Trial Outcomes & Findings for Dose Ranging Study of Brentuximab Vedotin in Adults With Lupus (NCT NCT02533570)
NCT ID: NCT02533570
Last Updated: 2018-06-11
Results Overview
Any treatment-emergent adverse events (TEAEs), any drug-related TEAEs, any SAEs, treatment-related serious adverse events (SAE), deaths, adverse events (AEs) leading to study discontinuation, and number of patients experiencing Grade 1, 2, and 3 TEAEs.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Up to 127 days (9 weeks after final dose)
Results posted on
2018-06-11
Participant Flow
Participant milestones
| Measure |
Placebo
Intravenous (IV) placebo every 3 weeks for a total of 4 doses
|
Brentuximab Vedotin 0.3 mg/kg
Intravenous (IV) Brentuximab vedotin (0.3 mg/kg) every 3 weeks for a total of 4 doses
|
Brentuximab Vedotin 0.6 mg/kg
Intravenous (IV) Brentuximab vedotin (0.6 mg/kg) every 3 weeks for a total of 4 doses
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
8
|
8
|
|
Overall Study
COMPLETED
|
4
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Intravenous (IV) placebo every 3 weeks for a total of 4 doses
|
Brentuximab Vedotin 0.3 mg/kg
Intravenous (IV) Brentuximab vedotin (0.3 mg/kg) every 3 weeks for a total of 4 doses
|
Brentuximab Vedotin 0.6 mg/kg
Intravenous (IV) Brentuximab vedotin (0.6 mg/kg) every 3 weeks for a total of 4 doses
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
Baseline Characteristics
Dose Ranging Study of Brentuximab Vedotin in Adults With Lupus
Baseline characteristics by cohort
| Measure |
Placebo
n=4 Participants
Intravenous (IV) placebo every 3 weeks for a total of 4 doses
|
Brentuximab Vedotin 0.3 mg/kg
n=8 Participants
Intravenous (IV) Brentuximab vedotin (0.3 mg/kg) every 3 weeks for a total of 4 doses
|
Brentuximab Vedotin 0.6 mg/kg
n=8 Participants
Intravenous (IV) Brentuximab vedotin (0.6 mg/kg) every 3 weeks for a total of 4 doses
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.5 years
STANDARD_DEVIATION 8.66 • n=99 Participants
|
50.8 years
STANDARD_DEVIATION 14.06 • n=107 Participants
|
45.0 years
STANDARD_DEVIATION 11.20 • n=206 Participants
|
47.4 years
STANDARD_DEVIATION 11.78 • n=7 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Up to 127 days (9 weeks after final dose)Any treatment-emergent adverse events (TEAEs), any drug-related TEAEs, any SAEs, treatment-related serious adverse events (SAE), deaths, adverse events (AEs) leading to study discontinuation, and number of patients experiencing Grade 1, 2, and 3 TEAEs.
Outcome measures
| Measure |
Placebo
n=4 Participants
Intravenous (IV) placebo every 3 weeks for a total of 4 doses
|
Brentuximab Vedotin 0.3 mg/kg
n=8 Participants
Intravenous (IV) Brentuximab vedotin (0.3 mg/kg) every 3 weeks for a total of 4 doses
|
Brentuximab Vedotin 0.6 mg/kg
n=8 Participants
Intravenous (IV) Brentuximab vedotin (0.6 mg/kg) every 3 weeks for a total of 4 doses
|
|---|---|---|---|
|
Number and Percentage of Subjects Having an Adverse Event (AE)
Treatment-Emergent Adverse Event
|
3 Participants
|
6 Participants
|
8 Participants
|
|
Number and Percentage of Subjects Having an Adverse Event (AE)
Treatment-Related Adverse Event
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number and Percentage of Subjects Having an Adverse Event (AE)
Serious Adverse Event
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number and Percentage of Subjects Having an Adverse Event (AE)
Treatment-Related Serious Adverse Events
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Having an Adverse Event (AE)
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number and Percentage of Subjects Having an Adverse Event (AE)
Adverse Events Leading to Study Discontinuation
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number and Percentage of Subjects Having an Adverse Event (AE)
Any Grade 1 Adverse Event
|
2 Participants
|
6 Participants
|
2 Participants
|
|
Number and Percentage of Subjects Having an Adverse Event (AE)
Any Grade 2 Adverse Event
|
2 Participants
|
4 Participants
|
7 Participants
|
|
Number and Percentage of Subjects Having an Adverse Event (AE)
Any Grade 3 Adverse Event
|
0 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 85 daysAssessment for response was made using data only for the visit of interest (Day 85), without regard for changes at prior on-treatment visits. SRI: SLE Responder Index; SLE: Systemic lupus erythematosus
Outcome measures
| Measure |
Placebo
n=4 Participants
Intravenous (IV) placebo every 3 weeks for a total of 4 doses
|
Brentuximab Vedotin 0.3 mg/kg
n=7 Participants
Intravenous (IV) Brentuximab vedotin (0.3 mg/kg) every 3 weeks for a total of 4 doses
|
Brentuximab Vedotin 0.6 mg/kg
n=7 Participants
Intravenous (IV) Brentuximab vedotin (0.6 mg/kg) every 3 weeks for a total of 4 doses
|
|---|---|---|---|
|
Proportion of Subjects Achieving an SRI Response at Day 85
|
0 Participants
|
1 Participants
|
2 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Brentuximab Vedotin 0.3 mg/kg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Brentuximab Vedotin 0.6 mg/kg
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=4 participants at risk
Intravenous (IV) placebo every 3 weeks for a total of 4 doses
|
Brentuximab Vedotin 0.3 mg/kg
n=8 participants at risk
Intravenous (IV) Brentuximab vedotin (0.3 mg/kg) every 3 weeks for a total of 4 doses
|
Brentuximab Vedotin 0.6 mg/kg
n=8 participants at risk
Intravenous (IV) Brentuximab vedotin (0.6 mg/kg) every 3 weeks for a total of 4 doses
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
Other adverse events
| Measure |
Placebo
n=4 participants at risk
Intravenous (IV) placebo every 3 weeks for a total of 4 doses
|
Brentuximab Vedotin 0.3 mg/kg
n=8 participants at risk
Intravenous (IV) Brentuximab vedotin (0.3 mg/kg) every 3 weeks for a total of 4 doses
|
Brentuximab Vedotin 0.6 mg/kg
n=8 participants at risk
Intravenous (IV) Brentuximab vedotin (0.6 mg/kg) every 3 weeks for a total of 4 doses
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
25.0%
2/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
General disorders
Infusion Site Pain
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
General disorders
Infusion Site Pruritus
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
General disorders
Oedema Peripheral
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
General disorders
Malaise
|
25.0%
1/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Infections and infestations
Fungal Infection
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Infections and infestations
Influenza
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Infections and infestations
Tinea Manum
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Infections and infestations
Tinea Pedis
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Injury, poisoning and procedural complications
Avulsion Fracture
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Injury, poisoning and procedural complications
Tooth Fracture
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
25.0%
1/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
25.0%
1/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Limb Discomfort
|
25.0%
1/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
37.5%
3/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Psychiatric disorders
Mental Status Changes
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Psychiatric disorders
Depression
|
25.0%
1/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.0%
1/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Skin and subcutaneous tissue disorders
Dermal Cyst
|
25.0%
1/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
25.0%
1/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
12.5%
1/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
|
Vascular disorders
Vascular Compression
|
25.0%
1/4 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
0.00%
0/8 • Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor may extend the embargo for a period up to 60 days to allow for the filing of a one or more patent applications. The sponsor cannot require changes to the communication and cannot otherwise extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER