
1/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Vascular disorders
Flushing
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Vascular disorders
Haematoma
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
20.0%
1/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/8 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
0.00%
0/5 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
13.3%
2/15 • Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER